NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications
Table 3. Other Important Achievements for Trials by Disease Area, Trial Phase, & Trial # from MM/DD/YYYY to MM/DD/YYYY -
Please Note: Other important achievements refer to important information from secondary endpoints of the trial (e.g., validation of an integrated
biomarker) as well as other important analyses (e.g., meta-analyses; special population analyses). Include important achievements that were
reported only in the past 5-6 years. QOL funded by DCP CCOP Research Base grant should NOT be included in this table, but can be
referenced/described in the collaborations section of the Research Plan. Applicants should briefly explain the importance of the achievement as it
is the importance of the achievement that is the focus of the table for reviewers, not number of publications.
Cancer
Site
etc.
Trial
Phase
Year
(Publication)
Trial
Number
& Brief
Title
Experimental
Agent or
Regimen
Secondary
Endpoint or
Sub-study
Result
Manuscript
or Abstract
Reference
Description of Importance
from Secondary Endpoint or
Sub-study
Date Trial
Activation
Date Trial
Closure
Total Accrual
Table 4. List of Approved Applications for Use of “Banked” Biospecimens from Applicant Clinical Trials from MM/DD/YYYY to
MM/DD/YYYY - Include approved applications for use of biospecimens only over the past 5-6 years. These applications are for use of “banked”
specimens from completed treatment trials only; NOT for use of specimens for analyses that were included in the study’s protocol document or
from banking only protocols.)
Cancer
Site
etc.
Year of
Request
Trial
Phase
Trial Number &
Brief Title
Brief Description of Request
# and Type
Samples
Provided
Date
Samples
Provided
Reference to Publication Resulting
from Approved Request or Other
Result (or Pending Publication)
Table 5. Summary Accrual for All Clinical Trials (All Cancers) by Trial Phase by Members of the Applicant Network Group
(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.
Type Study Accrual &
Accrual Period
(MM/DD/YYYY to
MM/DD/YYYY)
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
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
Accrual by Applicant
Members to Trials NOT
Led by Applicant
Network Group
5 5 10 100 110 20 200 220 30 310 340
Operations Center 5 5 5 50 55 10 100 110 15 160 175
TOTALS: 10 10 15 150 165 30 300 330 45 470 515
Type Study Accrual &
Accrual Period
(MM/DD/YYYY to
MM/DD/YYYY)
Per Patient Biospecimen
Collection by Applicant
Members to Trials Led
by Applicant Network
Group Operations Center
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
Total
All Treatment Studies
(Should include accrual from all
treatment trials for all phases and
pilot studies as noted above)
Screened
Only
Screened &
Intervention
Note: This
is # Pts with
≥1
specimen(s)
(NOT # of
specimens)
3 2 10 60 70 20 150 170 30 215 245
Total
Page 196 of 241