jueves, 9 de mayo de 2013

"Restaurando" la confianza en la industria farmacéutica...

Lack of trust in the pharmaceutical industry threatens the future of biomedical research. Although more than half of funded clinical trials in the United States are supported by industry1 and many scientists, clinicians, and others in industry are committed to advancing biomedical science and improving the health of patients, there is a need to restore confidence in pharmaceutical companies and the research they sponsor. As editors of a journal that publishes articles supported by industry, we are familiar with many of the complicated issues related to industry-supported and industry-analyzed studies. We have had discussions with leaders of the pharmaceutical industry about concerns they have regarding the erosion of trust in their companies. We also have had discussions with academic leaders and leading scientists about ways to improve the reputation of pharmaceutical industry research and have participated in initiatives to harmonize reporting by physicians, investigators, and others who have financial relationships with industry and other conflicts of interest. (...)

At the same time, the credibility of pharmaceutical company research has declined. Numerous high-profile reports involving some of the world's largest and previously most well-respected companies have detailed serious concerns about manipulation and misrepresentation of data from industry-sponsored research.(...)

Despite these challenges, several options are available to pharmaceutical companies to help restore credibility and trust in their sponsored research.

  • First, although companies that sponsor biomedical research studies can be involved in designing clinical studies, the data analysis should be performed by academic investigators who are not employed by the company sponsoring the research.(...)
  • Second, preparation of the manuscript reporting the study results should primarily be the responsibility of the academic investigators, especially with respect to the initial drafts of the paper, which establish the frame and tone of the article, both of which are difficult to change after a first draft has been prepared.(...)
  • Third, data from clinical trials could be made publicly available to qualified investigators for analyses of important research questions.(...)
  • Fourth, the pharmaceutical industry could collectively agree to refrain from direct-to-consumer advertising for some specified period after a drug is approved or until postmarketing studies are completed.(...)

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