Reversing Study Dropout Rates
Posted by: Tina Schlecht, PharmD, MBA
Taking medications is hard. Following study protocol instructions correctly is even harder.
Patients who have trouble with medication compliance in a clinical trial are more likely to become discouraged, and less likely to see the trial through to completion.
According to research by Tufts Center for the Study of Drug Development, only half of the patients randomized into a clinical trial go on to complete the trial.[i] The impact of poor compliance and low retention can affect the results of a trial in many ways such as increasing costs, underestimating medication effectiveness, overestimating safety, and underestimating risks and adverse effects.[ii]
How can study sponsors overcome these issues? The answer is to improve ongoing patient education and communication. Patients who receive thorough instructions and attention not only at the beginning of a trial, but throughout, are more likely to have confidence in the study staff, the study medication, and the trial as a whole.[iii] This confidence leads directly to increased enthusiasm for participating in the trial, resulting in better compliance and a decrease in dropout rates.
Education and communication can be accomplished in a number of ways. Health care providers are the most important resource for educating and engaging patients. When patients enroll in a study, the primary investigator and study coordinator play a central role in patient education. However, there is another, equally valuable member of the health care team, who can also make a profound and pivotal difference, especially after the patients leave the clinical site: the pharmacist.
Continuous communication with a pharmacist not only puts the patient at ease and breeds confidence, but also helps to ensure that the patient properly follows the protocol and avoids medication errors. Think about it. Who knows better than a pharmacist about dosing, time intervals for drug administration, and how to take a medication? As such, pharmacists use a patient-centered approach in collaboration with other providers on the health care team to successfully optimize patient health and medication outcomes.[iv]
Taking a closer look, the National Association of Boards of Pharmacy reports that, by providing patient counseling and education, medication compliance monitoring, and medication reviews, pharmacist involvement increases medication compliance and reduces medication errors.[v]
For example, the Pennsylvania Project by the University of Pittsburgh concluded that pharmacist interventions significantly improved patient medication compliance for five classes of medications.[vi] Another study of patients with heart failure in a community setting found that, among the patients who received monthly pharmacist counseling, non-compliance was less than half of that observed among usual care patients.[vii]
These studies, and others, demonstrate that experienced, well-trained pharmacists are the key to improving outcomes for study patients and study sponsors in a timely and cost effective manner.
[i] Getz, K. “Patient Recruitment and Retention.” BCCRIN and VCHRI Clinical Research Symposium, Vancouver General Hospital, Vancouver, British Columbia. March 2012.
[ii] What is Patient Adherence? Improving Patient Adherence in Clinical Trials. Kathy Zonca. November 5, 2012.
[iii] Report on the ISPE Project Concerning Patient Experiences with Clinical Trial Materials. ISPE. November 2013.
[iv] Pharmacists’ Patient Care Process. Joint Commission of Pharmacy Practitioners. May 29, 2014.
[v] Pharmacist Communication Shown to Increase Medication Adherence and Reduce Errors, NABP, April 30, 2010.
[vi] The Pennsylvania Project: Pharmacist Intervention Improved Medication Adherence and Reduced Health Care Costs. Health Affairs, August 2014.
[vii] Thinking Outside the Pillbox, A System-wide Approach to Improving Patient Adherence for Chronic Diseases, A NEHI Research Brief, August 2009.