Ethical Dilemmas and Malfunctions in Clinical Trials Research
Authors: Stuart J. Pocock
Journal: Annals of Internal Medicine (2012)

Editorials15 May 2012Ethical Dilemmas and Malfunctions in Clinical Trials ResearchStuart J. Pocock, PhDStuart J. Pocock, PhDFrom London School of Hygiene & Tropical Medicine, London WC1E 7HT, United Kingdom.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-156-10-201205150-00015 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Two articles in this issue raise ethical concerns about the conduct and monitoring of clinical trials that are worthy of debate and future action.Fan and colleagues (1) report a trial of a behavioral intervention strategy for patients with chronic obstructive pulmonary disease. The trial was stopped early primarily because of a statistically significant excess of deaths in the intervention group. This reminds us all that trials of behavioral strategies are no different from drug trials in their need for effective data monitoring for potential harm, even though some might argue that behavioral actions cannot conceivably harm patients. Appropriate structures ...References1. Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, et al. A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations. A randomized, controlled trial. Ann Intern Med. 2012;156:673-83. LinkGoogle Scholar2. Ioannidis JP. Contradicted and initially stronger effects in highly cited clinical research. JAMA. 2005;294:218-28. [PMID: 16014596] CrossrefMedlineGoogle Scholar3. Pocock SJ. Current controversies in data monitoring for clinical trials. Clin Trials. 2006;3:513-21. [PMID: 17170035] CrossrefMedlineGoogle Scholar4. DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet. 1999;354:1983-8. 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Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011;365:2268-76. [PMID: 22082198] CrossrefMedlineGoogle Scholar9. Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lomas G, et al; CRASH trial collaborators. Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet. 2004;364:1321-8. [PMID: 15474134] CrossrefMedlineGoogle Scholar10. Pocock SJ. When to stop a clinical trial. BMJ. 1992;305:235-40. [PMID: 1392832] CrossrefMedlineGoogle Scholar11. Petersen LA, Simpson K, SoRelle R, Urech T, Chitwood SS. How variability in the institutional review board review process affects minimal-risk multisite health services research. Ann Intern Med. 2012;156:728-35. LinkGoogle Scholar12. Martyn C. The ethical bureaucracy [Editorial]. QJM. 2003;96:323-4. [PMID: 12702780] CrossrefMedlineGoogle Scholar13. Gaw A. Exposing unethical human research: the transatlantic correspondence of Beecher and Pappworth. Ann Intern Med. 2012;156:150-5. [PMID: 22250147] LinkGoogle Scholar14. Al-Shahi R. Research ethics committees in the UK—the pressure is now on research and development departments. J R Soc Med. 2005;98:444-7. [PMID: 16199810] MedlineGoogle Scholar15. Califf RM. Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials. 2006;3:496-502. [PMID: 17170032] CrossrefMedlineGoogle Scholar16. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360:816-23. [PMID: 19228627] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Stuart J. Pocock, PhDAffiliations: From London School of Hygiene & Tropical Medicine, London WC1E 7HT, United Kingdom.Disclosures: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0762.Corresponding Author: Stuart J. Pocock, PhD, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom; e-mail, stuart.pocock@lshtm.ac.uk. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoA Comprehensive Care Management Program to Prevent Chronic Obstructive Pulmonary Disease Hospitalizations Vincent S. Fan , J. Michael Gaziano , Robert Lew , Jean Bourbeau , Sandra G. Adams , Sarah Leatherman , Soe Soe Thwin , Grant D. Huang , Richard Robbins , Peruvemba S. Sriram , Amir Sharafkhaneh , M. Jeffery Mador , George Sarosi , Ralph J. Panos , Padmashri Rastogi , Todd H. Wagner , Steven A. Mazzuca , Colleen Shannon , Cindy Colling , Matthew H. Liang , James K. Stoller , Louis Fiore , and Dennis E. Niewoehner How Variability in the Institutional Review Board Review Process Affects Minimal-Risk Multisite Health Services Research Laura A. Petersen , Kate Simpson , Richard SoRelle , Tracy Urech , and Supicha Sookanan Chitwood Metrics Cited byThe 'wicked problem' of telerehabilitation: Considerations for planning the way forwardThe perils of early study discontinuationAction plans to reduce hospitalizations for chronic obstructive pulmonary disease exacerbations: focus on oral corticosteroidsCollaborative Self-Management and Behavioral ChangeNavigating the Institutional Review Board Approval Process in a Multicenter Observational Critical Care Study*Self-Management in Chronic Obstructive Pulmonary Disease. Time for a Paradigm Shift?Deconstructing a Negative Study 15 May 2012Volume 156, Issue 10Page: 746-747KeywordsAtrial fibrillationChronic obstructive pulmonary diseaseClinical trialsForecastingHead injuryInstitutional review boardsMortalityResearch ethicsSafetyTherapeutic drug monitoring ePublished: 15 May 2012 Issue Published: 15 May 2012 Copyright & PermissionsCopyright © 2012 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...