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Clinical trial design steps

This is the final blog post in the clinical trial series. As discussed in the previous posts, multiple types of clinical trials exist and they generally happen in sequence, from Phase 1 though Phase 3, evaluating drug candidates’ safety and efficacy in humans which ultimately leads to accurate product positioning of the drug by Phase 3. Depending on the compound, indication(s) and trial design, completing the clinical trial process is extensive, costly and time consuming.

At the completion of each clinical trial, the principal investigators and sponsors of the clinical trial, such as biotech companies, analyze the data to determine whether the trial met the goal(s) set out for the compound. Depending on whether the compound has met the expectations of the specific primary endpoint or not, provides guidance whether the trial has succeeded based on a certain ideas of what the drug was hypothesized to do. In most trials, the investigators who design it postulate concepts prior to trial initiation a set of pre-specified endpoint(s) that they predict the compound should be able to achieve. Thus in most trials this is the so called ‘primary endpoint’ by which the trial is initially judged.

For example, if a compound is designed to lower glucose by X mg%, then results from a trial of patients given the compound should on average have glucose below X mg%. If so, then the trial is judged as being positive. Additionally, in most trials the investigators set out multiple secondary and possibly exploratory endpoints which are used to gather further analysis and understanding of the potential of the drug. These endpoints are also important hurdles to judge activity of the compound. Based on the results of the trial, the clinical investigators decide on the next steps in the clinical development of the compound. Both primary and secondary endpoints help determine the accuracy of the investigators’ hypothesis.

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