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Patient Engagement Drives Clinical Trial Compliance and Retention

October 18, 2016
Posted by: Jamie Zacher, PharmD

Every patient that drops out of a clinical trial costs the study sponsor time and money.  According to research by the Tufts Center for the Study of Drug Development, only one-half of patients randomized into a clinical trial go to completion.[1] When a patient drop out and is lost to follow-up, new patients must be recruited to fill their place and this extends the length of the study.  Patient drop outs and lost to follow-ups also mean increased costs for a study sponsor, for which the average cost per patient in a clinical trial is estimated to be $36,500.[2]  Clearly, patient retention is key to a smoothly running trial. A prime way to prevent and minimize dropouts is by engaging patients in a meaningful way and timely manner.

Patient engagement begins with patient enrollment. The investigator, study coordinator, and all study staff need to make sure that each patient feels important and appreciated. Each patient needs to feel they are receiving the best care possible while they are contributing to the greater good. Engagement should especially continue even after the patient leaves the clinical site. This is successfully achieved by including a clinical trial research pharmacist on the healthcare team.

Why can this be so important?  The pharmacist is the trained medication expert, whose responsibility it is to contact each patient at crucial points in the study to ensure patient understanding of all study requirements and of particular importance, administration of the study medication. Pharmacists are generally able to build a trusting, professional relationship with the patients by providing support and encouragement.  This leads to increased patient confidence and understanding as well as improved adherence and retention as the patient feels they have another trusted study team member to turn.

Let’s look at a real world example of how a clinical trial research pharmacist (CTRP) was able to avert a trial crisis and help retain a patient who was considering dropping out. On a weekend, a patient became frustrated because a phone message left at the clinical site was not returned.  When the patient went in for the next scheduled appointment, there was no one at the site. The patient called the CTRP pharmacist in frustration to express their concerns and stated they were planning to drop out of the study.  The pharmacist immediately intervened by proactively locating the study coordinator, who then promptly contacted the patient and resolved the issues of the patient.  The patient then decided to stay enrolled in the study.  If the CTRP hadn’t been in place to receive this stress call from the patient, the sponsor would have lost this patient, as well as time, cost and most importantly the clinical data.

Patient engagement is critically import to retaining enrolled patients in clinical trials.  It maximizes the sponsor company’s time and resources and the CTRP pharmacist brings added-value to the clinical trial team. In an upcoming blog, we’ll discuss more options to keep patients engaged in a clinical trial to drive compliance and health outcomes.

[1]Getz, K. “Patient Recruitment and Retention.” BCCRIN and VCHRI Clinical Research Symposium, Vancouver General Hospital, Vancouver, British Columbia. March 2012

[2] Biopharmaceutical Industry-Sponsored Clinical Trials: Impact on State Economies, Battelle Technology Partnership Practice, Pharmaceutical Research and Manufacturers of America, March 2015

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