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Basic Concepts of Study Design in Clinical Development

Drug Development
Workshop profile:
This workshop is aimed at writers who wish to learn about the concepts underlying clinical development (e.g. the standard sections of a study protocol aimed at proving efficacy or the literature on clinical trials of efficacy). The workshop is suitable for those setting out to write regulatory documents as well as those who already have experience in medical communications or medical publishing who wish to understand the concepts underlying experimental study design.
To raise basic understanding of both study design and study conduct issues and the importance of these for valid and relevant experiments in trials intended as confirmatory studies of efficacy.
This workshop focuses on the theoretical concepts underlying good design and not the process of either protocol or report generation, nor the wider content of these documents. The following topics are covered: • The design characteristics of a confirmatory study of efficacy • The relationship between the study objective, the study hypotheses, the choice of endpoint and choice of control group • Factors governing the identification of the study population • The basis of sample size and its relationship with ‘power’ • Robustness of data based on the example of the full analysis set (also known as ITT) and a per protocol analysis set • Bias: blinding and randomising to treatment groups and identifying bias in data • The relationship between statistical significance, clinical relevance and ‘generalisability’ There will be classroom-format presentations as well as group exercises. The approach is intuitive, not statistical.