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Top Trends in the Pharmaceutical Industry

Historically, the pharmaceutical industry has been resistant to change and slow to act. But the COVID-19 pandemic pandemic has been a paradigm-shifting event that jump-started the entire healthcare sector and pharmaceutical industry. The century-defining moment forced large and small companies alike to respond with alacrity as they worked to develop COVID-19 vaccines, diagnostics, therapeutics, and new technologies to overcome the virus.

For medical and biotech companies, R&D is accelerated, digitization swept the industry, and workplaces are now remote. Along the way, companies discovered new challenges and bold technological solutions.

But, as we continue to navigate the pandemic, the question remains whether or not the changes will last. Is this the new normal? If so, what does that mean for the future of the industry? Will these changes be enough to address the threats to the pharmaceutical industry?

Today, we’ll discuss the key trends in the pharmaceutical industry going into 2022.

Trend #1

Continued Shifts in Consumer Behavior & Attitudes

Consumer behavior and attitudes underwent major changes in response to the pandemic. And for the majority of healthcare providers (80%), these persona changes are considered the number one issue facing pharmaceutical companies in the future.

While this can encompass a range of attitudes, Deloitte research points at several consumer trends that have only been accelerated by the pandemic, including:

Increased use of digital technology and willingness to share data – Consumers are more willing than ever to use digital tools to monitor their health, order prescriptions, and communicate with healthcare providers. By and large, medical consumers increasingly believe that these tools and trackers can help change behavior for the better.

Interest in and use of telehealth services – The pandemic increased medical consumer adoption of virtual visits. This grew from 15% to 19% between 2019-2020, then jumped to 28% by 2021.

Interest in tools to make decisions about their care or prescriptions – Out-of-pocket American consumers want the ability to price shop and see what other consumers have to say before deciding on care treatment.

In response to shifting consumer attitudes, big pharma companies are rapidly embracing a patient-centric ethos that champions better communication, collaboration, and openness. And this movement isn’t limited to just the relationship between providers and patients but among the entire healthcare ecosystem, including:

Patient advocacy groups
Physicians
Health systems
Health Plans
Regulators
Technology providers
Wellness companies
Trend #2

Digital Solutions to the Forefront

The emergence of new technologies was underway before the pandemic, but the forced shift to remote work and digital solutions fast-tracked this trend. For example, telehealth services – which are both patient-centric and a means of protection for patients and providers alike – gained widespread prominence. Thanks to information and communication technologies (ICT), patients could obtain a prescription or consult a doctor from the safety of their homes.

Despite digital solutions experiencing early adoption, the convenience they offer is the most compelling argument why they will become a lasting feature of the pharmaceutical and healthcare landscapes.

According to researchers at BMC Public Health, telehealth services provide various benefits, particularly in non-emergency and routine care cases, including:

Reduces use of resources in healthcare centers
Improves access to care and caregivers
Minimizes risk of COVID transmission
Provides a convenient and affordable way to perform routine checkups

Telehealth services aren’t the only digital innovation the pharmaceutical industry is turning to drive efficiency and adapt to the shifting landscape. Per PR Wire:

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Companies are using digital platforms to maintain stock of their essential medications and other medical supplies. Automating manufacturing processes and warehouses are playing an important role as the need for increased data availability rises… Digital tools will also enable some key business processes—such as auditing or product release—to be done remotely, potentially decreasing the risk of disruption while improving efficiencies.”

This demonstrates that biopharma companies are more willing than ever to embrace technological tools that help them provide better, more effective therapies. This type of disruptive innovation in pharma will become critical for companies in order to keep up and provide quality solutions. For instance, a growing number of pharmaceutical and medical device companies are now leveraging insights management platforms – such as Within3 – to help identify thought leaders in the life science industry, connect all parties in meaningful discussion and information sharing, and discover actionable takeaways that inform team decision-making.

Trend #3

Cyber Threats are Increasing In Response to Digitalism

Cybersecurity is another leading concern for big pharma leaders.1 This makes sense. A successful cyberattack on a company that produces life-saving drugs, devices, or interventions could potentially interrupt production, which could then put lives in jeopardy.

10% of pharma manufacturers were at high risk of a ransomware attack

In May, Black Kite Cybersecurity evaluated the cybersecurity posture of the 200 top global pharmaceutical companies and 166 of their third-party vendors. Black Kite discovered that 10% of pharma manufacturers were at high risk of a ransomware attack. Other notable findings included:

The average cost of a pharmaceutical cyberattack is $31.1 million.
Medium-sized pharmaceutical companies are most susceptible to a ransomware attack.
12%+ of vendors are likely to incur a ransomware attack.
Nearly half of all pharmaceutical companies have 1,000+ employee credentials leaked.

The embrace of internet of things (IoT) tools within pharma only create further vulnerabilities and exposures that savvy hackers could exploit. And the consequences of a successful attack could be grave, including the potential for stolen IP, lost clinical trials, damaged reputation, litigation, and so on.

 

So, what are the most common cyber threats pharma needs to prepare for? They include:

Malware and ransomware
Third-party vendors
Phishing attacks
IoT breaches
Employee error or negligence

These are just a few of the more common problems the pharma industry faces. When all it takes is a single security breach to jeopardize the success of a company and the health of consumers, it’s vital that pharmaceutical companies prioritize risk mitigation and cybersecurity.

Trend #4

Increased Patient Engagement

Patients want more say at each step of their care journey.

Modern healthcare consumers want greater involvement when it comes to making decisions about their care and pharmaceutical interventions. Put simply, patients want more say at each step of their care journey.

Here, patient engagement is the name of the game. And for life science organizations, that means involving end-consumers in every aspect of development, including trials, drug design, and decision-making processes.

Once more, digital technologies have facilitated this trend. There are now new ways for patients to collaborate with drug and device developers and participate in trials. For instance, virtual trials and remote monitoring make it possible to involve an even greater number of patients in studies.

Trend #5

High-Tech Solutions for R&D

Going forward, digital technology will continue to be intertwined in the R&D process. Innovations in artificial intelligence can help accelerate both drug discovery and drug development pipelines. And machine learning makes it possible to optimize anything from pharmaceutical manufacturing processes to marketing and post-launch strategies.

But what startups and technology trends are set to impact the pharmaceutical industry in 2022 and beyond?

According to the Global Startup Heat Map, the top ten areas of focus for technology companies within R&D include:

Artificial intelligence
Big data & analytics
Flexible production
Precision medicine
Blockchain technology
Additive manufacturing
Extended reality
Real-world data
Digital Therapeutics
Curative therapies

As these technologies continue to evolve and become an even more permanent fixture of the pharmaceutical landscape, industry leaders are expecting massive shakeups on the horizon. From how pharmaceutical companies develop their products to the ways they interact with consumers, digitalism has reshaped the entire life sciences sector.

Trend #6

A Global Marketplace

Thanks to digital technologies, many companies in the pharmaceutical sector are now setting their sights on global expansion.

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According to the Global Pharma and Healthcare Market Forecast:

The market size is projected to reach $1.57 trillion by 2027, up from $1.12 trillion in 2020. Currently, North America controls 50% of the consumption market share. But Asia-Pacific, with its 25% market share, is seen as the most lucrative destination for expansion.

The widespread availability and adoption of modern solutions have made such international growth more possible than ever. What once was a logistics nightmare is now made effortless with the help of digital engagement and collaboration solutions that help companies manage insights across teams and geographies. Teams of researchers can operate from different countries seamlessly. Using insights management platforms like Within3, it becomes easier for organizations to communicate, share information, review data, and engage KOLs or critical stakeholders, no matter where they are based.

 

For pharmaceutical companies that have considered global operations, now’s the perfect time to do so.

Within3

The Digital Solution for a Modern Pharmaceutical Company

COVID-19 has accelerated the digital revolution within the pharmaceutical industry. Going forward, companies must partner with the right technologies or else be left behind.

 

This is where Within3 can be a differentiator in your organization and help you stay atop current trends in the pharmaceutical industry.

 

Our insights management platform means pharmaceutical companies can abandon slow and fragmented insight-gathering methods that rely on manual processes. Network analytics and social listening enable better expert selection, and virtual advisory board meetings or other discussions are more productive, with AI-powered natural language processing to surface key results. From development to delivery, we provide tools that make it possible to collaborate and engage with key stakeholders in a way that drives better business results.

 

How does our solution prepare you for the pharma world of tomorrow? Request a demo today.

Sources

  1. Deloitte. Biopharma leaders prioritize R&D, technological transformation, and global market presence. https://www2.deloitte.com/us/en/insights/industry/life-sciences/pharmaceutical-industry-trends.html/#endnote-5
  2. Deloitte. A Consumer-Centered Future of Health. https://www2.deloitte.com/content/dam/Deloitte/nl/Documents/life-sciences-health-care/deloitte-nl-healthcare-consumer-centered-future-of-health.pdf
  3. NCBI. The role of telehealth during COVID-19 outbreak: a systematic review based on current evidence. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395209/
  4. PR News Wire. Pharmaceutical Drugs Market Players Focus On Digital Solutions To Mitigate Long-Term Risks In Terms Of The COVID-19 Impact https://www.globenewswire.com/news-release/2021/08/18/2282912/0/en/Pharmaceutical-Drugs-Market-Players-Focus-On-Digital-Solutions-To-Mitigate-Long-Term-Risks-In-Terms-Of-The-COVID-19-Impact.html
  5. BlackKite. The 2021 Ransomware Risk Pulse: Pharmaceutical Manufacturing. https://blackkite.com/wp-content/uploads/2021/05/The-2021-Ransomware-Risk-Pulse-_-Pharmaceutical-Manufacturing.pdf
  6. Startus. Top 10 Pharma Industry Trends & Innovations in 2021 https://www.startus-insights.com/innovators-guide/top-10-pharma-industry-trends-innovations-in-2021/
  7. Global News Wire. Global Pharma and Healthcare Market Size 2021 By Emerging Trends. https://www.globenewswire.com/news-release/2021/07/13/2262197/0/en/Global-Pharma-and-Health-Care-Market-Size-2021-By-Emerging-Trends-Industry-Share-Growth-Strategy-Developing-Technologies-Market-Potential-Traders-Regional-Overview-and-Covid-19-Imp.html

A Deep Dive into the Medical Device Development Process

Taking a new medical device from the ideation phase to the finish line isn’t a sprint—it’s a marathon. Device discovery is just the first step of a long and winding road that medtech companies must travel to even have the opportunity to bring their innovative medical product to market.

For that reason, medical device research and development isn’t for the faint of heart. There are several stages of medical device development, from R&D to clinical trial design. Not to mention countless regulatory hurdles at every phase, that winnow out would-be entrants.

But the companies that undergo this gauntlet and emerge relatively unscathed do so with a product that’s been tried, tested, and certified.

So, what does the medical device product development process entail? What are the medical device design components? How long does it take? And what are the challenges medtech companies must prepare for?

Let’s dive in.

01

What Is Medical Device Development?

In the world of digitalism, technology that is widely considered to be the most advanced in its field can rapidly become outmoded in a matter of years, if not months. And the medtech space is no exception.

For that reason, billions of dollars are invested in medical technology development on an annual basis. And, as demand for medical technology innovation rises with each passing year, increasingly more companies enter the space.

Medical device development is the cyclical process of taking an idea for a medtech product and turning that dream into reality.

But, as mentioned, that’s easier said than done.

The companies that actually make it to the product market release stage are in the minority. According to Frontiers in Public Health:1

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There are only a few technologies and resources that penetrate the market. Medical device development (MDD) is expensive and risky…Product development, from conception to release to market, is a very complex process.

It significantly relies on the application of exact processes that enable developers to optimally stage development, testing, validation, verification, and market release.

That said, there are different categories of medical product development that can impact the expected timeline and obstacles. The FDA classifies these products based on the risk they pose. The three classes are:

Class I: General Controls – These pose the lowest amount of risk to patients. Examples include surgical tools, sutures, or masks. These are subject to “general controls,” which consider the following elements:

Good manufacturing practices
Standards and reporting adverse events to FDA
Registration
General recordkeeping requirements

Class II: General Controls with Special Controls – This encompasses most medical devices, which pose a slightly higher risk to patients. Examples include powered wheelchairs, catheters, and syringes. As a result, they are given special controls in addition to the general controls. These include:

Labeling requirements (information that must be included on a product label)
Device-specific mandatory performance standards
Device-specific testing requirements

Class III: General Controls and Premarket Approval – These pose the highest risk to patients. They tend to be devices that are implanted, sustain or support life, or have the potential to cause unreasonable risk of illness or injury. Examples include pacemakers, breast implants, and ventilators. In addition to the controls listed above, class 3 devices must gain premarket approval, wherein medical device manufacturers demonstrate that the device is safe and effective.

02

How To Develop a Medical Device—What Are the Different Design Phases?

When it comes to the product pipeline, the FDA’s quality system regulation (QSR) outlines five stages of processing that every medical product must undergo to reach regulatory approval. The stages are:3

STAGE 1—DEVICE DISCOVERY AND CONCEPT

The inception of most medical devices typically comes from a moment where a researcher sees an unmet need in the medical market. From there, they create a concept for their idea or device that could meet that need, reduce costs, and optimize care delivery.

This is followed by a proof of concept brief that fleshes out the idea and the steps necessary to demonstrate that the product is viable and that there are financial opportunities that justify the exorbitant R&D costs.

As a part of the process, medical researchers need to categorize their product as a class I, II, or III device. How they classify the product will then impact what testing and certification it must undergo.

STAGE 2—PRECLINICAL RESEARCH AND PROTOTYPE

After the idea has met internal approval—i.e., demonstrated to have a market position, viability, and financial feasibility—the product enters phase two.

To begin, researchers produce a medical device prototype that can be safely tested—not on humans—but in a controlled lab setting.

During this stage, researchers begin brainstorming risks and customer or user needs. Here, customer feedback is essential, whether in the form of:

Surveys
Parent and family councils
Focus groups
Competitor analysis

This input can then play a crucial role in optimizing the product’s design, which typically follows an iterative process where each newer model is tested and improved upon previous attempts.

STAGE 3—MARKET APPROVAL

As mentioned, these steps are established by the QMS framework. Therefore, the application process depends heavily on your product. A Class I product will have far fewer regulatory hoops it must jump through when compared to a Class III product.

A design history file (DHF) chronicles the tests and controls the product has passed and also outlines the design and manufacturing steps taken to develop the product to its current state. This document is then subject to FDA audits to confirm that the medical device is safe for the general public.

STAGE 4—FDA DEVICE REVIEW

After DFH and FDA testing is completed, medical device manufacturers must apply for FDA clearance. Typically, they will need to file one of three applications:

Humanitarian device exemption
Premarket notification or 510(k)—Class I, II, and III devices
Premarket approval application—Class III devices

If necessary, the FDA may consult an Advisory Committee about whether or not the product should be granted FDA approval. After this, the FDA decides whether the device is:

Approved
Not approved
Needs further information

The findings are then required by law to be submitted with all supporting evidence into the Federal Register.

STAGE 5—POST-MARKET DEVICE SAFETY MONITORING

Despite all of the testing a medical device undergoes during the previous four stages, it’s still possible that new problems emerge after it hits the market.

Therefore, the FDA monitors the device’s performance and safety even after it has been approved and gone to market. There are three means by which the FDA engages in safety monitoring. They include:

Manufacturer inspections
Reporting programs
Active surveillance
03

How Long Does it Take to Develop a Medical Device?

According to Gail A. Van Norman, MD,4 “Bringing a device to market takes an average of 3 to 7 years, compared with an average of 12 years for drugs.” But, in truth, the answer to expected timelines depends heavily on the device itself, with the utmost factor being its classification.

Put simply, the more regulations a product faces, the longer it will inevitably take to reach the market. So, although it’s not always the case, the rough estimate timeframe by classification looks as follows:

A simple class I device could take as little as 18-24 months
A class II device typically takes 3-6 years
A class III device typically takes 5-9 years
04

What Are the Challenges with Medical Device Development?

There are four primary factors that make medical device development a serious undertaking. Each of these elements can contribute to the length and the cost of the entire process. They include:

Research & Development – R&D is a lengthy and exorbitantly costly process. It requires rigorous clinical trials, studies, and intense collaboration, sometimes on a global scale. Naturally, these preexisting R&D challenges were exacerbated by the pandemic. But this is where virtual work platforms—such as Within3—make it easy to control costs, interact and collaborate from anywhere in the world, and conduct clinical studies.

High costs – EAccording to FDA Impact on US Medical Technology Innovations Survey:5 “The average total cost for participants to bring a 510(k) product from concept to clearance was approximately $31 million, with $24 million spent on FDA dependent and/or related activities. For a Class III Medical device going through a Premarket Approval (PMA), the average total cost from concept to approval was $94 million, with $75 million spent on stages linked to the FDA2.”

Regulations – There are dozens if not hundreds of regulatory requirements even the most simple of medical devices must satisfy. Design control includes:

Design and development planning
Design input
Design output
Design review
Design verification
Design validation
Design transfer
Design changes

Security – Both the physical device, the IP, and the information systems hosting this research are under constant threat of malicious activity—whether by internal or external forces. This data needs to be protected from unauthorized access and use. Therefore, secure software and IT processes must be put in place to ensure the confidentiality, integrity, and availability of information regarding the device’s design and development.

05

How the Medical Device Development Process can Be Improved

Taking medical devices from concept to market may take several years and cost tens of millions of dollars. And even then, due to the complex nature of the process, there’s still a significant chance that the product fails to produce impactful ROI by the time it finally crosses the finish line and reaches the market.

So, how can you change that? How do you increase your odds of producing a viable product, and do so faster and cheaper?

So, how can you change that? How do you increase your odds of producing a viable product, and do so faster and cheaper? Using Within3’s insights management platform, your team can streamline the various phases of medical device development. Our solution is trusted by the world’s top medical device organizations to help them collaborate virtually, manage the insight lifecycle, and perform clinical trials.

Request a demo today.

Sources

  1. 1 Frontiers in Public Health. Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7438805/
  2. 2 FDA. Device Development Process. https://www.fda.gov/patients/device-development-process/step-1-device-discovery-and-concept
  3. 3 FDA. Quality System (QS) Regulation/Medical Device Good Manufacturing Practices. https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices
  4. 4 Science Direct. Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices. https://www.sciencedirect.com/science/article/pii/S2452302X16300183
  5. 5 StarFish. White Paper COst to Develop Medical Devices. https://starfishmedical.com/assets/StarFish-Whitepaper-Cost-to-Develop-Medical-Devices-July-2020.pdf

A Guide to HCP Digital Engagement Strategies

In recent years, there’s been a push toward healthcare consumerism, wherein patients become active participants in their care choices and strategies. Because of this, they now expect a personalized, convenient customer experience – whether that’s in-person or in the digital sphere.

To foster this engagement and make informed purchasing decisions, patient-consumers require more information, decision-making tools, and incentives for making wise choices.

Currently, healthcare professionals (HCPs) are the people that patient-consumers trust the most when it comes to healthcare-related purchasing decisions. For this reason, it’s crucial that pharma reps are able to reach HCPs and engage them in order to collaborate and gain insights. As such, businesses in the pharmaceutical and life science sector that wish to reach these industry influencers must be purposeful in their HCP engagement strategies, especially when it comes to digital.

But what does a well-crafted HCP digital engagement strategy look like? Read on to learn how to strengthen HCP engagement.

01

Responsibilities of HCPs

Healthcare providers play a pivotal role within the healthcare ecosystem, acting as the primary drivers for preventing and managing health conditions. And the term HCP encompasses a range of medical professional roles, namely primary care physicians, nurse practitioners, family practice doctors, and medical specialists. This is why pharma reps seek to engage with HCPs, since they work most closely with consumers and have valuable insights.

From initial contact to ongoing care, HCPs provide a wide array of medical services, including but not limited to:

Health education and guidance
Diagnosis and treatment of chronic and acute illnesses or conditions
Preventative health services
Health promotion

Over the last few decades, there’s been a gradual movement to replace the traditional fee-for-service medical approach with a value-based care model, which helps healthcare professionals transition from a reactive treatment posture to a proactive one. This shift created a new spate of industry challenges for HCPs and pharmaceutical representatives who wish to reach them.

02

Challenges in reaching HCPs

In the past, the vast majority of interaction with HCPs by pharmaceutical and life science companies was conducted on an in person basis rather than through digital channels. Even before COVID-19 struck, the industry already faced some serious hurdles regarding this type of outreach, including:

Difficulty in demonstrating that the value the company offers aligns with the HCP’s needs
Smaller sales forces
A shift from primary care to specialty drugs
Diminishing face-to-face access

Naturally, COVID-19 has completely altered the landscape of the healthcare space, changing how HCPs operate with both their patients and pharma reps or life science liaisons.

The in-person restrictions combined with mounting health concerns made it even harder to market to and interact with HCPs effectively. For pharma companies and pharma marketers especially, this paradigm shift has forced them to reevaluate how they traditionally sold their services, going beyond simply providing product info. In fact, a recent Accenture COVID-19 Healthcare Provider survey revealed these three key findings:

COVID has created lasting changes in what healthcare providers need and value.
Pharma companies are beginning to redefine their relevance within the new landscape.
Virtual engagement and other digital communication strategies are here to stay.
03

The importance of digital engagement in the pharmaceutical industry

Throughout the pandemic, digital solutions bridged the gap between healthcare consumers and HCPs. They helped bring medicine and telehealth services directly to a person’s home.

Now, healthcare providers want even more of that, particularly when it comes to digital interaction. Historically, this is an area where pharma has moved at a snail’s pace to adopt. According to a McKinsey study on digital maturity, pharma lags behind every single industry besides the public sector.

Within this scoring system, one of pharma’s most glaring areas was a consistent lack of customer orientation:

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For pharma, this indicates that companies pay too little attention to the customer decision journeys that patients and healthcare providers undertake to access, interact with, and benefit from their products…Nearly

40 percent of pharma companies admit they do not understand these journeys well enough to map digital touchpoints and align them with their digital strategy.

According to the study, pharma companies who are ahead of the curve have made a concerted effort to base their strategic decisions on how digital can positively impact their business model and are constantly looking to scale up digital initiatives and capabilities.

Companies that wish to be competitive must adapt or fall even further behind. There was a significant (65%+) decrease in interaction frequency between HCPs and pharma reps during the pandemic and the decline in pharma-HCP engagement isn’t expected to recover fully post-pandemic.

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According to another McKinsey study:

28 percent of surveyed physicians indicate that the crisis will have a lasting impact on their willingness to welcome pharma reps for live meetings… US physicians expect a 15 percent reduction in overall interactions, with all of that decline coming from in-person interactions.

When it comes to collaboration and engagement, digital solutions can aid the pharma industry and fix some of the future challenges of working with HCPs.

04

What is HCP engagement?

Today, HCPs prefer to access digital channels to connect with peers and patients, study research updates, and engage with medical and scientific information.

Modern pharma HCP engagement focuses on providing multi-channel tools and solutions to help facilitate health representatives’ conversations with the people that matter the most: doctors, patients, and payers.

By adopting engagement technologies and tools, such as the Within3 engagement platform, life science companies can create value with virtual engagement and revolutionize the way they gather important insights from HCPs.

05

Types of digital tools and channels for HCP engagement

Within3 has made smarter virtual HCP engagement possible. It’s a better way for pharmaceutical, medical device, and other life-science companies to interact and collaborate with HCPs and patients.

As a virtual communications platform, it empowers essential stakeholders to engage in meaningful discussion anywhere, anytime, and from any connected device. The Within3 HCP engagement platform promotes better HCP engagement and more collaborative insights from the pharmaceutical industry in several ways, including:

VIRTUAL ENGAGEMENT PLATFORMS

Traditionally, video conferences have been the way key decision-makers met digitally. But even these are outmoded. Now, you can utilize a virtual advisory board on a virtual engagement platform, such as Within3, that delivers superior insights and engagements. Features include:

Asynchronous discussions – Foster 24/7 discussions that empower both advisors and moderators to engage at their convenience when and where they want.

Moderation tools – A central moderator dashboard gives you a virtual middle ground where all stakeholders can come to engage and participate by:

Checking progress
Sending private messages
Reviewing prompt responses

A singular platform – Within3 was custom-built with flexible HCP engagement in mind. A variety of collaborative tools and smart features make it easier to produce meaningful insights and then leverage those to make better decisions.

STEERING COMMITTEES AND PANELS

Steering committee members need to have an open line of communication that’s accessible around the clock. Now, there’s a better way for stakeholders to organize essential materials, interact with one another, read resources, and provide feedback. HCPs can engage with one another on-demand using tools like:

Resource Center – A centralized resource library helps organize and secure important materials, making it easier for stakeholders to access critical documents when they need them – whether it’s meeting minutes, trial participant responses, or study results.

Virtual meeting management – Conducting studies from a decentralized space can be a massive organizational challenge. Simply arranging a time and a place to meet virtually can waste precious time. But now, it’s possible to schedule, execute, and archive stakeholder meetings from a singular, secure, digital location.

Asynchronous discussions – Give committee members and panelists the freedom to participate in meetings and collaborate in discussions whenever possible. In doing so, HCPs can enjoy accelerated insights and user-friendly engagement.

21ST-CENTURY PUBLICATION DEVELOPMENT

Historically, multi-author publications were slow and laborious. And the need for a constant back-and-forth between all parties becomes even more complicated when the authors are in different locations. Within3 creates a collaborative environment where authors can contribute, engage, and edit manuscripts from wherever they are in the world. Powerful tools include:

Virtual discussions – Conduct outlining and early drafting on manuscripts and studies virtually, so the entire team is on the same page.

Remote editing – Collaborate with co-authors remotely in real-time, making comments and edits on the fly.

Engagement tools – Powerful engagement tools like participation reminders and status updates help revolutionize the way HCPs collaborate and stay on track. This means shorter timelines, fewer logistical headaches, and better engagement.

CLINICAL TRIAL PERFORMANCE

Similarly, clinical trials require participation from a variety of parties – some of whom may be located in different timezones or even countries.

Virtual HCP engagement platforms drive collaboration and communication thus improving study design, training, and trial execution. Features include:

On-demand training – Empower individuals to access training resources when they need them.

Document annotation and co-authoring – Co-create trial design, protocols, and materials, and receive feedback from other key stakeholders.

Engagement tools – Inform and aid all crucial stakeholders – patients, payers, investigators, and site staff – throughout the process to ensure that a trial’s design is optimized and executed as planned.

INTERNAL ENGAGEMENT AND TRAINING

Often, teams must collaborate across the country, if not globally. Because everyone is in different time zones and on different schedules, you require a platform that’s accessible 24/7 and which facilitates internal engagement and training. This is especially important as many companies plan on becoming more intentionally virtual following the COVID pandemic. A virtual engagement platform empowers teams to do this by providing:

Often, teams must collaborate across the country, if not globally. Because everyone is in different time zones and on different schedules, you require a platform that’s accessible 24/7 and which facilitates internal engagement and training. This is especially important as many companies plan on becoming more intentionally virtual following the COVID pandemic. A virtual engagement platform empowers teams to do this by providing:

Training and knowledge assessment – On-demand training allows individuals to access and complete necessary training materials and programs.

Total participation – Asynchronous discussions make it possible for teams to collaborate and work toward a shared goal, engaging with one another around the clock.

06

How to strengthen HCP engagement to improve the pharma industry

COVID-19 has accelerated the transformation that was already underway within the world of healthcare. Now, HCPs want digital solutions that bridge the gap, helping them better engage with patients, colleagues, and pharma representatives.

Today, there are tools, such as Within3’s virtual engagement platform, that make it easier than ever for pharmaceutical, medical device, and other life-science companies to have conversations with the people who matter most.

Want to see more about what the future of digital engagement looks like? Request a demo today.

A Guide to Successful Clinical Trial Design

Prior to the COVID-19 pandemic, the majority of clinical operations, studies, and development were conducted in person. But COVID changed everything, forcing an industry-wide paradigm shift in how clinical trials were conducted and designed.

Now, as we return to a sense of normalcy, experts rightly wonder how the changes in communication strategies, tactics, and tools will impact clinical operations and trial design in the years to come.

With a shift to more virtual clinical trials, what lessons can we apply toward clinical study design? And what novel technologies can further bolster their efficacy and the clarity of the results?

This guide covers everything you need to know about successful clinical trial design in a post-COVID world.

01

Using technology to improve clinical trial design

Whenever developing a new drug, therapy, procedure, or medical intervention, it must undergo rigorous testing before its release. These medical studies, also known as clinical trials, seek to confirm that the study subject of the trials is safe and does what it claims to do.

But knowing whether the objective of the trial is an effective intervention poses a significant challenge. It’s much easier to determine correlation than causation. As a result, for a clinical trial to be meaningful, there needs to be a union between observational studies and experimental studies. You must ensure that any treatment effect is isolated by controlling for potential biases, confounding factors, and by minimizing possible variants.

Clinical trial design can make or break a study

Put simply, clinical study design can make or break a study. It must be designed properly to mitigate or entirely eliminate such factors from confusing the results, or leading to improper conclusions.

02

Why is clinical trial design important?

The process of developing a new drug is complicated, to say the least.

5 in 5,000 drugs in preclinical testing progress to human testing

It can take years and millions of dollars for a drug to go from the lab to the pharmacy. In fact, only five in every 5,000 drugs that enter preclinical testing will ever progress to human testing. And of these, only one will ever actually make it to market.

A properly designed clinical trial can provide strong evidence supporting cause-effect relationships and form the basis for clinical and public health policy. But a poorly designed trial can bury a promising therapy before it ever has a chance to develop.

The vast majority of errors in clinical trials are the result of poor planning and design. As one 2019 study notes:

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Clinical trial design is an important aspect of interventional trials that serves to optimize, ergonomize, and economize the clinical trial conduct…A well-conducted study with a good design based on a robust hypothesis evolved from clinical practice goes a long way in facilitating the implementation of the best tenets of evidence-based practice.

Generally speaking, there are several types of study designs, including:

Meta-analysis
Systemic review
Controlled randomized clinical trial
Cohort study
Case-control study
Cross-sectional study
Case reports and series
Animal research studies

And within each one of these, there are design elements that must be factored into the process.

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What are the key features of clinical trials?

There are many fundamental factors that researchers must weigh as they design a clinical trial, including:

Clearly defining the research question – Every clinical trial design begins with the fundamental clinical research question. Over time, the team must refine it from a vague concept to a testable and quantifiable hypothesis. Only after the question is well understood can a research team begin identifying the intrinsic challenges of the study.

Minimizing variation – The greater variation throughout the trial, the harder it will be to narrow down any treatment effect. Ways to reduce variation include:

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Constructing consistent and uniform endpoint definitions

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Using central labs for quantitating laboratory parameters

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Using standardized parameters in how study participants are treated and evaluated

Promoting randomization and stratification – The more randomization that’s introduced into a trial design, the less chance there is for bias to creep in. And a stratified randomized trial helps ensure that treatment groups or study subjects are balanced regarding potential confounding variables.

Blinding – As one of the most fundamental design elements of any clinical trial, blinding ensures that a study’s participants and researchers are unaware of the assigned intervention, which prevents biases or behavioral changes from muddying the results.

Placebos – Similarly, placebos or sham interventions, help ensure that blinding is maintained, though such design features are typically limited to pharmaceutical interventions and not medical devices.

Selection of the control group – A control group gives researchers important data of what would have occurred had the study’s participants either not been treated or been given a different intervention. There are three types of control groups:

Historical controls
Placebo controls
Active controls

Selection of a population – Researchers have to consider the intended target use for the intervention. A study on a drug that helps men aged 65+ manage their heart pressure would be moot if the tested population consisted of young adult women.

Selection of endpoints – An endpoint is intended to address the main objective of the trial. That means it needs to be, “clinically relevant, interpretable, sensitive to the effects of intervention, practical and affordable to measure, and ideally can be measured in an unbiased manner.” Typically, endpoints fall into one of three categories:

Continuous
Categorical
Event-time

Sample size – Statistically speaking, it’s impossible to draw conclusive results from a sample size that’s too small. Similarly, a sample that’s too large will be difficult to control and costly to conduct. As a result, researchers must calculate a happy medium based on the planned analyses.

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Types of clinical trials

While there are several types of clinical trial designs and clinical studies, it’s helpful to break them down into four broad categories:

Pharmaceutical clinical trials – Every prescription drug on the market must be approved by various regulatory authorities, such as the USFDA. For that, it must undergo rigorous pharmaceutical clinical trials that include an 11-step approval process:

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Animal testing

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Investigational New Drug application

3

Phase I trials

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Phase II trials

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Phase III trials

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Review meeting

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NDA application

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Application reviewal

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Drug labeling

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Facility inspection

For example, for the Pfizer COVID-19 vaccine, more than 43,000 participants underwent a randomized, placebo-controlled, observer, blinded, pivotal efficacy trial. Its primary endpoints were the efficacy of the vaccine against COVID.

Oncology clinical trials – Cancer-related clinical trials are intended to test new ways to:

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Treat cancer

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Improve clinical oncology

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Find and diagnose cancer

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Prevent cancer

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Manage symptoms of cancer and side effects of treatment

For these types of studies, the clinical study is often the last step in a multi-year process that began years earlier with lab research. But that’s not always the case. For instance, in 2020, the National Cancer Institute conducted an observational cohort study to help researchers determine how COVID impacted the outcomes of patients undergoing cancer treatment and how having cancer affects COVID.

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Disease-specific complexities

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Shared challenges with similar disorders or rare diseases

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Difficulty in selecting a large enough sample size

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According to an article published in the Journal of Child Neurology:

The randomized controlled trial is often considered the gold standard for establishing efficacy in a research setting. This design minimizes selection bias and distributes confounders, known and unknown, between study groups.

Medical device clinical trials – Medical devices go through a different approval process than a drug study. Typically, it starts with a small pilot study, followed by a larger pivotal trial. If successful, the manufacturer can then submit the device for FDA approval. From there, manufacturers often choose to also conduct post-marketing trials.

A recent medical device trial was conducted on an epinephrine auto-injector for patients with Anaphylaxis. This randomized, cross-over, unicentric trial was intended to evaluate the following:

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Primary outcome measures Patient satisfaction after three months of use through a questionnaire.

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Secondary outcome measures Adverse events related to the medical device and patient adherence to the medical device.

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How to design a clinical trial

Wondering how to design a clinical trial that is effective and actionable?

Form a testable hypothesis – Remember, the entire process begins with clearly defining your research question in terms of clinical interest. In doing so, you can logically identify the appropriate study design and the necessary components to test your question.

Recruit the right patients and associated professionals – A robust study requires engagement from a diverse group of stakeholders, including researchers, regulators, doctors, scientists, execs, sponsors, and patients.

Design the study – At this stage, communication and collaboration are critical. There needs to be an easy way for patients and investigators to participate and provide feedback. Here, engagement technologies can help optimize study design and engage all crucial stakeholders in the process.

Plan the phases – Typically, a clinical trial will need to undergo four primary phases, including:

Phase I A small group of healthy volunteers assesses the safety, effects, and side effects of a drug.

Phase II Randomized trials allow you to study the drug’s efficacy in terms of safety and effectiveness.

Phase III A much larger randomized and blind testing study will be conducted on a few hundred or several thousand patients. This provides a larger sample size, creating a much greater data pool to measure its benefits, effectiveness, or adverse reactions.

Phase IV Post-marketing trials are used to compare the effectiveness of the drug with other competitors and gauge its long-term safety and efficacy.

Set a budget and milestones – For a lengthy trial to be effective, you must regularly monitor your costs and measure your performance. This allows you to make improvements as you go instead of after the trials. It also creates accountability between all stakeholders.

Test the design – Before trials begin, perform an environmental scan to check for unanticipated factors or events that could throw off the trial or poke holes in the results.

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The biggest challenges in clinical trials & how to avoid them

Designing a clinical trial that is effective throughout all phases can be a herculean task, but it’s critical if you wish to bring your drug, therapeutic, or medical device to market. While there are several factors that add to the difficulty, some of the most significant challenges include:

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Complexity of trials

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Time constraints

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Financial demands

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A lack of communication

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Slow recruitment

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Increasing complexity of regulations and compliance standards

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Data collection hurdles

And such issues were only exacerbated during the COVID-19 Pandemic.

As the Lancet notes,

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The COVID-19 pandemic has not only re-emphasized the importance of well-designed randomized clinical trials but also highlighted the need for large-scale clinical trials structured according to a master protocol in a coordinated and collaborative manner.

So, how do you avoid or address these common issues?

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Using technology to improve clinical trial design

Here is yet another place where, increasingly, technology is filling the gap—especially in response to COVID restrictions and limitations.

For instance, shifting a virtual advisory board or other type of interaction to a virtual engagement platform like Within3, allows for seamless communication, coordination, and collaboration, which helps sites, patients, and payers optimize a study’s design and then execute that vision. It allows for on-demand training, makes it possible to design trial protocols and materials then receive instant feedback, and keeps all critical stakeholders engaged.

By using the platform, you can streamline the entire clinical trial design process. This results in improved trial execution, smarter decisions, and fewer logistical headaches.

Want to see how modern engagement technology can improve your clinical trial designs? Read our case study to learn more.

Sources

  1. Medicine Net. Drug Approvals - From Invention to Market … A 12- Year Trip. https://www.medicinenet.com/script/main/art.asp?articlekey=9877
  2. NCBI. Clinical Trial Designs. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6434767/
  3. NCBI. Fundamentals of Clinical Trial Design. https://www.fda.gov/media/82381/download
  4. FDA. Drug Approval Process. https://www.fda.gov/media/82381/download
  5. New England Journal of Medicine. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. https://www.nejm.org/doi/full/10.1056/nejmoa2034577
  6. NIH. What are Clinical Trials? https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials
  7. NCI. Clinical Trials, NCI COVID-19 in Cancer Patients, NCCAPS Study. https://clinicaltrials.gov/ct2/show/NCT04387656
  8. NCBI. Clinical Trials in Rare Disease: Challenges and Opportunities. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3964003/
  9. NIH. Clinical Tirals.Gov. Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device. https://clinicaltrials.gov/ct2/show/NCT02854969?term=medical+device&draw=2&rank=5
  10. The Lancet. How COVID-19 Has Fundamentally Changed Clinical Research. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(20)30542-8/fulltext