Making Clinical Trials More Effective By Keeping Focus On The Patient
A Q&A with Justin Schroeder, Executive Director, Marketing, Business Development and Design, PCI Pharma Services
The need for clinical trials to meet the requirements of regulators, deliver high-quality data, and come in on budget has led to study designs that focus on timeliness and convenience, yet may unduly burden and inconvenience patients. Today, priorities are changing as sponsors realize studies designed around the needs of patients also result in benefits to other stakeholders. This has led to the rise of patient-centric clinical trials.
Introduction
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.
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