Most academic institutions not prepared to meet new trial regulations: Study
The study, published in the journal BMC Medicine, details survey data from more than 350 US academic institutions that conduct clinical trials. “Relatively few” reportedly had the staff or policies needed to comply with the new requirements by the US Department of Health and Human Services (HHS) and National Institutes of Health (NIH) for clinical trial registration and reporting
Perhaps even more troubling, according to researchers, these results actually represent a “best-case scenario,” because the hundreds of institutions that did not respond are less likely to be in compliance than those that did respond.
“Some organizations only conduct a handful of clinical trials, so I wasn’t surprised that small organizations haven’t adopted policies and hired staff to ensure compliance,” Evan Mayo-Wilson, the study’s lead author and assistant scientist in the Department of Epidemiology at the Bloomberg School, told Outsourcing-Pharma.
“But some academic organizations conduct lots of clinical trials, and I was surprised that those organizations didn’t have relevant policies and staff. An organization that is running dozens of trials probably needs a strategy to ensure its trials are registered and reported on time,” he added.
Final rule
In 2017, the HHS put into effect a set of rules that required researchers to make trial data public in an effort to honoring its pledge to clinical trial participants. Known as the final rule, it aimed to hold researchers to a higher standard improve problems of the past.
Over a period of several months before the final rule came into effect, Mayo-Wilson and his team conducted an online survey of academic institutions that have accounts at ClinicalTrials.gov, to determine how ready they were to comply with the new requirements.
Only 43% of respondents had a policy on clinical trial registration and only 35% had a policy on the reporting of trial results. Additionally, few policies allowed organizations to punish investigators who failed to register trials or report results, with just one organization responding it punished a researcher for non-compliance.
“Drug companies tend to be quite centralized. Academic organizations have lots of investigators who are responsible for managing their own studies, and we don’t like being told what to do,” Mayo-Wilson explained. “New regulatory requirements can be difficult to implement in decentralized systems, especially when people are opposed to them.”
In fact, the US Food and Drug Administration (FDA) Amendments Act and the Final Rule give the FDA the power to assess civil money penalties on trial sponsors of more than US$11,000 per day per trial for non-compliance. However, despite scientists and journalists documenting numerous cases of non-compliance, the FDA has not assessed any penalties to date.
Moving forward
The study also found that organizations compliant with the new rules tend to conduct large numbers of clinical trials. Researchers suspect this is because it can be difficult for institutions that conduct only a few clinical trials to support staff with expertise in regulatory compliance compared to institutions that devote more staff resources to the complexities of trial registration and reporting.
“We can’t rely on individual scientists to get this done,” Mayo-Wilson said. “The new regulations are long and complex. It’s tremendously helpful to have specialists who can help investigators comply with the new requirements.”
Source: BMC Medicine
DOI: 10.1186/s12916-018-1042-6
“Clinical trial registration and reporting: a survey of academic organizations in the United States”
Authors: E. Mayo-Wilson, J. Heyward, A. Keyes, J. Reynolds, S. White, N. Atri, G. C. Alexander, A. Omar, and D. E. Ford
