Integrated clinical/statistical report

An applicant may provide an overall summary of data from controlled studies. This section is optional and many firms do not include it because the results of the studies are presented in the integrated summaries of efficacy and safety, which will be discussed later in this chapter. The Guidelines for the Clinical and Statistical Sections of a New Drug Application also address the format and content of an integrated clinical/statistical report for a clinical study this too will be discussed later. 

The contents of a fully integrated clinical/statistical report should include the following information ... 

To ensure that the integrity of clinical research data is maintained and that there is total agreement between the data recorded on CRFs, the data entered in the computer, the data recorded in data listings and cross-tabulations, the data entered into statistical and clinical study reports and finally the... 

The clinical and statistical information and analyses from a clinical trial should be integrated into a single report. For uncontrolled studies, studies of conditions for which no claim is made in the application, or other studies being provided in the application in support of safety only, the effectiveness results may be presented more briefly than described here complete safety analyses should always be performed. For all analyses, tables, and figures, the patient population from which these data were generated should be clearly identified. 

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