Protocols
How do I find out about NCI priorities for clinical questions in different diseases?
NCI's Cancer Therapy Evaluation Program (CTEP), Clinical Investigations Branch (CIB) organizes comprehensive programs of treatment clinical trials. Requests or questions regarding NCI priorities for clinical questions should be directed to the CIB investigator responsible for that disease area. A list of CTEP CIB staff and associated responsibilities can be found here.
How do I find out about current NCI-sponsored clinical trials?
You can search NCI's list of 8,000+ clinical trials now accepting participants.
What is the process for submitting a proposal for a phase III trial?
To submit a proposal for a phase III trial, the following steps are required:
| Step 1. | Use the NCI Concept Template (Microsoft Word Document) or an individual Cooperative Group template. |
| Step 2. | Submit the concept to one or more of the NCI's cooperative groups. Each group reviews concepts internally, at the level of a disease committee, then again at a scientific prioritization committee. |
| Step 3. | The Cooperative Group will send the concept to the relevant NCI disease-specific task force, which will provide feedback to the Group and the investigator. |
| Step 4. | The Cooperative Group will consider the comments from the NCI disease-specific task force. |
| Step 5. | If the Cooperative Group still wishes to proceed, they will propose the concept to the relevant NCI disease-specific steering committee. That steering committee must approve the concept for development. |
| Step 6. | If the NCI disease-specific steering committee approves the concept, then the Cooperative Group develops a final protocol document, which must be reviewed for technical completeness by NCI. |
Area of Interest | CTEP CIB Staff Member |
| Adolescent and Young Adult Oncology | Dr. Nita Louise Seibel +1 (301) 496-2522 seibelnl@mail.nih.gov |
| Aging (older patients) | Dr. Meg Mooney +1 (301) 496-2522 mooneym@ctep.nci.nih.gov |
| AIDS Malignancies Autologous and Allogenic Stem Cell Transplant | Dr. Richard Little +1 (301) 435-9193 littler@mail.nih.gov |
| Brain Tumors (adult) | Dr. Bhupinder Singh Mann +1 (301) 496-2522 mannb@mail.nih.gov |
| Breast Cancer | Dr. Jo Anne Zujewski +1 (301) 435-9207 zujewskj@mail.nih.gov |
| Gastrointestinal Malignancies | Dr. Jack Welch +1 (301) 496-6512 Jack.Welch@nih.gov |
| GU (Prostate, Renal, Bladder, Germ Cell, Testicular) | Dr. Bhupinder Singh Mann +1 (301) 496-2522 mannb@mail.nih.gov |
| Gynecology | Dr. Jo Anne Zujewski +1 (301) 435-9207 zujewskj@mail.nih.gov |
| Head and Neck (including thyroid) | Dr. Bhupinder Singh Mann |
| Leukemia, Acute (adult) | Dr. Richard Little +1 (301) 435-9193 littler@mail.nih.gov |
| Leukemia, Chronic (adult) | Dr. Richard Little +1 (301) 435-9193 littler@mail.nih.gov |
| Lung | Dr. Jack Welch +1 (301) 496-6512 Jack.Welch@nih.gov |
| Lymphoma (adult) | Dr. Richard Little +1 (301) 435-9193 littler@mail.nih.gov |
| Melanoma, Squamous cell and other skin cancers Mesothelioma | Dr. Howard Streicher |
| Minority Accrual | Andrea Denicoff |
| Myeloma Therapy for Hematologic Malignancies | Dr. Richard Little +1 (301) 435-9193 littler@mail.nih.gov |
| Neuroendocrine Tumors | Dr. Jack Welch +1 (301) 496-6512 Jack.Welch@nih.gov |
| Nutrition | Dr. Meg Mooney +1 (301) 496-2522 mooneym@ctep.nci.nih.gov |
| Pediatric Bone tumors (e.g. Osteosarcoma, Ewing Sarcoma) | Dr. Nita Louise Seibel +1 (301) 496-2522 seibelnl@mail.nih.gov |
| Pediatric Brain Tumors (including all PBTC protocols) | Dr. Malcolm A. Smith +1 (301) 496-2522 smithm@ctep.nci.nih.gov |
| Pediatric Germ Cell Tumors Pediatric Hepatic Tumors (e.g. Hepatoblatoma) | Dr. Nita Louise Seibel +1 (301) 496-2522 seibelnl@mail.nih.gov |
| Pediatric Hodgkin Disease Pediatric Leukemia | Dr. Malcolm A. Smith +1 (301) 496-2522 smithm@ctep.nci.nih.gov |
| Pediatric Neuroblastoma | Dr. Malcolm A. Smith +1 (301) 496-2522 smithm@ctep.nci.nih.gov |
| Pediatric NHL | Dr. Malcolm A. Smith +1 (301) 496-2522 smithm@ctep.nci.nih.gov |
| Pediatric Other Solid Tumor Pediatric Renal Tumors (e.g. Wilms) Pediatric Retinblastoma Pediatric Soft Tissue Sarcoma (e.g. rhabdomyosarcoma, etc.) | Dr. Nita Louise Seibel +1 (301) 496-2522 seibelnl@mail.nih.gov |
| Pediatric Transplant Studies | Dr. Malcolm A. Smith +1 (301) 496-2522 smithm@ctep.nci.nih.gov |
| Sarcoma (adult) | Dr. Meg Mooney +1 (301) 496-2522 mooneym@ctep.nci.nih.gov |
| Surgery | Dr. Meg Mooney +1 (301) 496-2522 mooneym@ctep.nci.nih.gov |
| Supportive Care, Health-Related Quality of Life, & Patient Reported Outcomes (PROs) | Andrea Denicoff |
| Thymoma | Dr. Jack Welch +1 (301) 496-6512 Jack.Welch@nih.gov |
