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Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v18.i1.80
10 pages

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

ABSTRACT

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 agencies—for 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.