NCI National Clinical Trials Network (NCTN) Program Guidelines

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
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