Data suggest US, UK universities fall woefully short on reporting clinical trial results
Clinical trial data are used by patients, doctors and policymakers to make informed choices about the benefits and safety of interventions — while the methods and results of all trials are crucial to the pace and direction of scientific progress. However, there is a large body of evidence that suggests that completed clinical trials are commonly left unreported, and educational institutions in the United States and the United Kingdom — arguably the two biggest regions that breed the bulk of medical innovation — have emerged as one of the key culprits guilty of these violations.
In the United States, Congress passed a law in 2007 requiring trial sponsors — including universities — to post the results of certain clinical trials on clinicaltrials.gov within a year of trial completion, and a decade later in January 2017 the rule was finalized. Since 2017, 40 leading US universities should have posted the results of 450 clinical trials — but over a third (31%) of those results are missing, according to an analysis by Universities Allied for Essential Medicines (UAEM) in partnership with non-profit research advocacy group TranspariMED.
The violators include some of the most active trial sponsors: For example the MD Anderson Cancer Center, which has only reported 77% of due trials, Mayo Clinic (42%), UC San Francisco (37%), New York University (21%), and Columbia University (17%).
A summary of results by percentage of each university evaluated can be seen below:
Overall, 140 clinical trials are still missing results and five universities are responsible for half of the unreported trials: University of California San Francisco (17 trials without results), Columbia (15 trials), Mayo Clinic (13), MD Anderson Cancer Center (12) and Chicago (8), according to the report.
These transparency violations are concerning considering at least half of the valuable medicines that exist today were originally developed in university labs with taxpayer funding, including almost all vaccines, many HIV and tuberculosis drugs, and even insulin, the report noted. Between 2010 and 2016, every single one of the 210 FDA-approved medicines can be traced back to funding from the NIH, according to a study published in the official journal of the National Academy of Sciences.
Meanwhile, these transparency transgressions are echoed in the UK. Regulations in Europe are similar. Any trial of of any medicinal product conducted since 2004 in an EU country has already been required to register on the European Union Clinical Trials Register (EUCTR) and since 2012, sponsors must ensure that all registered trials since 2004 disclose their results to the EMA within 12 months of trial completion. But the delays to the EMA’s software platform pushed the final date for results posting by sponsors to late December 2016.
In a BMJ study published in 2018 — led by Ben Goldacre, a best-selling author, medical doctor and researcher who focuses on unpacking the misuse of science and statistics in his books Bad Science and Bad Pharma — it was found that in Europe, of the 7274 trials where results were due, 49.5% reported results. Trials with a commercial sponsor (such as a drug developer) were substantially more likely to post results than those with a non-commercial sponsor (68.1% v 11.0%), the analysis suggested.
Out of his labs at the University of Oxford, Goldacre set up an EU TrialsTracker to continuously monitor the reporting of trials. As of 10 January 2019, Goldacre and his team have identified 8,062 registered trials that are ‘unambiguously’ due to report results — but results on just over half (53.6%) have been posted to the registry. The data, which suggested that UK universities were less reliable than drug developers, sparked the interest of House of Commons Science and Technology Committee. UK universities could be brought in front of the committee if they fail to improve their track record, and the committee will ask them to explain themselves in a follow-up evidence session if improvements are not made.