Request for Information (RFI): ClinicalTrials.gov Modernization NOT-LM-20-003

Key Dates

Related Announcements

None

Issued by

National Library of Medicine (NLM)

Purpose

Introduction

The purpose of this Request for Information is to solicit public input to guide the National Library of Medicine (NLM) in planning infrastructure enhancements aimed at users and submitters of ClinicalTrials.gov as part of a multi-year modernization initiative.

Background

ClinicalTrials.gov is the world’s largest public clinical research registry(1) and results database(2), providing information on more than 320,000 clinical studies and over 40,000 results on a wide range of diseases and conditions. More than 145,000 unique visitors use the public website daily to find and learn about clinical studies, resulting in an average of 215 million pageviews each month(3).

ClinicalTrials.gov is maintained by NLM on behalf of the National Institutes of Health (NIH) and enhances transparency across the clinical research enterprise in support of U.S. legal requirements (e.g., 42 CFR Part 11)(4), the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information(5), and other policies, such as those of other U.S. Federal agencies(6) and international entities(7). The potential benefits of registration and results reporting include greater public availability of information about ongoing and completed clinical studies(8). This information may help individuals find and compare clinical studies for which they may be eligible to enroll. Maintaining this database of searchable records of studies and their results helps enhance public trust in clinical research and can:

• honor the contribution of people who volunteer to participate in clinical trials to advance medical knowledge;
• encourage complete, unbiased, and timely reporting of individual studies;
• provide a more complete set of studies to inform medical and other decisions;
• provide insight into the clinical research enterprise to improve study focus, design, and reporting; and
• help funders and researchers identify and address key research needs.

Study sponsors and investigators are responsible for ensuring that their studies listed on ClinicalTrials.gov follow all applicable laws and regulations for the scientific and ethical conduct of research studies in humans. Studies listed on ClinicalTrials.gov are not evaluated by NLM for scientific validity or conformance to ethical, legal, and policy requirements. However, NLM staff conduct a limited quality control review of information submitted to ClinicalTrials.gov for apparent errors, deficiencies, or inconsistencies(9-11).

NLM is embarking on a modernization initiative to update the technological infrastructure underlying ClinicalTrials.gov, enhance its public-facing components, and deliver a modern user experience with a platform and services that continue to accommodate growth and enhance efficiency. We aim to gather information to help maximize the value of ClinicalTrials.gov to its many users, while continuing to provide essential services to support existing legal and policy requirements. This RFI is not intended to modify existing legal and policy requirements for clinical trial registration and results reporting.

NLM will host a public meeting on April 30, 2020, to provide an open forum for further eliciting detailed input on topics of interest identified in responses received through this RFI.

75-Day Comment Period

Comments must be received no later than March 14, 2020.

Information Requested

NLM is requesting public comment to guide efforts to enhance and better support the users of ClinicalTrials.gov, particularly within the topic areas outlined below. Response to this RFI is voluntary, and respondents are free to address any or all topics listed below, and other relevant topics, for NLM consideration:

1. Website Functionality. NLM seeks broad input on the ClinicalTrials.gov website, including its application programming interface (API).
   1. List specific examples of unsupported, new uses of the ClinicalTrials.gov website; include names and references for any systems that serve as good models for those uses.
   2. Describe resources for possible linking from ClinicalTrials.gov (e.g., publications, systematic reviews, de-identified individual participant data, general health information) and explain why these resources are useful.
   3. Provide specific examples of how you currently use the ClinicalTrials.gov website, including existing features that work well and potential improvements.
   4. Describe if your primary use of ClinicalTrials.gov relies on (1) a wide range of studies, such as different study types, intervention types, or geographical locations or (2) a more limited range of studies that may help identify studies of interest more efficiently. Explain why and, if it applies, any limiting criteria that are useful to you.
2. Information submission. NLM seeks broad input on initiatives, systems, or tools for supporting assessment of internal consistency and improving the accuracy and timeliness of information submitted through the ClinicalTrials.gov Protocol Registration and Results System (PRS).
   1. Identify steps in the ClinicalTrials.gov registration and results information submission processes that would most benefit from improvements.
   2. Describe opportunities to better align the PRS submission process with your organization's processes, such as interoperability with institutional review board or clinical trial management software applications or tools.
   3. Describe any novel or emerging methods that may be useful for enhancing information quality and content submitted to the PRS and displayed on the ClinicalTrials.gov website.
   4. Suggest what submission-related informational materials you currently find useful and what other materials would make the submission and quality control process easier for you.
   5. Suggest ways to provide credit, incentivize, or recognize the efforts of individuals and organizations in submitting complete, accurate, and timely registration and results information submission.
3. Data Standards. NLM seeks broad input on existing standards that may support submission, management, and use of information content (e.g., controlled terminologies for inclusion and exclusion criteria).
   1. Provide input on ways to balance the use of standards while also retaining needed flexibility to ensure submitted information accurately reflects the format specified in the study protocol and analysis plan.
   2. List names of and references to specific standards and explain how they may be useful in improving data quality, enabling reuse of data to reduce reporting burden, or improving consistency and management of data on ClinicalTrials.gov.

Submitting a Response

For consideration, your responses must be received by March 14, 2020. Responses to this RFI must be submitted electronically using the web-based form at:
https://nlmenterprise.co1.qualtrics.com/jfe/form/SV_e2rLEUAx99myump

Comments received, including name and affiliation of commenter, will be posted without change after the close of the comment period. Please do not include any proprietary, classified, confidential, or sensitive information in your response. Do not include personally identifiable information that you do not wish to have made public. The Government reserves the right to use any non-proprietary technical information in summaries of the state of the science, and any resultant solicitation(s).

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

References

1. Zarin DA, Tse T, Williams RJ, Rajakannan T. Update on Trial Registration 11 Years after the ICMJE Policy Was Established. N Engl J Med. 2017;376(4):383-91.
2. Zarin DA, Fain KM, Dobbins HD, Tse T, Williams RJ. 10-Year Update on Study Results Submitted to ClinicalTrials.gov. N Engl J Med. 2019;381(20):1966-74.
3. Trends, Charts, and Maps (Available at https://clinicaltrials.gov/ct2/resources/trends).
4. FDAAA 801 and the Final Rule webpage (Available at https://clinicaltrials.gov/ct2/manage-recs/fdaaa).
5. NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information; NOT-OD-16-149 (Available at https://grants.nih.gov/grants/guide/notice-files/not-od-16-149.html).
6. Key U.S. Policies (Available at https://clinicaltrials.gov/ct2/manage-recs/resources#KeyUSPolicies).
7. Key International Policies (Available at https://clinicaltrials.gov/ct2/manage-recs/resources#InternatPolicies).
8. What Is the Purpose of Trial Registration and Results Submission? (Available at https://clinicaltrials.gov/ct2/manage-recs/background#WhatIsThePurpose).
9. ClinicalTrials.gov Protocol Registration Quality Control Review Criteria (Available at https://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf).
10. ClinicalTrials.gov Results Quality Control Review Criteria (Available at https://prsinfo.clinicaltrials.gov/ResultsDetailedReviewItems.pdf).
11. PRS Guided Tutorials (Available at https://prsinfo.clinicaltrials.gov/tutorial/content/index.html#/lessons/cMcbAsAhlEQlFPfY3TZmzUrO6y7QS2M2).

Inquiries

Please direct all inquiries to:

ClinicalTrials.gov Information Team
National Library of Medicine
Email: [email protected]