January 2, 2020
CRF Commissions Independent Review of the EXCEL Trial
January 3, 2020—The Cardiovascular Research Foundation (CRF) announced it has commissioned an independent review of the EXCEL trial.
According to CRF, the organization was engaged by the sponsor of the EXCEL trial, Abbott, to organize the independent Clinical Endpoint Committee and to perform specific analytical and other related services. Other than providing these services, CRF had no role in the conduct of the trial.
Gregg Stone, MD, who serves as principal investigator of the trial, is a leader of the Faculty of CRF but is not an employee of CRF. Dr. Stone continues to be involved with the organization, noted the advisory.
In the statement, the CRF asserted, “Because of our commitment to excellence, we have commissioned an independent review of the matter. We are also available to assist the relevant societies and medical academies to ensure a comprehensive review of available data from the EXCEL trial.
“CRF is committed to clinical research using high academic and operational standards. We fully support the balanced and transparent presentation and dissemination of all clinical trial results.”
On December 12, 2019, Dr. Stone and the EXCEL leadership issued a response to the recent news reports and society statements questioning the conduct and data of the EXCEL trial.