Patient recruitment is the process of finding and enrolling suitable participants for clinical trials. It is a crucial aspect of drug development and medical research, as it affects the validity, reliability, and generalizability of the results. Patient recruitment can also be challenging, time-consuming, and costly, involving various ethical, regulatory, and logistical issues. Many factors influence patient recruitment, such as the design and complexity of the trial, the availability and accessibility of the target population, the awareness and motivation of the potential participants, and the competition and collaboration among different stakeholders. To overcome these challenges, patient recruitment service providers offer various solutions, such as public education, patient outreach, site support, and data analytics. These services aim to increase the enrollment rate, reduce the dropout rate, and improve the quality and diversity of the trial participants.
Patient recruitment in the US Patient recruitment in the US includes a variety of services—typically performed by a Patient Recruitment Service Provider—to increase enrollment into clinical trials. Presently, the patient recruitment industry is claimed to total $19 billion per year. Patient enrollment is the most time-consuming aspect of the clinical trial process. The leading cause of missed clinical trial deadlines is patient recruitment, taking up to 30 percent of the clinical timeline. Improving patient recruitment rates offers pharmaceutical and medical device companies opportunities to accelerate the pace of clinical trials – making it possible to reduce time to market. As the number of patients needed for clinical trials rises – as safety and regulatory issues drive trends toward larger and longer trials – the demand for patient recruitment services grows. Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. They are conducted in a series of phases, each designed to address a separate purpose:
Phase I: Researchers test a new drug or treatment in a small group of people (20–80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II: The study drug or treatment is given to a larger group of people (100–300) to see if it is effective and to further evaluate its safety. Phase III: The study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV: Post marketing studies delineate additional information including the drug's risks, benefits, and optimal use. Pharmaceutical companies submit trial data to the U.S. Food and Drug Administration (FDA) as part of a New Drug Application, the application for FDA approval to market a drug in the U.S. Patient recruitment service providers educate the public about the value of clinical trial participation and the measures in place to protect study participants. The 2001 "Will & Why Survey" of more than 5,000 people in the U.S. showed that 81 percent of the population was not aware of safeguards such as the Declaration of Helsinki, the Belmont Report, Institutional Review Boards, and the informed consent process. However, after learning about these protective measures, nearly 40 percent of respondents reported they would be more likely to participate in a clinical trial.
Patient recruitment in Europe In Europe, patient recruitment is the leading cause of missed clinical trial deadlines, taking up to 30%of the clinical timeline. Improving patient recruitment rates offers pharmaceutical and medical device companies one of the most significant opportunities to accelerate the pace of clinical trials and reduce time to market. Many factors hinder the enrollment and retention of patients in clinical trials in Europe: some of these factors include lack of awareness and trust, complex and restrictive eligibility criteria, practical and ethical barriers, and regulatory and organizational challenges. Different actors and stakeholders in the clinical research field, such as pharmaceutical companies and patient advocacy groups, have proposed and implemented various strategies and initiatives to address these challenges and improve patient recruitment in Europe. Some of these include increasing awareness and trust, simplifying and expanding eligibility criteria, reducing practical and ethical barriers, and harmonizing and streamlining regulatory and organizational processes.
Origin The discipline of patient recruitment was formed over three decades ago in the U.S. to meet the challenge of successful on-time enrollment. It has evolved into a field that includes feasibility modeling and analysis; country selection; site selection, training and support; metrics and evaluation; marketing communications, media; and public relations. The patient recruitment sector has experienced rapid growth in recent years, particularly in response to increasing number of global clinical trials. Technology has impacted the evolution of patient recruitment. Many companies have developed proprietary software to help make processes more efficient, and providers increasingly rely on the Internet not only for advertising and early screening, but also for tasks such as tracking data and measuring site performance.
Services
Patient recruitment The goal of patient recruitment is to raise awareness of clinical trial opportunities and to encourage enrollment. Services are contracted for by pharmaceutical companies, biotechnology companies, medical device companies, contract research organizations (CROs), or a medical research site. Services include:
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