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Simple tools for projecting patient recruitment

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Poor recruitment to clinical trials is a well-recognised and serious problem. Various predictors of poor recruitment have been identified and of course should be accounted for in trial design. Trial planning however will need a realistic projection of sample recruitment that also allows for random variation – yet available information may be minimal early in the development of a proposal. Such projections are also required when estimating power for survival analyses (the yield of events depends both on numbers and timing of patient accrual) – for example if using the Stata add-on artsurv.

I show here how minimal information, simple formulae and some reasonable assumptions can be combined to estimate both a sensible projection of expected numbers and a plausible range of variation; in turn this variation indicates the extent to which achieving the target sample size may be delayed. Simple calculations also indicate potential gains from restricting eligibility to better-performing sites and the relative lack of benefit from opening better-performing sites first.

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Correspondence to Paul Silcocks.

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This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Silcocks, P. Simple tools for projecting patient recruitment. Trials 14, P137 (2013) doi:10.1186/1745-6215-14-S1-P137

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Keywords

  • Public Health
  • Clinical Trial
  • Survival Analysis
  • Simple Calculation
  • Trial Design

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