Trial Transparency: NIH Says Final Rule From 2017 has Helped

Posted 09 January 2018 By Zachary Brennan

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Almost a year ago, the National Institutes of Health (NIH) made effective a new policy to better disseminate information from NIH-funded clinical trials through ClinicalTrials.gov, and the agency says that so far, it’s seen some improvements.

Back in 2007, section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) established a requirement that "applicable clinical trials" must be registered and information must be submitted to Clinicaltrials.gov.

In 2016, NIH issued a rule to further increase the availability of information about clinical trials, clarify FDAAA 801 and describe requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov (changes made to FDAAA 801 by the final rule are available in a summary and table).

NIH leaders said that the issuance of the final rule, which took effect 18 January 2017, would result in "rapid increases" in the percentage of trials registered and shared via ClinicalTrials.gov, and the agency is now saying there has been progress.

NIH told Focus via email on Tuesday: "Overall, registration and results submissions to ClinicalTrials.gov continues to grow in the timeframe in which the rule became effective. The increase in results reporting is likely due to the Final Rule, which clarified definitions and expectations in the law and also established clear effective and compliance dates. NIH expects that with continued outreach and education and additional organizational efforts, rates of reporting will continue to increase." 

But NIH also acknowledged that it "has not taken action against any investigator as related to this matter."

A recent report from TranspariMED highlighted the requirement that trial results have to be posted to ClinicalTrials.gov and that those who fail to comply must pay a fine of up to $10,000 each day until overdue results are posted.

"In reality, however, this law has never been enforced … To date, commercial trial sponsors alone have run up over US$25 billion in fines for failing to post summary results, but no fines have been collected," the report said.

Another issue is that industry-funded studies are exempt from the NIH requirements.

Glen Weiss, clinical associate professor of medicine at the University of Arizona School of Medicine in Phoenix, told Focus: "Like other policies, including FDAAA 801, there will be a lot of noncompliance. I predict many will choose not to do NIH studies if they have the option. Industry funded studies are exempt and in oncology this is the majority of trials that enroll patients and complete enrollment."

And though a report from last month said trial transparency is improving for some companies, there are still gaps between the practices of different companies.

The new NIH policy leaves open "a big loophole for industry sponsored trials," Weiss added. "Also, the data entry on ClinicalTrials.gov is not user friendly, reminds me of trying to program in DOS...that interface needs a major overhaul such as to allow uploading of de-identified study CRFs [case report forms] that allow optical reading/search capabilities. An upload could in theory take minutes for an entire study rather than hours manual input for a handful of patients."

Weiss has proposed draft language that could help clarify informed consent forms for cancer trials and ensure study information and results are made transparent.

Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov

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Categories: Biologics and biotechnology, Drugs, Clinical, Research and development, News, US

Tags: NIH, clinical trial transparency, final rule, FDAAA

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