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- Patient recruitment 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 one of the biggest 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. (en)
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