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NCI is establishing a new Clinical Trials Reporting Program (NCI CTRP), based on a June 2005 recommendation submitted by the Clinical Trials Working Group (CTWG), which was approved by the National Cancer Advisory Board.
Even though NCI grantees are currently subject to trial reporting requirements, an upgraded set of reporting requirements will apply, starting January 2009. In the long-term, the new reporting measures will help provide critical data to assist NCI in better coordinating research efforts to optimize our nation's investment in cancer research.
NCI clinical trials reporting will include up-to-date information about the status of all NCI-funded and/or sponsored clinical research regardless of drug development phase, type of intervention or treatment, study design, or program through which funding is provided.
The CTRP goal is to provide NCI with a more global view of emerging knowledge from cancer trials and to identify important patterns and insights in a timely way in order to assure patient safety and an optimal return on the nation's investment in cancer clinical trials. This goal enhances NCI's commitment to protecting human research participants in NCI-supported trials, safeguarding the integrity of the data resulting from this research, and applying measures to enable effective monitoring of research.
NCI's clinical trials reporting policy requires all grant awardees to be responsible for submitting required data and documentation to NCI and other NIH offices, as applicable. As the initiatives of the CTWG become fully implemented, electronic reporting to NCI will be required in a manner that is compliant with standards specified by the NCI.
Summary clinical trials data from all NCI-funded and sponsored trials will be submitted electronically at intervals based on the data reporting mechanism specified. Data will include, but not be limited to, select patient demographics and accruals, treatment, toxicity and outcomes.
The NCI Clinical Trials Reporting requirements will help provide the information to assist NCI with more efficient coordination of research efforts. In particular, it will provide critical data reporting to help NCI carry out its overall goal of having large clinical trials, especially phase 3 trials, prioritized through disease-specific steering committees. These committees will facilitate the sharing of ideas across a broad range of investigators, basic and translational scientists, NCI staff, community oncologists and patient advocates in the development of clinical trial concepts. |
