NIH: ‘If we don’t report our results we will repeat mistakes’

“We’re in an age of innovation related to processes, technology, and people,”​ said Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP).

Change is underway, not only in the private sector but in government-funded research as well, he said, addressing delegates at the Association’s Annual Meeting last month. In the keynote following, officials from the National Institutes of Health (NIH) addressed some of these changes that could affect clinical trial operations across all sectors.

Of these changes, Dr. Jodi Black, PhD, deputy director of the Office of Extramural Research, NIH, said that new trials are going to be withheld if not in compliance with reporting requirements. NIH will be consulting with the US Food and Drug Administration (FDA) as the agency is charged with leveraging the fine of up to $11,000 per day – though no fines have been issued to date.

As Outsourcing-Pharma.com previously reported, AllTrials penned an open letter to the Agency imploring them to fine clinical trial sponsors​ that don’t publish trial results. As part of this call to action, AllTrials launched a tracking tool​ publically flags sponsors and trials that break reporting requirements. As of today, fines of more than $117m​ could have been imposed.

While the FDA has yet to impose any fines, Black reiterated during her keynote that the NIH won’t award research grants if it is unable to validate that the applicant registers and publically reports trials.

The public benefits of access to clinical trial information:​

• Meet ethical obligation to human subjects
• Inform future research and research funding decisions
• Mitigate information bias
• Evaluate research integrity
• Prevent duplication of trials of unsafe or ineffective medicine
• Enhance patient access to enrollment in clinical trials

“There’s going to be an awful lot of peer pressure to make sure this happens,”​ she explained. “The goal is to get everybody compliant, not to punish people … The goal is to get the information out there.”​

Without a complete picture, it’s difficult for funders to make good decisions, explained Dr. Rebecca J. Williams, PharmD, MPH, assistant director, ClinicalTrials.gov, National Library of Medicine, NIH.

“You’re not making the best informed decision if all the evidence isn’t in the literature,”​ she said.

Williams echoed the requirements are meant to increase trust in clinical research enterprise and were not invented to interfere with scientific integrity.

“We are in a new era of public accountability and transparency,” ​she added, “by making information available it’s also a lot easier for people to see whether or not you have fulfilled your obligations.”​

Avoiding past mistakes​

More than a quarter of a century ago Ian Chalmers published a report in JAMA titled, “Under reporting research is scientific misconduct​.” Since then, the FDA has made several regulatory changes, including those outlined in Section 801 of the FDA Amendments Act​ of 2007 (FDAAA 801).

But there are still problems – despite the law, Black said, noting that insufficient policies to ensure public access to clinical trial data impedes scientific progress and dishonors research participants.

“If we don’t report our results we will repeat mistakes,”​ she said.

In an effort to avoid past mistakes, the NIH is now requiring good clinical practice training for those involved in the clinical trial process. The agency is also requiring multi-site trials to use a single institutional review board (IRB), which it says will reduce the time it takes to initiate trials, and together with the FDA has developed an FDA protocol template and has worked to enhance ClinicalTrials.gov.

As the regulatory landscape continues to evolve, Black reiterated that “sharing results should not be optional.”​

“This is a problem with the entire system,”​ she added. “There is a huge cultural problem here … This is a problem we all have to work together to solve.”​