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Regulatory Focus™ > News Articles > 2020 > 2 > Modernizing ClinicalTrials.gov: NIH Seeks Feedback

Modernizing ClinicalTrials.gov: NIH Seeks Feedback

Posted 17 February 2020 | By Zachary Brennan 

Modernizing ClinicalTrials.gov: NIH Seeks Feedback

As part of a multi-year modernization initiative, the National Institutes of Health’s (NH) National Library of Medicine (NLM) is seeking comments from users and submitters to ClinicalTrials.gov on what can be done to improve the clinical research registry.

The website is home to information on more than 300,000 clinical trials and since 2007, certain trials must be registered and information must be submitted to Clinicaltrials.gov. FDA in 2018 released draft guidance explaining how it can assess fines of up to $10,000 for companies that fail to submit required clinical trial registration and/or results information or submit false or misleading information.

Now, the NLM is updating the technological infrastructure underlying the website (including its application programming interface) and enhancing some of its public-facing components and user experience.

Before 14 March, stakeholders can provide feedback on the functionality of ClinicalTrials.gov, ways to improve the accuracy and timeliness of information submitted through its Protocol Registration and Results System (PRS) and how to improve the use of data standards.

More specifically, the NLM is seeking to understand new uses of ClinicalTrials.gov that may be currently unsupported, resources (i.e. publications) that can be linked to the site and further information on how users are working with the current site.

In addition, the request for information (RFI) seeks a better understanding of how to further align the PRS with companies’ or organizations’ processes and/or trial management software, novel ways to enrich data quality and content, and ways to make the submission process easier.

The NLM said it will host a public meeting on 30 April to provide an open forum for further eliciting input on topics of interest identified in responses to this RFI.

The library also notes that this RFI is not intended to modify existing legal and policy requirements for clinical trial registration and results reporting.

Request for Information (RFI): ClinicalTrials.gov Modernization

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