> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# HHS, NIH Move to Increase Clinical Trial Transparency
- URL: https://www.fdaweb.com/hhs-nih-move-to-increase-clinical-trial-transparency/
- Published: 2016-09-16T12:00:00.000Z
- Updated: 2026-09-14T21:32:41.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5136828

HHS has issued a new rule and the National Institutes of Health (NIH) has issued a new policy, both of them intended to increase the availability of clinical trial information and data on clinicaltrials.gov, which is run by NIH. The [final rule](https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-22129.pdf?ref=fdaweb.com) applies to “responsible parties,” a clinical trial sponsor or a designated principal investigator, and requires registration at clinicaltrials.gov no later than 21 days after enrolling the first participant. Registration includes submitting: **1**) descriptive information, **2**) recruitment information, **3**) location and contact information, and **4**) administrative information (see NIH [summary](https://www.nih.gov/news-events/summary-hhs-nih-initiatives-enhance-availability-clinical-trial-information?ref=fdaweb.com)).  

The rule also requires a responsible party to submit summary results for any applicable clinical trial that is required to be registered, regardless of whether the drug, biological, or device products under study have been approved, licensed, or cleared for marketing by FDA. This is an expanded requirement; previously summary results needed to be submitted only if the product had been approved, licensed, or cleared. In general, results information must be submitted no later than one year after a clinical trial has ended.

In a *JAMA* online [article](http://jama.jamanetwork.com/article.aspx?articleid=2553888&ref=fdaweb.com), NIH officials describe several efforts underway to improve clinical trial efficiency. For example, inconsistent information submitted to FDA and NIH for clinical trial applications has long been recognized as a source of delays and inefficiencies. “NIH is encouraging the use of a clinical trial protocol template that was developed through a collaboration between NIH and FDA and that meets International Council for Harmonization (ICH) E6 Good Clinical Practice Guidance,” wrote the officials. “Use of the protocol template will help ensure that investigators prepare protocols that contain all the information necessary to enable efficient and timely review by institutional review boards (IRBs) and to be in compliance with FDA IND application regulations.”

Another effort is the development of a standardized electronic system for NIH to use for management and oversight of NIH-funded clinical trials. “The system will permit the collection of clinical trial information across the NIH-supported biomedical research enterprise, which will be used for strategic planning and identifying the best, safest, and least burdensome ways to gather important data to improve human health,” the officials said in *JAMA*.

Investigators and sponsors who fail to comply with the new regulation may be subject to civil monetary penalties assessed by FDA. “In addition, NIH will withhold clinical trial funding to grantee institutions if the agency is unable to verify adequate registration and results reporting from all trials funded at that institution,” the officials wrote. “The availability of results will promote innovations in clinical trial design and avoid duplication of unsuccessful strategies, thereby avoiding unnecessary risks to research participants.”