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Taking the time to manage risk in the planning stage optimizes the trial process and provides the best opportunity for the success of the study. If consideration is not given to carefully communicating rationale, objectives, study design, methodology, statistical considerations and data management in an organized manner, endpoints may not be achieved, wasting investment and, most importantly, putting subjects through a trial for no purpose. Ensuring risk is managed in a clear and well thought out manner during protocol development is key as the study protocol is the cornerstone of all clinical trials.