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Abstract:
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Patient recruitment and drug supply planning are the biggest challenges for clinical study design. The innovative statistical technique for modeling patient recruitment in multicenter clinical trials will be discussed. It allows predicting recruitment with credibility boundaries at initial and ongoing stage of the study, evaluating study/site performance and the minimal number of sites needed to complete in time with a given confidence, providing recommendations on adaptive adjustment. Predicting in time the recruitment profile provides the opportunity to evaluate drug supply needed to cover patient demand for a given risk of stock out and establishes the basis for a novel approach in optimizing drug supply planning. All calculations are based on derived closed-form expressions, no Monte Carlo simulation involved. Technique is validated on real data, case studies will be considered.
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