Compliance: A Key Factor to a Successful Clinical Trial
Posted by: Theresa Matkovits, Ph.D., Senior Vice President, Head of Drug Development, ContraVir Pharmaceuticals
The high failure rate of clinical trials has significant impact on providing potential curative treatments to patients in need. It is with this goal in mind that innovators struggle in designing clinical programs that can bring life-changing treatments to market. Drug development remains a high cost and risky undertaking, given the high failure rate if a compound is unable to demonstrate the desired efficacy signal in the clinic.
One key factor that has been identified in the high failure rate of clinical trials is the adherence of patients participating in clinical trials to the dosing, treatment, and study procedures that are very carefully put in place in clinically rigorous protocols. Due to the rigor that is required in order to demonstrate an “effect” relative to a standard of care treatment, even a small deviation in medication adherence can result in a trial failing to meet its pre-specified clinical endpoint.
Additionally, the current nature of clinical studies include strict timelines and competition among sites to enroll eligible subjects which can many times result in the inclusion of subjects that are simply not “medication-compliant”. The issue of medication adherence is therefore one key factor sponsors should carefully look at monitoring closely when designing and planning the medical and operational oversight of their trials.
Unfortunately, the issue of medication adherence many times goes unmanaged and falls solely on site staff to oversee. As clinical sites are many times running multiple concurrent trials and are themselves pressed to remain productive, the one-on-one daily management of medication adherence of study subjects can many times be neglected. It is therefore in the best interest of the patients in need that sponsors look towards solutions that can help to support their clinical sites in providing additional resources to maintain close and frequent interactions with subjects enrolled in key studies. It simply is no longer sufficient to rely solely on very busy clinical practices to ensure successful adherence of patients in enrolled in trials.
Extra measures need to be taken to support clinical sites and the patients who play such a key role in bringing these important medicines into clinical practice.
Sponsors should consider enlisting and engaging “wrap-around” services for their clinical trials that help to ensure medication adherence is closely managed and monitored. With the emergence of technological advances, clinical supply solutions now exist that can assist by delivering patient reminders for study drug administration.
A more personal approach can also be considered for complex studies where medication adherence is critically important, as is many times the case in the acute care setting. Enlisting the support of remote pharmacists to call patients directly can be an invaluable resource to ensuring the proper administration of study medication. Additionally, the pharmacist becomes a valuable resource to patients who may have ancillary questions regarding the study in which they are participating. This close engagement with trial subjects on a personal level provides the necessary support for the trials patients and sites that should benefit and drive towards more successful outcomes vis a vis de-risked clinical studies.