1. PI Name
* must provide value
(Must be different than Disease Group Leader.)
2. PI Email
* must provide value
(Type in email correctly. Must be different than Disease Group Leader.)
3. Management (Disease) Group
* must provide value
Brain Tumor Brain and Spine Mets Breast Cancer Cancer Control and Population Health Science (CCPS) Dermatology/Pathology Gastrointestinal Cancer Genitourinary Cancer Gynecological Cancer Hematologic Malignancies and Cellular Therapy (Heme/BMT) Immunotherapy Melanoma NCI Clinical Trials Cooperative Group/National Group Pediatric Cancer Phase 1 Psychiatry Radiation Oncology Sarcoma Thoracic Cancer Head and Neck Urology Other
If other, add Management (Disease) Group
4. Disease Group Leader (DGL)
* must provide value
Michael Abern (Urology) Todd Purves (Urology) David Ashley (Brain Tumor) Annick Desjardins (Brain Tumor) Susan Dent (Breast) Donald McDonnell (Breast, GU, GYN) Rani Bansal (Breast) Alex Thomas (NCTN) Niharika Mettu (Phase I) Jim Abbruzzese (Phase I) Brian Czito (GI) John Strickler (GI) Gerard Blobe (GI) Daniel George (GU) Andrew Armstrong (GU) Andrew Berchuck (GYN) Angeles Secord (GYN) Stefanie Sarantopolous (Heme/BMT) Harry Erba (Leukemia) Danielle Brander (Lymphoma) Mitch Horwitz (BMT/CAR-T) Cristina Gasparetto (Multiple Myeloma) April Salama (Melanoma) Georgia Beasley (Melanoma) Brian Brigman (Sarcoma) Richard Riedel (Sarcoma) Thomas D'Amico (Thoracic) Jeffrey Crawford (Thoracic, NCTN) Randall Scheri (Endocrine) Walter Lee (Head and Neck) Jameel Muzaffar (Head and Neck) Marvaretta Stevenson (Head and Neck) Vidhya Karivedu (Head and Neck) Christopher Hoimes (Cell Based Immunotherapy) Jeffrey Clarke (Cell Based Immunotherapy, Thoracic) Christopher Willet (RadOnc) Manisha Palta (RadOnc) Christopher Kelsey (RadOnc) Alex Thomas (RadOnc) Carey Anders (RadOnc) Scott Antonia (Immunotherapy) Smita Nair (Immunotherapy) Peter Fecci (Brain and Spine Mets) Carey Anders (Brain and Spine Mets) Kathryn Pollak (CCPS) Meira Epplein (CCPS) Michael Spiritos (DCI Raleigh) Neeraj Agarwal (DCI Raleigh) Linda Sutton (DCN) Melanie Thomas (DCN) Hui Chen (DCN) Tom Stinchcombe (Thoracic, CCRL) Other
(Must be different than PI. Choose "Other" and write in name if DGL not listed.)
If other, add Disease Group Leader
5. Disease Group Leader Email
* must provide value
(Type in email correctly. Must be different than PI.)
6. Short Title of Protocol
* must provide value
7. Protocol Source
* must provide value
Choose one
If other, name protocol source here
9. After consideration of
the protocol's scientific merit, investigational product's safety profile, risk/benefit analysis, current disease group study portfolio openings, patient need, and logistics of performing the study procedures at Duke: Does the PI plan to move forward with this study?
* must provide value
Yes
No
If not moving forward, provide reasons for declining the study:
* must provide value
You have selected not to move forward with this study. All subsequent questions are not required. Include summary of meeting minutes for this trial (and why decided to move forward).
* must provide value
Include text from the new protocol meeting minutes.
Protocol was discussed and prioritized at the disease group/new protocol meeting on:
* must provide value
Today M-D-Y
Was Duke selected by the sponsor?
* must provide value
Yes No Not Yet Determined
iRIS PRO Number
* must provide value
PROXXXXXX (Do not include leading zeros)
Is this a Duke multi-site IIT?
* must provide value
Yes
No
If yes, planned number of sites
* must provide value
Previous number of treatment lines for enrollment
* must provide value
Level 1 (Score Range 30-58)
Level 2 (Score Range 59-85)
Level 3 (Score Range 86-111)
Level 4 (Score Range 112-136)
Level 5 (Score Range 137-162)
Check with ARPM or RPM
Is there adequate staffing and resources (facilities and equipment) available to successfully complete the study? Consider complexity of visits and timing of data submission.
* must provide value
Yes
No
If no, please provide justification:
* must provide value
1. Direct likely survival/clinical benefit to Duke catchment area patients, including disproportionately impacted or minority patients based on prior work, including treatment and implementation science studies (15)
* must provide value
Yes
No
2. Duke investigator initiated trials, including cooperative group trials, including treatment, prevention, screening, early detection, and patient outcomes studies (15)
* must provide value
Yes
No
3. NCI, NCTN, NCORP or other federally funded trials, interventional or non-interventional (12)
* must provide value
Yes
No
4. First in human or first in disease treatment trial (10)
* must provide value
Yes
No
5. Multicenter academic center investigator-initiated trial or studies with a community engagement partner (10)
* must provide value
Yes
No
6. Duke Faculty led industry sponsored interventional trial (overall global PI, steering committee) (7)
* must provide value
Yes
No
7. Industry pivotal phase 1 - 3 trial (5)
* must provide value
Yes
No
8. External Correlative/translational and biomarker or other minimal risk non-exempt studies (2)
* must provide value
Yes
No
9. Exempt minimal risk studies that require budgeting or contracting (2)
* must provide value
Yes
No
View equation
Can this trial be used in sequence with another trial in your portfolio? If yes, what is the preferred order? (Example: Study A--patients have had no more than 2 prior regimens and Study B--patients could have had up to 3 prior regimens. Put patients on Study A before they would be eligible for Study B).
* must provide value
Are there competing studies? If yes, provide the details of the competing studies in the fields below.
* must provide value
Yes
No
Competing Study #1
Please provide the following information about this study:
-IRB#
-Study Title (FULL)
-Date Open to Accrual (MM/DD/YY)
-Accrual Goal
-#Enrolled to Date
-Expected Closure (MM/DD/YY)
* must provide value
Competing Study #2
Please provide the following information about this study:
-IRB#
-Study Title (FULL)
-Date Open to Accrual (MM/DD/YY)
-Accrual Goal
-#Enrolled to Date
-Expected Closure (MM/DD/YY)
Competing Study #3
Please provide the following information about this study:
-IRB#
-Study Title (FULL)
-Date Open to Accrual (MM/DD/YY)
-Accrual Goal
-#Enrolled to Date
-Expected Closure (MM/DD/YY)
What is the funding source for this study?
* must provide value
Choose one
If this is a Cooperative Group/NCTN trial, will this trial participate in the:
* must provide value
LAPS Grant
Non-LAPS Grant
Not applicable for this protocol
Choose one
Will the accrual to the study contribute to the annual accrual requirement of one of the Network Groups?
* must provide value
Yes
No
Not applicable for this protocol
Choose one
Based on the PI and study team past experience, is the projected per patient payment amount:
* must provide value
Below average
Average
Above average
May consult with Finance Team
Is there a compelling reason to move forward with the study given a below-average per patient payment amount?
* must provide value
Yes
No
Provide a narrative about the disease specific race/ethnicity/gender frequency for the eligible patient population seen at Duke in the last three years in the text box.
* must provide value
Review the Accrual Requirements Table
Racial Categories (Use CREST link) Females Males Unknown or Not Reported Total American Indian/Alaska Native Asian Native Hawaiian or Other Pacific Islander Black or African American White More than one race Unknown or not reported Column Totals
American Indian/Alaska Native: Females
* must provide value
American Indian/Alaska Native: Males
* must provide value
American Indian/Alaska Native: Unknown or Not Reported
* must provide value
American Indian/Alaska Native: Total
* must provide value
View equation
Asian: Females
* must provide value
Asian: Males
* must provide value
Asian: Unknown or Not Reported
* must provide value
Asian: Total
* must provide value
View equation
Native Hawaiian or Other Pacific Islander: Females
* must provide value
Native Hawaiian or Other Pacific Islander: Males
* must provide value
Native Hawaiian or Other Pacific Islander: Unknown or Not Reported
* must provide value
Native Hawaiian or Other Pacific Islander: Total
* must provide value
View equation
Black or African American: Females
* must provide value
Black or African American: Males
* must provide value
Black or African American: Unknown or Not Reported
* must provide value
Black or African American: Total
* must provide value
View equation
White: Females
* must provide value
White: Males
* must provide value
White: Unknown or Not Reported
* must provide value
White: Total
* must provide value
View equation
More than one race: Females
* must provide value
More than one race: Males
* must provide value
More than one race: Unknown or Not Reported
* must provide value
More than one race: Total
* must provide value
View equation
Unknown or Not Reported: Females
* must provide value
Unknown or Not Reported: Males
* must provide value
Unknown or Not Reported: Unknown or Not Reported
* must provide value
Unknown or Not Reported: Total
* must provide value
View equation
Total Females
* must provide value
View equation
Total Males
* must provide value
View equation
Total Unknown or Not Reported
* must provide value
View equation
All Totals
* must provide value
View equation
Ethnic Category (Use CREST link) Females Males Unknown or Not Reported Total Hispanic or Latino Not Hispanic or Latino Unknown (Individuals not reporting ethnicity) Ethnic Category: Total All Subjects
Hispanic or Latino: Females
* must provide value
Hispanic or Latino: Males
* must provide value
Hispanic or Latino: Unknown or Not Reported
* must provide value
Hispanic or Latino: Total
* must provide value
View equation
Not Hispanic or Latino: Females
* must provide value
Not Hispanic or Latino: Males
* must provide value
Not Hispanic or Latino: Unknown or Not Reported
* must provide value
Not Hispanic or Latino: Total
* must provide value
View equation
Unknown: Individuals Not Reporting Ethnicity: Females
* must provide value
Unknown: Individuals Not Reporting Ethnicity: Males
* must provide value
Unknown: Individuals Not Reporting Ethnicity: Unknown
* must provide value
Unknown: Individuals Not Reporting Ethnicity: Total
* must provide value
View equation
Ethnic Category: Females Total
* must provide value
View equation
Ethnic Category: Males Total
* must provide value
View equation
Ethnic Category: Unknown Total
* must provide value
View equation
Ethnic Category: Totals
* must provide value
View equation
Disease Protocol Portfolio Priority (Priority Gap/Competing Protocols)
* must provide value
1 Low Priority
2
3 Priority (maximum score for an industry protocol)
4
5 Highest Priority
Choose one
Level of Importance (Scientific/Patient Care Impact)
* must provide value
1 Low Importance
2
3 Important (maximum score for an industry protocol)
4
5 Highest Importance
Choose one
Adequate Staffing and Resources are Available to Successfully Complete the Study
* must provide value
1 Strongly Disagree
2
3 Agree (maximum score for an industry protocol)
4
5 Strongly Agree
Choose one
Available Patient Population Supports the Projected Accrual for the Study
* must provide value
1 Highly Unlikely
2
3 Likely (maximum score for an industry protocol)
4
5 Highly Likely
Choose one
Overall Feasibility Score
View equation
Is this study considered a rare tumor condition? Answer Yes or No. A rare cancer subtype is defined specific validated molecular or phenotypic alterations with an incidence of fewer than 40,000 patients per year in the United States, or 15 per 100,000 people per year, whichever is less. These specific, validated, molecular or phenotypic alterations should be associated with distinct biology, epidemiology and potential causes, prognoses, and outcomes and/or potential therapeutic strategies.
Note: All COMBOMatch and MyeloMATCH treatment trials are considered rare.
* must provide value
Yes
No
Add justification if answered "yes" to rare tumor condition.
* must provide value
Does the study population meet any of the following criteria?
* must provide value
May choose more than one
Provide estimated incidence and provide source:
* must provide value
Provide estimated incidence/mutation frequency nationally and provide source:
* must provide value
Provide estimated incidence and provide source:
* must provide value
Has the PI assessed the patient population at Duke for eligible participants?
* must provide value
Yes
No
We advise that the PI conduct an initial assessment of how many projected Duke patients are eligible to enroll in this study. Please complete the DCI IT Intake Form for additional support.
Which of the following best describes how the patient population was assessed?
* must provide value
May choose more than one
If Other, please describe.
* must provide value
We recommend using DEDUCE or a similar tool to assess the patient population in addition to other methods. For support on utilizing DEDUCE or ensuring a sufficient population at Duke is available, please collaborate with our Feasibility Tactical Team. Please complete the DCI Intake Form for additional support.
Are there key INCLUSION criteria that may limit the number of eligible patients for this study? If yes, list here:
* must provide value
If no limitations, write "none."
If no limitations, write "none."
Given careful consideration of the eligibility criteria and Duke patient population, how many subjects are predicted to enroll each year?
* must provide value
Answer must be a number
FOR ADULT STUDIES: I (PI) have read the NIH Policy and Guidelines on the inclusion of women and minorities as participants in research involving human subjects: Inclusion Across the Lifespan
* must provide value
Yes
No
Not applicable for this study
Either Adult or Peds must be marked "Yes"
FOR PEDS STUDIES: I (PI) have read the NIH Policy and Guidelines on the inclusion of children as participants in research involving human subjects for pediatric studies: Inclusion Across the Lifespan
* must provide value
Yes
No
Not applicable for this study
Either Adults or Peds must be marked "Yes"
Why is this trial important to open at DCI and within the disease group?
* must provide value
May choose more than one
If Other, please explain.
* must provide value
Email of person completing this form
* must provide value
Email address will receive an automated PDF of the completed survey.
Email address will receive an automated PDF of the completed survey.
Date Completed
* must provide value
Now M-D-Y H:M
Choose "Save and Return Later" if a second person is required to add information to this form. After choosing "Save and Return Later" you will be prompted to enter the email of the second person. They will receive a unique link to complete the survey. They should not use the original public survey link. Choose "Submit" if the form is complete. (Option to download a PDF will appear after submission). I (PI) attest that all these fields are correct.
* must provide value
Yes
No
Please correct any fields that need editing at this time.
PI Signature
* must provide value
Date Completed
* must provide value
Now M-D-Y H:M
I (Disease Group Leader) attest that all these fields are correct.
* must provide value
Yes
No
Please correct any fields that need editing at this time.
Disease Group Leader Signature
* must provide value
Date Completed
* must provide value
Now M-D-Y H:M
Submit
Save & Return Later