ABSTRACT
The clinical development plan (CDP) strategically outlines and documents the key goals metrics to assess performance, pathways of communication, and parties responsible for decision-making. The CDP requires a multidisciplinary, aspirational, innovative, and collaborative approach, while also providing the conceptual framework for the entire clinical trials program relating to the compound under investigation. Good clinical trial designs and clinical development plan cannot make the drug candidate better, but will increase the probability of success for an effective drug candidate and reduce the cost when the drug candidate is ineffective. The gold standard of trial design should include three essential elements: control, blinding and randomization. The selections of the target patient population, trial design type, primary and secondary clinical endpoints, randomization procedure, and statistical analysis methods will all contribute to the success, the timing and cost of the clinical trials and consequently the entire clinical development program.
