NCI Will No Longer Accept R01 and P01 Applications for Phase III Clinical Trials of Medical Interventions and Cancer Imaging Modalities
The National Cancer Institute (NCI) has announced that it will no longer accept investigator-initiated R01 and P01 applications that propose phase III clinical trials for cancer-related medical interventions or cancer imaging modalities. The policy change takes effect starting with the due date of September 25, 2013, for P01 grant applications and October 5, 2013, for R01 grant applications.
The NCI defines “cancer-related medical intervention” as any nonbehavioral invervention—including new drugs, immunotherapy, cellular therapy, surgery, and/or radiotherapy—with the goal of treating patients with cancer or preventing cancer in individuals not diagnosed with cancer, including symptom control studies. “Cancer imaging” is defined as any imaging modality relevant to cancer or cancer comorbidities.
Background
Historically, most phase III clinical trials have been conducted under the U10 activity code, but a limited number of phase III clinical trials are performed under the R01, P01, and U01 activity codes. The NCI has determined that it is no longer appropriate to support investigator-initiated phase III clinical trials for cancer-related medical interventions as well as phase III clinical trials for cancer imaging modalities.
In general, medical intervention phase III clinical trials require more time than allowed by a single 5-year funding cycle associated with R01 and P01 awards, and spanning a clinical trial over more than one funding cycle is impractical because the successful renewal of these awards cannot be guaranteed.
According to the NCI, more appropriate mechanisms for phase III trials of medical interventions and cancer imaging modalities will be available through the NCI National Clinical Trials Network (NCTN), the Community Clinical Oncology Program (CCOP), or its eventual successor.
Exceptions to Policy
R01 and P01 applications for phase III clinical trials that are limited to public health interventions, comparative effectiveness research, and other psychosocial, behavioral, and related interventions to address consequences of cancer, will continue to be accepted, provided that they have shorter-term endpoints and can be completed entirely within the 5-year grant cycle. This may include trials related to cancer prevention or cancer treatment efficacy, health-care delivery, and cancer survivorship.
In addition, the NCI will continue to accept R01 and P01 grant applications that request support for correlative laboratory studies auxiliary to new and ongoing phase III clinical trials.
Renewal applications to continue ongoing phase III efficacy clinical trials currently supported by NCI P01 and/or R01 awards will be permitted until completion of the trial, but no new phase III trials may be proposed.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
