TY - JOUR T1 - Streamlining cardiovascular clinical trials to improve efficiency and generalisability JF - Heart JO - Heart SP - 1156 LP - 1162 DO - 10.1136/heartjnl-2017-311191 VL - 103 IS - 15 AU - Faiez Zannad AU - Marc A Pfeffer AU - Deepak L Bhatt AU - Denise E Bonds AU - Jeffrey S Borer AU - Gonzalo Calvo-Rojas AU - Louis Fiore AU - Lars H Lund AU - David Madigan AU - Aldo Pietro Maggioni AU - Catherine M Meyers AU - Yves Rosenberg AU - Tabassome Simon AU - Wendy Gattis Stough AU - Andrew Zalewski AU - Nevine Zariffa AU - Robert Temple Y1 - 2017/08/01 UR - http://heart.bmj.com/content/103/15/1156.abstract N2 - Controlled trials provide the most valid determination of the efficacy and safety of an intervention, but large cardiovascular clinical trials have become extremely costly and complex, making it difficult to study many important clinical questions. A critical question, and the main objective of this review, is how trials might be simplified while maintaining randomisation to preserve scientific integrity and unbiased efficacy assessments. Experience with alternative approaches is accumulating, specifically with registry-based randomised controlled trials that make use of data already collected. This approach addresses bias concerns while still capitalising on the benefits and efficiencies of a registry. Several completed or ongoing trials illustrate the feasibility of using registry-based controlled trials to answer important questions relevant to daily clinical practice. Randomised trials within healthcare organisation databases may also represent streamlined solutions for some types of investigations, although data quality (endpoint assessment) is likely to be a greater concern in those settings. These approaches are not without challenges, and issues pertaining to informed consent, blinding, data quality and regulatory standards remain to be fully explored. Collaboration among stakeholders is necessary to achieve standards for data management and analysis, to validate large data sources for use in randomised trials, and to re-evaluate ethical standards to encourage research while also ensuring that patients are protected. The rapidly evolving efforts to streamline cardiovascular clinical trials have the potential to lead to major advances in promoting better care and outcomes for patients with cardiovascular disease. ER -