What is it about?
Present general design aspects to consider including patient population, active comparators and placebos, study power, pharmacokinetic–pharmacodynamic relationships, and minimization of missing data.
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Why is it important?
The advantages and disadvantages of more recent trial designs, including N-of-1 designs, enriched designs, adaptive designs, and sequential parallel comparison designs, are summarized, and recommendations for consideration are provided.
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This page is a summary of: Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations, Pain, September 2014, Wolters Kluwer Health,
DOI: 10.1016/j.pain.2014.05.025.
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