Research Design Service: East Midlands
National Institute for Health Research
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Questions that need answering when designing clinical trials

  Created on Thursday, 27 Mar 2014. Posted in News Items

The Health Research Authority has now published guidance to clarify which questions researchers, sponsors, peer reviewers, and ethics committees should ask when planning or reviewing clinical studies.

The HRA Guidance poses five questions:

  1. Is there a clear research question?
  2. Will the proposed study design answer the research question?
  3. Are the assumptions used in the sample size calculation appropriate?
  4. How will the safety and efficacy be monitored during the trial?
  5. How will the trial be registered and subsequently published?