Patient Centric Clinical Trials

The burdens of clinical trial participation are well-known. Traveling to trial sites, complying with medication regimens, and undergoing procedures all place strains on patients, leading some people to drop out and others to not comply with the protocol. What is changing is the willingness of sponsors to redesign their studies around patients and the recognition of how this benefits everyone.

Sponsors’ changing attitudes are underpinned by evidence the current system is flawed. According to a survey of 3,150 people by the Center for Information and Study on Clinical Research Participation, more than one-fifth of trial subjects find the experience somewhat or very stressful. Asked what they liked least about the experience, people cited the location of the medical center, the time-consuming nature of study visits, and the cumbersome procedures they had to follow.

The consequences of these experiences extend beyond patients. Sponsors need people to want to enroll in trials and take their medication per protocol if they are to gather high-quality data as fast as possible. Yet, trials designed without considering the needs of patients are unlikely to achieve optimal enrollment, retention, and compliance rates. Recognizing this, sponsors are increasingly building the patient perspective into all aspects of their clinical trials.

Sponsors that take the time to design patient centric clinical trials are rewarded with significant mid- to long-term benefits, according to Justin Schroeder, PCI Pharma Services. In this Q&A, Schroeder discusses the benefits of patient-centric clinical trials, the role packaging can play, and why it is worth incurring up-front costs and inconveniences to put the patient at the center of studies.