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Columbia University needs to do a better job at reporting clinical trial results

Guest blog: A Columbia University graduate calls on his alma mater to become a global transparency pioneer by signing up to the WHO Joint Statement on Public Disclosure of Results from Clinical Trials. The author is is currently pursuing a postdoctoral fellowship at New York University Langone Health.

I take great pride in the fact that I recently graduated from Columbia University’s graduate program in pathology and cell biology. During my studies, I had the opportunity to conduct research in stem cell biology that could one day benefit the field of medicine at large and potentially help save lives. I was even able to participate in a clinical rotation where I could observe first-hand the world-class care that patients were receiving at Columbia’s various medical centers.

However, contrary to my overall positive experiences at Columbia, it was disheartening to learn that Columbia was in violation of the federal law that mandates fair and transparent reporting of results from clinical trials.

Clinical trials are research studies that involve the testing of health-related interventions in human subjects. Such studies are essential and often one of the final phases for discovering new treatments or finding improvements in the existing treatments to various diseases. They are typically led by a research team that can include doctors, scientists, and other healthcare professionals, and patients will often volunteer for trials in the hopes of gaining access to new treatments that are not available otherwise.

However, the experimental nature of the studies can sometimes pose significant risks such as side-effects with potentially life-threatening outcomes. Clinical trials can be sponsored by pharmaceutical corporations, federal agencies such as the National Institutes of Health (NIH), and by medical centers like those at Columbia University. Following their completion, the clinical trials’ outcomes are published in peer-reviewed academic journals and the public registry

In March of 2019, a study conducted by the global, student-driven nonprofit Universities Allied for Essential Medicines and the nonprofit research advocacy group TranspariMED found that Columbia reported only 17% of their clinical trials.

According to the Food and Drug Administration Amendments Act, universities are required to submit results to a public registry within twelve months of completing the trial. Yet despite this, Columbia was the second-worst university in the nation at reporting the results of their clinical trials. There are a number of consequences of not reporting clinical trial results. It could slow down innovation by duplicating research or even promote malpractices like the suppression of negative results that could needlessly jeopardize patients’ well-being. These risks are not merely hypothetical, and a case from the University of Indiana can serve as an alarming example. While testing the drug Avastin in breast cancer patient volunteers, the side-effects were so detrimental that the trial was aborted before it was finished. Despite these alarming findings, the researchers did not release the results from the trial, meaning that the data remained hidden from the public, and only years later did the FDA declare Avastin unsuitable to treat breast cancer.

Following the publication of the UAEM and TranspariMED report and its coverage in publications such as Nature and STAT News, Columbia responded by retroactively releasing results of some previously unreported clinical trials.

[Editor's note: Good news update - all Columbia trials subject to US disclosure laws have by now posted their results.]

While a commendable gesture, it is concerning to imagine what would have happened had the report not been released. How long would Columbia go on flouting the federal law? What would it have taken for Columbia to hold itself to the standards of ethical conduct in scientific and clinical research?

As one of the world’s eminent research institutions with a stated mission “to advance knowledge and learning at the highest level and to convey the products of its efforts to the world,” Columbia must live up to its institutional values. The university needs to recognize the importance of proactively reporting clinical trial results and make a commitment to doing so rather than simply producing reactionary responses to criticisms and exposés.

The clinical trials transparency report is a part of UAEM’s larger campaign urging universities to sign onto the World Health Organization’s Joint Statement on Public Disclosure of Results from Clinical Trials. The Bill and Melinda Gates Foundation, the Wellcome Trust, Médecins Sans Frontières, among many others, have all signed on to the statement, yet no university has signed on.

Columbia has a tangible opportunity to demonstrate real leadership by being the first university signee and thus inspiring other academic institutions to follow suit.

Columbia is obligated not only by law but also by ethical and moral standards to report clinical trial results in a timely and transparent manner. Personally, as a researcher and a recent alumnus, I think Columbia can and needs to do better in order to further the scientific research enterprise and advance the pursuit of disease treatments. Only then can the University be fully accountable to taxpayers and respectful towards the sacrifices patients often make for science.

Note: This opinion piece was first published in the Columbia Spectator on 12 September 2019 and is reposted here with the author's permission. Students interested in advocating for greater clinical trial transparency at their own university should get in touch with UAEM.

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