NIH Promises Stronger Clinical Trial Oversight

Jodi Black

Jodi Black, National Institutes of Health (NIH)

Jodi Black, deputy director of the Office of Extramural Research at the National Institutes of Health (NIH), introduced an acronym probably new to many ACRP 2018 attendees: SCT, or “small crappy trials.” Turns out, NIH was funding a lot of them, she said.

After being “scolded” by Congress and the Government Accounting Office (GAO) a decade ago, NIH knew it faced several challenges in its efforts to rein in SCTs. At the top of the list were NIH inconsistencies in oversight, monitoring, registration, and reporting. Further, NIH had insufficient policies to ensure public access, Black said.

That’s why NIH has been working diligently over the past decade to try and tear down silos and ensure clinical trial information is shared as widely as is reasonably possible.

Enhancing transparency and public dissemination of data will reinforce public trust in clinical trials, said Rebecca Williams, assistant director of ClinicalTrials.gov. “We’re in a new era of public accountability and transparency,” she added.

Williams and Black were panelists for “Signature Series: Inside NIH: Turning Discovery into Health” at the ACRP 2018 meeting at the Gaylord National Resort & Convention Center at National Harbor, Md., just outside Washington, D.C., this afternoon (April 28).

NIH, which awards some $3 billion each year for clinical trials, will also continue to take steps to fight a nagging issue: the under-reporting of clinical trial results. “It remains a big problem,” said Black. “It dishonors research participants.”

Currently, NIH can withhold trial funds from academic medical institutions that don’t properly report results on ClinicalTrials.gov. In the months ahead, NIH could go to the U.S. Food and Drug Administration (FDA) to seek financial penalties for recalcitrant trial practitioners, Black said.

Since its launch in February 2008, ClinicalTrials.gov now houses more than 30,000 studies with summary results. It contains more than 270,000 records of interventional and observational studies and expanded access information. Updated nightly, it receives 200 million page views per month, with 93,000 unique visitors per day.

There are many benefits to addressing under-reporting, the NIH officials said. Those include:

  • Better informing future research and research funding decisions.
  • Mitigate information bias (e.g., non-publication).
  • Better evaluate research integrity (e.g., adherence to protocol).
  • Prevent duplication of trials of unsafe or ineffective interventions.
  • Provide access to data to support evidence-based medicine.
  • Enhance patient access to enrollment in clinical trials.

Introducing the panelists, ACRP Executive Director Jim Kremidas applauded NIH’s efforts. “I’m thrilled to see which way this industry in evolving,” he said.

Author: Michael Causey