3. Distorsion de la connaissance scientifique
Références
[1] Prasad VK. Malignant: How bad policy and bad evidence harm people with cancer. Baltimore: Johns Hopkins University Press 2020 ISBN:9781421437637;
[2] Kozauer N, Katz R. Regulatory innovation and drug development for early-stage Alzheimer's disease. N Engl J Med 2013;368:1169–71 10.1056/NEJMp1302513 [23484795]
[3] (2021). F.D.A. to Ease Alzheimer’s Drug Approval Rules - The New York Times. New York Times, 15 November 2021. Available at: https://www.nytimes.com/2013/03/14/health/fda-to-ease-alzheimers-drug-approval-rules.html?pagewanted=all Accessed November 15, 2021.
[4] Hwang TJ, Ross JS, Vokinger KN, et al. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study. BMJ 2020;371:m3434 10.1136/bmj.m3434 [33028575]
[5] Gyawali B, Hey SP, Kesselheim AS. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval. JAMA Internal Medicine 2019;179:906–13 10.1001/jamainternmed.2019.0462 [31135808]
[6] Naci H, Davis C, Savović J, et al. Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis. BMJ 2019;366:l5221 10.1136/bmj.l5221 [31533922]
[7] Schnog J-JB, Samson MJ, Gans ROB, et al. An urgent call to raise the bar in oncology. Br J Cancer 2021 10.1038/s41416-021-01495-7 [34400802]
[8] Del Paggio JC, Tannock IF. The fragility of phase 3 trials supporting FDA-approved anticancer medicines: a retrospective analysis. The Lancet Oncology 2019;20:1065–69 10.1016/S1470-2045(19)30338-9
[9] Tannock IF, Amir E, Booth CM, et al. Relevance of randomised controlled trials in oncology. The Lancet Oncology 2016;17:e560-e567 10.1016/S1470-2045(16)30572-1 [27924754]
[10] Zagury-Orly I, Schwartzstein RM. Covid-19 - A Reminder to Reason. N Engl J Med 2020 10.1056/NEJMp2009405 [32343505]
[11] Ladanie A, Schmitt AM, Speich B, et al. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016. JAMA Netw Open 2020;3:e2024406 10.1001/jamanetworkopen.2020.24406 [33170262]
[12] Salas-Vega S, Iliopoulos O, Mossialos E. Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines. JAMA Oncol 2017;3:382–90 10.1001/jamaoncol.2016.4166 [28033447]
[13] Tannock IF, Templeton AJ. Flawed trials for cancer. Annals of Oncology 2020;31:331–33 10.1016/j.annonc.2019.11.017 [32067676]
[14] Pundi K, Perino AC, Harrington RA, et al. Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov. JAMA Intern Med 2020 10.1001/jamainternmed.2020.2904 [32730617]
[15] Raynaud M, Zhang H, Louis K, et al. COVID-19-related medical research: a meta-research and critical appraisal. BMC Med Res Methodol 2021;21:1 10.1186/s12874-020-01190-w [33397292]
[16] van Nguyen T, Rivière P, Ripoll P, et al. Research response to coronavirus disease 2019 needed better coordination and collaboration: a living mapping of registered trials. Journal of Clinical Epidemiology 2020;130:107–16 10.1016/j.jclinepi.2020.10.010 [33096223]
[17] Tibau A, Molto C, Borrell M, et al. Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials. JAMA Oncol 2018;4:1610–11 10.1001/jamaoncol.2018.4300 [30267037]
[18] Chen EY, Raghunathan V, Prasad V. An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate. JAMA Internal Medicine 2019;179:915–21 10.1001/jamainternmed.2019.0583 [31135822]
[19] Walsh S, Merrick R, Milne R, et al. Aducanumab for Alzheimer's disease? BMJ 2021;374:n1682 10.1136/bmj.n1682 [34226181]
[20] Alexander GC, Emerson S, Kesselheim AS. Evaluation of Aducanumab for Alzheimer Disease: Scientific Evidence and Regulatory Review Involving Efficacy, Safety, and Futility. JAMA 2021;325:1717–18 10.1001/jama.2021.3854 [33783469]
[21] CardioBrief: FDA's Gottlieb Preparing To Lower The Bar To Approval 2017. Available at: https://www.medpagetoday.com/cardiology/cardiobrief/68224 Accessed November 15, 2021.
[22] CardioBrief. Cardiac Devices Could Become a Big Problem For Califf And The FDA 2016. Available at: http://www.cardiobrief.org/2016/11/07/cardiac-devices-could-become-a-big-problem-for-califf-and-the-fda/ Accessed November 15, 2021.
[23] Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). New Engl J Med 1987;316:1429–35 10.1056/NEJM198706043162301 [2883575]
[24] Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 2015;372:320–30 10.1056/NEJMoa1412082 [25399552]
[25] Hwang TJ, Carpenter D, Lauffenburger JC, et al. Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results. JAMA Intern Med 2016;176:1826–33 10.1001/jamainternmed.2016.6008 [27723879]
[26] Gigerenzer G. We need statistical thinking, not statistical rituals. Behav Brain Sci 1998;21:199–200 10.1017/S0140525X98281167
[27] Marks H. La médecine des preuves: Histoire et anthropologie des essais cliniques / 1900-1990. Le Plessis-Robinson: Institut Synthélabo pour le progrès de la connaissance 1999 ISBN:2-84324-044-1;
[28] FR_ALLEA_Code_de_conduite_europeen_pour_lintegrite_en_recherche.
[29] Boutron I, Dutton S, Ravaud P, et al. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 2010;303:2058–64 10.1001/jama.2010.651 [20501928]
[30] Khan MS, Lateef N, Siddiqi TJ, et al. Level and Prevalence of Spin in Published Cardiovascular Randomized Clinical Trial Reports With Statistically Nonsignificant Primary Outcomes: A Systematic Review. JAMA Netw Open 2019;2:e192622 10.1001/jamanetworkopen.2019.2622 [31050775]
[31] Lundh A, Barbateskovic M, Hróbjartsson A, et al. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study. PLOS Medicine 2010;7:e1000354 10.1371/journal.pmed.1000354 [21048986]
[32] Ioannidis JPA. Hundreds of thousands of zombie randomised trials circulate among us. Anaesthesia 2020 10.1111/anae.15297 [33124075]
[33] Angell M. The truth about the drug companies: How they deceive us and what to do about it. New York: Random House 2005 ISBN:9780375760945;
[34] Kassirer JP. On the take: How medicine's complicity with big business can endanger your health. Oxford, New York: Oxford University Press 2005 ISBN:9780195300048;
[35] Lundh A, Barbateskovic M, Hróbjartsson A, et al. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study. PLOS Medicine 2010;7:e1000354 10.1371/journal.pmed.1000354 [21048986]
[36] Hilal T, Gonzalez-Velez M, Prasad V. Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration. JAMA Intern Med 2020;180:1108–15 10.1001/jamainternmed.2020.2250 [32539071]
[37] Hilal T, Sonbol MB, Prasad V. Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration. JAMA Oncol 2019;5:887–92 10.1001/jamaoncol.2019.0167 [31046071]
[38] Mohyuddin GR, Koehn K, Sborov D, et al. Quality of control groups in randomised trials of multiple myeloma enrolling in the USA: a systematic review. The Lancet Haematology 2021;8:e299-e304 10.1016/S2352-3026(21)00024-7
[39] Prasad V, Kim C, Burotto M, et al. The Strength of Association Between Surrogate End Points and Survival in Oncology: A Systematic Review of Trial-Level Meta-analyses. JAMA Internal Medicine 2015;175:1389–98 10.1001/jamainternmed.2015.2829 [26098871]
[40] Carpenter DP. Reputation and power: Organizational image and pharmaceutical regulation at the FDA. Princeton (N.J.), Oxford: Princeton University Press 2010 ISBN:9780691141794;
[41] Temple R. Policy developments in regulatory approval. Stat Med 2002;21:2939–48 10.1002/sim.1298 [12325110]
[42] Landray MJ, Haynes R, Hopewell JC, et al. Effects of extended-release niacin with laropiprant in high-risk patients. N Engl J Med 2014;371:203–12 10.1056/NEJMoa1300955 [25014686]
[43] Echt DS, Liebson PR, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. New Engl J Med 1991;324:781–88 10.1056/NEJM199103213241201 [1900101]
[44] Nissen SB, Magidson T, Gross K, et al. Publication bias and the canonization of false facts. eLife 2016;5 10.7554/eLife.21451 [27995896]
[45] Song F, Parekh-Bhurke S, Hooper L, et al. Extent of publication bias in different categories of research cohorts: a meta-analysis of empirical studies. BMC Med Res Methodol 2009;9:79 10.1186/1471-2288-9-79 [19941636]
[46] Wang M, Cao R, Zhang L, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res 2020;30:269–71 10.1038/s41422-020-0282-0 [32020029]
[47] Hoffmann M, Mösbauer K, Hofmann-Winkler H, et al. Chloroquine does not inhibit infection of human lung cells with SARS-CoV-2. Nature 2020;585:588–90 10.1038/s41586-020-2575-3 [32698190]
[48] Horby P, Mafham M, Linsell L, et al. Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. N Engl J Med 2020;383:2030–40 10.1056/NEJMoa2022926 [33031652]
[49] Axfors C, Schmitt AM, Janiaud P, et al. Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials. Nat Commun 2021;12:2349 10.1038/s41467-021-22446-z [33859192]
[50] Naumann RW, Coleman RL, Burger RA, et al. PRECEDENT: a randomized phase II trial comparing vintafolide (EC145) and pegylated liposomal doxorubicin (PLD) in combination versus PLD alone in patients with platinum-resistant ovarian cancer. J Clin Oncol 2013;31:4400–06 10.1200/JCO.2013.49.7685 [24127448]
[51] Munafò MR, Nosek BA, Bishop DVM, et al. A manifesto for reproducible science. Nat Hum Behav 2017;1:21 10.1038/s41562-016-0021 [33954258]
[52] Baxter R, Tran TN, Hansen J, et al. Safety of Zostavax™--a cohort study in a managed care organization. Vaccine 2012;30:6636–41 10.1016/j.vaccine.2012.08.070 [22963800]
[53] Kerr NL. HARKing: hypothesizing after the results are known. Pers Soc Psychol Rev 1998;2:196–217 10.1207/s15327957pspr0203_4 [15647155]
[54] Gnant M, Mlineritsch B, Schippinger W, et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N Engl J Med 2009;360:679–91 10.1056/NEJMoa0806285 [19213681]
[55] Coleman RE, Marshall H, Cameron D, et al. Breast-cancer adjuvant therapy with zoledronic acid. N Engl J Med 2011;365:1396–405 10.1056/NEJMoa1105195 [21995387]
[56] Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. New Engl J Med 1989;321:406–12 10.1056/NEJM198908103210629 [2473403]
[57] Anderson JL, Platia EV, Hallstrom A, et al. Interaction of baseline characteristics with the hazard of encainide, flecainide, and moricizine therapy in patients with myocardial infarction. A possible explanation for increased mortality in the Cardiac Arrhythmia Suppression Trial (CAST). Circulation 1994;90:2843–52 10.1161/01.CIR.90.6.2843 [7994829]
[58] Grouse L. Post hoc ergo propter hoc. J. Thorac. Dis. 2016;8:E511-2 10.21037/jtd.2016.04.49 [27499984]
[59] Bertholf RL. Scientific Evidence, Medical Practice, and the Insidious Danger of Anecdotal Reports. Laboratory Medicine 2020;51:555–56 10.1093/labmed/lmaa093 [33095864]
[60] Smith GCS, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ 2003;327:1459–61 10.1136/bmj.327.7429.1459 [14684649]
[61] Höfler M. Causal inference based on counterfactuals. BMC Med Res Methodol 2005;5:28 10.1186/1471-2288-5-28 [16159397]
[62] Pearl J. An introduction to causal inference. The International Journal of Biostatistics 2010;6:Article 7 10.2202/1557-4679.1203 [20305706]
[63] Cucherat M, Laporte S, Delaitre O, et al. From single-arm studies to externally controlled studies. Methodological considerations and guidelines. Therapie 2020;75:21–27 10.1016/j.therap.2019.11.007 [32063399]
[64] Nagendran M, Pereira TV, Kiew G, et al. Very large treatment effects in randomised trials as an empirical marker to indicate whether subsequent trials are necessary: meta-epidemiological assessment. BMJ 2016;355:i5432 10.1136/bmj.i5432 [27789483]
[65] Bruns SB, Ioannidis JPA. p-Curve and p-Hacking in Observational Research. PLoS ONE 2016;11:e0149144 10.1371/journal.pone.0149144 [26886098]
[66] Patel CJ, Burford B, Ioannidis JPA. Assessment of vibration of effects due to model specification can demonstrate the instability of observational associations. Journal of Clinical Epidemiology 2015;68:1046–58 10.1016/j.jclinepi.2015.05.029 [26279400]
[67] Head ML, Holman L, Lanfear R, et al. The extent and consequences of p-hacking in science. PLoS Biology 2015;13:e1002106 10.1371/journal.pbio.1002106 [25768323]
[68] Silberzahn R, Uhlmann EL, Martin DP, et al. Many analysts, one dataset: Making transparent how variations in analytical choices affect results 2017.
[69] Chuard PJC, Vrtílek M, Head ML, et al. Evidence that nonsignificant results are sometimes preferred: Reverse P-hacking or selective reporting? PLoS Biol 2019;17:e3000127 10.1371/journal.pbio.3000127 [30682013]
[70] Michels KB, Rosner BA. Data trawling: to fish or not to fish. The Lancet 1996;348:1152–53 10.1016/S0140-6736(96)05418-9
[71] Data dredging - Wikipedia 2021. Available at: https://en.wikipedia.org/wiki/Data_dredging Accessed August 30, 2021.
[72] Berger ML, Sox H, Willke RJ, et al. Good Practices for Real-World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR-ISPE Special Task Force on Real-World Evidence in Health Care Decision Making. Value Health 2017;20:1003–08 10.1016/j.jval.2017.08.3019 [28964430]
[73] Ioannidis JPA. The Mass Production of Redundant, Misleading, and Conflicted Systematic Reviews and Meta-analyses. The Milbank Quarterly 2016;94:485–514 10.1111/1468-0009.12210 [27620683]
[74] Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629–34 10.1136/bmj.315.7109.629 [9310563]
[75] Easterbrook P, Gopalan R, Berlin J, et al. Publication bias in clinical research. The Lancet 1991;337:867–72 10.1016/0140-6736(91)90201-Y
[76] Song F, Parekh-Bhurke S, Hooper L, et al. Extent of publication bias in different categories of research cohorts: a meta-analysis of empirical studies. BMC Med Res Methodol 2009;9:79 10.1186/1471-2288-9-79 [19941636]
[77] Turner EH, Matthews AM, Linardatos E, et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008;358:252–60 10.1056/NEJMsa065779 [18199864]
[78] Han Y, Liu J, Sun M, et al. A Significant Statistical Advancement on the Predictive Values of ERCC1 Polymorphisms for Clinical Outcomes of Platinum-Based Chemotherapy in Non-Small Cell Lung Cancer: An Updated Meta-Analysis. Disease Markers 2016;2016:7643981 10.1155/2016/7643981 [27057082]
[79] Smits KM, Schouten JS, Smits LJ, et al. A review on the design and reporting of studies on drug-gene interaction. J Clin Epidemiol 2005;58:651–54 10.1016/j.jclinepi.2005.01.001
[80] Lee SM, Falzon M, Blackhall F, et al. Randomized Prospective Biomarker Trial of ERCC1 for Comparing Platinum and Nonplatinum Therapy in Advanced Non-Small-Cell Lung Cancer: ERCC1 Trial (ET). JCO 2017;35:402–11 10.1200/JCO.2016.68.1841 [27893326]
[81] Phillips AT, Desai NR, Krumholz HM, et al. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017;18:333 10.1186/s13063-017-2068-3 [28720112]
[82] Ivanov A, Kaczkowska BA, Khan SA, et al. Review and Analysis of Publication Trends over Three Decades in Three High Impact Medicine Journals. PLoS ONE 2017;12:e0170056 10.1371/journal.pone.0170056 [28107475]
[83] Psotka MA, Latta F, Cani D, et al. Publication Rates of Heart Failure Clinical Trials Remain Low. J Am Coll Cardiol 2020;75:3151–61 10.1016/j.jacc.2020.04.068 [32586589]
[84] The BMJ. Paul Glasziou and Iain Chalmers: Can it really be true that 50% of research is unpublished? - The BMJ 2017. Available at: https://blogs.bmj.com/bmj/2017/06/05/paul-glasziou-and-iain-chalmers-can-it-really-be-true-that-50-of-research-is-unpublished/ Accessed August 22, 2021.
[85] Nissen SB, Magidson T, Gross K, et al. Publication bias and the canonization of false facts. eLife 2016;5 10.7554/eLife.21451 [27995896]
[86] Gerber AS, Malhotra N. Publication Bias in Empirical Sociological Research: Do Arbitrary Significance Levels Distort Published Results? Sociological methods & research 2008;37:3–30 10.1177/0049124108318973
[87] Schuemie MJ, Ryan PB, DuMouchel W, et al. Interpreting observational studies: why empirical calibration is needed to correct p-values. Stat Med 2014;33:209–18 10.1002/sim.5925 [23900808]
[88] Albarqouni LN, López-López JA, Higgins JPT. Indirect evidence of reporting biases was found in a survey of medical research studies. J Clin Epidemiol 2017;83:57–64 10.1016/j.jclinepi.2016.11.013 [28088596]
[89] Wang C-H, Li C-H, Hsieh R, et al. Proton pump inhibitors therapy and the risk of pneumonia: a systematic review and meta-analysis of randomized controlled trials and observational studies. Expert Opinion on Drug Safety 2019;18:163–72 10.1080/14740338.2019.1577820 [30704306]
[90] Moayyedi P, Eikelboom JW, Bosch J, et al. Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin. Gastroenterology 2019;157:682-691.e2 10.1053/j.gastro.2019.05.056 [31152740]
[91] Haute Autorité de Santé. Bon usage des inhibiteurs de la pompe à protons – Note de cadrage 2021. Available at: https://www.has-sante.fr/jcms/p_3221957/fr/bon-usage-des-inhibiteurs-de-la-pompe-a-protons-note-de-cadrage Accessed August 22, 2021.
[92] Hutton JL, Williamson PR. Bias in meta‐analysis due to outcome variable selection within studies. Journal of the Royal Statistical Society: Series C (Applied Statistics) 2000;49:359–70 10.1111/1467-9876.00197
[93] Sipahi I, Debanne SM, Rowland DY, et al. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials. The Lancet Oncology 2010;11:627–36 10.1016/S1470-2045(10)70106-6
[94] U.S. Food and Drug Administration. Angiotensin Receptor Blockers (ARBs) NaN. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-no-increase-risk-cancer-certain-blood-pressure-drugs-angiotensin Accessed August 22, 2021.
[95] Effects of telmisartan, irbesartan, valsartan, candesartan, and losartan on cancers in 15 trials enrolling 138,769 individuals. Journal of Hypertension 2011;29:623–35 10.1097/HJH.0b013e328344a7de [21358417]
[96] Wayant C, Scheckel C, Hicks C, et al. Evidence of selective reporting bias in hematology journals: A systematic review. PLoS ONE 2017;12:e0178379 10.1371/journal.pone.0178379 [28570573]
[97] Chan A-W, Hróbjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291:2457–65 10.1001/jama.291.20.2457 [15161896]
[98] Hahn S, Williamson PR, Hutton JL, et al. Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies. Stat Med 2000;19:3325–36 ;
[99] Peters J, Mengersen K. Selective reporting of adjusted estimates in observational epidemiology studies: reasons and implications for meta-analyses. Eval Health Prof 2008;31:370–89 10.1177/0163278708324438 [19000980]
[100] Ioannidis JPA, Trikalinos TA. An exploratory test for an excess of significant findings. Clinical Trials 2007;4:245–53 10.1177/1740774507079441 [17715249]
[101] Krsticevic M, Saric D, Saric F, et al. Selective reporting bias due to discrepancies between registered and published outcomes in osteoarthritis trials. J Comp Eff Res 2019;8:1265–73 10.2217/cer-2019-0068 [31739691]
[102] Zhang S, Liang F, Li W. Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting. Journal of Clinical Epidemiology 2017;91:87–94 10.1016/j.jclinepi.2017.07.010 [28757260]
[103] Saini P, Loke YK, Gamble C, et al. Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews. BMJ 2014;349:g6501 10.1136/bmj.g6501 [25416499]
[104] Boutron I, Dutton S, Ravaud P, et al. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 2010;303:2058–64 10.1001/jama.2010.651 [20501928]
[105] Khan MS, Lateef N, Siddiqi TJ, et al. Level and Prevalence of Spin in Published Cardiovascular Randomized Clinical Trial Reports With Statistically Nonsignificant Primary Outcomes: A Systematic Review. JAMA Netw Open 2019;2:e192622 10.1001/jamanetworkopen.2019.2622 [31050775]
[106] Gyawali B, Prasad V. Negative trials in ovarian cancer: is there such a thing as too much optimism? Ecancermedicalscience 2016;10:ed58 10.3332/ecancer.2016.ed58 [27594913]
[107] Reynolds-Vaughn V, Riddle J, Brown J, et al. Evaluation of Spin in the Abstracts of Emergency Medicine Randomized Controlled Trials. Annals of emergency medicine 2019;75:423–31 10.1016/j.annemergmed.2019.03.011 [31101371]
[108] Lundh A, Barbateskovic M, Hróbjartsson A, et al. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study. PLOS Medicine 2010;7:e1000354 10.1371/journal.pmed.1000354 [21048986]
[109] Callaway E. Questions raised over medical journals'financial ties to industry. Nature 2010 10.1038/news.2010.564
[110] Smith R. Lapses at the new England journal of medicine. JOURNAL OF THE ROYAL SOCIETY OF MEDICINE 2006;99:380–82 10.1258/jrsm.99.8.380 [16893926]
[111] Richard Smith's non-medical blogs. The New England Journal of Medicine, open access, Plan S, and undeclared conflicts of interest 2019. Available at: https://richardswsmith.wordpress.com/the-new-england-journal-of-medicine-open-access-plan-s-and-undeclared-conflicts-of-interest/ Accessed August 19, 2021.
[112] Boutron I, Altman DG, Hopewell S, et al. Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial. JCO 2014;32:4120–26 10.1200/JCO.2014.56.7503 [25403215]
[113] Hansson L, Zanchetti A, Carruthers SG, et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. The Lancet 1998;351:1755–62 10.1016/S0140-6736(98)04311-6
[114] The paper mountain. Nature 2014 10.1038/d41586-019-00381-w
[115] Bastian H, Glasziou P, Chalmers I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep up? PLOS Medicine 2010;7:e1000326 10.1371/journal.pmed.1000326 [20877712]
[116] van Calster B, Wynants L, Riley RD, et al. Methodology over metrics: Current scientific standards are a disservice to patients and society. Journal of Clinical Epidemiology 2021 10.1016/j.jclinepi.2021.05.018 [34077797]
[117] CIRST. L’effet SIGAPS : La recherche médicale française sous l’emprise de l’évaluation comptable 2021. Available at: https://www.cirst.uqam.ca/publications/leffet-sigaps-la-recherche-medicale-francaise-sous-lemprise-de-levaluation-comptable-2/ Accessed August 01, 2021.
[118] Wislar JS, Flanagin A, Fontanarosa PB, et al. Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey. BMJ 2011;343:d6128 10.1136/bmj.d6128 [22028479]
[119] Ioannidis JPA, Klavans R, Boyack KW. Thousands of scientists publish a paper every five days. Nature 2018;561:167–69 10.1038/d41586-018-06185-8 [30209384]
[120] Peer Review Congress. Authorship for Sale: A Survey of Predatory Publishers and Journals - Peer Review Congress 2021 Accessed August 01, 2021.
[121] Seife C. For Sale: “Your Name Here” in a Prestigious Science Journal 2021. Available at: https://www.scientificamerican.com/article/for-sale-your-name-here-in-a-prestigious-science-journal/ Accessed August 01, 2021.
[122] Baccini A, Nicolao G de, Petrovich E. Citation gaming induced by bibliometric evaluation: A country-level comparative analysis. PLoS ONE 2019;14:e0221212 10.1371/journal.pone.0221212 [31509555]
[123] Locher C, Moher D, Cristea IA, et al. Publication by association: how the COVID-19 pandemic has shown relationships between authors and editorial board members in the field of infectious diseases. BMJ Evid Based Med 2021 10.1136/bmjebm-2021-111670 [33785512]
[124] Bagues M, Sylos-Labini M, Zinovyeva N. A walk on the wild side: ‘Predatory’ journals and information asymmetries in scientific evaluations. Research Policy 2019;48:462–77 10.1016/j.respol.2018.04.013
[125] Beall J. Predatory publishers are corrupting open access. Nature 2012;489:179 10.1038/489179a [22972258]
[126] Butler D. Investigating journals: The dark side of publishing. Nature 2013;495:433–35 10.1038/495433a [23538810]
[127] Yeo-Teh NSL, Tang BL. An alarming retraction rate for scientific publications on Coronavirus Disease 2019 (COVID-19). Account Res 2021;28:47–53 10.1080/08989621.2020.1782203 [32573274]
[128] Smaldino PE, McElreath R. The natural selection of bad science. R. Soc. open sci. 2016;3:160384 10.1098/rsos.160384 [27703703]
[129] Yordanov Y, Dechartres A, Porcher R, et al. Avoidable waste of research related to inadequate methods in clinical trials. BMJ 2015;350:h809 10.1136/bmj.h809 [25804210]
[130] Zarin DA, Goodman SN, Kimmelman J. Harms From Uninformative Clinical Trials. JAMA 2019;322:813–14 10.1001/jama.2019.9892 [31343666]
[131] Halpern SD, Karlawish JHT, Berlin JA. The continuing unethical conduct of underpowered clinical trials. JAMA 2002;288:358–62 10.1001/jama.288.3.358 [12117401]
[132] Cohen PJ. Failure to conduct a placebo-controlled trial may be unethical. Am J Bioeth 2002;2:24 10.1162/152651602317533604 [12189067]
[133] Chalmers I, Bracken MB, Djulbegovic B, et al. How to increase value and reduce waste when research priorities are set. The Lancet 2014;383:156–65 10.1016/S0140-6736(13)62229-1
[134] Glasziou P, Chalmers I. Research waste is still a scandal—an essay by Paul Glasziou and Iain Chalmers. BMJ 2018:k4645 10.1136/bmj.k4645
[135] Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. The Lancet 2009;374:86–89 10.1016/S0140-6736(09)60329-9
[136] Managing the COVID-19 infodemic: Promoting healthy behaviours and mitigating the harm from misinformation and disinformation 2021. Available at: https://www.who.int/news/item/23-09-2020-managing-the-covid-19-infodemic-promoting-healthy-behaviours-and-mitigating-the-harm-from-misinformation-and-disinformation Accessed August 01, 2021.
[137] Infodemic 2021. Available at: https://www.who.int/health-topics/infodemic#tab=tab_1 Accessed August 01, 2021.
[138] Washington Post. Major publisher retracts 64 scientific papers in fake peer review outbreak 2015. Available at: https://www.washingtonpost.com/news/morning-mix/wp/2015/08/18/outbreak-of-fake-peer-reviews-widens-as-major-publisher-retracts-64-scientific-papers/ Accessed August 23, 2021.
[139] Gaudino M, Robinson NB, Audisio K, et al. Trends and Characteristics of Retracted Articles in the Biomedical Literature, 1971 to 2020. JAMA Intern Med 2021;181:1118–21 10.1001/jamainternmed.2021.1807 [33970185]
[140] Jung RG, Di Santo P, Clifford C, et al. Methodological quality of COVID-19 clinical research. Nat Commun 2021;12:943 10.1038/s41467-021-21220-5 [33574258]
[141] Belluz J, Hoffman S. Let's stop pretending peer review works 2015. Available at: https://www.vox.com/2015/12/7/9865086/peer-review-science-problems Accessed August 23, 2021.
[142] Carlisle JB. False individual patient data and zombie randomised controlled trials submitted to Anaesthesia. Anaesthesia 2021;76:472–79 10.1111/anae.15263 [33040331]
[143] The BMJ. Time to assume that health research is fraudulent until proven otherwise? - The BMJ 2021. Available at: https://blogs.bmj.com/bmj/2021/07/05/time-to-assume-that-health-research-is-fraudulent-until-proved-otherwise/ Accessed August 31, 2021.
[144] Al-Marzouki S, Evans S, Marshall T, et al. Are these data real? Statistical methods for the detection of data fabrication in clinical trials. BMJ 2005;331:267–70 10.1136/bmj.331.7511.267 [16052019]
[145] Diener HC, Cunha L, Forbes C, et al. European Stroke Prevention Study. 2. Dipyridamole and acetylsalicylic acid in the secondary prevention of stroke. J Neurol Sci 1996;143:1–13 10.1016/s0022-510x(96)00308-5 [8981292]
[146] Enserink M. Fraud and ethics charges hit stroke drug trial. Science 1996;274:2004–05 10.1126/science.274.5295.2004 [8984655]
[147] Mehra MR, Ruschitzka F, Patel AN. Retraction—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. The Lancet 2020;395:1820 10.1016/S0140-6736(20)31324-6
[148] Mehra MR, Desai SS, Kuy S, et al. Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. DOI: 10.1056/NEJMoa2007621. N Engl J Med 2020;382:2582 10.1056/NEJMc2021225 [32501665]
[149] the Guardian. Huge study supporting ivermectin as Covid treatment withdrawn over ethical concerns 2021. Available at: https://www.theguardian.com/science/2021/jul/16/huge-study-supporting-ivermectin-as-covid-treatment-withdrawn-over-ethical-concerns Accessed August 20, 2021.
[150] Reardon S. Flawed ivermectin preprint highlights challenges of COVID drug studies. Nature 2021;596:173–74 10.1038/d41586-021-02081-w [34341573]
[151] Hill A, Garratt A, Levi J, et al. Erratum: Expression of Concern: "Meta-analysis of Randomized Trials of Ivermectin to Treat SARS-CoV-2 Infection". Open Forum Infectious Diseases 2021;8:ofab394 10.1093/ofid/ofab394 [34410284]
[152] Retraction Watch. Ivermectin meta-analysis to be retracted, revised, say authors 2021. Available at: https://retractionwatch.com/2021/08/10/ivermectin-meta-analysis-to-be-retracted-revised-say-authors/ Accessed August 20, 2021.
[153] Authors of meta-analysis on heart disease retract it when they realize a NEJM reference had been retracted – Retraction Watch 2021. Available at: https://retractionwatch.com/2020/12/09/authors-of-meta-analysis-on-heart-disease-retract-it-when-they-realize-a-nejm-reference-had-been-retracted/ Accessed August 01, 2021.
[154] Avenell A, Stewart F, Grey A, et al. An investigation into the impact and implications of published papers from retracted research: systematic search of affected literature. BMJ open 2019;9:e031909 10.1136/bmjopen-2019-031909 [31666272]
[155] Faggion CM. More detailed guidance on the inclusion/exclusion of retracted articles in systematic reviews is needed. Journal of Clinical Epidemiology 2019;116:133–34 10.1016/j.jclinepi.2019.07.006 [31306745]
[156] Gerstein HC, McMurray J, Holman RR. Real-world studies no substitute for RCTs in establishing efficacy. The Lancet 2019;393:210–11 10.1016/s0140-6736(18)32840-x
[157] Banerjee R, Prasad V. Are Observational, Real-World Studies Suitable to Make Cancer Treatment Recommendations? JAMA Netw Open 2020;3:e2012119 10.1001/jamanetworkopen.2020.12119 [32729916]
[158] Kumar A, Guss ZD, Courtney PT, et al. Evaluation of the Use of Cancer Registry Data for Comparative Effectiveness Research. JAMA Netw Open 2020;3:e2011985 10.1001/jamanetworkopen.2020.11985 [32729921]
[159] Concato J. Observational versus experimental studies: what's the evidence for a hierarchy? NeuroRx the journal of the American Society for Experimental NeuroTherapeutics 2004;1:341–47 10.1602/neurorx.1.3.341
[160] Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. The New England journal of medicine 2000;342:1887–92 10.1056/nejm200006223422507
[161] Criner GJ, Connett JE, Aaron S d., et al. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. The New England journal of medicine 2014;370:2201–10 10.1056/NEJMoa1403086 [24836125]
[162] Fletcher AE. Controversy over "contradiction": Should randomized trials always trump observational studies? American journal of ophthalmology 2009;147:384–86 10.1016/j.ajo.2008.04.024
[163] Ioannidis JP, Haidich AB, Pappa M, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA 2001;286:821–30 10.1001/jama.286.7.821 [11497536]
[164] Baron JA, Barry EL, Mott LA, et al. A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas. N Engl J Med 2015;373:1519–30 10.1056/NEJMoa1500409 [26465985]
[165] Bull-Otterson L, Gray EB, Budnitz DS, et al. Hydroxychloroquine and Chloroquine Prescribing Patterns by Provider Specialty Following Initial Reports of Potential Benefit for COVID-19 Treatment - United States, January-June 2020. MMWR Morb Mortal Wkly Rep 2020;69:1210–15 10.15585/mmwr.mm6935a4 [32881845]
[166] Watts Up With That? Hydroxychloroquine-based COVID-19 Treatment, A Systematic Review of Clinical Evidence and Expert Opinion from Physicians’ Surveys 2020. Available at: https://wattsupwiththat.com/2020/07/07/hydroxychloroquine-based-covid-19-treatment-a-systematic-review-of-clinical-evidence-and-expert-opinion-from-physicians-surveys/ Accessed December 11, 2021.
[167] Jackson, Coker. 65 Percent of Physicians in New Survey Would Give Anti-Malaria Drugs to Their Own Family to Treat COVID-19 2020. Available at: https://www.prnewswire.com/news-releases/65-percent-of-physicians-in-new-survey-would-give-anti-malaria-drugs-to-their-own-family-to-treat-covid-19-301037543.html Accessed December 11, 2021.
[168] Stockman LJ, Bellamy R, Garner P. SARS: systematic review of treatment effects. PLOS Medicine 2006;3:e343 10.1371/journal.pmed.0030343 [16968120]
[169] Arabi YM, Mandourah Y, Al-Hameed F, et al. Corticosteroid Therapy for Critically Ill Patients with Middle East Respiratory Syndrome. Am J Respir Crit Care Med 2018;197:757–67 10.1164/rccm.201706-1172OC [29161116]
[170] Lansbury LE, Rodrigo C, Leonardi-Bee J, et al. Corticosteroids as Adjunctive Therapy in the Treatment of Influenza: An Updated Cochrane Systematic Review and Meta-analysis. Crit Care Med 2020;48:e98-e106 10.1097/CCM.0000000000004093 [31939808]
[171] Simpson SH, Eurich DT, Majumdar SR, et al. A meta-analysis of the association between adherence to drug therapy and mortality. BMJ 2006;333:15 10.1136/bmj.38875.675486.55 [16790458]
[172] Vist GE, Hagen KB, Devereaux PJ, et al. Outcomes of patients who participate in randomised controlled trials compared to similar patients receiving similar interventions who do not participate. Cochrane Database Syst Rev 2007:MR000009 10.1002/14651858.MR000009.pub3 [17443630]
[173] Davis S, Wright PW, Schulman SF, et al. Participants in prospective, randomized clinical trials for resected non-small cell lung cancer have improved survival compared with nonparticipants in such trials. Cancer 1985;56:1710–18 10.1002/1097-0142(19851001)56:7<1710:aid-cncr2820560741>3.0.co 2-t; [3896460]
[174] Choueiri TK, Halabi S, Sanford BL, et al. Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial. JCO 2017;35:591–97 10.1200/JCO.2016.70.7398 [28199818]
[175] Gyawali B, Rome BN, Kesselheim AS. Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study. BMJ 2021;374:n1959 10.1136/bmj.n1959 [34497044]
[176] The James Lind Library. The trials and tribulations of the University Group Diabetes Program: lessons and reflections. - The James Lind Library 2021. Available at: https://www.jameslindlibrary.org/articles/the-trials-and-tribulations-of-the-university-group-diabetes-program-lessons-and-reflections/ Accessed August 31, 2021.
[177] Schwartz TB, Meinert CL. The UGDP controversy: thirty-four years of contentious ambiguity laid to rest. Perspect Biol Med 2004;47:564–74 10.1353/pbm.2004.0071 [15467178]
[178] Boissel JP. Histoire subjective du souci de la qualité des essais cliniques – Impressionist history of quality concerns with clinical trials ;
[179] Stamatakis E, Weiler R, Ioannidis JPA. Undue industry influences that distort healthcare research, strategy, expenditure and practice: a review. Eur J Clin Invest 2013;43:469–75 10.1111/eci.12074 [23521369]
[180] Sox HC, Rennie D. Seeding trials: just say "no". Ann. Intern. Med. 2008;149:279–80 10.7326/0003-4819-149-4-200808190-00012 [18711161]
[181] Hill KP, Ross JS, Egilman DS, et al. The ADVANTAGE seeding trial: a review of internal documents. Ann. Intern. Med. 2008;149:251–58 10.7326/0003-4819-149-4-200808190-00006 [18711155]
[182] Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. JNCI Journal of the National Cancer Institute 2009;101:1446–52 10.1093/jnci/djp335 [19815849]
[183] Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981–92 10.1056/NEJMoa1107039 [21870978]
[184] Chen P, Nirula A, Heller B, et al. SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. N Engl J Med 2021;384:229–37 10.1056/NEJMoa2029849 [33113295]
