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| Sitemap | Contact CTEP Search this site Home Investigator Resources NCI CTEP IAM User Access Update Coronavirus Guidance Biomarker Resources Career Development Opportunities Childhood Cancer Resources CIRB/Study Participant Protections Conflict of Interest Policy Funding Opportunities Investigator’s Handbook Radiopharmaceutical Development Initiative Registration and Credential Repository Protocol Development Adverse Events/CTCAE Agent/Drug Management Amendments Ancillary/Correlative and Biomarker Studies CDE/Data Policies/CDUS/DMU Informed Consent LOIs/Concepts Monitoring OEWG Information & Timeline Reports Project Team Member Applications Protocol Development Tools Industry Collaborations CTEP Agreements and Agents Guidelines for Collaborations with Industry Initiatives / Programs Experimental Therapeutics Clinical Trials Network (ETCTN) National Clinical Trials Network (NCTN) Pediatric Early Phase Clinical Trials Network (PEP-CTN) NCI Drug Development Project Teams The NCI Formulary About CTEP Contact Us Map & Directions Mission Organization Chart Staff Directory CTEP IAM Update NCTN ETCTN Pediatric MATCH CTEP BRANCHES OAD Office of the Associate Director Plans, evaluates and coordinates extramural clinical research programs testing combined modality approaches and the testing of investigational new agents CGCB Clinical Grants and Contracts Branch Advises and funds extramural investigators seeking to obtain an NCI grant or cooperative agreement to support a Phase 0, 1, or 2 clinical trial focused on promising anticancer drugs and therapies... CIB Clinical Investigations Branch Oversees late phase, multi-center clinical trials exploring new therapeutics and biomarkers CTMB Clinical Trials Monitoring Branch Ensures data integrity and compliance with protocol and regulatory requirements CTOIB Clinical Trials Operations and Informatics Branch Supports IT and other key aspects of protocol development, review, and conduct IDB Investigational Drug Branch Implements clinical trials of experimental therapeutics PMB Pharmaceutical Management Branch Delivers pharmaceutical support and registers investigators for NCI clinical trials RAB Regulatory Affairs Branch Provides IND support and implements agreements for pharmaceutical use CTEP ACTIVITIES NCI CTEP IAM User Access Update Coronavirus Guidance NCI COVID-19 Research Initiatives About the NCI COVID-19 in Cancer Patients Study (NCCAPS) NCI’s National Clinical Trials Network (NCTN) Experimental Therapeutics Clinical Trials Network (ETCTN) Blood and Marrow Clinical Trials Network (BMT CTN) NCTN Navigator Pediatric Brain Tumor Consortium (PBTC) Pediatric Early Phase-Clinical Trials Network (PEP-CTN) Pediatric Preclinical in Vivo Testing (PIVOT) Program The NCI Formulary CTEP RESOURCES Agent Management Cancer Trials Support Unit (CTSU) Central Institutional Review Board (CIRB) CTEP Forms, Templates and Documents CTEP-Sponsored Agents Guidelines and Tools for Protocol Development and Review Investigational Drug Accountability Training NCI Audit Guidelines NCI Patient-Derived Models Repository (PDMR) NCTN/NCORP Data Archive Registration and Credential Repository Special Exception (SPEX) and Treatment Referral Center (TRC) About the Associate Director Meg Mooney, MD, MS, is the CTEP Associate Director where she has oversight and coordination responsibilities for the programmatic, financial, and administrative functions for the entire CTEP program, which covers a broad, multidisciplinary, clinical research effort to coordinate nationwide phase 1-3 clinical trials programs testing new treatment approaches for cancer. More… Research Spotlights Selected CTEP Clinical Accomplishments – February 2023 Immunotherapy Combination Most Effective as Initial Treatment for BRAF+ Melanoma Drug combination helps children with acute promyelocytic leukemia avoid conventional chemotherapy 50 Years of Cancer: Collaboration in Combating Childhood Cancer Seeing a Promising Future for Progress against Childhood Cancer FDA Approval of Rylaze Will Address Drug Shortage for Childhood ALL Implementing Criteria to Expand Clinical Trial Eligibility — An Analysis of NCI -Sponsored Protocols For Kids with Medulloblastoma, Trial Suggests Radiation Can Be Tailored Nivolumab-Based Combinations Improve Survival in Advanced Esophageal Cancer COVID-19 Vaccines May Be Less Effective in Some People with Cancer Clinical Trials and Translational Research Advisory Committee: Strategic Planning Working Group Report, Nov. 4, 2020 Brentuximab May Mean Less Radiation for Children, Teens with Hodgkin Lymphoma Healthcast Podcast Featuring Drs. Jim Doroshow and Meg Mooney – 50 Years of Cancer: The Road to Better Treatment and Diagnostics Blinatumomab Improves Survival in Children with Relapsed Leukemia Trial Tests Abemaciclib As New Option for Early-Stage Breast Cancer Some Postmenopausal Women with Breast Cancer May Forgo Chemotherapy Other CTEP-Related Initiatives NCI Announces Funding for Development of Standardized Electronic Treatment Plans for NCI-Supported Clinical Trials Applicable across Clinical Research Sites NCTN/NCORP Data Archive: Expanding Access to Clinical Trial Data CTEP Highlights 2023 NCTN Audit Guidelines 2023 ETCTN Monitoring Guidelines Career Development Opportunities CTCAE v6.0-Solicitation of Changes Funding Opportunities LOI Submission Form NCI Informed Consent Template NCTN & Updated ETCTN Guidelines Protocol Status Update Form CTEP Scientific Meetings Early Drug Development (EDD) Annual Meeting Schedule NCTN Group Meeting Schedule Newsletters / Reports DCTD Newsletter – September 2021 PMB Newsroom Featured Trials A091903, A Randomized Phase II Trial of Adjuvant Nivolumab with or Without Cabozantinib in Patients with Resected Mucosal Melanoma EA8212, A Randomized Phase III Trial of Intravesical BCG VeRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE) NRG-BN012, A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients with Resectable Brain Metastases S2101, Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants with Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study 10559, A Phase 2 Study of Erdafitinib in Patients with Recurrent or Progressive IDH-Wild Type Glioma with an FGFR-TACC Gene Fusion 10483, Phase Ib Trial of Erdafitinib Combined with Enfortumab Vedotin Following Platinum and PD1/L1 Inhibitors for Metastatic Urothelial Carcinoma with FGFR2/3 Genetic Alterations 10614, A Phase 1/2 Study of Nivolumab and Ipilimumab in Combination with Sirolimus and Prednisone in Kidney Transplant Recipients with Selected Unresectable or Metastatic Cutaneous Cancers sCTEP Home Contact CTEP Site Map Accessibility Disclaimer Policy FOIA HHS Vulnerability Disclosure U.S. Department of Health and Human Services National Institutes of Health National Cancer Institute USA.gov NIH… Turning Discovery Into Health...
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