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 Lead Academic Participating Site Applicant Components by Major Cancer Category and Trial Phase
(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.
See Table 6 on page 197 for suggested categories for the Major Cancer Categories.
Type Study Accrual Period
(MM/DD/YYYY to
MM/DD/YYYY)
Cancer Type #1
Accrual by Main Lead Academic
Center
Accrual by Lead Academic
Component #1 (e.g. if academic
center has clinic at different
location with a different NCI
institution code)
Accrual by Affiliate(s) if part of
application
PILOT
Tx
Studies
PHASE
1
Tx
Studies
PHASE 2 Treatment Studies
(includes Phase 1/2 Studies)
Screened
Only
Screened &
Intervention
Total
Pts
PHASE 3 Treatment Studies
(includes Phase 2/3 Studies)
Screened
Only
Screened &
Intervention
Total
Pts
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 & intervention”
component category)*
Screened
Only
Screened &
Intervention
3 3 7 25 32 10 50 60 17 81 98
0 0 3 5 8 10 15 25 13 20 33
1 1 3 5 8 10 15 25 13 22 35
Total for Cancer Type # 1 4 4 13 35 48 30 80 110 43 123 166
Cancer Type #2
Accrual by Main Lead Academic
Center
Accrual by Lead Academic
Component #1 (e.g. if academic
center has clinic at different
location with a different NCI
institution code)
Accrual by Affiliate(s) if part of
application
Total for Cancer Type # 2
etc.
2 2 8 25 33 10 50 60 18 79 97
0 0 2 5 7 10 15 25 12 20 32
1 1 2 5
7
Page 207 of 241
Total
Pts
10 15 25 12 22 34
3 3 12 35 47 30 80 110 42 121 163
Grand TOTAL (All Diseases) 7 7 25 70 95 60 160 220 85 244 329
* 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 trial phase (Table 5 – accrual section of the table)
equals the totals for summary accrual for all trials by major cancer category (Table 6).