The authors Michael A. Rogawski, M.D., Ph.D. of University of California, Davis, and Howard J. Federoff, M.D., Ph.D. of Georgetown University Medical Center, call on the U.S. Department of Health & Human Services to use its authority to require reporting of clinical study results, even if product development is abandoned.
Federally and privately supported clinical trials are registered in a database (ClinicalTrials.gov) as required by the U.S. Food and Drug Administration (FDA) Modernization Act of 1997. Recently, Congress enacted the FDA Amendments Act of 2007, a provision that mandates the inclusion of “basic results” data from all clinical trials of approved drugs, biologics and devices (with some exceptions). Currently, though, there is no legal requirement that sponsors disclose the results of clinical trials for unapproved products, including those that have been abandoned, and many sponsors consider the data proprietary.
The practice of withholding study information has important implications say Rogawski and Federoff in “Disclosure of Clinical Trial Results When Product Development is Abandoned.” The authors explore the harms to patients and to the scientific process when access to scientific information derived from a failed or abandoned study is denied.
They say such withholding of information subverts an “implicit moral contract between the sponsors and study participants” pointing to the basic tenet –that research is acceptable only if society will gain knowledge, “a condition that requires the sharing of results, whether positive or negative.”
In addition, Rogawski and Federoff say not having the information could harm patients. “Selective reporting of clinical trial results can yield flawed estimates of drug effectiveness and provide an erroneous impression of the risk-benefit ratio of treatments, leading physicians to make inappropriate prescribing decisions.”
Another implication of the failure of the study sponsors to release data on negative trials for abandoned products is that “futile treatment strategies may be pursued unnecessarily by other entities” which could lead to “squandering of resources that could be applied to the development of potentially useful therapies.”
The authors also highlight the importance of academic journals as a destination for clinical trials results. The ClinicalTrials.gov database does not present detailed analysis or interpretation as would a journal publication. The peer-reviewed journal article “remains essential to the adequate reporting of clinical research, including studies of products whose development is not pursued.”
Rogawski and Federoff say “Congress has provided an opportunity to close the loophole,” so that all clinical trials results could be reported. The National Institutes of Health, the government organization responsible for ClinicalTrials.gov, is currently formulating a set of proposed regulations to satisfy the results reporting requirements of the FDAAA. A public comment period begins when the proposed regulations are published, expected later this year. “It is hoped the HHS will use its authority under FDAAA 801 to require reporting of the results for any trial registered in ClinicalTrials.gov, even if product development is abandoned.”
Rogawski and Federoff say even a single clinical trial participant could contribute to knowledge with respect to safety and efficacy of a drug or device.
“Every subject has a right to have his or her participation count.”
Rogawski and Federoff report having no personal financial interests related to the commentary.
About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization (BGRO), which accounts for the majority of externally funded research at GUMC including a Clinical Translation and Science Award from the National Institutes of Health. In fiscal year 2010-11, GUMC accounted for 85 percent of the university’s sponsored research funding.