Evaluating the Impact of Patient Recruitment and Retention Practices
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Evaluating the Impact of Patient Recruitment and Retention Practices
Drug Information Journal 46(5) 573-580 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512453040 http://dij.sagepub.com
Mary Jo Lamberti, PhD1, Adam Mathias, MPH1, Jane E. Myles, MS2, Deborah Howe, BS3, and Ken Getz, MBA1
Abstract The objectives of this study were to benchmark patient recruitment and retention practices across recently completed global clinical trials from a working group of biopharmaceutical companies. The data collection focused on recruitment and retention tactics used by companies as well as detailed information about the size and scope of the global trials conducted. In-depth organizational information regarding patient recruitment and retention structure and functions was collected. Despite numerous tactics available, participating companies indicated using a small number of patient recruitment and retention tactics. In addition, companies reported that 32% of studies did not implement any tactics. Traditional tactics were most widely used, including physician referrals (16%), newspaper advertisements (16%), and radio advertisements (13%). The relationship between use of recruitment tactics and enrollment data was explored and a positive association was found between use of nontraditional recruitment tactics and enrollment rates. Keywords patient recruitment, retention, global clinical trials
Introduction Despite more than two decades of focused attention and improvement efforts, patient recruitment and retention are among the largest challenges facing the clinical research enterprise today and among the greatest contributors to delays in drug development. These challenges and delays have been documented extensively in the peer-review and trade literature.1 For example, Sung et al,2 in a seminal 2003 article in the Journal of the American Medical Association, described patient participation in clinical research as 1 of the top 4 challenges facing the clinical research enterprise. Glass3 found that patient recruitment was viewed as one of the top factors in investigator dissatisfaction with clinical trial activities. Getz and Wenger4 noted that the growing difficulty that investigative sites have recruiting and retaining study volunteers is associated with rising protocol complexity. Specifically, an increasing number of procedures performed and dramatic growth in the number of inclusion and exclusion criteria per protocol have contributed to increased study durations and higher dropout rates. In response, biopharmaceutical companies have devoted substantial resources to patient recruitment and retention initiatives. The strategies and practices implemented by research sponsors, contract research organizations, patient recruitment providers, and investigative sites encompass a wide range of
activities, and yet, to date, there are few published data that document each activity’s effectiveness. Such data would greatly inform understanding and help improve practices in o
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