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Patient Recruitment: The New Challenge in Clinical Research

Pietro Bonacossa and Dr. Faiz Kermani, Chiltern International Ltd. Posted on: 22 Nov 02

Summary

Patient enrollment is of continued interest, as many companies believe it is possible to improve clinical cycle times by compressing the enrolment period. However, this means recognizing the fact that the nature of the trial will affect the recruitment period and so the degree of improvement that can be made will differ from trial to trial.
Confronting Patient Recruitment Woes Clinical trials are a vital step in bringing new drugs to market. This is shown by the industry’s US-based clinical trial activities having increased by 6% in 2001, the largest rise since 1990.1 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. As a result, most trials are plagued by delays that can cost pharmaceutical companies millions of dollars in missed sales. It has been estimated that delays in getting a drug to market cost companies around US$1 million a day.2 In fact, despite technological advances in pharmaceutical 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 longer3. Given that, on average, 40% of pharma companies’ R&D costs are devoted to clinical trials, and that year on year R&D expenditure is increasing by around 10%, companies can ill afford such a situation2. Achieving Realistic Recruitment Rates Patient enrollment is of continued interest, as many companies believe it is possible to improve clinical cycle times by compressing the enrolment period. However, this means recognizing the fact that the nature of the trial will affect the recruitment period and so the degree of improvement that can be made will differ from trial to trial. For example, in an analysis of 1,577 Phase II and III clinical studies active in 1997, median time for patient enrolment was found to vary with therapeutic class.2 For drugs in the anti-infective and anti-viral classes, median time for recruitment were 5 and 6 months, respectively, whereas for cardiac therapies (not including anti-hypertensive therapies) median time for enrolment was much longer at 16 months. For trials involving anti-hypertensive therapies the median enrolment time was only 8 months. The finding that the enrolment time for cardiac therapies was nearly double that for antihypertensives was associated with the availability of patients; ie hypertensive patients were being seen and diagnosed more frequently by primary care physicians during standard appointments. Understanding the frequency that the desired patients are seen by clinicians can therefore lead to a realistic assessment of the recruitment rate that can be achieved from trial centers for a particular study. Interestingly, in the same analysis, the largest trials, of over 400 patients, were quicker than the smaller trials in terms of the interval of first patient enrolled to last patient enrolled. This may be due to the considerable resources allocated to patient recruitment for these large studies, which are usually run by the major companies. In any case, it illustrates the complexity of the parameters involved in patient recruitment. References 1. Parexel. Pharmaceutical R&D Statistical Sourcebook, 2001. 2. Kermani F and Findlay G (2000). The Pharmaceutical R&D Compendium. http://www.cmr.org/rdcompendium.html 3. Frank Kirkpatrick, “Rev Up Patient Recruitment”(Pharmaceutical Executive, April 1st 2002) 4. Peck CC. Drug Development: Improving the Process. Food and Drug Law Journal 1997; 52/2:163-167. 5. Woodcock J. Larger Clinical Trials Could Detect AES Earlier. The Pink Sheet. 10 May 1999. 6. Hynes CL, McAuslane JAN and Walker SR. Issues of Concern in Clinical Development: The Growing Size of the Clinical Dossier. Proceedings of a CMR International Workshop. CMR International 2000.

Pietro Bonacossa and Faiz Kermani

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

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