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An Ounce of Retention is Worth a Pound of Recruitment

by | Mar 5, 2024 | Blog, Clinical Trials | 0 comments

Regardless of your role in clinical research, we can all agree with this simple truth: Patient recruitment is hard, time-consuming, and costly!

While many of us have experienced (or are currently acutely familiar with the challenges of study recruitment first hand, there are also numerous substantiated claims to support this theory. A few of these include….

  • Recruiting the planned sample size within the defined time frame in clinical trials has proven to be the chief bottleneck in the drug development process. Recruitment of participants takes up to 30% of development timelines, and ~1.2 billion USD is spent on this activity1.
  • Approximately 80% of clinical trials are delayed or closed because of problems with recruitment2.
  • The average cost to recruit one patient to a clinical study is nearly $7,0003.

Following all that time, effort, and cost, does the buck stop after individuals are recruited into a trial? No way! Enter retention…. An equally important yet challenging aspect of ensuring a successful clinical research study. Why is patient retention so important?

  • 30% of patients who agree to participate in a trial will drop out4
  • The average cost to recruit a new patient to replace a lost one was around $20,0003

And perhaps most importantly,

  • Poor patient retention can adversely affect a trial by introducing risk to the interpretation and validity of study data5!

With the rising cost of drug development, it is vital for all parties involved in recruiting and retaining patients to understand and implement strategies for success. Is it true that increasing retention in a study could decrease the need to recruit additional patients? Of course! Is it also true that higher retention rates mean less missing data, higher statistical power and reduced costs? Absolutely! The good news is…. Higher retention rates can positively impact recruitment, trial cost and timelines, and ultimately study success. So, how can we help improve patient retention rates?

One viable tactic to improve retention is to reduce participation burden for patients. A recent study determined that travel was the top factor in causing participation burden in studies6. Minimizing travel to study sites where feasible is one tactic to reduce patient burden. Another method to increase retention is to provide easy to use, convenient technologies that help patients and caregivers better manage their trial participation from within their day-to-day environment. It has been proven that offering clinical trials from home or virtually would increase willingness to participate by nearly 20%7. Additionally, bringing even a few aspects of trial participation directly to the home has also proven to have a positive impact with substantially higher retention (89% as compared to 69% in traditional trials)8.

Digital health technologies have enabled an abundance of new opportunities for clinical trials, and the technologies that are offered at home have proven to provide better data from “real-life” settings9. Additionally, for trial Sponsors, providing virtualization options(including allowing more aspects of participation to be performed from the home) reduces the clinical trial timeline and yields a return on investment of up to 14 times in Phase 3 deployment10.The FDA supports in home tech and believes that access to devices outside a clinical care setting may help bridge the gap by bringing health care directly to patients, wherever they are – at home, at work, in cities, in rural communities11.

So, why should we strongly consider using technology to meet the patient where they are, therefore helping patients who are enrolled stay enrolled?

  • Reduce patient burden: When patients are more comfortable and less burdened by the study, they are more likely to stay enrolled. Home participation allows patients to continue participating in the study without disrupting their daily routine12.
  • Reduce study costs: Offering in-home technology in clinical trials can help reduce patient drop out and replacement, therefore lowering cost. Additionally, technology that allows for study virtualization may be used to replace some in person clinic visits further reducing cost.
  • Increase data quality: Acquiring data in the patient’s natural environment can provide a more accurate assessment of the patient’s condition versus only collecting data during a clinic visit12.

While there are many solutions in the industry that can help achieve the above, there is only one singular, easy to use in-home technology that can do it all. The spencer® SmartHub can increase study drug adherence, patient engagement, and trial compliance. We have seen over 97% medication adherence in various diseases by physically dispensing and tracking study drug in a pouch format. In addition to providing real time drug accountability from the patient’s home, spencer also has proven to increase patient engagement (over 90% daily) by collecting ePROs, real world data and vital signs, and facilitating virtual visits directly from the device. Incorporating spencer in a clinical trial can provide 2x ROI or more just by improving patient retention, along with the benefits of increased study drug adherence and daily data collection.

What is one of the best parts about using spencer in your clinical trial? We already know that spencer is a technology that patients want and love to use! Our world class net promotor score and other data signal that spencer users highly recommend the platform to their family and friends. If you are interested in learning how spencer can impact trial success but increasing retention & patient engagement, as well as reducing burden for patients and their caregivers, reach out to us today!

References:

  1. Chaudhari N, Ravi R, Gogtay N, Thatte U. Recruitment and retention of the participants in clinical trials: Challenges and solutions. Perspect Clin Res. 2020;11(2):64-69. doi:10.4103/picr.PICR_206_19
  2. Decentralized clinical trials: Are we ready to make the leap? BioPharma Dive. Published online January 29, 2019. Accessed February 29, 2024. https://www.biopharmadive.com/spons/decentralized-clinical-trials-are-we-ready-to-make-the-leap/546591/
  3. Moore TJ, Zhang H, Anderson G, Alexander GC. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016. JAMA Intern Med. 2018;178(11):1451-1457. doi:10.1001/jamainternmed.2018.3931
  4. Miseta E. Tufts Finds Substantial Net Benefits To Using Decentralized Trials. Clinical Leader. Published online June 28, 2022. Accessed February 29, 2024. https://www.clinicalleader.com/doc/tufts-finds-substantial-net-benefits-to-using-decentralized-trials-0001#:~:text=Retention%20complicates%20the%20problem%2C%20as,from%2028.6%25%20to%2026.1%25
  5. Buben C. Integrating Patient Retention Strategies. Appl Clin Trials. 2013;22(6).
  6. Sine S, de Bruin A, Getz K. Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications. Ther Innov Regul Sci. 2021;55(5):1059-1065. doi:10.1007/S43441-021-00306-8/FIGURES/1
  7. Lesser N, Anderson D, Younossi A, Overman J, Chang C. Broadening clinical trial participation to improve health equity. Deloitte Insights. Published online October 4, 2022. Accessed February 26, 2024. https://www2.deloitte.com/xe/en/insights/industry/health-care/increasing-diversity-clinical-trials.html
  8. Green B. At-home clinical trials are the future. Stat. Published online April 26, 2023.
  9. Mittermaier M, Venkatesh KP, Kvedar JC. Digital health technology in clinical trials. NPJ Digit Med. 2023;6(1). doi:10.1038/s41746-023-00841-8
  10. Taylor N. Tufts links decentralized clinical trials to time, cost savings. Published January 28, 2022. Accessed August 15, 2023. https://www.outsourcing-pharma.com/Article/2022/01/28/tufts-links-decentralized-clinical-trials-to-time-cost-savings?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright
  11. CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies. FDA.
  12. 10 benefits of clinical trial home visits. delta healthcare consulting.