NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications
Table 5. Summary Accrual by Lead Academic Participating Site Applicant for All Clinical Trials for All Cancers by Trial Phase
(Include accrual only over the past 5-6 years)
Type Study Accrual
Accrual Period
(MM/DD/YYYY to
MM/DD/YYYY)
Accrual by Main Lead
Academic Center
PILOT
Treatment
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 and
intervention” component
category)*
Screened
Only
Screened &
Intervention
5 5 15 50 65 20 100 120 35 160 195
Accrual by Lead Academic
Component #1
(e.g. if academic center
has a clinic at a different
geographic location with
a different NCI
institution code) 1 1 5 10 15 20 30 50 25 42 67
Accrual by Affiliate(s) if
part of application
TOTALS:
Type Study Accrual
Accrual Period
(MM/DD/YYYY to
MM/DD/YYYY)
Per Patient Biospecimen
Collection Accrual by
Main Lead Academic
Center
Per Patient Biospecimen
Collection by Lead
Academic Component #1
(e.g. if academic center
has a clinic at a different
geographic location with
a different NCI
institution code)
Per Patient Biospecimen
Collection by Affiliate(s) if
part of application
1 1 5 10 15 20 30 50 25 42 67
7
7 25
70 95 60
160 220 85
244 329
PILOT
Treatment
Studies
PHASE 1
Tx
Studies
PHASE 2 Treatment Studies
(includes Phase 1/2 Studies)
Screened
Only
Screened &
Intervention
Total
PHASE 3 Treatment Studies
(includes Phase 2/3 Studies)
Screened
Only
Screened &
Intervention
Total
Page 206 of 241
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 and
intervention” component
category)*
Screened
Only
Screened &
Intervention
Note: This is
# Pts with ≥1
specimen(s)
(NOT # of
specimens)
3 2 15 50 65 20 100 120 35 155 190
Note: This is
# Pts with ≥1
specimen(s)
(NOT # of
specimens)
1
Note: This is
# Pts with ≥1
specimen(s)
(NOT # of
specimens)
1 5 10 15 20 30 50 25 42 67
1 1 5 10 15 20 30 50 25 42 67
*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 feasibility of administration of 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.
Total