About The Study

Event Identification for a Large and Complex Global Study

Challenge:

Within the landmark DAPT Study (see related Case Study), our Clinical Events team faced a number of challenges that had to be overcome in order to complete the study for all of the eight funding companies and the FDA:

  • Event adjudication for this large cohort consisted of two parts. First, we identified and adjudicated events from the native DAPT patients that we recruited and which were housed in our database. Second, we adjudicated events that were identified by the four stent manufacturers participating in these post-market studies
  • Post-marketing protocols: the four Manufacturers each contained inconsistent clinical study primary and secondary safety endpoints and definitions
  • Site reporting of events within the case report forms of these four studies originated in multiple databases
  • The need to work with multinational sites and a diverse set of regulatory authority requirements

Processing a high volume of events: 12,794 for the entire study, operationalized to 300 events at biweekly CEC meetings

Solution:

We were able to address these issues by taking proactive approaches, which began during the planning phase of the study. During this time our clinical team identified, trained, and created open communication lines within our organization, as well as with Manufacturer representatives, in order to create specific processes to assist with event identification, review, and clinical summary preparation for all subjects, whether sponsor-enrolled or manufacturer-contributed. Next, we reviewed each Manufacturer’s protocol, CRF, and planned safety reporting procedures, focusing on evaluation of key data points/terms, that could lead to better identification of events for adjudication. This also included developing event triggers to look at MedDRA terms that would identify potential events requiring review. This training process also included specifications regarding source document collection. During this phase we identified a group of skilled and experienced physicians to form a dedicated CEC for the study.During the study, we created customized reports for each contributing manufacturer. We also set up ongoing internal review of reported events in order to look for possible missed endpoints as well as for endpoint events within previously-submitted events. Part of these ongoing activities included a reassessment of any modifications to the Manufacturers’ clinical study protocols, case report forms, and endpoint definitions, and featured trend analysis regarding any impact to event identification.

Outcome:

In summary, a proactive approach featuring early planning as well as ongoing communication during the entire conduct of the trial, led to a more seamless collection of information, better throughput management, and more accurate and reliable data.