Clinical Trials/Clinical Practice
"Most major randomized, controlled trials before the year 2000 showed therapeutic benefits (Figure 1), according to data on NHLBI-funded trials for cardiovascular disease between 1970 and 2012. But after the year 2000, when the agency codified hypothesis pre-registration, trials mostly ended in null results. Useless drugs, with possible side effects, had almost certainly been approved, manufactured, and swallowed by Americans." --
- ClinicalTrials.govClinicalTrials.gov is a U.S. National Library of Medicine registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
- Do Physician Referrals of Patients to Clinical Trials Violate Anti-kickback Statutes or Fee-splitting Laws?Trial Site News, Daniel O'Connor, 23/38/2022
- EU Clinical Trials Register" The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004." -- website
- FDAAA Trials Trackerfdaaa.trialstracker.net, Built by the Bennett Institute for Applied Data Science, University of Oxford
- Despite U.S. law, many clinical trial results go unreportedReuters, by Julie Steenhuysen, 1/17/2020
- NIH blocks projects of two researchers who fail to make clinical trial results public"One in six NIH trials were not prospectively registered
Half of trial results were made public late or not at all"
-- TranspariMED, by Till Bruckner, 5/2023 - Patients 'betrayed' by Canadian researchers, advocate says of clinical trial probe"A shocking study found that only three per cent of Canadian human research trials testing new drug treatments or therapies meet all three international criteria that ensure fair and timely sharing of results for all to learn from." -- CTV News, Avis Favaro, 11/2023
- Top US institutes still aren’t reporting clinical-trial results on timeFleming, N. (2019). Top US institutes still aren’t reporting clinical-trial results on time. Nature. https://doi.org/10.1038/d41586-019-00994-1
- Why it's time to publish research “failures”"Publication bias affects the body of scientific knowledge in different ways, including skewing it towards statistically significant or “positive” results. This means that the results of thousands of experiments that fail to confirm the efficacy of a treatment or vaccine – including the outcomes of clinical trials – fail to see the light of day." -- Elsevier Connect, by Lucy Goodchild van Hilten, posted 5/5/2015
- Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug AdministrationJama Oncology, Natansh D. Modi, Ahmad Y. Abuhelwa, Ross A. McKinnon7/28/2022
- How should individual participant data (IPD) from publicly funded clinical trials be shared?Tudur Smith, C., Hopkins, C., Sydes, M.R. et al. How should individual participant data (IPD) from publicly funded clinical trials be shared?. BMC Med 13, 298 (2015). https://doi.org/10.1186/s12916-015-0532-z
- Individual Patient-Level Data Sharing for Continuous Learning: A Strategy for Trial Data SharingKuntz RE, Antman EM, Califf RM, Ingelfinger JR, Krumholz HM, Ommaya A, Peterson ED, Ross JS, Waldstreicher J, Wang SV, Zarin DA, Whicher DM, Siddiqi SM, Lopez MH. Individual Patient-Level Data Sharing for Continuous Learning: A Strategy for Trial Data Sharing. NAM Perspect. 2019 Jul 1;2019:10.31478/201906b. doi: 10.31478/201906b. PMID: 34532668; PMCID: PMC8406566.
- Not Accessible: Data From Pivotal Trials of New Cancer DrugsMedscape.com, Pam Harrison, 8/4/2022
- Sharing Individual Participant Data (IPD) within the Context of the Trial Reporting System (TRS)Zarin DA, Tse T. Sharing Individual Participant Data (IPD) within the Context of the Trial Reporting System (TRS). PLoS Med. 2016 Jan 19;13(1):e1001946. doi: 10.1371/journal.pmed.1001946. PMID: 26784335; PMCID: PMC4718525
- The Dangers of Medical Academia’s ‘Publish or Perish’ Culture and How It Can Affect Clinical PracticeCabells.com, Daley White, 8/9/2022
- Do Physician Referrals of Patients to Clinical Trials Violate Anti-kickback Statutes or Fee-splitting Laws?Trial Site News, Daniel O'Connor, 23/38/2022
- Is the Lancet complicit in research fraud?A blog entry written jointly by Patricia Murray and Peter Wilmshurst.
- Assessing Research Misconduct Allegations Involving Clinical ResearchORI (The Office of Research Integrity)
- Big Pharma's Internationalization of R&D to ChinaGrimes, S., & Miozzo, M. (2015). Big Pharma’s Internationalization of R&D to China. European Planning Studies, 23(9), 1873–1894. https://doi.org/10.1080/09654313.2015.1029442
- Biotech’s data supporting Alzheimer’s trials under scrutinyRetraction Watch, Adam Marcus, 8/26/2021
- Business Owner Found Guilty of Committing Fraud Regarding Human Clinical Research TrialsFDA ; Department of Justice, U.S. Attorney’s Office, Eastern District of Washington
- CFDA disputes claim that 80% of Chinese trials faked data but admits serious problemsFierce Pharma, by Phil Taylor, 10/24/2016
- Clinical trial coordinators sentenced to prison after data falsification schemeEndpointsNews, Paul Schloesser, 10/19/2022
- Clinical Researchers Plead Guilty in Connection with Scheme to Falsify Drug Trial DataU.S. Dept. of Justice, 6/8/2021
- Clinical Researchers Sentenced in Connection with Scheme to Falsify Drug Trial DataU.S. Dept. of Justice, 8/11/2021
- Clinical Trial Fraud Uncovered (BMS/Pfizer)"...BMS/Pfizer anticoagulant Eliquis (apixaban), a Factor Xa inhibitor approved late last year by the FDA, was delayed for months because of misconduct in its Chinese clinical trials." -- Science.org, by Derek Lowe, 7/12/2013
- Continued post-retraction citation of a fraudulent clinical trial report, 11 years after it was retracted for falsifying dataSchneider, J., Ye, D., Hill, A.M. et al. Continued post-retraction citation of a fraudulent clinical trial report, 11 years after it was retracted for falsifying data. Scientometrics 125, 2877–2913 (2020). https://doi.org/10.1007/s11192-020-03631-1
- CRO owner pleads guilty to obstructing FDA investigation into falsified clinical trial dataEndpoints News, Zachary Brennan, 1/13/2022
- Data fraud in clinical trialsGeorge SL, Buyse M. Data fraud in clinical trials. Clin Investig (Lond). 2015;5(2):161-173.
- Doctor, Clinic Owner and Staff Charged with Falsifying Clinical Trial DataU.S. Dept. of Justice, 3/8/2021
- Failed to properly register your trial? Just use a different study’s number. Actually, don’t.Retraction Watch, Adam Marcus, 5/20/2022
- False individual patient data and zombie randomised controlled trials submitted to Anaesthesia"In conclusion, I detected false data in almost half of the individual patient data spreadsheets for randomised controled trials submitted to Anaesthesia" -- Anaesthesia 2021, 76,472-479, J.B. Carlisle
- Fraud and misconduct in clinical research: A concernGupta A. Fraud and misconduct in clinical research: A concern. Perspect Clin Res. 2013 Apr;4(2):144-7. doi: 10.4103/2229-3485.111800. PMID: 23833741; PMCID: PMC3700330.
- 'Fraud' found at China site for key study of Pfizer and Bristol's EliquisFierce Biotech, 7/9/2013
- Roller Coaster Path to Approval for Eliquis Uncovered by FDA DocumentsNEJM Journal Watch CardioExchange Archive, Larry Husten, 6/24/2013
- US ex-doctor who ran fraudulent clinical trial sites is sentenced to 28 years in prisonBMJ 2020; 371 :m3946 doi:10.1136/bmj.m3946
- A General Framework for the Evaluation of Clinical Trial QualityBerger, Vance W, and Sunny Y Alperson. “A general framework for the evaluation of clinical trial quality.” Reviews on recent clinical trials vol. 4,2 (2009): 79-88. doi:10.2174/157488709788186021
- Research Integrity Toolbox"SOPs4RI (Standard Operating Procedures for Research Integrity) is a four-year (2019-2022), multi-partner project funded by the European Commission." -- website
- How to Detect, Manage, and Report Fraud and Fabricated Clinical Research DataAppliedclinicaltrialsonline.com, Lysa Triantafillou, 8/2/2018
- How to identify predatory journals in a search Precautions for nursesOermann, Marilyn H. PhD, RN, ANEF, FAAN; Nicoll, Leslie H. PhD, MBA, RN, FAAN; Carter-Templeton, Heather PhD, RN-BC, FAAN; Owens, Jacqueline K. PhD, RN, CNE; Wrigley, Jordan MSLS, MA; Ledbetter, Leila S. MLIS, AHIP; Chinn, Peggy L. PhD, RN, FAAN. How to identify predatory journals in a search: Precautions for nurses. Nursing: April 2022 - Volume 52 - Issue 4 - p 41-45 doi: 10.1097/01.NURSE.0000823280.93554.1a
Brook Jackson: Pfizer - Ventavia Research Group - ICON PLC
- RELATOR BROOK JACKSON’S COMBINED RESPONSE IN OPPOSITION TO RESPONDENTS’ MOTIONS TO DISMISS AMENDED COMPLAINT : Case 1:21-cv-00008-MJT Document 65 Filed 08/22/22False claims lawsuit update - response to Pfizer-ICON-Ventavia's motion to dismiss
- Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
This link opens in a new window
YouTube video, The BMJ, 3/16/2022 - Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial" A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.... Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails." -- BMJ 2021;375:n2635