A Clinical Research Tool that can Decrease Pharmaceutical Study Costs, Improve Subject Recruitment and Increase Patient Retention and Adherence

Download Article

DOI: 10.21522/TIJCR.2014.04.02.Art003

Authors : Nicole C. Hank, Nicole C. Hank

Abstract:

Clinical trials are a key research tool for advancing medical knowledge and patient care. They ultimately gear towards ameliorating and improving diagnosis and treatment of all diseases by introducing novel interventions and therapies. Essential to conducting a clinical trial is randomizing the proper study population through recruiting eligible participants based on inclusion and exclusion criteria, and ensuring study completion and adherence of study patient participation. Although these may seem simplistic, patient recruitment, retention and adherence are the most difficult challenges in clinical trials. While patient recruitment is one of the key elements to study completion, over 80% of clinical trials shockingly do not finish on time. Devising a potential strategy is vital in overcoming recruitment barriers; however, it is very costly and cumbersome. Lambda Health, LLC is in the process of creating a clinical research tool that can interface with EMR, in hopes of increasing patient retention through proper site selection, and setting reminders to patients about medication dosing, diary documentation, study procedures and visits scheduling. Ideally through implementing this tool into clinical trials, less effort and money will be spent on recruitment and the rates of adherence and retention will increase.

Keywords: Patient recruitment, retention rates, patient adherence, cost-effective, clinical research tool.

References:

[1]. Alexander, W. (2013). The Uphill Path to Successful Clinical Trials: Keeping Patients Enrolled. Pharmacy and Therapeutics, 38(4), 225–227.

[2]. Carlisle, B., Kimmelman, J., Ramsay, T., & MacKinnon, N. (2015). Unsuccessful Trial Accrual and Human Subjects Protections: An Empirical Analysis of Recently Closed Trials. Clinical Trials (London, England), 12(1), 77–83.

[3]. C. Brownstein, J.S. Brownstein, D.S. Williams, P. Wicks, and J. Heywood, "The Power of Social Networking in Medicine," Nature Biotechnology 27, 888-890, 2009.

[4]. Centerwatch (2016) http://www.centerwatch.com/news-online/2016/06/27/issue-patient-retention-clinical-trials/ June 2016.

[5]. Clinical Trial Media (2011), available at: http://www.centrewatch.com/professional/prv295.html.

[6]. Gabriel, A. P., & Mercado, C. P. (2011). Data retention after a patient withdraws consent in clinical trials. Open Access Journal of Clinical Trials, 3, 15–19.

[7]. G. MacDonald, Social Media Boosting Patient Recruitment, but FDA Guidance Needed, March 2011, available at: http://www.outsourcing-pharma.com/Clinical-Development/Social-media-boosting-patient-recruitment-but-FDA-guidance-needed Accessed 24 Jun 2011.

[8]. Medrio data (http://medrio.com/partners/the-top-5-cost-drivers-in-phase-i-clinical-trials/2015).

[9]. Social Media for Patient Recruitment Only the Beginnin (2011) http://www.healthcaretrendsnewsletter.com/2010/07/social-media-for-patient- recruitment-only-the-beginning/.

[10].  Tufts Center for Drug Development, 2016. Protocol Amendments Improve Elements of Clinical Trial Feasibility, But at High Economic and Cycle Time Cost http://csdd.tufts.edu/news/complete_story/pr_ir_jan_feb_2016.

[11].  Tufts Center for Drug Development, (2013) New Research from Tufts [CSDD] Characterizes Effectiveness and Variability of Patient Recruitment and Retention Practices.

[12].  Zonana M. (2015) How Poor Medication Adherence Is Damaging Your Clinical Trial Data and How to Fix it, Fast.