ISSN Print: 1050-6934
Volumes:Volume 28, 2018 Volume 27, 2017 Volume 26, 2016 Volume 25, 2015 Volume 24, 2014 Volume 23, 2013 Volume 22, 2012 Volume 21, 2011 Volume 20, 2010 Volume 19, 2009 Volume 18, 2008 Volume 17, 2007 Volume 16, 2006 Volume 15, 2005 Volume 14, 2004 Volume 13, 2003 Volume 12, 2002 Volume 11, 2001 Volume 10, 2000
Journal of Long-Term Effects of Medical Implants
Abstract of "Improving the Quality of External Research Conducted By Drug/Device Manufacturers Through Industry-Supported, Publicly Administered Funding Mechanisms"
Daniel F. Catanzaro
Myocardial Molecular and Cell Biology Laboratory, Division of Cardiovascular Medicine, SUNY Downstate Medical Center, 450 Clarkson Ave, Brooklyn, NY 11203
Studies aimed at evaluating drug/device mechanism or efficacy are considered unbiased when funded by disinterested parties, but subject to bias when the research is supported by entities that might benefit from a favorable outcome or might be disadvantaged by an unfavorable outcome. Therefore, conventional wisdom would maintain that only studies funded by disinterested entities are truly credible. Unfortunately, the agencies administering such independent funding, and the review committees they employ to evaluate the science, have often rejected studies of this type because they were considered to be part of the research and development process that should be funded by the drug/device companies themselves. By directly funding "investigator-initiated" studies as a mechanism for independent validation, the drug/device companies have achieved suboptimal returns on their investment, because the findings are often treated with caution and skepticism. A mechanism that could alleviate many of these biases and shortcomings involves placing at least portions of discretionary drug/device company research budgets into publicly administered agenciesfor example, an Institute of Drug/Device Evaluation to be created within the National Institutes of Health. Projects could be funded through both investigator-initiated mechanisms and requests for applications, and would be subject to peer review. This would open the funding pool to a broader pool of investigators, while peer review would strengthen proposals and greatly reduce the perception of bias. Moreover, the funding pool would be proscribed, as would be its application, thus eliminating the negative bias of current funding agencies. Drug companies would pay directly for necessary research that would be administered in a more rigorous manner. Tax incentives could be used to promote the cooperation of the drug/device manufacturers. Broadening access to drug/device industry funding and implementing more rigorous review standards will most likely improve the quality, safety, and efficacy of drugs and devices available to consumers.
|Begell Digital Portal||Begell Digital Library||eBooks||Journals||References & Proceedings||Research Collections|