Overcoming Clinical Trial Patient Recruitment and Retention Challenges
Henryette Schatt, Ph.D., YPrime
Clinical trial patients face more burdens today than ever before, but calculated, compassionate use of technology can ease participation for patients and their families, improving study recruitment and retention.
Patient recruitment and retention in clinical trials is a perpetual challenge in the life sciences industry. The onset of the COVID-19 pandemic has only added to that difficulty. Additionally, the introduction of increasing amounts of technology into trials — from eDiaries and additional measurements during visits to wearables and connected devices — has been a double-edged sword. Used properly, these technologies can minimise patient burden and help participants to feel valued; misapplied, they complicate trial participation or increase patient burdens.
To achieve a more patient-centric approach in both traditionally conducted trials and those implementing different technologies, it is useful to examine the burden on each patient continuously throughout the trial. Due diligence also demands scrutiny of the pros and cons of technology implementation (i.e., where, when, and how it is used). Finally, trial participants benefit from sponsors that examine and execute strategies to help patients feel more valued, better informed, actively engaged in their treatment, and more comfortable with participation overall.
Understanding Patient Burdens
One out of 10 (11%) investigative sites, on average, do not recruit any patientsi, adding to the time it takes for the remaining sites to accrue the number of participants required for a given study. This practice prolongs studies and, by extension, delays the associated therapy’s time to market.
Patient advocacy groups have identified increasing study complexity, placing more burden on participants, as one reason patients shun or leave studies (Fig. 1).ii Ubiquitous technology use is partially to blame: researchers empowered with data collection technology can slip into a mindset of “we have the patient here anyway,” leading them to collect data beyond what is needed for the study (e.g., track patient activity against some variable or assign additional questionnaires).
The arrival of digital endpoints in clinical trials did not ease the burden. A review of implementation methodology and outcome measures looked at 76 COPD studies utilising sensors to track activity.iii Because of the many different placement locations, different periods of wear, and the data management rules applied, more than 80 endpoints were reported. None of the endpoints were used twice, meaning there is no comparability, and it is difficult to use the data in a meaningful way.
Patients feel that added burden — they want to be “good” participants, bringing value and providing useful data, but that desire is difficult to sate when they cannot see the reason for the request. Accordingly, it is vital to ask patients directly, up front, what they are comfortable with and what they want to bring to the study. Study design must plan beyond what is scientifically possible within a study protocol to how the data may be used afterward.
Another impediment to patient recruitment and retention is therapeutic areas becoming more granular within each indication. For example, a study no longer just looks at solid tumours: it may examine different kinds of solid tumours, as well as the genetic profile of each patient having this type of tumour. This focused approach reduces the number of patients eligible for a given study, making patient recruitment harder and amplifying the importance of a high patient retention rate.
Site visits comprise one of the greatest challenges faced by patients. Study participants often have to travel a long way to reach the site and virtual visits are not always a viable solution, either because of the nature of the study, or because patients want in-person engagement and care from their physician. Again, an up-front conversation with patients can help determine the balance of on-site versus virtual visits (if the latter is an option).
When patients come to a study site, the visit often is a long day: they fill in questionnaires and may endure numerous procedures, from blood draws to physician examinations. When these days are planned, it can be easy to forget how ill the patients are. A healthy person might accomplish these tasks in an hour or two and then go home and feel fine. But, for patients afflicted by any number of conditions, each on-site visit is a gauntlet and, on top of the travel, it is exhausting.
To improve retention, what we ask of patients at the site should be re-examined. Clinical trial practises do not occur in a vacuum. Patient communities and advocacy groups pay attention to, and exchange information about, which studies treat patients with compassion and communicate well. That networking can make or break recruitment and retention.
It also warrants mention that, in many clinics, processes related to COVID-19 safety have added patient burdens. For example, limited contact between persons has a significant impact because it reduces patients’ personal interactions with their physicians. Distancing and limited contact also can impose restrictions on how many people are allowed into a hospital or a site, or patients can’t take their caregiver to the waiting area, which may leave the patient feeling alone and vulnerable.
How eCOA Can Serve Patients and Sponsors
The introduction of technology — be it eDiaries, wearables, or other connected devices — is not a panacea. Sponsor-distributed devices or apps on patient devices (i.e., bring-your-own-device, or BYOD) only make sense when they can support the patient by shortening/simplifying their site visits, providing useful information in proper context, or otherwise lessening their burdens.
Patient health literacy is continuously improving. They want more information about their participation, its value, and how the data collected is meaningful for their treatment. They also want more in-depth explanations and to have their concerns taken seriously: the patient who believes everything the doctor says, without question, is an endangered species. While that attitude may linger amongst some elderly patients, younger individuals are much more likely to challenge whatever the doctor tells them.
Thus, supporting the patient with information and helpful technology aids them in being a trial participant, helping them to feel more involved, providing clarity on the value they contribute, and giving transparency on their disease state. For example, a tremor assessment for a Parkinson’s disease patient can be very subjective, making it difficult to gauge disease progression. However, electronic data recorded daily can be used to create a curve, which a physician can share with the patient, based on meaningful data that is easy to interpret. This evidence also reinforces to the patient that the physician is being honest with them.
Another example of well-leveraged technology is a multi-function eDiary. In addition to recording and relaying patient data, such a device can be used to advise and support. It could be programmed to send reminders for upcoming visits, or to detail documentation the patient needs to bring, providing clarity on their responsibilities and tasks. Such a resource also provides patients with access to scientifically sound data relevant to their condition (a lot of data is available online, but it’s hard to know what is accurate, so access to verified information benefits study participants).
Such technology also can be used to share feedback with patients regarding their personal compliance, or to celebrate small wins throughout the study. For example, at the end of each week, the patient could be sent a message like, “You’ve completed nine out of 10 questionnaires this week. Two weeks to go — you are doing wonderfully!” Such a message can be encouraging and inform patients of the study’s overall progress.
Sponsors must consider the burden on patients’ families and how it might be alleviated, through technology or otherwise. Even if the family will not be taking the patient to site visits, they are always part of the patient’s life and giving them something that helps them support the patient is beneficial to all. For example, sponsors could share study or treatment information with family members/caregivers or create a video that helps patients explain their condition or the treatment to their children.
Paediatric trials are another area that stands to benefit greatly from the introduction of technology. Just as a video or gamification can be fruitful when explaining a condition to a patient’s young family members, it can help paediatric patients feel more comfortable, actively involved, and informed during clinical trials. Gamification can be used to contextualise information, making it easier for paediatric patients to understand their treatments or tasks associated with their participation, reducing fear and anxiety. Even something as simple as phrasing questions a different way can be helpful if patient needs are examined thoroughly during study design. For example, the training program on a study device might ask, “On a scale of one to 10, how much do you like chocolate?” That way, if a study questionnaire asks the patient to rate their pain on a 1-to-10 scale, they understand the question.
The conversation around data-sharing remains a heated one, based on fears of unblinding the study or otherwise compromising its results. Examining which information is sharable can help show all patients they are valuable, make them feel like active participants in their care, and encourage their continued trial participation. Even telling a patient, “We have 20 patients in the study; thank you for being one of them,” gives the participant some context and understanding of the study without being problematic.
Finally, offering patients a way to network with other patients, suffering from the same disease or experiencing the same feelings, can be a powerful recruitment and retention tool. Sometimes, because sponsors do not want to impact the outcome of a clinical trial, it is not possible during the trial to connect patients with one another. But, the possibility remains that sponsors could help patients to network following the study, allowing them to share what they are experiencing, tips around what helps them feel better in day-to-day life, etc.
Prioritise Patient-Centricity Before, During, and After a Trial
A vast amount of information must be communicated to patients in advance of a trial to help them in being compliant and successfully submitting their data. Often, site representatives do not have sufficient time to properly sit down with patients and walk them through all of this information, clarifying and contextualising it.
Therefore, study participants are left with lots of information but little guidance on what is important or what requires action. Such an information gap also can lead to patients signing documentation without really understanding it. Again, this is an area where technology can provide benefits: perhaps an animation or video depicting a typical day of trial participation, so patients know what to expect, but in a more effective way than a written description.
More and more sponsors reach out to patient advocacy groups when they are planning a study, seeking collaboration. They may ask some patients to experience a mock day in the trial to provide feedback on a typical visit. This provides additional data to keep in mind when designing the trial.
As noted above, patients like to feel part of a community while the study is ongoing. If they are connected to other trial participants or they can get some kind of information (blinded, if need be), it can be a powerful tool to mitigate feelings of isolation.
It is vital to follow up with patients after the trial. Historically, patients complete or leave a trial and they never hear from anyone about its findings or their peers who participated. That practise has to change: it often is the reason patients do not participate in subsequent trials, because they saw no return and the value of their participation was not communicated. This continuum of information — spanning pre-trial through post-trial — is vital to patient recruitment and retention.
The thoughtful implementation of technology in a clinical trial can serve each of these goals. It can aid patients and their families, plus contribute to more accurate data collection, more efficient study management, and faster time-to-market for the drug being studied.
Learn more about YPrime’s eCOA platform https://www.yprime.com/ecoa-platform/.
I. Lamberti, M. J., and Getz, K. Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development. Tufts Center for the Study of Drug Development. Tufts University. 2015. https://static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5aa3006371c10b74be71ec8e/1520631908682/CSSD_PhRMAWhitePaperNEWEST2.pdf
II. Rising Protocol Complexity is Hindering Study Performance, Cost, and Efficiency. Tufts Center for the Study of Drug Development. Tufts University. 2018.
III. Byrom, B., and Rowe, D. A. Measuring free-living physical activity in COPD patients: Deriving methodology standards for clinical trials through a review of research studies. Contemporary Clinical Trials. 2016 Mar;47:172-84. doi: 10.1016/j.cct.2016.01.006. Epub 2016 Jan 19. https://pubmed.ncbi.nlm.nih.gov/26806669/
About The Author
Dr. Henryette Schatt is a trained life sciences professional with a Ph.D. in Computational Chemistry from the University of Erlangen-Nuremberg. Since 2000, she has worked closely with research and development departments from various pharmaceutical companies. For the last seven years, she has focused on eClincal solutions, supporting sponsors in finding the right eCOA solution for their clinical studies. She strongly believes the use of technology can shorten drug development timelines, bringing new medications to those in need more quickly. She is a follower of the #NoGoingBack movement in life sciences. Henryette joined YPrime in 2021 as Senior eCOA Consultant.
YPrime solutions simplify clinical trial management. We build our technology on the latest platforms, holding ourselves to the highest quality measures. From designers and developers to managers and support techs, our seasoned team works with one goal in mind: ensuring an optimal experience for sponsors, sites, and patients.