There is a large amount of texts about this topic and it is hard to know where to begin. Are there any that are of particular quality or highly recommended?
Recommended reference texts:
ClinicalTrials: Design, Conduct and Analysis, Second Edition. Curtis L. Meinert
Statistical Issues in Drug Development, Second Edition. Stephen Senn
Example of sub-topics of interest are:
- Calculating sample size for a minimum effect size of interest
- Analysis strategies to maximise study power
- Common pitfalls regarding pre-specification; particularly the choice of primary, secondary endpoints, covariates and statistical modeling, and how pre-specification is reported and made available prior to study initiation
- Modern implementations of randomisation procedure and common pitfalls
- Testing the of the quality of blinding and how this is reported
- Allocation concealment, how the robustness of concealment should be monitored, and how it should be reported
- Logistics of conducting a hospital based clinical RCT; best-practices regarding patient flow through evaluation for inclusion and exclusion criteria, randomisation and monitoring
- Reporting and publishing the results of the RCT
Any and all suggestions are appreciated and I would be more than happy to monitor the responses, and edit this post to add the suggestions under the relevant subtopics, with links.