Comparative Effectiveness: Research Ethics in the News

A recent article in JAMA shows a lack of current comparative effectiveness (CE) research: Michael Hochman; Danny McCormick. Hochman M, McCormick D. Characteristics of published comparative effectiveness studies of medications. JAMA. 2010 Mar 10;303(10):951-8. PubMed PMID: 20215609. In six, leading medical journals, Hochman and McCormick indentified 104 studies (32% of research articles published over 16 months) that compared the effectiveness of two or more clinical interventions. With the recent public interest in encouraging CE research and CE data-driven policy, the authors believe 32% is inadequate. They write:

The fact that only 32% of the studies in these journals evaluating medications met our criteria for CE research supports previous concerns that only limited clinical research is currently devoted to helping physicians use existing therapies more effectively.

Hoping for an increase in CE research, the authors conclude that increased public funding and new regulatory action will be needed to overcome barriers to future comparative studies:

[O]ur findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies. In addition, our findings highlight the need for regulatory agencies like the FDA to require active-comparator trials for medication approval whenever feasible.

In an accompanying editorial, Conway and Clancy, indentify a number of next steps, including:

– a vetted inventory of CE research “so clinicians and patients can locate summaries of evidence and studies of interest;”
– attention to the best methods and appropriate resources for disseminating CE research information
– longitudinal assessments of CE research driven medicine in patient-centered care.

[Conway PH, Clancy C. Charting a path from comparative effectiveness funding to improved patient-centered health care. JAMA. 2010 Mar 10;303(10):985-6. PubMed PMID: 20215615.]

Readers looking for a quick overview of CE research and its implications in for the future of health policy and medical care can find a brief, new assessment from The Urban Institute. Elizabeth Docteur and Robert A. Berenson recently wrote: How Will Comparative Effectiveness Research Affect the Quality of Health Care? [PDF – 337 KB] The report provides a brief overview of the history of CE, describes the current debate and calls for:

– continued attention to the barriers, fears and concerns to CE research
– a plan for the dissemination of CE research that will “ensure practical implementation of findings”
– the complete integration of CE and evidence-based medicine in health care financing and delivery.

For a nuts-and-bolts account of the challenging task of translating CE research into better medical practice, see February’s “A Simple Health-Care Fix Fizzles Out” by Keith J. Winstein, in The Wall Street Journal (WSJ, Feb 11, 2010). Winstein uses the “Courage” trial as a case study; see: Boden WE, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. PubMed PMID: 17387127. This study found that a common procedure, implanting stents in clogged arteries, “yields no additional benefit when used with a cocktail of generic drugs.” Following the publication of the study, the use of stent implants declined by 13% in the U.S., but only briefly. Stent use in cardiology is now back to “peak levels.” William Boden, an author of the Courage trial, explains: “Most [cardiologists] haven’t voluntarily incorporated the Courage criteria into their practice …. What’s going to continue to drive practice is reimbursement.”

Related Links and Publications

AHRQ Effective Health Care Program
Comparative Effectiveness Research, HHS.gov/Recovery

Chalkidou K. The (possible) impact of comparative effectiveness research on pharmaceutical industry decision making. Clin Pharmacol Ther. 2010 Mar;87(3):264-6. PubMed PMID: 20160745.
Congressional Budget Office (CB0), The Congress of the United States. Research on the comparative effectiveness of medical treatments. December 2007. CB0, Pub. No. 2975. [PDF – 1.4 MB]
Garber AM, Tunis SR. Does comparative-effectiveness research threaten personalized medicine? N Engl J Med. 2009 May 7;360(19):1925-7. PubMed PMID: 19420360.
Institute of Medicine. Initial national priorities for comparative effectiveness research. Washington, DC: Institute of Medicine, 2009. [NAP, ISBN-10: 0-309-13836-1]
Khoury MJ, Rich EC, Randhawa G, Teutsch SM, Niederhuber J. Comparative effectiveness research and genomic medicine: an evolving partnership for 21st century medicine. Genet Med. 2009 Oct;11(10):707-11. PubMed PMID: 19752739.
Slutsky JR, Clancy CM. Patient-centered comparative effectiveness research: essential for high-quality care. Arch Intern Med. 2010 Mar 8;170(5):403-4. PubMed PMID: 20212173.
Sarah Thomas, AARP Public Policy Institute. Comparative Effectiveness: What’s at Stake for Consumers? November 20, 2008. [PDF – 63.6 KB]
Weinstein MC, Skinner JA. Comparative effectiveness and health care spending–implications for reform. N Engl J Med. 2010 Feb 4;362(5):460-5. PubMed PMID: 20054039.
Vanlare JM, Conway PH, Sox HC. Five Next Steps for a New National Program for Comparative-Effectiveness Research. N Engl J Med. 2010 Feb 17 PubMed PMID: 20164480.

Other Research Ethics News

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry Non-Inferiority Clinical Trials. March 2010. [PDF – 975 KB]

Kevin Naughton. Researchers’ organ failure. The Independent Weekly [AU]. February 27, 2010.

Trine Tsouderos. Exploring links between genes, violence, environment. Chicago Tribune. February 25, 2010.

Andrew Zajac. FDA creates partnership to boost regulatory science. Los Angeles Times. February 25, 2010.

ICMR to set up apex committee to regulate stem cell research. DNA India. February 21, 2010.

Yaadika N Chama. Zambia bans all microbicide clinical trials. The Zambian Chronicle. February 19, 2010.

Daniel Peake. Scandalous science: scientists cheating on data. Medill Reports (Northwestern University). February 17, 2010.

Marc Gerstein. Blood Simple: Columbia University’s Ten-Year Cover-Up of Patient Harm, Conflicts of Interest and Administrative Misconduct. truthout. February 16, 2010. [See, related: OHRP, Columbia and Hetastarch: Research Ethics in the News. Indiana Bioethics, October 13, 2009.]

Jonathan E. Rackoff. Whistle-Blower Protection a Must. Genetic Engineering & Biotechnology News. February 15, 2010.

Shishir Prasad. Full Stem Ahead. Forbes India. February 12, 2010.

– J.O.

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