Screening and Recruitment

The Chaponis (1998) survey of 19 USA-based companies reported also that 32% reported difficulty in finding suitable investigative sites for geriatric patients. In addition, those respondents involved in Phase IV outcomes, quality-of-life and pharmacoe-conomics studies, etc., said that the lack of 'incompany' geriatric expertise and resources was a barrier. Locating suitable investigative centers for geriatric studies is only part of the solution and works well for the smaller elderly experience studies. Nonetheless, in clinical studies undertaken for specific diseases in aging, much larger numbers of patients must be enrolled.

Even the large resources of the NIH can be strained. The Systolic Hypertension in the Elderly Person (SHEP) investigation recruited 4736 patients aged 60-96 years (average 72). The patient screening and selection was organized from 16 sites but took 31 months to complete, which had initially been projected to be 24 months. Nearly 450 000 patients were screened (SHEP Cooperative Research Group 1991).

Hall (1993) reported on 15 cardiovascular studies funded by the National Heart and Lung Blood Institute (NHLBI) over 10 years. All overran their projected recruitment times by an average of 27%. Over-optimistic projections are the norm, and this norm has been called 'Lasagna's Law' (Spilker and Cramer, 1972). For pharmaceutical clinical physicians and their staff, similar overruns are not excused by management, and raise the temptation to 'move the target' by closing recruitment at a lower level. This solution compromises the statistical robustness of the study; both the problem and this solution are career busters. Better to project realistically and plan recruitment and fallback strategies. Hall (1993) also varied the recruitment strategies used; the most successful was community screening. This can be done through appeals to senior centers, churches, shopping centers and major industrial sites (Melish 1982). Medical chart review is also productive if the condition has a International Classification of Disease

(ICD) code and charts are available to the investigators.

For large studies, mass-mailing to registered voters, members of organized groups such as AARP, or members of a disease association can be helpful, with 7-12% response rate (McDerman and Bradford 1982). Use of media campaigns can result in up to 11% of first protocol visits (Levenk-row and Farquhar 1982). These need at least 3-6 months of planning for resources to respond to the initial wave of inquiries. The approach can be a newspaper article and advertisements in regional papers, TV and radio. Appeals to community physicians for referrals are usually disappointing, possibly caused by the physician believing that he/she will lose a paying patient to a research clinic.

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