Skip to main content

Currently Skimming:

2 Conflict of Interest Policies: An Overview
Pages 5-20

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 5...
... • The financial disclosures required by the Physician Payments Sunshine Act will provide useful information and will facilitate transparency and communication, but consideration of the context of the conflict of interest is also necessary to accurately represent the value of those. • Conflict of interest policies are intended to enhance academic– industry relationships, support the objectivity of research, and maintain public trust by managing conflicts, not by eliminating or avoiding them.
From page 6...
... It also conflates actual conflicts, potential conflicts, and perceived conflicts, Lo said. The IOM committee observed that all conflicts of interest involve perceptions or appearances because they are specified from the perspective of people who do not have sufficient information with which to assess the actual motives of a decision maker and the effects of those motives on the decisions themselves.
From page 7...
... The underlying question, said Gabriela Lavezzari, assistant vice president for scientific affairs at the pharmaceutical industry association PhRMA, is how a patient might be affected by these policies. PhRMA performed a landscape analysis of key stakeholders in the drug development ecosystem, from academia, industry, professional associations, government agencies, legal experts, health policy analysts, and bio-ethicists, Lavezzari said.
From page 8...
... When research collaborations with industry are reduced, that reduces research productivity, said an individual academic researcher. In addition, conflict of interest policies increase the amount of time spent complying with policies and the resources devoted to monitoring policies.
From page 9...
... Extreme instances of true conflicts of interest have generated attention and have led to negative perceptions of industry relationships and to stricter policies. Part of the reason, Lo observed, is that there have been some prominent and well-publicized cases in which biased or inaccurate research findings resulted in harm to patients.
From page 10...
... The underlying implicit assumption in most conflict of interest policies today is that more disclosure is equivalent to more transparency. Transparency in turn is assumed to lead to less undue influence and bias, greater accountability and trustworthiness, and enhanced public trust.
From page 11...
... Clinicians care for patients, which can create conflicts involving how they are financially compensated for their expertise, how they manage their patients, how their institutions hold them accountable for providing cost-effective care, and how they relate to their scientific colleagues, graduate students, postdoctoral fellows, and those in industry, said Cohen. In addition, faculty members seek to protect not only their academic freedom but also their autonomy and their control over their research, clin
From page 12...
... They aim to protect intellectual property and benefit from royalty and licensing payments while also creating and disseminating new knowledge. The collaborative research enterprise for institutions has expanded greatly over the past two decades, according to Todd Sherer, associate vice president for research and executive director of the Office of Technology Transfer at Emory University.
From page 13...
... Industry would like to control intellectual property, reduce the high cost of product development and regulatory burdens, and balance the needs of its own researchers for autonomy with the need to commercialize products, Cohen said. Some people believe that the only way to manage these conflicts is to avoid developing relationships between industry and academics.
From page 14...
... Having more robust peer review processes before clinical trials start would produce better research, as would having more explicit standards, guidelines, and checklists for preclinical and clinical studies. The comparative arm should be a reasonable comparison, not just the weakest result in the control arm so that the ex
From page 15...
... The reporting requirements of Section 6002 of the Affordable Care Act, often referred to as the Physician Payments Sunshine Act2 that will go into effect in 2014 have been designed to help patients make informed decisions and to discourage financial relationships that inflate health care costs. Beginning August 1, 2013, manufacturers are to collect and track data on their financial relationships with physicians and teaching hospitals.
From page 16...
... Creative forms of collaboration can break down the silos between industry and academia while avoiding some of the issues associated with traditional collaborations, Cohen continued. One such example is the Medical Device Innovation Consortium developed by FDA, which facilitates collaborations among academia, industry, and federal partners, said Michelle McMurry-Heath, associate director for science at FDA's Center for Devices and Radiological Health.
From page 17...
... Patient- and device-recorded data and surveys, genetic and blood analysis with specimen banking, and device integration allow for improved health care delivery and the rapid creation of large cohorts for registries and clinical trials. All of the study data must be secured according to the guidelines of the Health Insurance Portability and Accountability Act of 1996.3 The result is that the study, Cohen said, is similar to the Framingham Heart Study, except that it is able to be carried out on a global scale because of the digital nature of the data collection and analysis.
From page 18...
... The new regulations establish standards that provide a reasonable expectation that the design, conduct, support, and reporting of research funded under PHS as grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest, Rockey said. The term "reasonable expectation" signals that conflicts will arise but that they will be managed to produce objective research.
From page 19...
... , which was created to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics. For example, a centerpiece of the NCATS program has been the Discovering New Therapeutic Uses for Existing Molecules program, through which eight companies have made available to academic researchers their libraries of molecules and compounds that have gone through preclinical trials but have not progressed further.
From page 20...
... Most patients will not look at whatever disclosure information is available, but researchers, investigative journalists, policy makers, and others will look for patterns that apply more broadly. Where institutions implement quality improvement measures to improve patient outcomes, "that's the kind of value we're most likely to see," Lo said.


This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More information on Chapter Skim is available.