B01. RFI Biostatistical Software for MRDC ORA Program Office.docx

REQUEST FOR INFORMATION (RFI)

1.0 RFI TITLE: BIOSTATISTICAL SOFTWARE

2.0 AGENCY: MRDC Office of Regulated Activities (ORA)

3.0 OFFICE: Office of Regulated Activities Defense Health Agency Research & Development Medical Research & Development Command (DHA R&D – MRDC)

4.0 LOCATION: 1541 Porter St Fort Detrick, MD 21702

5.0 SUBJECT: The ORA of the DHA R&D - MRDC is conducting market research to for a biostatistical software (SW) solution can be provided to meet requirements for biostatical software. This market research may also assist with the further development and/or refinement of the requirements.

6.0 DISCLAIMER: This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein.

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.

7.0 DESCRIPTION: The ORA of the DHA R&D - MRDC has a requirement for biostatistical software - Cytel’s East Horizon software (brand name or equal – see East Software website at https://cytel.com/east-horizon/ for “salient operating characteristics). East Software Suite consisting of the modules sequential, survival, adapt, endpoints, multiarm, escalate, exact and MAMS are requested. These modules help with study design for all the study types currently in the ORA portfolios to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards.

8.0 SUBMISSION INSTRUCTIONS: Responses are requested from any vendors who either sell East Software or who have a SW solution with the same (equal) characteristics. As such, all capable and qualified sources are encouraged to respond to this request.

White papers should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF.

2. Cover Page (1page)

· Title

· Organization

· Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)

· Topic area(s) addressed

Please note that responses are due no later than 23 April 2025. The preferred method of submission is via email. The point of contact for this action is Matthew Gembe. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis.

9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Matthew Gembe at: matthew.w.gembe.civ@health.mil no later than the close of business 23 April 2025. Telephonic communication will not be considered as submission nor receive response.

Attachment:

East Software Information

Attachment 1 – East Software Information

East BASE Popular tools for fixed-sample clinical trial designs

• Wide variety of fixed sample options (Normal, Binomial, Survival endpoints) • Multiple Complex patterns of accruals, dropouts and response lag

• Run R function Test variety of superiority, non-inferiority, equivalence, and confidence-interval based designs Gov’t Need:

This module helps with study design for all the study types currently in the ORA portfolios to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards.

East MULTIARM - Hosted- Designated User Functions:

-Tools for multi-arm fixed-sample clinical trial.

-Establish strong control of the family-wise error rate. • Fast design by batch simulation -Types of power: global, disjunctive, conjunctive, marginal • Tests include: Dunnett, Bonferroni, Sidak, Holm, Hochberg, Hommel, Fixed Sequence, Fallback Gov’t Need:

This module helps with study design for Multiple arm studies to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards.

East ENDPOINTS - Hosted - Designated User Functions:

Design by simulation

• Variety of multiple testing procedures (eg. Hochberg, Fallback) • Serial and parallel gatekeeping) Gov’t Need:

This module helps with study design for all the study types currently in the ORA portfolio to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards.

East ESCALATE - Hosted - Designated User Better characterization of the MTD

• Clearly communicate critical information to clinicians

• Improve screening and selection of active agents to carry forward Gov’t Need:

This module helps with study design for ORA’s Phase 1 and phase 2 trials to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards.

East EXACT - Hosted - Designated User Functions:

- Exact single-stage, optimal and mini-max two-stage, group sequential designs for singlearm studies.

Tools for small sample clinical trials with binomial endpoints Gov’t Need:

This module helps with study design for sample clinical trials with binomial endpoints to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards. Ideal for small sample size trials or phase 2 small single arm screening trials.

East Sequential - Hosted - Designated User Functions:

Extensive selection families of stopping rules for efficacy and futility.

• Display boundaries on multiple scales. • Optimize trial design for savings in sample size, study duration, and cost • Conditional and Predictive Power calculations for interim decisions Gov’t Need:

This module helps with study design for Adaptive platform trials to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards.

East Survival- Hosted - Designated User Functions:

variable and fixed subject follow-up

• Piecewise hazard rates, accruals, and dropouts

• Charts for predicting events/sample size, accrual, and study duration

• Simulate non-proportional hazards Gov’t Need:

This module helps with study design for all the study types currently in the ORA portfolio to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards.

East Adapt- Hosted - Designated User Functions:

• Adaptive rules for increasing sample size, or other possibilities

• Methods include CHW, CDL, Müller-Schäfer • Specific adaptive tools for survival (e.g., adapt sample size and events) Gov’t Need:

This module helps with study design for Adaptive platform trials to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards.

East MAMS - Hosted - Designated User Functions:

• Multiple treatments to be compared with a control • Allows several primary research questions to be answered in a single trial with increased efficiency compared to separate trials.

Gov’t Need:

This module helps with study design for Adaptive platform trials to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards.