Optimizing Clinical Trial Medicine Kits for Better Patient Compliance and Retention
Posted by: Joe Martinez, RPh, PDE, PPC
Patient-centricity is providing a vehicle for global clinical research professionals to improve the feasibility and outcomes of clinical trials. The International Society for Pharmaceutical Engineering (ISPE) engaged the Center for Information and Study on Clinical Research Participation (CISCRP) to conduct a study to assess the patient experience with clinical trial medicine kits in terms of challenges and means of improvement. (1)
A total of 1,425 study volunteers completed an online survey about standard clinical trial medicine kits. The following are some highlights of the results:
- 30% reported that the kit design did not help them with compliance.
- Approximately 33% found the booklet labels to be very useful, while 12% (statistically significant) surveyed reported they never opened the booklet label.
- 78% indicated that it would be “very helpful” or “somewhat helpful” to have their prescriptions delivered directly to their homes.
- 77% reported it is “very helpful” to have the study staff and pharmacists tell and show them how to use, take and store the clinical trial medicine.
- 76% indicated that it is “very helpful” to have an opportunity to ask questions regarding how to use, take and store clinical trial medicine.
In addition, patients noted that they were open to using technology as a means of communication, including reminders sent by e-mail or text message. Finally, and of significance, investigative site personnel and pharmacists, where available, proved to be critical collaborative partners in improving the patient experience with clinical trial kits.
There are a few interesting take-aways from this study. To begin, from the critical learning stance, it is clearly understood that when it comes to clinical trial medicine kits, one size does not always fit all, and it is imperative to customize clinical trial kits to accommodate individual patient preferences.
It is also interesting to note that the study patient’s trust and confidence in the clinical research process itself increased when study staff or pharmacists were available to review the clinical trial kit instructions with them.
Finally, study patients indicated that the investigative staff, including the pharmacist, where applicable, were instrumental in helping them to comply with their medication kit dosing requirements and enhanced their overall positive experience.
This information bears out what we know in our gut to be true in clinical trial design and implementation. Clinical trial protocol needs to be as simple as possible and easily understood. Even then, many patients will need additional hand holding by investigative staff and their pharmacist to ensure their understanding of the trial protocol and to answer their questions. Also, clinical trial medicine kits need to be appropriate to the trial, therapeutic disease state and to accommodate patient behavior. By implementing processes to address these challenges upfront, the clinical sponsor and CRO can position the clinical trial to achieve and potentially exceed the intended primary endpoints and health outcomes.