In the world of medical R&D, there’s a growing consensus that patient engagement in clinical trials provides myriad benefits for patients and researchers alike. When patients are fully engaged and integrated into the drug development process, it leads to better outcomes and more reliable results. But there are barriers to improving the process, including defaulting to old ways of thinking and resistance to new technology.
Increasingly, pharma teams know they can design more successful trials with fewer costly protocol amendments by engaging patients much earlier in the process. Traditionally, trial teams listen to patients after studies are designed – but there’s ample evidence that it’s good business to include patients along every step of the way.
How can you improve patient engagement in clinical trials? Here’s what you need to know.
Engagement starts with awareness
More virtual clinical trials and R&D research are being conducted with each passing year. And every one of these endeavors requires patients or participants to engage in complex and rigorous testing.
Currently, there are more ongoing trials than there are volunteers, with the former are outpacing the latter. This shortage of clinical trial participants inevitably leads to delays and cancellations. In fact, patient recruitment in clinical trials and patient retention are the primary reasons a clinical trial shuts down. Per researchers from the Indian Society for Clinical Research: “55% of trials were terminated due to the single highest reason of low accrual rate. The average enrollment efficiency is also reported to be <40% for Phase III and IV trials. Globally, more than 80% of trials fail to enroll on time resulting in an extension of study and or addition of new study sites.”
But for companies wondering how to increase enrollment in clinical trials, this lack of participation isn’t because people don’t want to be a part of clinical trials. They do. It’s just that most don’t even know that the trials are happening in the first place. Put simply, clinical trial awareness is essential.
According to the NIH, approximately 85% of patients were unaware that clinical trials existed, let alone that they could participate in them. Of those, 75% of the patients said they would have been willing to enroll in a trial had they known about it.
For the people who have participated in a trial, more than 77% said they found out about the trial from their healthcare provider. And of those, 32% said that their provider went out of their way to introduce and then explain the trial’s details.
These numbers demonstrate that healthcare providers are the key to increasing patient clinical trial participation.
Wondering how to increase enrollment in clinical trials and get better participants?
First, you must work closely with healthcare providers to raise awareness by promoting your clinical trial and enlisting interested parties. And the choice to take part in a clinical trial should be included in the conversation about their treatment options. Similarly, encourage current participants to be advocates by spreading the word with friends and family in person and on social media.
Involve patients in your trial design
Drug development teams often underestimate the power of the patient voice in clinical trials. In fact, you may not even consider trial participants until clinical trial development is underway. But you can do more to include patient voices all along the path to commercialization – and increasingly, consumers and industry stakeholders alike expect a commitment to patient centricity in trial design and execution. As clinical teams evolve their traditional operational models, teams might try new approaches, including:
- Engaging with patients to get their feedback on a proposed trial protocol
- Set up a virtual resource center or community where patients can find the information they need or ask questions of experts
- Involving patients in the development of trial websites or educational materials
You can increase patient trial retention and efficacy by including their voice from the outset and considering obstacles patients face in the real world. Instead of designing a trial and then recruiting volunteers, you should engage patients first to create the most effective trial possible. They could provide invaluable feedback and insights about how to tweak and optimize the process across various touchpoints. For example, as Clinical Leader notes:
“Pharmacokinetic (PK) blood draws are collected at 2, 4, 8, and 12 hours post-infusion. A blood draw is not a big deal for most patients, but when there is a stringent schedule that needs to be adhered to, it can be an inconvenience for patients, especially those who have to travel far for the appointment. What will the patient do in between draws? Do they have to stay at the hospital all day? Are they able to attend to other responsibilities planned for that day?”
How can you include patients in the clinical trial design?
Most healthcare providers who heed their opinions will use some combination of surveys and outreach to a patient advocacy group and community. Other new approaches might include video calling patients individually or in groups via teleconference. In doing so, you can ask questions like:
- What is your daily life like with the condition?
- What are the barriers you face?
- What barriers do you see with a trial?
- What benefits do you hope to receive from participation?
By receiving feedback, you can avoid mistakes that might otherwise dissuade patients from volunteering or cause them to drop out of the trial midway through. By making them active participants in their healthcare provision, you also incentivize patients to be enthusiastic and engaged throughout the entire care journey.
Be clear about what the trial entails
After creating the clinical trial design with the patient voice in mind, you need to facilitate robust communication with healthcare providers and would-be volunteers.
Remember, awareness is essential. But it’s only the first step of successful engagement.
To recruit and (importantly) retain clinical trial participants, patients must have a clear picture of the journey. In most cases, clinical trials can consume weeks, if not months of their life. In some capacity, the patients must sacrifice their time – be transparent about how much upfront.
At this stage, building trust is incredibly important. Patients need to know exactly what to expect before they sign up. Surprising them after the fact is one of the quickest ways to increase dropouts.
Patients must be convinced that their sacrifice to participate in the trial will be worth it; after everything is said and done, it will be beneficial – whether for themselves or others. Therefore, it’s essential that you walk them through the clinical journey throughout the entire process so that they know what to expect.
When you do this, be sure to use clear and concise language in a way that:
- Addresses patients needs and concerns
- Outlines the purposes of the clinical study
- Discusses the tangible benefits to participants
- Details the risks and commitments
Eliminate or mitigate common clinical trial participation burdens
Several barriers and burdens might prevent many would-be trial participants from signing up. These include:
Socioeconomic – Trial participation is often costly both in terms of time and dollars. Just consider some of the costs, including:
- Taking time off from work
- Hiring childcare
- Traveling to and from the trial
Geographic – Many patients don’t have clinical trials occurring at their local treatment center. Therefore, they have to travel significant distances to participate. And that time and gas cost can quickly add up if trials take place daily.
Educational – Lack of awareness about the option to participate and everything that entails can often prevent patients who would otherwise be interested from volunteering.
Diversity – Opening up trials to a wider array of participants, while also reducing the barriers above, help increase diversity in clinical trials. This, in turn, contributes to a more robust and comprehensive study that has been successfully tested on a variety of people from all walks of life.
How can you address these barriers to entry?
Here, technology platforms such as Within3 can help decentralize trials, thus reducing many of the burdens that participants may consider impediments. Using digital tools to support remote clinical trials or limited in-person participation increases accessibility, thus improving engagement.
Armed with telehealth and IoT devices, it becomes much easier for patients to participate in studies, communicate with key stakeholders, perform tests – all from the comfort of their homes.
Clear communication with patients
From beginning to end, maintaining an open channel of dialogue with patients is a fundamental aspect of the engagement. And this is especially true, seeing as COVID has accelerated the adoption of a decentralized model that limits face-to-face interactions. Effective communication is paramount to ensure both a successful trial and a positive patient experience in this digital world.
Patients who are confused about the clinical trial journey are more likely to drop out. That lack of clear communication can delay, if not entirely derail, your efforts. Participants must be engaged with clear and concise explanations from onboarding to conducting trials and sharing results. They also need to have any questions or qualms addressed.
Ways you can embrace a model of clear communication include:
- Using a technology platform like Within3 to facilitate dialogue and disseminate key information
- Being detailed and specific
- Minimizing clinical jargon
- Explaining things in simple-to-understand terms
- Reinforcing critical messages through repetition
- Confirming that patients absorbed the main takeaways
In the real world: successful patient engagement
When a leading pharma company wanted to optimize the protocol for an upcoming phase II study, they considered both patient and investigator input. Key to the study’s success would be assessing logistical considerations for patients and confirming the trial’s primary and secondary endpoints.
To ensure both patients and investigators would have the opportunity to provide input, the pharma company used its insights management platform to set up two asynchronous engagement sessions. First, the team conducted an anonymous patient session to gather feedback about the proposed trial protocol. They asked the patients questions about their symptoms and willingness to visit clinic sites. After the patients could provide input, the team engaged investigators. In this session, investigators considered patient input and responded to questions about protocol specifics that might present barriers to participation.
By using patient input to inform the investigator session, the pharma team optimized the study design with updated recruitment considerations.
Within3 – Engaging clinical trial patients
Patient engagement is a vital component of any successful trial. When patients feel valued and are invested in the process, you increase retention rates and transform them into clinical trial ambassadors.
But in today’s world, engaging and communicating with trial participants can be tricky without the right technology.
Here is where Within3 can help you improve clinical trial recruitment and design more successful trials.
Our insights management platform makes it simple for patients and investigators to:
- Offer feedback on a study’s trial design
- Better understanding of logistical issues patients may face
- Optimize patient recruitment processes
- Validate primary and secondary endpoints
Request a demo to learn how Within3 can help improve patient engagement in clinical trials.