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Editorials |

Ethical Dilemmas and Malfunctions in Clinical Trials Research

Stuart J. Pocock, PhD
[+] Article and Author Information

From London School of Hygiene & Tropical Medicine, London WC1E 7HT, United Kingdom.

Potential Conflicts of Interest: 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, mailto:stuart.pocock@lshtm.ac.uk.


Ann Intern Med. 2012;156(10):746-747. doi:10.7326/0003-4819-156-10-201205150-00015
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Two articles in this issue raise ethical concerns about the conduct and monitoring of clinical trials. Fan and colleagues report a trial of a behavioral intervention strategy for patients with chronic obstructive pulmonary disease that was stopped early because of excess deaths in the intervention group. Petersen and colleagues illustrate how IRB requirements can be time-consuming and can adversely affect a trial's internal and external validity. The editorialist discusses these studies and the importance of ethical safeguards in clinical trials.

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Monitoring committees: protecting the patients and ensuring reliable research findings
Posted on May 22, 2012
Alain, Braillon, Public Health
80000 Amiens. France
Conflict of Interest: None Declared

Pocock stressed the importance of Independent Data Monitoring Committees (IDMC) which are "established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial" (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for HumanUse http://ichgcp.net/?page id=358).(1)

Focusing on the stopping of an ongoing trial for emergence of "negative" trends or harm disregarded others issues (eg. facing the results from the development of another trial may merit stopping the one on which one is working).(2)

Commenting Fan and colleagues's behavioral intervention strategy for patients with chronic obstructive pulmonary disease, Pocock rightly pledged that all major trials, not only those involving drugs, should have IDMC.(1,3) IDMCs were recommended as early as 1967 by the National Heart Lung and Blood Institute task force (Greenberg Report) and have became a mandatory requirement for the registration of pharmaceuticals. Mangano and Browner enlarged this scope in 1986 when they wisely set up an IDMC for an observational study.(4) However, 25 years later this remains an exception and Institutional Review Boards too often failed to require establishment of IDMC. Last, importance of two other monitoring committees cannot be neglected: a) the Trial Management Group with those responsible for the day-to-day management of the trial to monitor the progress of the trial and ensure that the protocol is adhered; b) the Trial Steering Committee which provide overall supervision to ensure implementation of Good Clinical Practice and which should agree protocol amendments.

References

1 Pocock SJ. Ethical dilemmas and malfunctions in clinical trials research. Ann Intern Med 2012 ;156(1:746-7

2 Braillon A. The many moral responsibilities of independent data- monitoring committees. Am J Bioeth. 2011;1:16-7

3 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

4 Mangano DT, Browner WS, Hollenberg M, London MJ, Tubau JF, Tateo IM. Association of perioperative myocardial ischemia with cardiac morbidity and mortality in men undergoing noncardiac surgery. The Study of Perioperative Ischemia Research Group. N Engl J Med 1990;323:1781-8

Conflict of Interest:

None declared

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