Presentation of Data in Regulatory Clinical Study Reports

17 Presentation of Data in Regulatory Clinical Study Reports 

As noted in Section 10.1, in addition to discussing safety assessment in clinical trials, this chapter provides an overview of clinical trials in general. As well as reviewing different types of trials in Section 10.2, this section provides a brief introduction to presenting general clinical trial data in clinical study reports before looking specifically at the presentation of safety data. 

Describing, or summarizing, the tremendous amount of data that are collected in a clinical trial is typically a very useful first step in reporting the results of the trial. Simple descriptors such as the total number of participants in the trial, the numbers that received the drug treatment and the placebo treatment, respectively, and the average age of the participants in each treatment group help to set the scene for more detailed reporting. 

The Study Population Results section often comes at the beginning of the Results section in the clinical study report and tells the reviewer about the disposition of the subjects in the study. The ITT population is typically used for these descriptions. Much of the information may be presented in tabular form in in-text tables to make the regulatory reviewers task as easy as possible. All data that are reported in a clinical study report need to be verifiable against original source tables provided in the overall submission, and so each in-text table indicates where the source data relevant to the entries in the table are located. 

It is worth noting here that documentation of premature withdrawals from a study is important for various reasons. The implications of premature withdrawals are different in the analysis of safety and the analysis of efficacy. From a safety perspective, these data relate to tolerability of the drug. From an efficacy perspective, dropouts lead to missing data, and the way(s) that missing data are addressed is important from the point of view of full interpretation of the analysis presented. The issue of missing data is addressed in Section 11.2.4. 

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