This topic more or less falls within the theme of these GEITP pages — having to do with fraud and corruption in science; however, this editorial [see attached] is more specifically about laziness, or “lack of respecting federal existing requirements.” For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct CLINICAL TRIALS to record their results in a federal database, so that physicians and patients can see whether new treatments are safe and effective. Even after a 2007 law mandated that “it is required that clinical trials registered in the federal database be made public” (in a timely manner), few trial sponsors have consistently done so. ☹
In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again — enacting a long-awaited “Final Rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect two years ago (on 18 Jan 2018), giving trial sponsors ample time to comply. But a recent investigation shows that many still ignore this requirement, while federal officials do little or nothing to enforce the law. Science journal examined more than 4,700 trials whose results should have been posted on the NIH website ClinicalTrials.gov, under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors — including (ironically) NIH itself — has been lackadaisical. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial [see attached editorial].
However — of 184 sponsor organizations having at least five trials due (as of 25 Sept 2019), 30 companies, universities, or medical centers never met a single deadline (see https://scim.ag/ctgov). As of that date, these habitual violators had failed to report any results for 67% of their trials, and they averaged 268 days late for those and all trials that missed their deadlines. They included such eminent institutions as Harvard University–affiliated Boston Children’s Hospital, University of Minnesota, and Baylor College of Medicine — all three among the top 50 recipients of NIH grants in 2019. The violations cover trials in virtually all fields of medicine, and the missing or late results offer potentially vital information for the most desperate patients. [For example, in one long-overdue trial, researchers compared the efficacy of different chemotherapy regimens in 200 patients with advanced lymphoma; another — nearly two years late — tested immunotherapy against conventional chemotherapy in about 600 people with late-stage lung cancer.]
On a somewhat related topic, a personal irritation that some colleagues know I’ve been upset about — is when any scientific grant is finished, and the researcher (postdoc, grad student or other) has all the data, but “never gets around to writing up the manuscript.” The grant, given to the Principal Investigator, is a gift, it is a privilege, paid for with taxpayers’ money, and everyone should feel responsible to the taxpayers for completing the task of writing up the project which was funded, whether or not the data are exciting, or boring, or completely negative and disappointing. ☹
comment: Todd, this is an excellent idea. They’ve had the Journal of Irreproducible Results (JIR) — since 1955. For anyone not aware of this journal, it is a spoof (science satire). Sort of like Mad Magazine. 😊 [JIR was founded in Israel in 1955 by virologist Alexander Kohn and physicist Harry J. Lipkin, who wanted a humor magazine about science — for scientists.]
Science 17 Jan 2020; 367: 240-243