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December 23, 2020

What are virtual clinical trials?

A global pandemic disrupted countless clinical trials. What did pharma teams learn?
virtual clinical trials

Before the pandemic, life science clinical trial development teams largely depended on in-person investigator meetings and patient visits. With in-person interaction, a range of time-consuming factors – including scheduling problems between study participants, patient availability, and expected long drug development cycles – all contribute to the years-long journey of clinical trials toward their endpoints. And virtual clinical trials were still a nascent idea that offered promise but did not enjoy widespread acceptance.

Clinical trials already present serious and complicated challenges. Adding a global pandemic into the mix increased the complexity and the sense of urgency.

The calamity drastically disrupted the fragile timelines of trials. Thousands of trials – about 80% of non-COVID studies – were stopped or interrupted worldwide.  According to Deloitte, approximately 6,000 clinical trials were underway in early 2020, just as COVID-19 restrictions took effect. Data collection suffered accordingly, and trials for critical therapies were indefinitely delayed or even abandoned.

The challenges of clinical trials won’t disappear as the pandemic becomes a part of normal life. However, their nature will surely evolve along with technology – and hopefully, become more manageable. Virtual clinical trials (also known as decentralized clinical trials, remote clinical trials, or siteless trials) are a significant tool in transforming studies into more efficient and productive processes than ever before, with beneficial impacts on patient recruitment in clinical trials and strengthening patient engagement in clinical trials.

The future of virtual clinical trials

In many ways, virtual engagement had already changed the clinical trial process prior to the pandemic. Patient-facing technologies integrate digital health tools such as mobile devices and apps, monitoring devices, and social engagement platforms. Yet clinical teams need more than video conferencing platforms and instant messaging to ensure safe and successful studies. At every drug and device development phase, they must enable viable, virtual engagement with HCPs, investigators, patients, and other trial stakeholders.

Toward this overall goal, life science teams learned to rethink meeting structure, evolving from large-format live meetings to asynchronous communication with on-demand webcast elements. The change allowed work to continue, and teams began to see that virtual engagement could serve life science companies more than a crisis-induced stopgap.

In a relatively short time, the virtual trial landscape advanced quickly. New technology is available, and legacy solutions focused on a single type of technology must evolve or offer new capabilities. Now, the focus is on end-to-end solutions that further streamline operations across the clinical trial value chain.

Virtual clinical trials save time for all participants

Within3’s virtual engagement platform enables asynchronous meetings – sessions like virtual advisory boards that take place over a prescribed period (usually a week to ten days or as long as needed). This translates into fewer scheduled one-off meetings and more productive time spent in fluid sessions with more trial participants able to chime in. Stakeholders can log in when they choose, free from the distractions of what may be inconvenient times so they can more fully engage. Patients are also mostly relieved of the burden of traveling to investigation sites. Who benefits from virtual clinical trials?

Patients

Patients stand to benefit from virtual clinical trials in a number of ways. Engaging virtually during the course of a trial frees patients from concerns about scheduling, transit, work and family time interruptions, and other factors that may lead them to discontinue participation in a study. Because recruitment and enrollment are two of the biggest obstacles to the success of a clinical trial, maintaining participation allows trial sponsors to complete more trials and bring more treatments to market.

Patients also benefit from virtual trial participation when they are involved in the process early on, from engagements that optimize clinical trial design through activities like a rare disease advisory board where patients can contribute insight about their lived experiences.

Investigators

Investigators are typically pressed for time – as busy HCPs, they must achieve a balance between day-to-day duties and trial activities. Providing virtual venues to gauge their satisfaction, provide training, or gather input can result in a better overall experience.

Trial sponsors

When pharma teams can progress through the phases of a clinical trial with fewer enrollment issues, higher investigator satisfaction, and more complete data, they achieve better results with fewer amendments and setbacks.

Consumers

Successful clinical trials result in more safe, effective treatments for diseases.

More efficient patient recruitment means more patients

Recruitment of patients and enrollment problems are primary factors in clinical trial delays. With digital, web-based recruitment through search engines and social media, teams move faster and have a broader geographic reach, a benefit for teams exploring how to increase enrollment in clinical trials. Reaching more patients in various locations also helps expand diversity in clinical trials – a long-term goal of clinical teams across the life science industry that results in more effective treatments.

In-person requirements at an investigation site can be a difficult travel prospect for many patients – particularly the elderly, financially struggling, and those with disability and mobility issues. A digital platform can permit more patients access to the trial process. For some, virtual clinical trials will be available in their homes, where they can use their own devices.

Certainly, digital technology can only go so far with clinical trials that need the ongoing presence of some patients. But life science companies can work with patient advocacy groups to fill in the gaps by reaching out to help find virtual solutions for more potential participants.

A good virtual engagement platform expands the conversation

A virtual engagement platform like Within3 uses asynchronous meetings so clinical teams can increase accessibility for busy KOLs and patients who have travel concerns. Bringing people together at a virtual conference table over several days creates a more comfortable platform for real communication. Junior HCPs can forthrightly share relevant experiences without deferring to established senior (or more loquacious) colleagues. More study participants feel comfortable contributing at length, leading to better data collection and increased actionable information.

In this kind of virtual setting, the clinical trial process can now include more holistic feedback to inform patient treatment and education, better trial design, and HCPs who are better informed about how different patients may experience their condition.

What are the benefits of virtual clinical trials?

Beyond offering more convenience for physicians, patients, and other stakeholders, virtual clinical trials provide a number of other benefits for clinical teams:

  1. Deeper, more actionable insights. Without scheduling challenges or logistical concerns, many Within3 clients achieve 100% trial participation in their over-time sessions, resulting in more valuable decision-making data and a more holistic view of critical issues.
  2. Emphasis on patient-centricity. Pharmaceutical and medical device organizations increasingly adopt patient-centered approaches and strengthen relationships with advocacy groups, clinicians, and health plans. By making it easier to engage patients without requiring travel and in a way that protects and ensures their privacy, life science organizations can be true to their patient-centric goals and harness a valuable insight stream.
  3. More diverse perspectives. Asynchronous engagement adds many seats to any team’s virtual conference table and provides an opportunity for all trial participants to contribute equally. In face-to-face settings, a few dominant voices can control the discussion or shut out contributions from rising stars or naturally reticent people. By providing equal time to all, clinical teams receive more holistic input for more informed decision-making.
  4. Thinking outside the budget. With significantly reduced hours for honoraria, asynchronous engagement allows teams to reallocate funds tagged for a single event to be used in multiple over-time events, reaching more patients, payers, and HCPs.

One-on-one engagement is still, for many, the ideal and, in some cases, remains absolutely essential. The virtual clinical trial model offers virtual engagement options that can expand the reach and productivity of clinical studies while simplifying them simultaneously. To learn more about how clinical teams adopt virtual engagement, download our white paper.

 

Sources
The Lancet. Covid-19 and readjusting clinical trials. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31787-6/fulltext
National Library of Medicine. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. https://www.ncbi.nlm.nih.gov/books/NBK548981/
Deloitte. What is the future of virtual clinical trials? https://www2.deloitte.com/us/en/blog/health-care-blog/2022/what-is-the-future-of-virtual-clinical-trials.html
Clinical Trials Arena. The evolving landscape of decentralised/virtual clinical trials. https://www.clinicaltrialsarena.com/analyst-comment/evolving-landscape-virtual-clinical-trials/

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