References
- 1Collins 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
- 2Califf RM. Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials. 2006; 3: 496–502. DOI: 10.1177/1740774506073173
- 3Eisenstein 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
- 4Bowman 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
- 5ISIS-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
- 6Gruppo Italiano per lo studio della streptochinasi nell’Infarto miocardico (GISSI). Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet. 1986; 1: 397–402.
- 7GUSTO 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
- 8Neal 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
- 9Baigent 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
- 10Vos 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
- 11Sabatine 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
- 12Schwartz 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
- 13International 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 . - 14Grimes 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
- 15The RECOVERY Collaborative Group. Dexamethasone in hospitalized patients with COVID-19. N Engl J Med. 2020; 384: 693–704. DOI: 10.1056/NEJMoa2021436
- 16World 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 . - 17O’Grady C. Poor trials of health steps are worse than none, scientists say. Science. 2021; 374: 1180–1181. DOI: 10.1126/science.acx9739
- 18Bugin 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
- 19WHO 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
- 20Konstam MA. Real world data as trial End points. Circulation. 2020; 142: 214–216. DOI: 10.1161/CIRCULATIONAHA.120.048019
- 21Frobert 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
- 22Wallentin 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
