5 Takeaways: Clinical trial preparation
- Early involvement with an experienced CRO, such as Datapharm, will make for a smoother and optimised trial experience
- A well written protocol with a clear statistics section justifying the study design is essential to present to an Ethics Committees for approval and to design an appropriate database for data collection.
- Sample size calculation is critical and requires knowledge of the analyses to be performed, the intended significance and power levels, and estimated factors from previous studies, most commonly the expected effect size and variability in the primary outcome.
- A SAP contains details about analysis populations, primary and secondary endpoints, interim analyses, statistical tests, tables, figures, and is best signed off prior to finalising the data set to be analysed.
- All randomisation lists are kept securely so that the sponsor and our team cannot become unblinded during the study. If a code break is needed, investigators are provided with a codebreak password within an electronic data capture system.
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