Patient recruitment

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 $5.9 billion per year.[1]

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.[2] 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:

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” [3] 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 trials.

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:

Patient retention

If a trial is lengthy or if it requires invasive procedures, the greater the need for retention support to help keep patients involved for the entire trial timeline. For those engaged in global clinical studies, particularly lengthy trials with extension studies, the need for patient retention services is significant. A variety of support services that are considered retention specific include:

Current Process

E6-GCP guidelines suggest that an investigator should have adequate resources to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period. There are many different recruitment methods, including media (i.e., television, radio and newspaper), physician referrals, press releases, fliers, random mailings, cold calls and the internet. These methods must be selected before study start. Also, some common factors such as-sample size, suitability of the strategy as per study design and overall budgetary constraints must not be ignored.[7]

References

  1. IBM Institute for Business Value analysis, 2003 report
  2. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success, Joan F. Bachenheimer, Bonnie A. Brescia, Gower Publishing, 2007
  3. The Will & Why Survey, a Harris Interactive/BBK Healthcare Poll, 2001
  4. Zhou, Eric S.; Dunsiger, Shira I.; Pinto, Bernardine M. (August 2013). "Proactive versus reactive recruitment to a physical activity intervention for breast cancer survivors: Does it matter?". Clinical Trials 10 (4): 587–592. doi:10.1177/1740774513480004. PMID 23515464.
  5. Pharma's Facebook, Newsweek, March 10, 2009
  6. Whispering Tweets into a Patient's ear: Top Ten Suggestions for Clinical Trial Recruiters, March 2009
  7. http://www.hcltech.com/sites/default/files/patient_recruitment_and_retention_strategy_in_clinical_trials.pdf
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