Clinical Events Committee

“Complete, consistent, and timely adjudication of clinical endpoints by independent experts is essential for the accurate representation of safety and effectiveness outcomes from drug and device clinical trials. Our approach relies on clinical leaders from multiple specialties who combine their clinical expertise with experience in the nuances of event adjudication to maximize the efficiency and accuracy of the adjudication process. Over the past 25 years, our highly experienced operational staff and clinical trialists have worked with a vast array of clinical trial sponsors and investigators to design systems to address the individualized requirements of more than 200 clinical trials with adjudication of over 60,000 clinical events. We are proud to provide leadership and collaborate with others in development of standardized CEC processes and endpoint definitions”.

Don Cutlip, MD
Chief Medical Officer

Maintaining independence and consistency by ensuring adherence to protocol-defined endpoint events is a vital aspect of clinical studies. The Baim Institute consistently innovates our processes and sets the industry gold standard in clinical endpoint event adjudication.

Our approach is fit for purpose:

We work closely with our sponsors to ensure that the system specifications are adequate for the nuanced nature of each study. Each study database is designed by the Baim Institute’s internal adjudication experts. Our approach has reduced the time to adjudication of events in a trial, and our unique CEC model provides rapid identification and confirmation of endpoint events to assure an expedited closing of the clinical database.

The Baim Institute employs a team of MD and RN specialists who are experienced in the interrogation of clinical study datasets to identify and adjudicate study endpoint events across a broad range of therapeutic areas. This team of clinical reviewers averages more than 30 years of critical care experience across a variety of therapeutic areas and has an average of eight years of event adjudication experience.

Our centralized identification of study endpoint events results in a higher quality clinical study and greater assurance of the consistency of reported study endpoints. The interface and features provide mechanisms that ensure a timely turnaround of service and the ability to adjudicate cases in-stream, which results in a scalable, efficient adjudication process. The integration of electronic data collection methods along with an extensive quality control process are what make The Baim adjudication process the industry gold standard.

To further validate the accuracy of these events, the Baim Institute’s medical team prepares clinical narrative summaries for submission to its Clinical Events Committee (CEC) for final adjudication. The Baim CEC meets frequently. and membership includes leading academic-based physicians in various areas of clinical specialty across multiple therapeutic areas.

Our experience is comprehensive:

  • Processed and submitted more than 60,000 cases for CEC adjudication.
  • Organized and led the Academic Research Consortium efforts to implement consensus definitions for stent thrombosis in clinical trials of drug eluting stents under the leadership of Donald Cutlip, MD.
  • Conceived and led Valve Academic Research Consortium efforts to implement consensus definitions for clinical studies of percutaneous heart valves.
  • Provided the adjudication and analysis for the FDA special panel meeting on stent thrombosis and DES. 

References

  • Seltzer JH, Heise T, Carson P, Canos D, Hiatt JC, Vranckx P, Christen T and Cutlip DE. Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium. Am Heart J. 2017;190:76-85.

  • Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW and Serruys PW. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344-51.

  • Krucoff MW, Mehran R, van Es GA, Boam AB and Cutlip DE. The academic research consortium governance charter. JACC Cardiovasc Interv.4:595-6.

  • Vranckx P, Cutlip DE, Mehran R, Kint PP, Silber S, Windecker S and Serruys PW. Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. Addendum to the historical MI definitions used in stent studies. EuroIntervention. 2010;5:871-4.

Our CEC group provides the following services:

  • Generation of CEC Charters.
  • Selection, and vetting through conflict of interest, the required quorum of CEC physicians.
  • Narration and coding of endpoint events, including report quality narratives.
  • Identification of potential endpoint events.
  • Adjudication of potential events across multiple therapeutic areas by a panel of medical experts.
  • Online adjudication database platform, including results dataset transfers.
  • Entry of results into sponsor’s clinical database.