Preparing Clinical Study Reports

The requirements for reporting clinical trials to international regulatory authorities are similar in intent but differ in detail. Sponsors approach preparation of NDA/BLA documentation in a modular format. Each module satisfies a specific documentation need. The modules are generally organized as follows:

• Module I. Includes a basic summary of the study, not unlike a publication. It includes: study rationale, objectives, methods, results, and conclusions. Module I also has a large appendix, which includes: list of investigators; drug lot numbers; concomitant diseases and medications; intent-to-treat analysis; patient listings of adverse events and relevant laboratory abnormalities; and publications on the study.

• Module II. Includes the protocol and any modifications, case report form, detailed methodology, and the glossary of original terminology and preferred terms.

• Module III. Presents the detailed efficacy findings, including the intent-to-treat analysis population and the efficacy data listings.

• Module IV. Presents the detailed safety findings, including the intent-to-treat analysis population and the safety data listings.

• Module V. Includes individual center summary reports, quality assurance measures, statistical methods and analyses, and randomization lists.

The skills necessary to prepare a clinical study report include:

• Advanced research design, methodology, and statistics.

• Preparation and review of study tabulations.

• Ability to confirm that study tabulations conform to protocol design.

• Ability to verify study tabulations against computer data listings.

• Clarification of outstanding issues regarding data analysis and presentation.

• Drafting of assigned study report sections according to the clinical study report prototype.

• Interpretation of adverse events.

• Interpretation of laboratory findings.

• Interpretation of efficacy findings.

• Ensuring that data support the conclusions.

• Ensuring that reports satisfy regulatory requirements.

• Developing clear, simple graphs, tables, and figures to illustrate and support findings.

• Ability to write a clear, concise report that accurately summarizes and interprets the results.

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