Guest Column | March 5, 2024

Best Practices For Complete Registration And Reporting Of Summary Results On ClinicalTrials.gov

By Kelly Franzetti, Clinical Trials Transformation Initiative

Survey questionaire GettyImages-1195871692

ClinicalTrials.gov is the go-to source of information about clinical trials, and patients, family members, healthcare professionals, researchers, and the public all use it to discover information about current research as well as the results of completed clinical trials (Figure 1). Sponsors of clinical trials and other responsible parties are required to register certain trials and submit their summary results information to this data bank. However, multiple sources suggest that sponsors are not always reporting this information in a timely fashion and such information may be incomplete or inaccurate.1,2

Improving timely, accurate, and compete clinical trial registration and reporting of summary results is critical for ensuring access and transparency (Figure 1).

To address this issue, the Clinical Trials Transformation Initiative (CTTI) — as part of its public-private partnership with the FDA — investigated factors and barriers to registration and summary results information reporting and made suggestions for improvement of these aspects for applicable clinical trials.

Methods

CTTI conducted a literature review and qualitative in-depth interviews and used the information from these activities to develop a survey about barriers to timely, accurate, and complete registration and summary results information reporting and to examine proposed solutions. Participants selected were individuals responsible for submitting required clinical trial information into ClinicalTrials.gov and/or managing their organization’s compliance with the ClinicalTrials.gov registration and results information reporting requirements.

Definitions

Applicable clinical trials are controlled interventional trials:

  • that involve at least one drug, biological, or device product regulated by the FDA with at least one U.S. trial site,
  • that are conducted under an investigational new drug application or investigational device exemption, or
  • that involve a drug, biological, or device product manufactured in and exported from the U.S. for study in another country. (Note that Phase 1 and feasibility trials are excluded from this definition.)3

Results

The results of the project’s evidence gathering are detailed in CTTI’s 2024 Report on Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information on ClinicalTrials.gov. Respondents to the interviews and survey were asked about strategies for addressing challenges, which are summarized below.

Suggested Best Practices

  1. There are many challenges to registration and reporting on ClinicalTrials.gov, so collaboration is key to facilitate communication and compliance. Specifically, collaboration between administrative units and responsible parties is essential.
    • Administrative unit: the entity itself or individual(s) at an organization/institution/company that provides oversight and/or registers and/or reports results information on ClinicalTrials.gov.
    • Responsible party: the person or entity responsible for registering and submitting and updating information about a clinical trial to ClinicalTrials.gov.
  2. Use a centralized approach: A single administrative unit within the organization with expertise in ClinicalTrials.gov can help PIs and study teams comply with requirements. This will provide consistency and quality and may improve the timeliness of submissions. These administrative units can monitor and control records, conduct quality reviews, and keep up-to-date with ClinicalTrials.gov records.
  3. Study leads, including PIs, lead investigators, study officers, and other individuals designated as responsible parties should learn about and understand the requirements so that they are invested in registration and reporting. Starting places for learning include the ClinicalTrials.gov Protocol Registration and Results System Resources(PRS) and the ClinicalTrials.gov Training Materials.
  4. Administrative units can also provide education, resources, guidance, and support to teams, including information checklists, decision trees, standard operating procedures, and one-on-one support.
  5. Be proactive: Administrative units can alert PIs and study teams to deadlines, needed updates, and problems.
  6. Provide prompt and clear communication to keep teams aware of study record status and needed updates.
  7. Administrative units can track and trend PRS reviewers’ comments to create best practices for the organization’s data submitters and internal reviewers. This may increase the success of future submissions by implementing improvements based on the reviewer’s suggestions and will engender consistency across records.
  8. Use internal database or other tracking system to help keep track of records, due dates, impending updates, and communication with study teams.
  9. Collaborate with the human research protection program/institutional review board and link with their systems to facilitate awareness of a trial’s status.

Survey respondents also suggested that the FDA can help by providing resources such as pre-recorded informational sessions, virtual and in-person events, conferences and workshops, and better communication about guidance and compliance actions. This work was designed to cover areas under FDA authority and intended to be complementary to the NIH’s ClinicalTrials.gov modernization initiative4, which addresses technical infrastructure, user experience, and application interface of ClinicalTrials.gov.

To improve timely, accurate, and complete registration and reporting of results on ClinicalTrials.gov, CTTI suggests a centralized, proactive approach that includes communicating with and educating responsible parties about the significance and scientific benefits of registering and reporting of summary results information.

References:

  1. Zarin DA, Tse T, Williams RJ, et al. Update on Trial Registration 11 Years after the ICMJE Policy Was Established. N Engl J Med 2017; 376: 383–391.
  2. DeVito NJ, Goldacre B. Evaluation of Compliance With Legal Requirements Under the FDA Amendments Act of 2007 for Timely Registration of Clinical Trials, Data Verification, Delayed Reporting, and Trial Document Submission. JAMA Intern Med 2021; 181: 1128.
  3. FDAAA 801 and the Final Rule - ClinicalTrials.gov, https://classic.clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrialsMustBeRegistered (accessed 26 September 2023).
  4. Report on the ClinicalTrials.gov Modernization Effort. Summary of Progress: 2019-21,
    https://www.nlm.nih.gov/od/bor/clinicaltrialswg/NLM_BOR_CTG_WG_Modernization_Update_
    Report.pdf

About The Author:

Kelly Franzetti manages the development and implementation of CTTI projects. In collaboration with team leaders, she creates project plans and budgets, and manages the implementation of those plans.

Prior to joining CTTI, Ms. Franzetti was a senior scientist for Merck, where she planned, executed, statistically analyzed, and reported on infectious disease studies from discovery through testing in support of antibacterial development. Earlier in her career, she worked in clinical research, first as a research technician and later as a study manager at Charles River Laboratories, where she was responsible for complex preclinical research studies. She also worked as a research associate for the Walter Reed Army Institute of Research, where she planned and executed all in vivo bacterial and viral studies. Ms. Franzetti has a B.S. in biotechnology and conservation from Delaware Valley University.