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