Overcoming Study-Patient Burdens in Medical Research
Study-patient recruitment and retention continue to be significant challenges in medical research. According to a Tufts Center for the Study of Drug Development report, 48% of study sites miss their enrollment targets, and 11% fail to enroll a single patient. This results in the need for study sponsors to nearly double study timelines to meet recruitment goals. In addition, 1/3 of studies do not receive recruitment support, leaving individual study sites to allocate valuable time and resources to participant recruitment. All told, 80% of studies are delayed due to patient recruitment issues. Aside from patient recruitment challenges, clinical trials have increasing drop-out and lost-to-follow-up rates. The industry expectation is to plan for approximately a 30% drop-out rate; however, trial adherence rates can average 43%-78% in patients with chronic conditions.
As an industry, we can do better. Delays in patient recruitment and retention have significant down-stream consequences to drug development and therapeutic interventions that compound throughout all phases of research. Not only do these delays increase the cost of drug development, but they also delay the discovery and delivery of life-changing therapies to the patients who need them most.
Historically, medical research has relied on patients recognizing their value of contributing to research. We have expected them to share in our deep-seated value of “feeling good” for advancing science and helping their fellow humans on a similar disease-specific journey. However, this intrinsic value only carries so much weight when placed against work-time lost for study visits, long-term commitments toward lengthy trials, travel difficulties to study sites, lengthy study visits, and perceived study invasiveness. Clinical professionals feel potential study participants may not be experiencing adequate personal benefits enticing them to clinical research. Although study-patients do benefit from the possibility of receiving experimental treatments, many research studies are observational or translational and don’t offer that advantage.
The study-patient burden is the main deterrent to the recruitment and retention issue. In traditional research models, study participants find out about a qualifying study from their healthcare provider. They travel to a medical facility/study-site for screening, baseline, monitoring, and follow-up visits – depending on the study design. However, this model increases the burden on study participants and their caregivers, such as work-time loss, study site visits outside typical physician visits, transportation issues, use of paid-time-off hours, overcoming mobility/disability limitations, inconvenient study-visit timing, and inability to commit to repeat visits. Participation in a research study can also be a financial burden as study compensation and remuneration may not adequately cover financial loss (e.g., lost wages) to participate.
Moreover, the traditional research design of using a study center, may inherently bias trials against less ambulatory participants, those with greater debilitating disease states, and have greater financial constraints or transportation challenges. In addition, aging populations have conditions unique to them, yet their age may limit their ability to participate in research studies such as travel inconveniences or hesitation to commit to repeat visits. In some ways, the study-patient burdens and trial biases have similar root causes. Research benefits from diversity, and research professionals and ethic committees have long been trying to find ways to include all qualifying participants, regardless of socio/economic, disability, age, or geographic status. With improved technology, ride-share services, telemedicine, and at-home research services, participants with limiting mobility, disease, or age are now afforded better opportunities to participate in research.
Fortunately, more patient-centric approaches to research are emerging. It stands to reason that addressing study-patient burdens, then participant satisfaction and study recruitment/retention rates will increase. In turn, this results in a reduction of study costs, increased study quality/data collection, and increased speed of therapeutic development.
Some methods for a patient-centered approach include direct relationships with patients, advocacy group involvement, e-screening and consent, at-home study visits and biospecimen collection, study-site transportation, and personalized 1:1 relationships and follow-up. Patients’ contributions to medical research are invaluable, and the research industry needs a “new normal” in study recruitment, retention, and satisfaction. Instead of asking participants to come to us to contribute to research, we need to validate their contributions by decreasing their burden and going to them.
Brian Neman serves as the Co-Founder and CEO of Sanguine Biosciences. Brian focuses on all items relating to commercialization and relationships with researchers; he is an adjunct professor of Digital Health at USC, and co-founded Sanguine in 2010 out of his graduate program in healthcare administration at USC. He is also on the boards and committees of various organizations including HD Care, BIOCOM Big Data Committee, and more.
Burrows, A. The 8 biggest challenges facing clinical trial professionals. Clinical and Medical Affairs. Informa Connect. Published November, 2016. https://informaconnect.com/report-biggest-challenges-clinical-trials-pt-1/. Accessed March 31, 2020.
Clinical Trial Delays: America’s Patient Recruitment Dilemma. Clinical Trials Arena. Published July 18, 2020. https://www.clinicaltrialsarena.com/analysis/featureclinical-trial-patient-recruitment/. Accessed April 1, 2020.
Handen, J. What Does Patient-Centricity Really Mean … And Why Do We Need It? Clinical Leader. Published May 22, 2018. https://www.clinicalleader.com/doc/what-does-patient-centricity-really-mean-and-why-do-we-need-it-0001. Accessed April 1, 2020.
Handen, J and Patrick, D. 3 Major Challenges With Global Clinical Trials – And How To Overcome Them. Clinical Leader. Published August 2, 2018. https://www.clinicalleader.com/doc/major-challenges-with-global-clinical-trials-and-how-to-overcome-them-0001. Accessed March 31, 2020.
Ilancheran, M. Improving patient retention & engagement through health programs. Clinical Leader. Published December 21, 2016. https://www.clinicalleader.com/doc/improving-patient-retention-engagement-through-health-programs-0001. Accessed April 1, 2020.
Tufts Center for the Study of Drug Development. 89% of Trials Meet Enrollment, but Timelines Slip, Half of Sites Under-Enroll. Impact Report, 2013, 15(1)