About The Study

Creating a Clinical Event Committee in a New Therapeutic Area

Challenge:

In a recent study with cardiac endpoints, we were unexpectedly required to adjudicate non-cardiac deaths. With little notice, we were asked to review approximately 250 deaths to adjudicate a possible association to cancer. This work needed to be completed within three weeks to meet a deadline for presentation at a major scientific conference.

Solution:

To successfully meet this aggressive timeline, we needed to identify four oncologists, expedite their conflict-of-interest (COI) review in order to on-board them quickly, and complete contracts and database build, all within one week, leaving two weeks for adjudication and production of results.

We began the process by working closely with our extended faculty to identify and create three CEC teams; two teams consisting of two oncologists each to adjudicate the non-cardiac deaths where cancer was found, and the third team consisting of two cardiologists who reviewed the cardiac and vascular deaths to determine the mechanism of death.

The Baim Institute team worked with Faculty to quickly design a clinical database specific for the adjudication results. We were able to begin with our existing database framework and supplement it with additional fields specifically required in this case.  The Clinical Specialists reviewed the source documents for all identified non-cardiac events and prepared a clinical summary to allow for the efficient review and adjudication at the two scheduled meetings held one week apart.

Outcome:

Once the database was complete, two CEC meetings were held one week apart to adjudicate all deaths. Data entry was completed, QC was performed, and data was exported within one week of the second meeting. Results of the adjudications were presented by the study PI two weeks later.