Promoting Transparency in Pharmaceutical Industry–Sponsored Research

Abstract

Strong, evidence-based practice requires that objective, unbiased research is available to inform individual clinical decisions, systematic reviews, meta-analyses, and expert guideline recommendations. Seeding trials, publication planning, messaging, and ghostwriting, as well as selective publication and reporting of trial outcomes have been used by industry to distort the medical literature and undermine clinical trial research, explicitly by obscuring information that is relevant to patients and physicians. Policies that promote transparency into the clinical trial research process, through improved and expanded disclosure of investigator contributions and funding, comprehensive publicly-available trial registration, and independent analysis of clinical trial data, have the potential to address these subversive practices by improving accountability among industry and investigators. Minimizing the impact of marketing on clinical trial research, and strengthening the science, will protect both the integrity of the medical literature as well as the public’s health.

Access of primary and secondary literature by health personnel in an academic health center: implications for open access

“…Clinical trials allow the reader to home in on a single factor, whether in treatment or patient characteristics. In 2011, NIH invested $3.5 bUIion to fund clinical trials research [46,47]. Clearly, the value of these trials to health persormel, and thus the public at large, is increased as this research is accessed in clinical settings.…”

Does probiotics reduce crying time in infantile colic in exclusively breastfed babies? A comprehensive meta-analysis

“…However, the likelihood is small since the Table II : Crying time after 3 weeks use of probiotics trials were fully investigator-initiated and data controlled with transparent disclosure of potential conflicts of interest by the respective authors. 15,16 Recently few studies have addressed the role of changing intestinal microbiota in the pathogenesis of colic. Colicky infants were found to have increased colonization by coliforms especially E.coli and decreased and altered colonization.…”

Prospects for a transparency revolution in the field of business history

“…Within the physical sciences, the creation of systems to promote research transparency had been driven by concerns related to research in fields as diverse as psychology, pharmaceuticals, and climate change. 36 The ongoing transparency revolution in the physical and social sciences has been driven, in part, by rising public scepticism about the claims of experts and the motives of powerful organisations such as universities, governments, intelligence agencies, and large companies. 37 Funding bodies have also become aware that the incentive structure for academics may encourage researchers to consciously or unconsciously cherry-pick or otherwise misrepresent data in order to fit preconceived research findings.…”