Perils Lurking in the Discussion Section of a Clinical Study Report:
When in Doubt, Leave it Out

Help When You Need It.

The Discussion section of a clinical study report is fun to write. This section is the most speculative and creative section of the report, allowing the report creators to interpret the relevance of the study data. Including too much speculation in your Discussion, however, can have unintended consequences.

One pharmaceutical company, in its zeal to interpret study data, included in its Discussion section a description of additional studies needed to further elucidate the pharmacologic actions of its study drug. One major problem emerged: the company didn't conduct these additional studies. You can imagine the company's surprise, then, when FDA asked for these additional studies during its review of the company's new drug application. Oops. A long dialog ensued, and the company was finally able to convince FDA that the drug was approvable in the absence of these additional studies. This dialog caused a considerable delay to the drug's approval, however.

Academic researchers and scientists love to talk about additional studies: they are curious people. Researchers earn their living by identifying research questions and describing new knowledge to be gained by conducting additional studies.

Commercial companies, on the other hand, need to limit expenses. Clinical studies are expensive. Many drugs are approved without knowing their exact pharmacology or mechanism of action. Thus, while it's fun to speculate about certain studies, companies need to focus mainly on those studies important to their corporate objectives.

It is important for companies and researchers to discuss the meaning of data and directions of future research. When writing the Discussion section of the clinical study report, however, such speculation may best be omitted. An interpretation that seemed logical last year may no longer be relevant in the context of information obtained this year.

By all means, consider using your Discussion section to interpret your results in the context of other data. However, speculative Discussion points and interpretation may best be left to later submissions, such as the summary documents of your new drug or biologics license application.