NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications Table 7. Summary Accrual By Major Cancer Category and Trial Phase to All Trials Led by Applicant Network Group by Members of the Applicant Network Group & Other Groups (Include accrual only over the past 5-6 years) Accrual figures should include eligible & ineligible patients. Screened patients refer to patients who are screened only for studies that have screening as a distinct part of the protocol - patients are consented and screened as part of the trial but may not undergo randomization/intervention because the screening excludes them from that part of the study (i.e., patient’s tumor did not have the required characteristic for treatments if the tumor is tested as part of the study). “Screened Only” and “Screened and Intervention” are mutually exclusive categories of accrual. Pilot studies refer to studies testing the feasibility of administration of the therapeutic intervention/approach and/or are explicitly determined to be “pilot studies” at the time of NCI/DCTD approval. Biospecimen information is for collections for patients enrolled on these tx trials only. Examples of the Major Cancer Categories for Adult Cancer Accrual to be used: (1) Breast; (2) Gastrointestinal (can be split into Colorectal Cancer and Non-Colorectal Cancer GI); (3) Genitourinary (can be split into Prostate Cancer and Non-Prostate Cancer GU); (4) Thoracic Malignancies; (5) Head & Neck Cancers; (6) Leukemia; (7) Lymphoma; (8) Myeloma; (9) Brain; (10) Gynecologic Cancers (can be split into Ovarian Cancer or Non- Ovarian Gynecologic Cancer); (11) Melanoma; and (12) Sarcoma; as well as an “Other Category (Specify Types – e.g., Neuroendocrine)” if needed and a “Non-specific Cancer Types” if needed for pilot or phase 1 study accrual if not tracked by disease type, as noted in the asterisk note below the table. Major Cancer Categories for Pediatric Cancer Accrual should follow general categories used in pediatric oncology. Type Study Accrual & Accrual Period (MM/DD/YYYY to MM/DD/YYYY) PILOT Tx Studies PHASE 1 Treatment Studies PHASE 2 Treatment Studies (includes Phase 1/2 Studies) Screened Only Screened & Intervention Total Patients PHASE 3 Treatment Studies (includes Phase 2/3 Studies) Screened Only Screened & Intervention Total Patients All Treatment Studies (Include accrual from all treatment trials for all phases and pilot studies – if trial does not have a screening component, then it should be totaled in the “screened and intervention” component category)* Screened Only Screened & Intervention Accrual by Applicant Members to Trials Led by Applicant Network Group Operations Center 3 3 5 50 55 10 100 110 15 156 171 Accrual by Members of Other Groups to Trials Led by Applicant Network Group Operations Center 1 1 5 15 20 5 30 35 10 47 57 Total for Cancer Type # 1 4 4 10 65 75 15 130 145 25 203 228 Cancer Type #2 Accrual by Applicant Members to Trials Led by Applicant Network Group Operations Center Accrual by Members of Other Groups to Trials Led by Applicant Network 2 2 5 50 55 10 100 110 15 154 169 Group Operations Center 1 1 5 15 20 5 30 35 10 47 57 Total for Cancer Type # 2 3 3 10 65 75 15 130 145 25 201 226 etc. Grand TOTAL (All Diseases) 7 7 20 130 150 30 260 290 50 404 454 * If any pilot or phase 1 treatment trials are not disease-specific (and accrual is thus not tracked by a cancer type), accrual for those trials should be listed under a row entitled “Non-specific Cancer Type” in the table above. Please Note: Totals for the summary accrual for this table may not match totals in Tables 5 and 6 since Table 7 tracks accrual only to treatment trials LED by the Network Group applicant by its members as well as members of other Groups and Tables 5 and 6 track accrual by members of the Network Group to ALL treatment trials. Total Pts Page 198 of 241
PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications Table 8. Operational Timelines for Development of Clinical Trial Proposals (LOIs and Concepts) Submitted after 4/1/2010 to Date of Application Preparation (4/1/2010 to MM/DD/YYYY) Sorted by Major Cancer Category, Start Date, and Trial # (4/1/2010 is used as start date as prior to that date, NCI/DCTD did not have standard definitions for milestones in the study development process) * For major cancer categories, use the same categories that are used for Tables # 6 and #7 on pages 197 and 198, respectively. IND Studies – Pilot and Phase 1 Cancer Site * etc. Trial Phase LOI or Concept Trial Number & Brief Title Operational Efficiency Start Date for LOI/Concept Date of LOI/Concept Approval Median Days in Development for IND Studies – All Pilot & Phase 1: _____ IND Studies - Phase 2 (Includes Phase 1/2 Trials) Cancer Site * etc. Trial Phase LOI or Concept Trial Number & Brief Title Operational Efficiency Start Date for LOI/Concept Median Days in Development for IND Studies - Phase 2: _____ IND Studies - Phase 3 (Includes Phase 2/3 Trials) Cancer Site * etc. Trial Phase LOI or Concept Trial Number & Brief Title Operational Efficiency Start Date for LOI/Concept Median Days in Development for IND Studies - Phase 3:_____ Median Days in Development for All IND Studies:_____ Create the Same Tables for NON-IND Studies…….. Median Days in Development for ALL Studies: _____ Date of LOI/Concept Approval Date of LOI/Concept Approval Date 1st Protocol Submission Date 1st Protocol Submission Date 1st Protocol Submission # Protocol Revisions # Protocol Revisions # Protocol Revisions Date NCI/DCTD Approval Date NCI/DCTD Approval Date NCI/DCTD Approval Date Study Open for Patient Accrual Date Study Open for Patient Accrual Date Study Open for Patient Accrual # Days in Development # Days in Development # Days in Development Comments Comments Comments Page 199 of 241
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NCTN Program Guidelines Table of Co
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PART 1: Overview of NCTN Program Se
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Page 147 and 148: PART 2: Submission of New/Competing
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Page 189 and 190: TYPE OF STUDY PART 3: Submission No
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Page 201 and 202: Participating Site Member Category
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Page 239 and 240: Part 4: Summary of Updates to Guide
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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