NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications
Table 6. Summary Accrual By Major Cancer Category and Trial Phase by Members of the Applicant Network Group Operations
Center to All Trials (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)
Cancer Type #1
PILOT
Treatment
Studies
PHASE 1
Treatment
Studies
PHASE 2 Treatment Studies
(includes Phase 1/2 Studies)
Screen
Only
Screened &
Intervention
PHASE 3 Treatment Studies
(includes Phase 2/3 Studies)
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)*
*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 so that the totals for summary accrual for all trials by Group members by trial phase
(Table 5 – accrual section of the table) equals the totals for summary accrual for all trials by members by major cancer category (Table 6).
Total
Pts
Screen
Only
Screened &
Intervention
Total
Pts
Screen
Only
Screened &
Intervention
Accrual by Applicant
Members to Trials Led by
Applicant Network Group
Operations Center
Accrual by Applicant
Members to Trials NOT
Led by Applicant Network
3 3 5 50 55 10 100 110 15 156 171
Group Operations Center 2 2 3 25 28 5 50 55 8 79 87
Total for Cancer Type # 1 5 5 8 75 83 15 150 165 23 135 258
Cancer Type #2
Accrual by Applicant
Members to Trials Led by
Applicant Network Group
Operations Center
Accrual by Applicant
Members to Trials Led by
Applicant Network Group
Operations Center
2 2 5 50 55 10 100 110 15 154 169
3 3 2 25 27 5 50 55 7 81 88
Total for Cancer Type # 2 5 5 7 75 82 15 150 165 22 235 257
etc.
Grand TOTAL
(All Diseases) 10 10 15 150 165 30 300 330 45 470 515
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Total
Pts