The occurrence of just one serious or fatal adverse event in a clinical trial may lead to lack of marketing approval or a labelled warning in the prescribing information of a product. Certain types of adverse events are common concerns in clinical trials investigating pharmaceuticals (e.g. hepatic, dermatologic, cardiac and hypersensitivity adverse events). To improve the assessment of the causal role of an investigational product in such safety events, collecting detailed information beyond what is routinely done can be critical. Consequently, developing sample supplemental data collection forms would be very useful to clinical trial stakeholders.

The objective of this project is to create supplemental data collection forms for hepatic adverse events, serious hypersensitivity reactions, severe dermatologic reactions, and potentially selected cardiac events. These sample data collection forms would be included in a submitted publication describing the value of detailed data collection for key adverse events in clinical trial safety assessment.

First a literature review of relevant information will be performed including clinical event definitions (e.g. anaphylactic reaction) and available published examples of supplemental data collection forms. Also, examples will be compiled of products which have been withdrawn from further clinical development/not approved or have a labelled warning based on one or two serious/fatal adverse occurrences in the pivotal clinical trials. The role of detailed event information in the causality assessment of such safety events will be evaluated. Supplemental data collection forms will be developed for common pharmaceutical safety concerns guided by identified published event definitions or other clinical information.

Mainly Microsoft Office, internet searches

The primary objective would be for the work to be included as part of a published manuscript.

However, presentation of a poster at a local venue or potentially at a conference such as the Drug Information Association global annual meeting or the Society for Clinical Trials annual meeting is a consideration.