Registry-based trials: a potential model for cost savings?

Autor:	Anderson BR; Division of Pediatric Cardiology, NewYork-Presbyterian/Morgan Stanley Children's Hospital, Columbia University Irving Medical Center, New York, NY, USA., Gotlieb EG; The Wharton School, University of Pennsylvania, Philadelphia, PA, USA., Hill K; Department of Pediatrics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA., McHugh KE; Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA., Scheurer MA; Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA., Mery CM; Texas Center for Pediatric and Congenital Heart Disease, Dell Children's Medical Center, University of Texas Dell Medical School, Austin, TX, USA., Pelletier GJ; Division of Cardiac Surgery, Nemours Cardiac Center, Alfred I duPont Hospital for Children, Wilmington, DE, USA., Kaltman JR; National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA., White OJ; CardioAccess, Fort Lauderdale, FL, USA., Trachtenberg FL; New England Research Institutes, Watertown, MA, USA., Hollenbeck-Pringle D; New England Research Institutes, Watertown, MA, USA., McCrindle BW; Department of Cardiology at SickKids, Labatt Family Heart Centre, University of Toronto, The Hospital for Sick Children, Toronto, Canada., Sylvester DM; Department of Cardiology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA., Eckhauser AW; Section of Pediatric Cardiothoracic Surgery, Division of Cardiothoracic Surgery, Department of Surgery, University of Utah, Salt Lake City, UT, USA., Pasquali SK; Division of Pediatric Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI, USA., Anderson JB; Division of Pediatric Cardiology, Cincinnati Children's Hospital and Medical Center, Cincinnati, OH, USA., Schamberger MS; Division of Pediatric Cardiology, Riley Children's Hospital, Indianapolis, IN, USA., Shashidharan S; Division of Cardiovascular Surgery, Children's Healthcare of Atlanta, Atlanta, GA, USA., Jacobs JP; Division of Cardiovascular Surgery, Department of Surgery, Johns Hopkins All Children's Heart Institute, St. Petersburg, FL, USA., Jacobs ML; Division of Cardiac Surgery, Department of Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA., Boskovski M; Division of Cardiac Surgery, Harvard Medical School, The Brigham and Women's Hospital, Boston, MA, USA., Newburger JW; Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.; Department of Pediatrics, Harvard Medical School, Boston, MA, USA., Nathan M; Department of Pediatrics, Harvard Medical School, Boston, MA, USA.; Department of Cardiac Surgery, Boston Children's Hospital, Boston, MA, USA.
Jazyk:	angličtina
Zdroj:	Cardiology in the young [Cardiol Young] 2020 Jun; Vol. 30 (6), pp. 807-817. Date of Electronic Publication: 2020 May 08.
DOI:	10.1017/S1047951120001018
Abstrakt:	Background/aims: Registry-based trials have emerged as a potentially cost-saving study methodology. Early estimates of cost savings, however, conflated the benefits associated with registry utilisation and those associated with other aspects of pragmatic trial designs, which might not all be as broadly applicable. In this study, we sought to build a practical tool that investigators could use across disciplines to estimate the ranges of potential cost differences associated with implementing registry-based trials versus standard clinical trials. Methods: We built simulation Markov models to compare unique costs associated with data acquisition, cleaning, and linkage under a registry-based trial design versus a standard clinical trial. We conducted one-way, two-way, and probabilistic sensitivity analyses, varying study characteristics over broad ranges, to determine thresholds at which investigators might optimally select each trial design. Results: Registry-based trials were more cost effective than standard clinical trials 98.6% of the time. Data-related cost savings ranged from $4300 to $600,000 with variation in study characteristics. Cost differences were most reactive to the number of patients in a study, the number of data elements per patient available in a registry, and the speed with which research coordinators could manually abstract data. Registry incorporation resulted in cost savings when as few as 3768 independent data elements were available and when manual data abstraction took as little as 3.4 seconds per data field. Conclusions: Registries offer important resources for investigators. When available, their broad incorporation may help the scientific community reduce the costs of clinical investigation. We offer here a practical tool for investigators to assess potential costs savings.
Databáze:	MEDLINE
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