Elizabeth A. Boyd

Improving the use of research evidence in guideline development: 4. Managing conflicts of interests

AbstractBackgroundThe World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the fourth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this.ObjectivesWe reviewed the literature on conflicts of interest to answer the following questions:1. What is the best way to obtain complete and accurate disclosures on financial ties and other competing interests?2. How to determine when a disclosed financial tie or other competing interest constitutes a conflict of interest?3. When a conflict of interest is identified, how should the conflict be managed?4. How could conflict of interest policies be enforced?MethodsWe searched PubMed, the Cochrane Methodology Register and selectively searched for the published policies of several organizations, We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments.Key questions and answersWhat is the best way to obtain complete and accurate disclosures on financial ties and other competing interests? • Although there is little empirical evidence to guide the development of disclosure forms, minimal or open-ended formats are likely to be uninformative. We recommend the development of specific, detailed, structured forms that solicit as much information as possible about the nature and extent of the competing interests. How to determine when a disclosed financial tie or other competing interest constitutes a conflict of interest? • There is no empirical evidence to suggest that explicit criteria are preferable to ad hoc committee decisions when deciding if a disclosed financial tie is a conflict of interest. However, explicit criteria may make decision-making easier. When a conflict of interest is identified, how should the conflict be managed? • Descriptive studies suggest that appropriate management strategies are best determined on a case-by-case basis. Thus, WHO should use a wide range of management strategies to address disclosed conflicts of interest, with public disclosure of conflicts associated with each meeting as a minimum and recusal of conflicted individuals as the other extreme. How could conflict of interest policies be enforced? • Although there are no empirical studies of the enforcement of conflict if interest policies, descriptive studies of other organizations and institutions suggest that WHO convene a standing committee to review all financial disclosure statements prior to the commencement of committee meetings/hearings and to make management recommendations when necessary. A standard policy requiring all financial ties to be made public (i.e., recorded into the meeting minutes) should reduce the number of problematic cases. In instances where the conflicts seem intractable, a recommendation of recusal may be necessary to protect the greater interests of WHO and its constituents.

Reporting Science and Conflicts of Interest in the Lay Press

Background Forthright reporting of financial ties and conflicts of interest of researchers is associated with public trust in and esteem for the scientific enterprise. Methods/Principal Findings We searched Lexis/Nexis Academic News for the top news stories in science published in 2004 and 2005. We conducted a content analysis of 1152 newspaper stories. Funders of the research were identified in 38% of stories, financial ties of the researchers were reported in 11% of stories, and 5% reported financial ties of sources quoted. Of 73 stories not reporting on financial ties, 27% had financial ties publicly disclosed in scholarly journals. Conclusions/Significance Because science journalists often did not report conflict of interest information, adherence to gold-standard recommendations for science journalism was low. Journalists work under many different constraints, but nonetheless news reports of scientific research were incomplete, potentially eroding public trust in science.

Guideline funding and conflicts of interest: article 4 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

INTRODUCTION Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that healthcare recommendations are informed by the best available research evidence. This is the fourth of a series of 14 articles prepared to advise guideline developers in respiratory and other disease. It focuses on commercial funding of guidelines and managing conflict of interest effectively in the context of guidelines. METHODS In this review, we addressed the following topics and questions. (1) How are clinical practice guidelines funded? (2) What are the risks associated with commercial sponsorship of guidelines? (3) What relationships should guideline committee members be required to disclose? (4) What is the most efficient way to obtain complete and accurate disclosures? (5) How should disclosures be publicly shared? (6) When do relationships require management? (7) How should individual conflicts of interest be managed? (8) How could conflict of interest policies be enforced? The literature review included a search of PubMed and other databases for existing systematic reviews and relevant methodological research. Our conclusions are based on available evidence, consideration of what guideline developers are doing, and workshop discussions. RESULTS AND DISCUSSION Professional societies often depend on industry funding to support clinical practice guideline development. In addition, members of guideline committees frequently have financial relationships with commercial entities, are invested in their intellectual work, or have conflicts related to clinical revenue streams. No systematic reviews or other rigorous evidence regarding best practices for funding models, disclosure mechanisms, management strategies, or enforcement presently exist, but the panel drew several conclusions that could improve transparency and process.

Assessing faculty financial relationships with industry: a case study

FINANCIAL TIES BETWEEN ACAdemic researchers and private industry are currently under intense scrutiny. About

Improving the use of research evidence in guideline development

1.5 billion from industry flows into academic institutions annually, and 1 study has shown that 28% of surveyed life sciences faculty report funding from private sponsors. There is growing concern among federal and state agencies and academic institutions that industry sponsorship may influence the outcomes of research and undermine traditionally held academic values of intellectual freedom, open exchange of ideas, and research in the interest of the public good. Such concerns are not without foundation. Several studies have shown an association between single-source sponsorship of clinical research and publication of results favoring the sponsor’s product; another study has shown that unfavorable results of economic analyses of oncology drugs are less likely to be reported when the study is funded by a pharmaceutical company. Faculty researchers receiving research support from industry are also more likely to restrict their communication with colleagues than faculty not receiving industry sponsorship, and many faculty who receive gifts from corporate sponsors are subject to prepublication review or data use restrictions. In addition to the effects that corporate sponsorship might have on design, outcome, or publication of results, concern exists that a growing number of faculty researchers also have personal financial relationships with the companies sponsoring their research. In 1996, Krimsky et al Author Affiliations: Center for Health Care Evaluation, Health Services Research and Development Program, Department of Veterans Affairs, Palo Alto, Calif (Dr Boyd); Institute for Health Policy Studies, School of Medicine (Drs Boyd and Bero), and Department of Clinical Pharmacy, School of Pharmacy (Dr Bero), University of California, San Francisco. Dr Bero serves as chair of the Chancellor’s Advisory Panel on Relations with Industry at the University of California, San Francisco, from September 1999 to present. Corresponding Author and Reprints: Lisa A. Bero, PhD, Department of Clinical Pharmacy and Institute for Health Policy Studies, University of California, San Francisco, 3333 California St, Suite 265, San Francisco, CA 94143-0936 (e-mail: bero@medicine.ucsf.edu). Context A growing number of academic researchers receive industry funding for clinical and basic research, but little is known about the personal financial relationships of researchers with their industry sponsors.