An essential component of drug and device safety study design is developing a protocol that reflects preparedness in reporting and responding to adverse drug events. In order to understand what serious adverse events (SAEs) may occur in a study population, it is important to thoroughly investigate previously reported SAEs in comparable populations. Identifying SAE rates in these populations helps to anticipate event rate estimates and reporting thresholds for use in new studies and post-marketing safety surveillance.


A multi-billion dollar biotechnology company approached Venebio for consultation as they entered Phase III studies with a new compound. The company wanted to understand the rate of SAEs that have been previously reported in similar study populations in order to inform their study design and establish a threshold at which an SAE should be further evaluated as a potential safety signal.


Venebio designed a thorough search strategy using the United States database to identify SAE rates among any trials reporting results on one of nearly thirty drugs of interest. Drugs of interest were selected based on the drugs that were most frequently reported as a concomitant medication in the Client’s clinical trials to-date, thus reflecting a patient base likely to resemble the population who will be using the Client’s compound in future studies.

A literature review team was trained on conducting the search and screening trial documentation for inclusion. More than 3,000 clinical trials were reviewed for potential inclusion in the report. After screening was complete, trained reviewers began a data abstraction process. All abstractions were reviewed for consistency, completeness, underwent quality review, and were assembled into a report for the Client’s clinical development team.


The deliverable was used to support the Client’s clinical trial protocol development, and to establish reporting thresholds for post-marketing safety surveillance. Identifying frequently reported SAEs helped the Client better anticipate the most commonly occurring adverse events in this particular patient population, a critical component in monitoring patient safety.

How Venebio addressed the challenge

Because the SAEs of interest were so extensive and nuanced, a more traditional search of the published literature was not appropriate. A research librarian and methodologic expert were consulted during the planning phase of the project to develop a strong project strategy that would produce useful information appropriate for clinical trial protocol development. Venebio assembled a team of trained reviewers who applied their skills in systematic and comprehensive review to this unique research question.