DCI Weighted Prioritization & Feasibility Form: Therapeutic &/or Interventional Trials

IRIS PRO Number: ______
PI Name: ______
Short Title: ______

Hello,

Please complete the Weighted Prioritization & Feasibility Survey for Therapeutic &/or Interventional Trials. Please provide data for all fields.

PIs: Review for accuracy, answer all PI designated fields and e-sign. You may update any field that requires correction.
Disease Group Leaders (DGLs): Review for accuracy and e-sign. You may update any field that requires correction.

Thank you,

The Protocol Review and Monitoring Committee (PRMC)

Step 1 of 3 (Entered by Regulatory)

Step 3 of 3 (Signed by both PI and Disease Group Leader).

Submit this completed form to PRMC.

INITIAL ASSESSMENT

This priortization & feasibility survey is required for all new Therapeutic &/or Interventional trials as of 2/5/2024. It may also be requested at the time of Continuing Review & Two Year Check In, in IRIS (when not previously completed).

The process flow:

- Regulatory person completes Step 1. Option to download survey.
- After Step 1 is completed, it advances to Step 2 automatically (PI fills out). Option to download survey.
- After completion of Step 2 by the PI, the Disease Group Leader (DGL) receives the form and completes. Option to download survey.
- Regulatory (person who completed Step 1) will receive the completed survey (Step 3 of 3, signed by both PI and DGL).
- Regulatory person should upload the completed (Step 3 of 3) survey with the PRMC submission.

Are you completing this form as part of a continuing review or two year check in requirement?

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Yes

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1. PI Name

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2. PI Email

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3. Management (Disease) Group

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If other, add Management (Disease) Group

4. Disease Group Leader (DGL)
Non-Oncology CRU staff: if you are unsure which DGL to choose, please choose April Salama, MD (interim Associate Director of Clinical Research). Please send Dr. Salama the protocol synopsis over email (april.salama@duke.edu) so that she is informed about the protocol.

Contact the PRMC if you have questions.

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If other, add Disease Group Leader

5. Disease Group Leader Email

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6. Short Title of Protocol

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7. Protocol Source

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Industry-Initiated (Company Sponsor)

Duke Investigator-Initiated (Duke IIT)

External Investigator-Initiated (Outside Institution IIT)

NCI Clinical Trials Cooperative Group/National Group

Federal (non-NCI)

Other

If other, name protocol source here

8. Protocol Sponsor

* must provide value

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?

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Yes

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If not moving forward, provide specific reasons for declining the study:

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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).

Consider including in the summary:
• Who presented the trial for discussion
• Do the enrollment site(s) include a sufficient patient population
• Does the trial meet an unmet need
• Explain the scientific merit of the trial
• Explain if there are OR are not competing trials and how the trial will be successful in meeting the enrollment goal.
• How the trial contributes to minority enrollment representative of the catchment area
• Will the study enroll at the Duke community sites? If not, indicate the reason.

Duke community sites include: Duke Regional, Duke Raleigh, Duke Women's Cancer Care Raleigh (Macon Pond), Duke Cancer Center Cary, Duke Health Cary, Duke Southpoint and DCN Clinical Sites: Smithfield, Henderson, Laurinburg, Lumberton, Clayton, etc.

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Protocol was discussed and prioritized at the disease group/new protocol meeting on:

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M-D-Y

Was Duke selected by the sponsor?

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iRIS PRO Number

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Is this a Duke multi-site IIT?

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Yes

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If yes, planned number of sites

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Previous number of treatment lines for enrollment

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Protocol Intensity Score

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)

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Is there adequate staffing and resources (facilities and equipment) available to successfully complete the study? Consider complexity of visits and timing of data submission.

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Yes

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If no, please provide justification.

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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)

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Yes

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2. Duke investigator initiated trials, including cooperative group trials, including treatment, prevention, screening, early detection, and patient outcomes studies (15)

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Yes

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3. NCI, NCTN, NCORP or other federally funded trials, interventional or non-interventional (12)

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Yes

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4. First in human or first in disease treatment trial (10)

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Yes

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5. Multicenter academic center investigator-initiated trial or studies with a community engagement partner (10)

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Yes

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6. Duke Faculty led industry sponsored interventional trial (overall global PI, steering committee) (7)

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Yes

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7. Industry pivotal phase 1 - 3 trial (5)

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Yes

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8. External Correlative/translational and biomarker or other minimal risk non-exempt studies (2)

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Yes

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9. Exempt minimal risk studies that require budgeting or contracting (2)

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Yes

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Weighted Total

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).

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Are there competing studies? If yes, provide the details of the competing studies in the fields below.

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Yes

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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)

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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)

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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)

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What is the funding source for this study?

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Industry Partner

Federal

Internal Funding

Other

If other, explain.

If this is a Cooperative Group trial, will this participate in the:

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LAPS Grant

Non-LAPS Grant

Not applicable for this protocol

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Based on the PI and study team past experience, is the projected per patient payment amount :

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Below average

Average

Above average

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Is there a compelling reason to move forward with the study given a below-average per patient payment amount?

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Yes

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Explain the reason:

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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.

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Review the Accrual Requirements Table

ACCRUAL PROJECTIONS

The CREST Dashboard is a tool that may be used to project the number of accruals (race, ethnicity, gender) for this trial. Please enter the information in the tables below. You may use other tools to complete the accrual projections section.

Instructions to use the CREST Dashboard:

Click link to CREST Dashboard (must be on Duke VPN/or on-site)
How to use CREST Dashboard for Accrual Projections_2024.pdf (Document will download)

If you have questions related to the CREST Dashboard, please contact the Community Outreach, Engagement, & Equity Office.

If you need access to the CREST Dashboard, please submit an IT ticket.

Reference (document will download):

Demographic Characteristics of DCI Patients Catchment Area and US Pop for projected accruals.pdf

All fields in the table below are mandatory. The survey will not be accepted without data in each field.

Gender column totals should match the ethnicity table (next question).

Racial Category	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

Ethnic Category	Females	Males	Unknown or Not Reported	Total
Hispanic or Latino
Not Hispanic or Latino
Unknown (Individuals not reporting ethnicity)
Ethnic Category: Total All Subjects

Disease Protocol Portfolio Priority (Priority Gap/Competing Protocols)

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1 Low Priority

3 Priority (maximum score for an industry protocol)

5 Highest Priority

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Level of Importance (Scientific/Patient Care Impact)

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1 Low Importance

3 Important (maximum score for an industry protocol)

5 Highest Importance

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Adequate Staffing and Resources are Available to Successfully Complete the Study

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1 Strongly Disagree

3 Agree (maximum score for an industry protocol)

5 Strongly Agree

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Available Patient Population Supports the Projected Accrual for the Study

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1 Highly Unlikely

3 Likely (maximum score for an industry protocol)

5 Highly Likely

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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.

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Yes

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Add justification if answered "yes" to rare tumor condition.

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Does the study population meet any of the following criteria?

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No, this study population does not meet the rare disease criteria.

A rare cancer type defined by the NCI as < 6/100,000 cases (national incidence rate)

A narrow molecular subtype (e.g., rare mutations, targeted therapies)

An uncommon clinical presentation (e.g., comorbidities, prior therapies)

Provide estimated incidence and provide source:

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Provide estimated incidence/mutation frequency nationally and provide source:

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Provide estimated incidence and provide source:

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Has the PI assessed the patient population at Duke for eligible participants?

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Yes

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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?

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Epic

Clinical judgment

Historical data from OnCore

DEDUCE

Tumor Registries (not at Duke) (DCN)

MrT

CREST Dashboard

Other

If Other, please describe.

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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:

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Are there key EXCLUSION criteria that may limit the number of eligible patients for this study? If yes, list here:

Resource: Review Checklist for Unnecessary Exclusion Criteria_2023.xlsx

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Given careful consideration of the eligibility criteria and Duke patient population, how many subjects are predicted to enroll each year?

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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

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Yes

Not applicable for this study

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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

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Yes

Not applicable for this study

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Why is this trial important to open at DCI and within the disease group?

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Fills an important gap in the current disease group portfolio. There are no competing trials.

There is a significant need for this patient population to be provided this option. There may be 1-2 competing trials, but the number of patients far exceeds the accrual available across these competing trials.

This is a Duke Investigator Initiated Trial or a National Cooperative Group Trial that is important to the disease group's research interest.

This is an important new class of agents/treatment.

This study has the potential to shift clinical paradigms and/or provides a significant scientific impact.

Offers an especially promising therapy with potential for substantial benefit to subjects and minimal safety concerns.

As part of its design the study makes a special effort to enroll underrepresented/minority populations.

Other

If Other, please explain.

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REGULATORY: SIGN-OFF

Note: When moving forward with a new trial, submit step 3 of 3 completed (signed by both PI and Disease Group Leader) to the PRMC with iRIS submission. PRMC requires this completed form as part of the approval process.

The process flow:

- Regulatory person completes Step 1. Option to download survey.
- After Step 1 is completed, it advances to Step 2 automatically (PI fills out). Option to download survey.
- After completion of Step 2 by the PI, the Disease Group Leader (DGL) receives the form and completes. Option to download survey.
- Regulatory (person who completed Step 1) will receive the completed survey (Step 3 of 3, signed by both PI and DGL).
- Regulatory person should upload the completed (Step 3 of 3) survey with the PRMC submission.

Email of person completing this form

* must provide value

Backup Email

Date Completed

* must provide value

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

PI Signature

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Add signature

Date Completed

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M-D-Y H:M

I (Disease Group Leader) attest that all these fields are correct.

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Yes

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Disease Group Leader Signature

* must provide value

Add signature

Date Completed

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M-D-Y H:M

Regulatory: Submit step 3 of 3 completed (signed by both PI and Disease Group Leader) to the PRMC with iRIS submission. PRMC requires this completed form as part of the approval process.

Version

Important for all steps! Please ensure to hit "SUBMIT" for the survey to be recorded and advance to the next step!

You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.