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Getting Patient Recruitment Right

Posted on: 14 Feb 03

Summary

"Time to Market" is one of the most important phrases in clinical research - the sooner you can get your product approved the most financial value it will have for your company. But while pharmaceuticals companies pay close attention to the scientific side of designing their clinical trials, few consider how they will get enough patients to participate. In fact, despite technological advances in clinical R&D, nearly 80 percent of all clinical studies for new products fail to finish on time, and 20 percent of those are delayed six months or longer (1). The successful clinical development of any drug relies upon several key factors, one of which is to be able to recruit your patients within the project time frames to meet development and regulatory milestones. This creates a challenge for both sponsors and contract research organizations, since the typical NDA needs approximately 4,000 patients worth of data. In addition, there are other factors that can cause poor accrual, such as competition between trials for the same patient population, and a declining trend in specialist referrals and generally smaller healthcare budgets. Recruit strategically So what options do pharmaceutical sponsors and CROs have to boost patient recruitment? One strategy is to contract with recruitment specialists. Clinical trials require strict protocols and drug regimens that cannot be avoided. But during the last few years, several recruitment specialists have begun to provide clinical trial patient recruitment campaigns in order to accelerate enrollment. These campaigns entail media planning, communication strategies and field-based recruitment methods. When properly implemented, these campaigns allow clinical trial planners to model various resource investment scenarios, estimate specific costs, and forecast timetables. Get your message across Because recruiting patients has become as competitive as marketing products, some of the defining characteristics of a comprehensive recruitment program are similar to approaches used in strategic marketing. Advertising costs are the single largest expense of many patient enrollment programs, so expertise in media buying is critical for achieving the lowest cost per qualified referral. Successful enrollment is dependent on recruiters' ability to produce a broad range of targeted patient messages, including television, radio, and print ads; direct mail campaigns; free public service announcements; clinical educational presentations; internet and website programs; and community outreach initiatives. Use technology Analyzing recruitment performance by site also helps sponsors identify the top performing sites. It also reports signs of decreasing lead generation and the need to reallocate resources and provide additional on-site support. As a result, more recruitment consulting firms are developing simple-to-use web-based data collection systems that make it easy for sites to input the most current data. The wealth of information on the Internet regarding healthcare continues to grow, with some estimated 12,000 sites dedicated to health and medical topics. Within the USA, sponsors and CROs are now posting information regarding their clinical trials on the Internet. Involve the patient Several factors contribute to the lack of patient participation to clinical studies. According to an online study of 2,031 adults conducted by Harris Interactive (2) in February 2002, only a small minority of the public is confident that clinical trial patients
  • are not treated like guinea pigs (24 percent),
  • do not suffer more pain or side effects than they would from standard treatments (13 percent).
  • high quality care (32 percent)
  • receive honest and accurate information (25 percent) However, most survey respondents believe it is "essential" (43 percent) or "very important" (40 percent) that all new pharmaceutical products be tested on humans before they are approved for general use. Some experts suggest that a public education campaign may help turn those who are "somewhat confident" into "very confident." The main challenge is to reassure potential trial recruits that they will not suffer as a result of their participation. One way to boost public confidence in participation is for pharma companies to sponsor trial-site education, such as the courses offered by National Institutes of Health's Human Participants Protection Education for Research Teams (3). These courses are designed to augment policies established by medical center institutional review boards and regulations enforced by federal, regional, and local agencies. Participants learn how to maximize recruiting efforts cost effectively; clarify FDA policies and considerations regarding review of patient recruitment materials for clinical trials; organize case studies of recruitment for a variety of clinical trials; compete for a limited number of patients; utilize proven methods that sponsors have used to increase patient enrollment; enhance communication strategies for clinical trial recruitment; and improve minority recruitment initiatives. References 1. Frank Kirkpatrick, "Rev Up Patient Recruitment." Pharmaceutical Executive, April 1st 2002). 2. Misconceptions and Low Awareness Slow Recruitment for Cancer Clinical Trials. http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=213 3. Human Participant Protections Education for Research Teams. http://cme.nci.nih.gov/
  • Dr Faiz Kermani

    Last updated on: 27/08/2010 11:40:18

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