According to a warning from federal officials last week, dozens of drug companies, universities and medical device manufacturers owe more than a decade’s worth of data from clinical trials.
According to a warning from federal officials last week, dozens of drug companies, universities and medical device manufacturers owe more than a decade’s worth of data from clinical trials. Rules that were issued in the wake of a federal court ruling stated that clinical trial sponsors must submit missing data from trials conducted between 2007 and 2017, according to Stat News. Furthermore, these companies and institutions must do so “as soon as possible.”
Over the course of this time period, numerous trials were exempted from reporting their data to ClinicalTrials.gov, which is a public database. According to a letter published by the National Institutes of Health at the end of July, companies and institutions may face “civil monetary penalties” if they do not comply. However, there is no set deadline for when they must publish the missing data.
As a result of the COVID-19 outbreak, there has been a lot of debate about how clinical trials are conducted. The pandemic has shed light on flaws in the overall process, and many critics have begun to raise the alarm.
Back in March, the U.S. Food and Drug Administration released guidelines for how researchers and clinicians should proceed with clinical trials that were already underway when the pandemic struck, according to HemOnc Today. Some of these guidelines included allowing patients to be treated at a community clinic (rather than a trial center), mailing prescriptions and conducting consultations via telemedicine.
However, many professionals in the industry argued that these recommendations should have already been in place. Gwen Nichols, MD, chief medical officer of the Leukemia & Lymphoma Society, told the news source that the guidelines came as a “real wake-up call” for those working on clinical trials. Now, experts are hoping that these guidelines stay in place after the pandemic comes to an end.
In general, clinical trials have been slow-going as more experts shift their focus to COVID-19. An analysis published in Circulation: Heart Failure recently took a closer look at how COVID-19 is impacting research in the heart failure realm. Specifically, experts examined how one heart failure trial, CONNECT-HF, was being impacted by the pandemic.
They discovered that just 11.5% of programs dedicated to CONNECT-HF were now considered “essential.” In addition, just 32% of heart failure programs had resumed clinical research as of May 2020, with 27% considering a return within the next two to three months. About 41% of programs had no plans to resume clinical research as of May 2020.
“During the COVID-19 pandemic, regulatory agencies have advocated for operating clinical research programs with flexibility; ensuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risk to trial integrity,” the experts concluded. “Unfortunately, these recommendations do not provide tangible ways to ensure continuation of research activity. By reducing in-person visits to keep participants and staff safe, it is unclear how slowed enrollment, delayed follow-up visits, and not having ways for reliable safety assessment will affect future outcomes actively enrolling clinical trials.”
The authors of the report noted that allowing scientists to work from home “when feasible” may potentially make an impact on existing clinical trials, as well as those that might be carried out in the future. In turn, researchers would be able to continue on with their examinations without interruption.
