Descripción: |
Academic-industry partnerships in biomedical research come in many forms, but
those that occur around clinical research are the most prominent. Researchers at academic
medical centers have historically conducted a large proportion of industry-sponsored
clinical trials, as they alone had the knowledge, infrastructure, and patient base to design,
conduct, and analyze large-scale trials. In recent years, contract-research organizations
(CROs) have become popular choices for industry as they offer lower costs, faster trials,
and complete industry control of results, but academic investigators are and will continue
to be important actors in industry-sponsored clinical trials.
Conflicts of interest occur when a set of circumstances creates a risk in which
professional judgment or actions regarding a primary interest will be unduly influenced
by a secondary interest. For academic researchers and institutions that conduct industry
trials, conflicts of interest are common. Academic institutions and researchers frequently
have significant financial interests in industry or marketable research. This stems back to
the Bayh-Dole Act of 1980, which gave intellectual property rights developed using
federal funding to academic institutions and small businesses in order to spur innovation
and translational research, bringing new treatments to market. The Act was a great
success but fundamentally altered the missions of universities and academic medical
centers, changing them from institutions focused on freely disseminating new and basic
knowledge to engaging in profit-guided institutions that focused on marketable research.
Much legislation and regulation has focused on identifying and managing
conflicts of interest. Both the Food and Drug Administration (FDA) and National
Institutes of Health (NIH) have conflict of interest policies for research they fund and
oversee. NIH policies affect all institutions that receive Public Health Service (PHS)
funding, which includes nearly every university and academic medical center. It requires
prospective disclosure of conflicts of interest prior to grant awards and the beginning of
research. The FDA, on the other hand, only looks at the financial disclosure statements of
non-industry investigators associated with clinical trials after the trials are complete, and
it is unclear how much the FDA even uses this post-research oversight.
Most troubling about many conflict of interest policies is the tendency to view
transparency and disclosure as the end goal, instead of a necessary but insufficient step
towards recognition and management of conflicts of interest. Transparency is only
meaningful if action is taken as a result of that disclosure. The rebuttable presumption
that an individual or institution that holds a significant financial interest in research
involving human subjects may not conduct such research except in compelling
circumstances is model of such a policy that goes beyond disclosure to regulate action
taken as a result of the disclosure. Recommendations centering on the idea that
transparency is necessary but not sufficient condition of conflict of interest policy are
provided for all stakeholders involved academic investigators conducting industrysponsored
clinical trials.
Conflicts of interest must be actively recognized and managed, because the nonaligning
interests of the multiple parties involved in industry-sponsored clinical trials
place a great deal of conflicting pressure on academic investigators. However, the value
of having such investigators involved in clinical trials is worth the effort. |