765 Can a Registry Match the Data Quality of a Clinical Trial? Lessons Learned from INTERMACS

Purpose: Registries and clinical trials have different but overlapping purposes. The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) seeks to enroll all patients in the United States who receive an FDA approved durable mechanically assisted circulatory support device (MCSD). Methods and Materials: The purposed of this investigation is to evaluate INTERMACS data quality and compare to a typical clinical trial. Results: The design of INTERMACS is similar to a clinical trial. The INTERMACS protocol includes enrollment criteria, endpoints, adverse event (AE) definitions, and a study manual. INTERMACS is a collaboration among NHLBI, FDA, CMS, industry, hospitals and researchers. The registry requires IRB approval, participation agreements, conflict of interest forms and informed consent. INTERMACS has 130 hospitals in the United States. This is 90% of the MCSD hospitals. All CMS certified destination therapy hospitals are members. INTERMACS screens 90% of implanted patients in the country and 93% are consented and enrolled for a total of 5690 patients. INTERMACS contains 92% of the required follow-up forms. Data entry requires chart abstraction and does not include medical documents. The Medical Events Committee reviews AE data. Questions are forwarded to monitors who review medical records during on-site audits (30/yr) and quarterly phone audits. Conclusions: INTERMACS surpasses a clinical trial in national coverage, longevity, duration of patient follow-up, and the ability to evaluate approved devices. INTERMACS is similar to a clinical trial in endpoint specification and definitions. The INTERMACS auditing process is similar to a clinical trial but with less frequency. While INTERMACS provides medical review of the major AEs, this does not meet the adjudication rigor of a well-funded device trial. The data quality of INTERMACS is sufficient for FDA post market studies and, under pre-specified conditions, can provide the control arm of an FDA pre-market study.