Regulatory authorities in the United States and abroad are putting a greater emphasis on the use of oversight committees during the conduct of clinical research to ensure the proper and independent reporting of safety and efficacy of investigational drugs and medical devices.
"Oversight committees for Clinical Events and Data Monitoring are crucial elements for the efficient execution of clinical trials," said Roxana Mehran, MD, Chief Scientific Officer of the CRF Clinical Trials Center. Dr. Mehran is internationally recognized for her work as an expert clinical trialist with extensive experience in complex data analyses and outcomes research within the field of interventional cardiovascular medicine.
Applying uniform rules for the assessment of clinical endpoints and safety adverse events is one of the most important ways that sponsors can ensure the safety of trial participants and the validity and integrity of their trial data.
Event adjudication in randomized controlled trials also helps to remove potential bias from results, making research findings more relevant and able to withstand scrutiny by both regulatory entities and the practicing medical community. Clinical Event Committees (CEC) systematically identify, adjudicate, and classify clinical endpoint events to ensure they are consistent with prevailing standards. Data Monitoring Committees (DMC) actively monitor patient safety and treatment efficacy data to provide a risk-benefit profile of the investigative treatment or procedure over the life of the trial.
Currently, the CRF Clinical Trials Center offers keen expertise in developing and maintaining both types of committees for a variety of cardiovascular trials under its Event Adjudication and Reporting division. The group is led by Sorin J. Brener, MD, and Alejandra Guerchicoff, PhD, two leading professionals in the field with a strong background in regulatory and safety reporting.
"Event adjudication is a wise investment for sponsors who are looking to conduct well organized trials. Clinical Event and Data Monitoring Committees can help ensure that your trial data is consistent, reliable and of high quality," said Dr. Brener, Director, Event Adjudication and Reporting.
"Led by a dedicated team of cardiologists and researchers, the CTC can also provide a large, experienced network of physicians with the right knowledge and expertise needed for each trial," said Dr. Guerchicoff, Co-Director, Event Adjudication and Reporting.
"The CRF Clinical Trials Center has an impressive reputation in the cardiovascular field with exclusive access to a large contingent of leading physicians in cardiovascular medicine," said Helen Parise, ScD, Executive Director, CRF Clinical Trials Center. "For each trial, we can pull together a highly knowledgeable and skilled panel of physician leaders to deliver the most sophisticated and efficient adjudication services."