Questions that need answering when designing clinical trials – new guidance from the HRA

The Health Research Authority has published useful 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?

Janet Wisely, Chief Executive of the HRA, commented: "I am delighted the HRA has been able to support this important work, which is in line with our aims to support 'research on research'. The research itself gives a valuable insight and we have been able to produce comprehensive guidance to improve study design and support effective scientific and ethical review of research. Therefore, we help to build both public confidence and participation in health research, and so improve the nation's health by making sure that patient and public opportunity to do so is maximised by streamlining the processes by which high quality research is assessed and carried out."

The guidance can be obtained from the HRA website.