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Challenges in Patient Recruitment for Clinical Trials: Overcoming the Bottleneck
Decision Resources, Inc, Dec 2005, Pages: 12
Patient recruitment and retention in clinical trials is wide recognized as the leading bottleneck in the new drug development pipeline, and it is likely to remain an area of heightened concern for the next five years. As the recruiting culture becomes more sophisticated with the involvement of multiple service vendors and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials.
This report explores how new approaches to recruitment that are multifaceted, trial-specific, data-driven, and customer-focused can be used to ease patient enrollment delays, which significantly impact R&D budgets and can even directly result in millions of dollars of lost sales.
Business Implications
- Patient recruitment is likely to remain an area of heightened concern for pharmaceutical companies for at least the next five years. The forces affecting patient enrollment are numerous and complex (e.g., unfavorable media portrayal of the industry, more studies competing for a limited number of patients, patient concerns about side effects) and do not lend themselves to quick and easy solutions. The major effect of these forces is delayed trials that drain drug developers' R&D budgets.
- Pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. The recruiting culture is becoming more sophisticated with the involvement of multiple service vendors (e.g., contract research organizations [CROs], niche companies with expertise in specific therapeutic areas or data collection/ analysis technology). Achieving success in this environment requires trial sponsors to play a larger role in the recruitment process (rather than leaving it entirely to investigative sites) and to develop more collaborative working relationships with all stakeholders, including investigators and patients.
- New approaches to recruitment are multifaceted, trial-specific, data-driven, and customer-focused. Chief among innovations being used to improve recruitment success are developing in-house recruitment expertise; understanding the motivations of patients, investigators, and physicians; building alliances and/or outsourcing with specialized recruitment firms; developing individualized, site-centric strategies and campaigns; utilizing improved metrics, measurement tools, and methods of data collection; raising public awareness of clinical trials; and global recruiting initiatives. It will likely be another decade before the field of patient recruitment is
able to successfully integrate many of these approaches.
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