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NCI will be able to better manage its clinical research portfolio to facilitate data-driven allocation of resources with the new reporting requirements. It will also enhance NCI's capability to analyze and report findings from its clinical research portfolio that will impact clinical practice and cancer care. NCI also plans to improve coordination and cooperation among the diverse components of the current system including industry and federal regulatory agencies.
Because of its role as the sponsor of a large number of cancer clinical trials implemented across a wide range of settings, NCI has the opportunity to take a global view of emerging knowledge from cancer trials, and to identify important patterns and insights in a timely manner.
In addition to facilitating NCI's management of its clinical research portfolio, the long term benefits of the NCI Clinical Trials Reporting Program include the following:
- Investigators will be able to explore data from other trials addressing similar questions that are already completed or in process to avoid duplication of efforts
- Researchers will be able to examine the rich profile of data from the clinical research enterprise that supports the cancer research community's ability to prioritize efforts
- Patients and physicians will be able to identify relevant opportunities for participation in clinical trials and enhance patient accrual to trials
- Potential harm will be reduced as toxicity and adverse events become more readily recognized; this critical information can be more rapidly disseminated to other investigators and practicing physicians
- Patterns of favorable outcomes will be recognized sooner and disseminated more rapidly throughout the clinical trials community and to practicing physicians
The new requirements will apply to all grantees, regardless of the NCI funding program. In the past, each program maintained its own set of reporting requirements, which are stated along with the consequences for non-compliance within the terms of agreement for each grant.
Clinical trials investigators are required to report data that are explicitly defined within the terms of the grant award. A clinical trial is defined as a prospective study involving human subjects designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions. These interventions may include drugs or agents, treatments, devices, or behavioral or nutritional strategies. Participants in these clinical trials may be patients with cancer or people who do not have a diagnosis of cancer but whose genetic or personal profile makes them more at risk to develop the disease.
Additional information regarding the definition of a clinical trial can be found at Essential Elements of a Data Safety Monitoring Plan for Clinical Trials Funded by the NCI (http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines).
Ongoing trials must be registered within a six month period, from January 1 to June 30, 2009.
New trials that begin after January 1, 2009 must be registered within a given time period after activation.
Starting in July 1, 2009 quarterly reporting of all trial updates and entry of accrual information will be required for specific mechanisms.
Throughout 2008, NCI will be conducting a pilot project with select sites to monitor ease of reporting, identifying common data elements (CDEs) to be reported, training help desk staff, and preparing communications and education information for the clinical trials community, pilot site participants, and NCI staff.
The grants management office has responsibility for the enforcement of regulations related to non-compliance or performance. Grantees may receive an extension in order to become compliant. Non-compliant grantees may face termination of their grant award.
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