Columbia University, the oldest academic institution in New York and the fifth oldest in the United States. The institution’s clinical research has an impact and reaches worldwide. With $800 million in externally funded research, over 200 research centers and institutes coupled with about 400 new inventions per year, not to mention over 600 patents, Columbia research means serious business. On its official seal is the Latin motto In Lumine Tuo videbimus lumen (in Thy light shall we see the light). These are important words with forceful connotation when it comes to responsibility and accountability. Columbia University hasn’t lived up to their motto nor its clinical trial reporting requirements for fair and transparent reporting. A Columbia graduate student in pathology and cell biology recently discussed this topic in the Columbia Spectator. He noted that a recent study from UAEM and TranspariMED found that Columbia only reported on the results of 17% of their clinical trials. The Food and Drug Administration Amendments Act requires universities to submit results to a public registry within 12 months post completion of a clinical trial. Columbia’s ranking in the nation for reporting of clinical trial results: second-worst in the nation.
TrialSite News appreciates the stance this author, a recent graduate of the Graduate School of Arts and Sciences at Columbia University. The author is currently pursuing a postdoctoral fellowship at New York University Langone Health. Clearly, Columbia is doing a great job of educating its students. How about going to the next level of clinical research contribution by opening up.
Consequences of Limited Transparency
The author notes that consequences for not reporting clinical trial results are significant—from the potential to slow down innovation by duplicating research to the potential of jeopardizing patients’ well being from suppression of negative results. The author notes, rightly, that this isn’t just a theoretical topic. In the case of from the University of Indiana, serves as an example when adverse side effects led to clinical trial termination yet the sponsor withheld the data from the public and only years later did the FDA declare Avastin unsuitable to treat breast cancer.
Columbia Published More Results Post Study
After the UAEM and TranspariMED, clinical trial results disclosure report hit the press and went viral (e.g. via Nature and STAT News) Columbia then started retroactively releasing results from some studies. The author, while acknowledging the gesture, wonders whether they would have done this if the press hadn’t started making noise about major academic medical centers not following the law.
Clinical Trials Transparency
The author notes that the clinical trials transparency report is part of UAEM’s larger campaign pressing universities to join in with the World Health Organization’s Joint Statement on Public Disclosure of Results from Clinical Trials. Prominent organizations such as The Bill and Melinda Gates Foundation, the Wellcome Trust, Médecins Sans Frontières and others have all signed on. Not one university has done so yet.Source: Columbia Spectator