Notice Number: NOT-CA-15-011
Release Date: January 28, 2015
National Cancer Institute ( NCI)
The National Cancer Institute (NCI) announces its new policy aimed at ensuring public availability of results from NCI-supported clinical trials.� This policy, referred to as the NCI Clinical Trial Access Policy, applies to all NCI funded research grant, cooperative agreements, and/or contracts that support covered interventional clinical trials.
This new policy reflects comments received in response to NCI’s Request for Information announced in the NIH Guide for Grants and Contracts Notices released September 30, 2013 (NOT-CA-13-019) and November 4, 2013 (NOT-CA-14-005).
On November 19, 2014, the National Institutes of Health (NIH) issued a Request for Public Comments on the “Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-019.html). When the final NIH Policy on Dissemination of NIH-Funded Clinical Trial Information is implemented, all NIH-funded investigators including NCI investigators will be subject to the NIH policy. The NCI Clinical Trial Access policy, announced by this Notice, will then be updated accordingly or withdrawn.
Consistent with the mission of the National Cancer Institute (“NCI”) to provide evidence-based approaches to cancer therapy, NCI believes that the full value of NCI-Supported Interventional Clinical Trials can be realized only if the final results of clinical trials are published as rapidly as possible. Timely and comprehensive access to the final results of clinical trials by investigators, clinicians and patients is particularly important for interventional cancer research studies because of their potential to directly impact patient care.
Covered Trials.� “Covered Trials” means all initiated or commenced NCI-Supported Interventional Clinical Trials whether extramural or intramural. Extramural trials include research grants, cooperative agreements, and contracts to conduct Interventional Clinical Trials in all phases and disciplines (e.g., treatment, prevention, supportive care, diagnosis). “Covered Trials” excludes Observational Studies and any NCI-Supported Interventional Clinical Trial in which no subjects are enrolled, but includes any NCI-Supported Interventional Clinical Trial in which at least one subject is enrolled even if the trial is not completed.
Final Trial Results.� “Final Trial Results” means summary data and information about the Covered Trial including, at a minimum, data and information that characterize the study design including allocation, drop-outs, and population included in the analysis; the baseline characteristics of the population studied; pre-specified primary and secondary endpoints; adverse events; and other relevant information, including study limitations.
Interventional Clinical Trials.� “Interventional Clinical Trials” means studies involving human beings (subjects) in which the investigator assigns study subjects (randomly or not randomly) to receive a specific intervention based on the applicable protocol. Such subjects may receive diagnostic, therapeutic, behavioral, and/or another type of intervention. These interventions may, but need not, be investigational or involve an investigational agent (e.g., clinical trials involving surgery, radiation, or screening tests). The subjects are then followed and biomedical and/or health outcomes are assessed. “Interventional Clinical Trials” encompasses all types of trials in all phases including pilot trials, phase zero trials, and normal (or healthy) volunteer trials.
NCI-Supported Clinical Trials.� “NCI-Supported” in the context of clinical trials means all clinical trials financially supported � whether in whole or in part � by the NCI. Clinical trials that are wholly funded by private entities (and in which the data from the clinical trial belong to the private funder) are not considered to be NCI-supported even if such studies are conducted at the NCI-designated Cancer Centers and benefit from the Cancer Center infrastructure.
Observational Studies.� “Observational Studies” means those studies in which investigators observe and analyze the outcomes of patients receiving care in a routine setting.
Primary Completion Date.� “Primary Completion Date” means the date that the final subject was examined or received an intervention for the purpose of final collection of data for the primary outcome, regardless of whether the clinical trial concluded according to the pre-specified protocol or was terminated.
The NCI Clinical Trial Access Policy (the “Policy”) applies to all Covered Trials. With respect to NCI-funded grants, cooperative agreements, and contracts that support a Covered Trial, this Policy will be incorporated as a Term and Condition of the award.
With respect to research contracts involving a Covered Trial, submission of this information will be incorporated as a contract deliverable and failure to comply with this Policy will be cause for penalty or contract termination.
IV. Results Reporting Expectation
For every Covered Trial, Final Trial Results are expected to be reported in a publicly accessible manner within twelve (12) months of the Trial’s Primary Completion Date regardless of whether the clinical trial was completed as planned or terminated earlier. Accordingly, data from incomplete trials are also expected to be reported within twelve (12) months of the date that the last subject had data collected or was examined even if the Trial does not achieve its primary aim.
To comply with the Policy, Final Trial Results may be reported in a publicly accessibly manner in various ways, which include but are not limited to: publishing trial results in a peer-reviewed scientific journal, �submitting study reports to publicly accessible registries dedicated to the dissemination of clinical trial information (such as ClinicalTrials.gov), or any other formalized reporting format that may become available (e.g., abbreviated reports submitted to specific journals via simplified posting procedures). NCI will not mandate use of a single mechanism but any mechanism �used must enable ready access to the Final Trial Results not only by researchers and providers but by patients as well. If publication in a journal is the mechanism selected to satisfy the Policy, the institution must also comply with the NIH Public Access Policy (http://publicaccess.nih.gov/) under which "investigators funded by the NIH must submit or have submitted for them, to the National Library of Medicine's PubMed Central, an electronic version of their final peer-reviewed manuscripts upon acceptance for publication, to be made publically available no later than 12 months after the official date of publication."
V. Responsible InstitutionsWith respect to each Covered Trial, the awardee or contract recipient, as applicable, is responsible for ensuring reporting of Final Trial Results in accordance with this Policy. For Covered Trials involving multiple awardees, the lead institution is responsible for ensuring compliance with the Policy. For example, for a multi-center Interventional Clinical Trial that is NCI-Supported that involves several NCI-designated Cancer Centers, the lead Cancer Center is responsible for ensuring Policy compliance.
Please direct all inquiries to:
Jeff Abrams, M.D.
National Cancer Institute (NCI)