Access to clinical trials is critical for VA's ability to advance knowledge and care for Veterans and the nation. The VHA Office of Research and Development (ORD) is committed to informing Veterans and the public about its research and maximizing the impact of the studies it supports. As a leader in clinical trials access, ORD has been making clinical trial information available through public registries for more than a decade. To achieve these goals, Principal Investigators (PIs) of ORD funded clinical trials are responsible for registering their trials with and submitting summary results to the National Library of Medicine's (NLM) public registry, ClinicalTrials.gov, as a condition of funding. ClinicalTrials.gov provides patients, family members, health care professionals and members of the public easy access to information on clinical trials for a wide range of diseases, conditions and health problems.
ORD uses the same definition of a clinical trial as the International Committee of Medical Journal Editors (ICMJE) and the World Health Organization. This definition is "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." VA PIs should note that by applying this definition and registering a clinical trial prior to enrollment of the first participant, the trial will be eligible for publication in ICMJE member journals and other journals that follow the ICMJE requirements. (For more information, see http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html and/or N Engl J Med 2004;351:1250-1.) For the subset of VA clinical trials that fall under Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), registration at ClinicalTrials.gov will also help meet those requirements specified in the law.
Upon notification of funding approval, VA PIs must register their clinical trials in ClinicalTrials.gov through ORD mechanisms. Meeting this requirement allows for study funds to be distributed from ORD. Subsequently, PIs are also responsible for providing regular updates on the study and ensuring results are reported.
ORD clinical trial PIs are responsible for all aspects of registering, updating, and reporting results of their studies in ClinicalTrials.gov. To assist investigators in meeting these requirements, ORD has standardized some processes through HSR&D's ART Program (ART Website: http://art.puget-sound.med.va.gov). Please note that some steps require direct interaction with the ClinicalTrials.gov system and staff.
VA investigators funded by any ORD research service (Clinical Science, Health Services, and Rehabilitation) must have their clinical trial registered as a condition of award. Cooperative Studies Program (CSP) clinical trials are registered through the CSP Coordinating Center. Investigators are notified of the requirement at the time of award. When all other Just-In-Time (JIT) system requirements are completed, investigators are contacted by the ART Program and provided instructions for registering their clinical trial.
To keep the clinical trial information current for the public and to meet ClinicalTrials.gov requirements for maintaining records, registration records must be updated or verified as correct at least every six months. PIs must also update the record within 30 days of a change to any of the following: overall recruitment status, recruitment status at any study site, and the last follow-up date for the primary outcome measure (e.g., primary completion date).
The ART Program sends an automated email reminder to the PI when a six-month update is due. Updates, like registrations, are completed using the ART Website. Updates are required every six months until the study is completed. Failure to provide updates in a timely manner will impact project funding. The funding ORD service is notified of trials overdue for an update.
PIs of ORD funded clinical trials must submit summary results for their clinical trials to ClinicalTrials.gov. This requirement applies to all ORD trials regardless of whether the trial meets the definition of an "Applicable Clinical Trial" as described in Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801). Results information must be submitted within one year of the study Primary Completion Date. This date is the one specified by the PI regarding when the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome. Results information includes Participant Flow, Baseline Characteristics, all pre-specified Primary and Secondary Outcomes, and Adverse Events.
To facilitate investigators in meeting these requirements, ORD notifies the PI by an ART Program email prior to the due date. Instructions for submitting results through the ClinicalTrials.gov Protocol Registration and Results System (PRS) are provided. Please note that ClinicalTrials.gov staff members are available to provide one-on-one assistance to investigators throughout the results submission process. This includes helping investigators prepare for submission, orienting investigators to the PRS and guiding investigators through the data entry process. To schedule an introductory call with ClinicalTrials.gov staff or otherwise request help, send an email to email@example.com with the request.
Further questions concerning individual ORD Service trial registration, results reporting or policies can be directed to the following points of contact:
Clinical Science Research & Development Service
Kristina Nord, MSW
Health Science Specialist
Phone: (202) 443-5614
Health Services Research & Development
Phone (202) 443-5797
Rehabilitation Research & Development Service
Shirley Groer, PhD
Scientific Program Manager
Phone: (202) 443-5767
Cooperative Studies Program
Grant Huang, MPH, PhD
Acting Director, CSP
Chair, ORD Clinical Trials Registration & Results Work Group
Phone: (202) 443-5700
(Study Chairs may also contact their CSP Coordinating Center.)
Questions concerning the ART Website or PRS access can be directed to:
Coordinator, ART Program
Phone: (206) 277-4163