A number of esteemed medical research institutions have routinely violated a federal law that requires public reporting of clinical study results.
Their actions have deprived doctors and patients of data that can help gauge the safety and benefits of clinical treatments, and left holes in a federal database used by patients, caretakers and medical professionals to compare the efficacy and side effects of treatments for fatal diseases.
The biggest offenders included four of the top 10 recipients of federal medical research funding from the NIH: Stanford University, the University of Pennsylvania, the University of Pittsburgh, and the University of California, San Diego. According to a STAT News investigation, all four disclosed research results late or not at all at least 95% of the time since reporting became mandatory in 2008.
Meanwhile, the U.S. government, which has the power to impose fines on institutions that fail to disclose trial results, or to suspend their research funding, has not levied a single fine despite the fact that it could have collected billions of dollars as a result of the violations.
The legislation was created to ensure that findings from human testing of drugs and medical devices were quickly made public through ClinicalTrials.gov, the NIH’s website. Its passage was driven by concerns that the pharmaceutical industry was hiding negative results to make treatments look better.
STAT analyzed data reporting for all institutions—hospitals, universities, federal agencies, corporations and nonprofits—required to report results to ClinicalTrials.gov for at least 20 human experiments since 2008. Most—including staff scientists at the NIH, which oversees the reporting system—violated the law most of the time. While some experts interviewed by the news agency voiced concerns that the researchers might face pressure from corporate sponsors to delay reports for commercial reasons, researchers and others interviewed by STAT attributed the insufficient reporting habits to being too busy and lacking administrative funding, and vowed to make improvements.
“I do think institutions, particularly academic institutions, are being honest when they discuss the lack of time and staff (and funding) to support clinical trial results reporting,” Joseph Ross, an associate professor of medicine and of public health at Yale University, told CWWeekly. “Unlike a large pharmaceutical company, most institutions do not have a centralized staff responsible for affairs in this way. They have an IRB [institutional review board], and they have a legal team that covers the entire university or medical school, but each trial is conducted by an individual investigator. And that investigator is responsible for all aspects of the trial, including registration and results reporting.
“While the IRB likely knows about every clinical study being conducted at the institution, likely no other organization within the institution does. In order to support results reporting, most institutions should likely consider creating an organization affiliated with the IRB in order to track clinical research studies and ensure compliance. However, this costs money and requires personnel. These costs can be supported through grant funding—provided they are budgeted—when the clinical research is externally supported. The challenge is that a fair bit of academic research studies are conducted without external grant funding.”
Ross also noted, “A fair portion of the clinical research studies conducted by academic organizations are not of medical products regulated by the FDA, and are thus not required to be registered and report results under the rule of law. But it remains good scientific practice to do so.”
STAT identified roughly 9,000 trials in ClinicalTrials.gov that are subject to the law’s disclosure requirements. Its analysis focused on 98 universities, corporations and nonprofits that served as sponsors or collaborators on at least 20 such trials between 2008 and Sept. 10 of this year.
The FDA, which regulates prescription drugs, is empowered to levy fines of up to $10,000 a day per trial for late reporting to ClinicalTrials.gov. In theory, it could have collected $25 billion from drug companies since 2008—enough to underwrite the agency’s annual budget five times over. But neither FDA nor NIH, the biggest single source of medical research funds in the U.S., has penalized an institution or researcher for failing to post data.
Asked about the government’s inaction, Ross said, “I think it’s a tricky line to walk but that the government should begin issuing warnings for all responsible parties conducting clinical trials, including industry, the NIH and academic institutions. Right now, it’s not clear what government organization is responsible for ensuring compliance with clinical trial registration and results reporting. The National Library of Medicine, within the NIH, manages ClinicalTrials.gov. And the rule of law is that clinical trials of medical products that are regulated by the FDA are required to be registered and report results. But it seems that [the Department of Health and Human Services] is responsible for oversight.”
Meanwhile, NIH officials remain troubled by the findings. Dr. Francis Collins, the agency’s director, conceded in a prepared statement that they are “very troubling.” Kathy Hudson, an NIH deputy director, told STAT that lapses in reporting betray research volunteers who assume personal risks based on the promise that they are making a contribution to public health, saying, “If no one ever knows about the knowledge gained from a study, then we have not been true to our word.”
By J. Michael Whalen
This article was reprinted from Volume 19, Issue 50, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »