Conflict of Interest in Medical Research, Education, and Practice (2009) / Chapter Skim
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7 Conflicts of Interest and Development of Clinical Practice Guidelines
7 Conflicts of Interest and Development of Clinical Practice Guidelines
Pages 189-215
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From page 189... ...
. Financial relationships with pharmaceutical, medical device, and biotechnology companies may create conflicts of interest and a risk of undue influence on judgment both for entities that sponsor the development of clinical practice guidelines and for the individuals who participate in their development.
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From page 190... ...
It then reviews what the committee learned about the nature and the effects of sources of funding on the development of clinical practice guidelines, the financial interests of individual participants, and policies on financial relationships and conflicts of interest. A later section reviews other methods for promoting objectivity in the development of clinical practice guidelines and trust in those guidelines.
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From page 191... ...
-- withdrew from the work of developing clinical practice guidelines. Instead, the agency supports evidence-based practice centers that conduct systematic reviews that government agencies, professional societies, and other groups can request and use to develop guidelines and other recommendations.
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From page 192... ...
Shortcomings in the processes for the development and reporting of clinical practice guidelines persist. These shortcomings include the incomplete disclosures of the financial relationships of the participants and the funding sources and informal procedures, which increase the opportunity for undue influence and bias (see, e.g., Shaneyfelt et al.
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From page 193... ...
Any of the responsible parties identified in Table 7-1 could have financial relationships with industry that could unduly influence recommendations -- even when systematic reviews and other safeguards are employed. Thus, some groups have conflict of interest policies that apply not only to the expert panels that develop guidelines but also to some or all of the other responsible or involved parties.
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From page 194... ...
Individual panel members who have financial relationships with industry often have expertise that is pertinent to the development of a guideline. Risks of Industry Relationships As observed above, relationships with industry and conflicts of interest in the development of clinical practice guidelines may exist at both the individual level (i.e., participants may have industry ties)
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From page 195... ...
Review of evidence Studies examining the association between industry ties and the outcomes of systematic reviews or meta-analyses raise concerns. Although these studies do not deal explicitly with the entire process of developing clinical practice guidelines, they examine a key element. In one study, industry-sponsored meta-analyses of drug trials were less transparent about the methods that they used, were much more likely than Cochrane Collaboration reviews to recommend the experimental drug without reservation, and had fewer reservations about the methodological limitations of the trials included in the analysis (Jorgensen et al., 2006)
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From page 196... ...
Expert panel deliberations The committee found no systematic studies of the relationship between participant financial relationships and the content of guidelines. One study did find, however, that only 7 percent of participants in guideline development surveyed believed that their own relationships with industry influenced their recommendations, but 19 percent believed that their coauthors' recommendations were influenced by such relationships (Choudhry et al., 2002)
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From page 197... ...
Some groups involved in guideline development have sought partners. For example, the American College of Cardiology and the American Heart Association have collaborated in their guideline development program since the 1980s (ACC/AHA, 2009)
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From page 198... ...
The committee is aware that some smaller professional societies that have sought to fund clinical guideline development and systematic reviews without industry support have found it difficult to do so (personal communication, Roger Chou, assistant professor of medicine and medical informatics and clinical epidemiology, Oregon Health Sciences University, April 2, 2008)
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From page 199... ...
Nature and Extent of Individual Relationships with Industry The committee found little systematic study and documentation of financial relationships between industry and the individuals who author clinical practice guidelines. A 2002 study reported that the authors of practice guidelines had widespread financial relationships with the pharmaceutical industry (Choudhry et al., 2002)
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From page 200... ...
. A recent set of revisions to the guidelines reported no industry funding for guideline development meetings, and 7 of the 24 authors reported no "potential" conflicts of interest (Dellinger et al., 2008)
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From page 201... ...
The majority of the authors surveyed reported no discussion of financial relationships during the guideline development process. Journal articles and other publications that contain practice guidelines vary greatly in the extent to which they include disclosures of the relevant financial relationships of the participants in the guideline development process. For the most part, disclosures emphasize financial relationships with pharmaceutical and device companies, although some describe ties to other kinds of organizations (e.g., federal research agencies and managed care organizations)
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From page 202... ...
Example B FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST All participants involved in guideline development have disclosed potential conflicts of interest to their colleagues, and their potential conflicts have been documented for future reference. They will not be published in any guideline, but kept on file for reference, if needed.
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From page 203... ...
Consequences of Financial Relationships The committee found no systematic studies that investigated the association between the funding source and the development process or the content of the clinical practice guidelines. As illustrated in Box 7-2, it did find cases that raised concerns about the influence of industry funding.
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From page 204... ...
. POLICIES ON CONFLICTS OF INTEREST IN CLINICAL PRACTICE GUIDELINE DEVELOPMENT Characteristics of Policies The committee examined a convenience sample of conflict of interest policies identified through the National Guideline Clearinghouse, presentations at committee public meetings, organizational websites, documents describing guidelines, assessments of specific guidelines, other publications,
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From page 205... ...
The frequent lack of transparency of conflict of interest policies limits the ability of guideline readers to consider financial relationships and conflicts of interest as part of their assessment of the credibility of a set of guidelines. To give a sense of what readers of guidelines may encounter, Box 7-3 includes additional examples of the range of summary statements in the National Guideline Clearinghouse.
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From page 206... ...
Example C FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST The American Academy of Neurology (AAN) is committed to producing indepen dent, critical and truthful clinical practice guidelines (CPGs)
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From page 207... ...
Thus, a "Not stated" response does not necessarily indicate that a group has no policy. Other Strategies to Limit Bias in the Development of Clinical Practice Guidelines Those committed to the development and implementation of sound, credible, and useful guidelines have devised a number of methods and tools that can be used to support the creation of such guidelines.
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From page 208... ...
Unfortunately, as Steinberg and Luce (2005) have observed, rigorous methods for clinical practice guideline development and reviews of the clinical evidence are not applied consistently, and the conclusions of evidence reviews are not always interpreted appropriately.
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From page 209... ...
Creating a diverse expert panel. The inclusion of individuals with a range of rel evant professional and other backgrounds on guideline development panels can help check financial, professional, and other sources of bias; promote the fuller consideration of potential outcomes, relevant evidence, and aspects of implemen tation; and help win broader acceptance by professionals, consumers or patients, health care plans, and others who play roles in the successful implementation of guidelines (see, e.g., IOM [1990, 1992, 2008]
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From page 210... ...
Even when the developers of clinical practice guidelines use sound methods, they are often limited by shortcomings in the evidence base. A review of the guidelines in the National Guideline Clearinghouse reveals recommendation after recommendation that is supported by weak, mixed, or no evidence.
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From page 211... ...
Recommendation 7.1 proposes several such steps. RECOMMENDATION 7.1 Groups that develop clinical practice guidelines should generally exclude as panel members individuals with conflicts of interest and should not accept direct funding for clini cal practice guideline development from medical product companies or company foundations.
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From page 212... ...
In addition to expanded disclosure about funding, the committee recommends an end to direct industry funding of clinical practice guidelines. It recognizes that this step might have the undesirable effect of reducing the involvement of professional societies in guideline development but believes that it is necessary to avoid the conflicts that come from industry financing.
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From page 213... ...
Three desirable steps are for • journals to require that all clinical practice guidelines accepted for publication describe (or provide an Internet link to) the developer's conflict of interest policies, the sources and amounts of funding for the guideline, and the relevant financial interests of guideline panel mem bers, if any; • the National Guideline Clearinghouse to require that all clinical practice guidelines accepted for posting describe (or provide an Inter net link to)
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From page 214... ...
should reduce conflicts of interest among the pool of experts considered for participation in clinical practice guideline development (Recommendations 5.1, 6.1, and 6.2)
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From page 215... ...
DEVELOPMENT OF CLINICAL PRACTICE GUIDELINES 215 of interest would challenge professional societies, patient advocacy groups, and other entities that develop clinical practice guidelines to confront the scope and appropriateness of their financial ties with industry, eliminate questionable ties, and prudently manage others (Recommendation 8.1)
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