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4 Conflicts of Interest in Biomedical Research
Pages 97-121

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From page 97...
... Research partnerships among industry, academia, and government are essential to the discovery and development of new medications and medical devices that provide improved means for the prevention, diagnosis, and treatment of health problems. Historically, the federal government has taken the lead in supporting discoveries in basic science, whereas commercial firms have focused on the discovery of specific medicines and then their development through clinical trials to the regulatory approval of marketable products.
From page 98...
... COLLABORATION AND DISCOVERY IN BIOMEDICINE The path from a scientific discovery to the marketing of a new drug, device, or biological product is typically long and complex and involves a diversity of expertise and resources. For example, basic researchers, often at academic medical centers and other research institutions, can identify new potential targets for therapies and new strategies for treatment, suggest additional diseases that may be able to be treated by existing and newly developed compounds, and suggest both how to target therapies to the patients who are the most likely to benefit and how to avoid particular treatments for patients at high risk for adverse events from those treatments.
From page 99...
... Finally, pharmaceutical companies also supply or raise the capital needed to fund the lengthy process of bringing a product to market. Medical device companies and biotechnology companies play analogous roles in translating discoveries made through basic research into products or services for medical and public health practice, although the specific details differ from those involved with the drug approval process.
From page 100...
... Examples of medical devices that have been developed as a result of close academicindustry collaborations include implanted defibrillators (Jeffrey, 2001) , prosthetic heart values (Gott et al., 2003)
From page 101...
... Extent of Academic-Industry Relationships Industry relationships with academic biomedical researchers are extensive. A 2006 national survey of department chairs in medical schools and large independent teaching hospitals found that 67 percent of academic departments (as administrative units)
From page 102...
... A study of disclosures at the University of California at San Francisco found that by 1999, approximately 8 percent of principal investigators at the institution reported personal financial ties to the sponsor of a particular research project (Boyd and Bero, 2000)
From page 103...
... . A 1995 survey of life sciences faculty in the 50 most research intensive institutions found that 14 percent of those with funding from industry reported that trade secrets had resulted from their research, whereas 5 percent of those without funding from industry did so (Blumenthal et al., 1996a)
From page 104...
... Research Funding from Industry and Pro-Industry Findings in Published Research Several systematic reviews and other studies provide substantial evidence that clinical trials with industry ties are more likely to have results that favor industry. One meta-analysis found that clinical trials in which a drug manufacturer sponsors clinical trials or the investigators have financial relationships with manufacturers are 3.6 times more likely to find that the drug tested was effective compared to studies without such ties (Bekelman et al., 2003)
From page 105...
... Other studies have found that research funded by industry was more likely to report conclusions that favored the sponsor's drug, even if the results did not in fact support such conclusions. For example, studies that have examined clinical trials involving specific clinical specialties or particular clinical problems have found an association between industry sponsorship and results that favor industry.
From page 106...
... Sometimes the information became known only after legal proceedings led to the disclosure of confidential internal industry documents. In addition, systematic reviews that look at meta-analyses rather than individual clinical trials as the unit of analysis also find an association between industry funding and conclusions that favor the sponsor's product.
From page 107...
... . Published clinical trials suggest that selective serotonin reuptake inhibitors have a favorable benefit-risk profile in children with depression.
From page 108...
... Chapter 5 discusses ghostwriting and also participation on speakers bureaus and recommends that academic medical centers forbid faculty from accepting the authorship of ghostwritten articles and participation in speakers bureaus. Terms of Research Contracts Some academic health centers allow provisions in research contracts that give industry sponsors important control over the reporting of research findings.
From page 109...
... Issues Involving Research Participants or Students As Chapter 3 discussed, academic medical centers vary in their policies on disclosure to research participants of investigator's conflicts of interest. It also noted that several surveys suggest that participants in clinical trials currently are not highly concerned about investigators' financial conflicts of interest.
From page 110...
... Because the PHS regulations were not specific on many issues and because some studies indicated shortfalls in their implementation, AAMC issued a report in 2001 with recommendations to help academic medical centers develop sound conflict of interest policies for research involving human subjects (AAMC, 2001) . A key policy recommendation called for institutions to establish a "rebuttable presumption" that researchers may not conduct research involving human participants when they have a financial stake in its outcome.
From page 111...
... Unlike the PHS regulations that cover both clinical and nonclinical research, the 2008 AAMC-AAU recommendations focused on clinical research. One recommendation did, however, call for medical center conflict of interest committees to review investigator conflicts of interests in certain nonclinical studies.
From page 112...
... Requirements to Register and Report on Clinical Trials Congressional, journal editor, and other requirements for the registration of clinical trials are, in part, a response to concerns about conflict of interest in industry-sponsored research and research reporting. The registration of clinical trials and the provision of key details about the trial protocol and the data analysis plan ensure that basic methods for the conduct and analysis of the findings of a study as well as the primary clinical end points to be assessed and reported are specified before the trial begins and before data are analyzed.
From page 113...
... Efforts to improve the design of clinical trials and other types of research stretch back decades and include a range of techniques, including the random assignment of subjects to intervention and control groups and the blinding of investigators and participants to treatment assignment. In addition, NIH has supported programs to train physician investigators to conduct rigorous clinical research.
From page 114...
...  7 How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules  8 Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking or stratification)  9 Method used to implement the random allocation sequence (e.g., numbered containers or central telephone)
From page 115...
... Chapter 3 includes a committee recommendation supporting such a program. Issues Involving Research Participants and Students As described in Chapter 3, AAMC recommended in 2001 and again in 2008 policies that require some form of disclosure of investigator conflicts of interest to research subjects, and many medical schools have adopted those policies.
From page 116...
... Some studies also suggest that metaanalyses sponsored by a single company tend to present conclusions favorable to industry sponsors even when the actual findings of the analyses are not favorable. Moreover, when investigators themselves have a financial stake in the outcomes of their research, it creates conflicts of interest, which may lead to bias and the erosion of confidence in the research enterprise.
From page 117...
... Government and press investigations and payment data reported by companies have revealed failures of individual researchers to fully and accurately disclose their financial relationships with industry, as required by institutional or government policies. The preceding section of this chapter provided an overview of recommendations for action that should be taken by research institutions, research sponsors, investigators, and medical journals to protect the integrity of biomedical research, safeguard research participants, and preserve public trust.
From page 118...
... . A specific example of a compelling situation might involve the participation in a pilot study of the inventor of an implanted medical device that requires a complex, new surgical procedure that has not been mastered by others.
From page 119...
... Nonclinical Research Most of the discussion of conflicts of interest in research has focused on clinical research. This emphasis reflects concerns that research participants might be harmed or that bias might contribute to the making of incorrect decisions about approving new drugs and devices or changing clinical practice.
From page 120...
... The development of illustrative case studies might help institutions better understand and manage conflicts of interest in nonclinical research. Other Relevant Recommendations in This Report The adoption of the recommendations made elsewhere in this report would also affect researchers, research institutions, and companies.
From page 121...
... CONFLICTS OF INTEREST IN BIOMEDICAL RESEARCH 121 Taken together, the changes recommended here should not burden socially valuable collaborations between academic researchers and industry. Rather, they should help justify and maintain public trust in their integrity.


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