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Regulation and Comparative Effectiveness Research

Regulation and Comparative Effectiveness Research To the Editor Dr Platt and colleagues1 proposed waiver of informed consent and regulatory changes to facilitate the conduct of low-risk comparative effectiveness trials. Their point regarding changes implemented by health care systems in the absence of systematic evaluation is well taken, yet their thesis raises questions. Risks and unintended consequences of research extend beyond the view by Platt et al1 of adverse events due to the intervention; their example concerning “a comparison study of marketed agents for routine bathing” (actually a study testing 3 screening and decolonization strategies for methicillin-resistant Staphylococcus aureus using 1 agent) is illustrative.2 If 1 strategy is superior, some patients may develop an infection (or an adverse reaction to an antibiotic) because of the research. In general, other potential risks exist, such as cost implications for patients based on treatment assignment. The Belmont Report3 espouses 3 principles: respect for persons (autonomy), beneficence (minimizing risks vs benefits), and justice (equitable bearing of research burdens and benefits). Informed consent provides the mechanism for honoring autonomy by describing what the study involves, ensuring the rights of patients, and giving patients an opportunity to ask questions—making it a vehicle for transparency and engagement. Platt et al1 encouraged “engagement of patients in the research process” but then proposed to disengage the people directly affected by it. The authors assumed that eliminating informed consent and institutional review board oversight would be sufficient to accelerate the number of randomized clinical trials (RCTs). However, RCTs would still require significant resources separate from clinical care. Research personnel must continuously monitor the study to ensure adherence to randomization, the protocol and data collection procedures, and onerous research-related billing compliance processes (Medicare requires notification even for standard care RCTs).4 Randomized clinical trials require statistical analysis after data entry, verification and reporting to a data and safety monitoring board, or both, not to mention investigator time devoted to protocol planning, resolving unforeseen issues, and interpretation and dissemination of trial results. Given cost pressures on health care organizations, it seems unlikely that the changes suggested by Platt et al would prompt testing of care practices via RCT methods without large increases in funding. Asserting that “all stakeholders share a moral obligation to contribute to learning…” discards the principle of autonomy (and potentially justice) by having the need to know trump individual rights. Whether the proposed changes would proliferate knowledge is uncertain. Alternatively, improving observational study methods would avoid this tradeoff while potentially requiring fewer resources. Section Editor: Jody W. Zylke, MD, Senior Editor. Back to top Article Information Corresponding Author: Lynn E. T. Shaffer, PhD, OhioHealth Corp, McConnell Heart Health Center, 3773 Olentangy River Rd, Columbus, OH 43214 (lynn.shaffer@ohiohealth.com). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. References 1. Platt R, Kass NE, McGraw D. Ethics, regulation, and comparative effectiveness research: time for a change. JAMA. 2014;311(15):1497-1498.PubMedGoogle ScholarCrossref 2. Huang SS, Septimus E, Kleinman K, et al; CDC Prevention Epicenters Program; AHRQ DECIDE Network and Healthcare-Associated Infections Program. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013;368(24):2255-2265.PubMedGoogle ScholarCrossref 3. US Department of Health and Human Services. Ethical principles and guidelines for the protection of human subjects of research.http://www.hhs.gov/ohrp/policy/belmont.html. Accessed on April 3, 2014. 4. Centers for Medicare & Medicaid Services. Medicare claims processing manual, chapter 32, §69.6: requirements for billing routine costs of clinical trials.http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c32.pdf. Accessed on May 29, 2014. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Regulation and Comparative Effectiveness Research

JAMA , Volume 312 (9) – Sep 3, 2014

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References (2)

Publisher
American Medical Association
Copyright
Copyright © 2014 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2014.7655
Publisher site
See Article on Publisher Site

Abstract

To the Editor Dr Platt and colleagues1 proposed waiver of informed consent and regulatory changes to facilitate the conduct of low-risk comparative effectiveness trials. Their point regarding changes implemented by health care systems in the absence of systematic evaluation is well taken, yet their thesis raises questions. Risks and unintended consequences of research extend beyond the view by Platt et al1 of adverse events due to the intervention; their example concerning “a comparison study of marketed agents for routine bathing” (actually a study testing 3 screening and decolonization strategies for methicillin-resistant Staphylococcus aureus using 1 agent) is illustrative.2 If 1 strategy is superior, some patients may develop an infection (or an adverse reaction to an antibiotic) because of the research. In general, other potential risks exist, such as cost implications for patients based on treatment assignment. The Belmont Report3 espouses 3 principles: respect for persons (autonomy), beneficence (minimizing risks vs benefits), and justice (equitable bearing of research burdens and benefits). Informed consent provides the mechanism for honoring autonomy by describing what the study involves, ensuring the rights of patients, and giving patients an opportunity to ask questions—making it a vehicle for transparency and engagement. Platt et al1 encouraged “engagement of patients in the research process” but then proposed to disengage the people directly affected by it. The authors assumed that eliminating informed consent and institutional review board oversight would be sufficient to accelerate the number of randomized clinical trials (RCTs). However, RCTs would still require significant resources separate from clinical care. Research personnel must continuously monitor the study to ensure adherence to randomization, the protocol and data collection procedures, and onerous research-related billing compliance processes (Medicare requires notification even for standard care RCTs).4 Randomized clinical trials require statistical analysis after data entry, verification and reporting to a data and safety monitoring board, or both, not to mention investigator time devoted to protocol planning, resolving unforeseen issues, and interpretation and dissemination of trial results. Given cost pressures on health care organizations, it seems unlikely that the changes suggested by Platt et al would prompt testing of care practices via RCT methods without large increases in funding. Asserting that “all stakeholders share a moral obligation to contribute to learning…” discards the principle of autonomy (and potentially justice) by having the need to know trump individual rights. Whether the proposed changes would proliferate knowledge is uncertain. Alternatively, improving observational study methods would avoid this tradeoff while potentially requiring fewer resources. Section Editor: Jody W. Zylke, MD, Senior Editor. Back to top Article Information Corresponding Author: Lynn E. T. Shaffer, PhD, OhioHealth Corp, McConnell Heart Health Center, 3773 Olentangy River Rd, Columbus, OH 43214 (lynn.shaffer@ohiohealth.com). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. References 1. Platt R, Kass NE, McGraw D. Ethics, regulation, and comparative effectiveness research: time for a change. JAMA. 2014;311(15):1497-1498.PubMedGoogle ScholarCrossref 2. Huang SS, Septimus E, Kleinman K, et al; CDC Prevention Epicenters Program; AHRQ DECIDE Network and Healthcare-Associated Infections Program. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013;368(24):2255-2265.PubMedGoogle ScholarCrossref 3. US Department of Health and Human Services. Ethical principles and guidelines for the protection of human subjects of research.http://www.hhs.gov/ohrp/policy/belmont.html. Accessed on April 3, 2014. 4. Centers for Medicare & Medicaid Services. Medicare claims processing manual, chapter 32, §69.6: requirements for billing routine costs of clinical trials.http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c32.pdf. Accessed on May 29, 2014.

Journal

JAMAAmerican Medical Association

Published: Sep 3, 2014

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