Randomized Trials Fit for the 21st Century. A Joint Opinion from the European Society of Cardiology, American Heart Association, American College of Cardiology, and the World Heart Federation
References
- Collins R, MacMahon S. Reliable assessment of the effects of treatment on mortality and major morbidity. I: clinical trials. Lancet. 2001; 357: 373–380. DOI: 10.1016/S0140-6736(00)03651-5
- Califf RM. Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials. 2006; 3: 496–502. DOI: 10.1177/1740774506073173
- Eisenstein EL, Collins R, Cracknell BS, Podesta O, Reid ED, Sandercock P, et al. Sensible approaches for reducing clinical trial costs. Clin Trials. 2008; 5: 75–84. DOI: 10.1177/1740774507087551
- Bowman L, Baras A, Bombien R, Califf RM, Chen Z, Gale CP, et al. Understanding the use of observational and randomized data in cardiovascular medicine. Eur Heart J. 2020; 41: 2571–2578. DOI: 10.1093/eurheartj/ehaa020
- ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet. 1988; 2: 349–360. DOI: 10.1016/S0140-6736(88)92833-4
- Gruppo Italiano per lo studio della streptochinasi nell’Infarto miocardico (GISSI). Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet. 1986; 1: 397–402.
- GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993; 329: 673–682. DOI: 10.1056/NEJM199309023291001
- Neal B, MacMahon S, Chapman N. Blood pressure lowering treatment trialists C. Effects of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomised trials. Blood pressure lowering treatment trialists’ collaboration. Lancet. 2000; 356: 1955–1964. DOI: 10.1016/S0140-6736(00)03307-9
- Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005; 366: 1267–1278. DOI: 10.1016/S0140-6736(05)67394-1
- Vos T, Lim SS, Abbafati C, Abbas KM, Abbasi M, Abbasifard M, et al. Global burden of 369 diseases and injuries in 204 countries and territories, 1990– 2019: a systematic analysis for the global burden of disease study 2019. Lancet. 2020; 396: 1204–1222. DOI: 10.1016/S0140-6736(20)30925-9
- Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017; 376: 1713–1722. DOI: 10.1056/NEJMoa1615664
- Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018; 379: 2097–2107. DOI: 10.1056/NEJMoa1801174
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficacy Guidelines [Cited Dec 8 2021]. Available from:
https://ich.org/page/efficacy-guidelines . - Grimes DA, Hubacher D, Nanda K, Schulz KF, Moher D, Altman DG. The good clinical practice guideline: a bronze standard for clinical research. Lancet. 2005; 366: 172–174. DOI: 10.1016/S0140-6736(05)66875-4
- The RECOVERY Collaborative Group. Dexamethasone in hospitalized patients with COVID-19. N Engl J Med. 2020; 384: 693–704. DOI: 10.1056/NEJMoa2021436
- World Health Organization. An international randomised trial of additional treatments for Covid-19 in hospitalised patients who are all receiving the local standard of care 2020 [Cited Dec 8 2021]. Available from:
https://www.who.int/publications/m/item/an-international-randomised-trial-of-additional-treatments-for-covid-19-in-hospitalisedpatients-who-are-all-receiving-the-local-standard-of-care . - O’Grady C. Poor trials of health steps are worse than none, scientists say. Science. 2021; 374: 1180–1181. DOI: 10.1126/science.acx9739
- Bugin K, Woodcock J. Trends in COVID-19 therapeutic clinical trials. Nat Rev Drug Discov. 2021; 20: 254–255. DOI: 10.1038/d41573-021-00037-3
- WHO Solidarity Trial Consortium. Repurposed antiviral drugs for COVID-19—interim WHO solidarity trial results. N Engl J Med. 2021; 384: 497–511. DOI: 10.1056/NEJMoa2023184
- Konstam MA. Real world data as trial End points. Circulation. 2020; 142: 214–216. DOI: 10.1161/CIRCULATIONAHA.120.048019
- Frobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013; 369: 1587–1597. DOI: 10.1056/NEJMoa1308789
- Wallentin L, Gale CP, Maggioni A, Bardinet I, Casadei B. Euroheart: European unified registries on heart care evaluation and randomized trials. Eur Heart J. 2019; 40: 2745–2749. DOI: 10.1093/eurheartj/ehz599
DOI: https://doi.org/10.5334/gh.1178 | Journal eISSN: 2211-8179
Language: English
Submitted on: Sep 20, 2022
Accepted on: Nov 3, 2022
Published on: Dec 16, 2022
Published by: Ubiquity Press
In partnership with: Paradigm Publishing Services
Publication frequency: 1 issue per year
© 2022 Louise Bowman, Franz Weidinger, Michelle A. Albert, Edward T. A. Fry, Fausto J. Pinto, For the Clinical Trial Expert Group and ESC Patient Forum, published by Ubiquity Press
This work is licensed under the Creative Commons Attribution-NonCommercial 4.0 License.