PreSolit Notice 06.13.23.pdf

1.0 GENERAL INFORMATION

Title: Pediatric Proton and Photon Therapy Comparison Cohort Coordinating Center Document Type: Pre-solicitation Notice – Notice ID 75N91023Q00105 Solicitation Number: 75N91023Q00105 Posted Date: June 13, 2023 Response Due Date: June 28, 2023 Product Service Classification Code: B529 – Scientific Data Studies NAICS Code: 541990 – All Other Professional, Scientific, and Technical Services

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Bethesda, MD 20892

Description:

It is anticipated that this acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) via request for written quotation. The North American Industry Classification System code is 541990 and the business size standard is $19.5M.

There is no solicitation at this time. When the solicitation is issued, it is anticipated that only one

(1) award will be made and awarded as a firm fixed price type Purchase Order. The Period of Performance is estimated to be twelve (12) months from the effective date stated in the award.

2.0 BACKGROUND:

The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) carries out studies to quantify second cancer risks associated with ionizing radiation exposures in pediatric cancer patients. The Branch has a specific interest in the risk of second tumors following proton therapy in children, because concerns have been raised about whole-body scatter doses from neutrons, brain necrosis and other late effects including second tumors.

Pediatric radiation oncology is undergoing rapid changes due to the widespread introduction of proton therapy. By reducing high-dose exposure to nearby normal tissue protons should reduce a wide-range of serious adverse-effects, such as second cancers. To date, no studies have directly evaluated the potential benefits or risks of protons for children, and some case series have raised concerns about some serious unanticipated side-effects, such as brain necrosis. There is widespread agreement amongst the clinical and scientific community that large-scale collaborative efforts are urgently required to address these questions. The REB/DCEG aims to create the first prospective cohort study including pediatric cancer patients treated with proton therapy and a comparison group of similar patients treated with photon therapy. This new cohort will build upon a foundation created by the US Pediatric Proton Consortium Registry (PPCR).

This state-of-the-art registry currently includes 18 US proton therapy centers and has recruited more than 3,000 pediatric proton patients who have actively enrolled in the registry since 2012.

Thus, the coordinating center study team has developed infrastructure and expertise critical to management of contributing study centers and data collection processes. For the Pediatric Proton and Photon Therapy Comparison Cohort, there is a critical need to obtain data from proton patients who are not enrolled in the PPCR and a control group of patients treated with photon therapy, which will allow for comparisons between patients treated with proton versus photon therapy. To obtain a sufficient number of proton and photon therapy patients, data will need to be obtained from multiple different proton and photon therapy centers, requiring a coordinating center to ensure uniform procedures and systems for data handling across the centers. Data from the PPCR will be incorporated into the new cohort study to form the foundation of the proton therapy cohort, so it is important that equivalent data is obtained from proton and photon centers using the same procedures and systems. A primary aim for NCI in the development of the Pediatric Proton and Photon Therapy Comparison Cohort will be to quantify the subsequent cancer risks after proton therapy compared to photon therapy.

3.0 OBJECTIVE

The Contractor shall assemble existing data from medical records for a group of pediatric cancer patients who received proton or photon therapy. The objective is to acquire a high-quality data set through uniform acquisition of standard data elements across multiple participating proton and photon treatment centers, with data acquired so that it is consistent with similar data from proton-treated patients in the PPCR. Data obtained will be used to compare outcomes in patients treated with proton versus photon therapy.

4.0 SCOPE

The Contractor shall obtain and monitor data acquisition and management by individual hospital centers where pediatric cancer patients have been treated with protons or photons in order to form a cohort of data from medical records. The Contractor shall maintain and manage a data platform that mirrors the platform used in the PPCR for acquisition and storage of de-identified proton and photon patient data, provide training and access to study staff at participating centers, and provide summary reports of data obtained for quality control purposes. The Contractor shall provide technical and informational assistance to individual centers to define, access, de-identify, and upload copies of required radiotherapy and imaging data, to be comparable to the proton radiotherapy and imaging data in the PPCR.

5.0 CONTRACT REQUIREMENTS

The Contractor shall:

4.1 Coordinate and monitor data collection from existing medical records for eligible pediatric cancer patients treated with proton or photon therapy at participating hospital centers. This shall include orientation of staff at participating sites to the data requirements for the study and institution of procedures that will result in the systematic collection of de-identified medical and radiotherapy treatment data from existing medical records of eligible patients.

Orientation and monitoring activities will typically occur via email communication, teleconference or video conference, with travel to the participating centers considered on an as-needed basis to monitor study progress and data quality.

4.2 Assign unique study participant IDs to all eligible pediatric cancer patients treated with proton or photon therapy to facilitate creation of a cohort of data from medical records.

4.3 Monitor data collection progress through regular communication and occasional site visits on an as-needed basis with participating hospital centers.

4.4 Maintain a data acquisition and storage system to house de-identified data for a multi-center cohort of pediatric patients treated with protons or photons. Provide access and training to participating centers.

4.5 Maintain systems for data collection and transfer of de-identified radiotherapy plans, images and dose data. Provide access and training to participating centers.

4.6 Monitor data obtained from participating centers regularly for quality and completeness across all participating sites. Consult with study centers, if needed, to provide guidance and facilitate resolution of data quality issues or questions about collection of specific data elements. Provide NCI with quarterly progress reports to show progress of data collection and notify NCI of missing data fields or other data quality issues.

4.7 Consult with study centers, if needed, to review archived and current radiotherapy plans.

The Contractor shall provide guidance and technical support to participating centers to facilitate collection and de-identification of final radiotherapy plans at participating hospital sites. This work, to be performed by the participating sites, may include locating and unarchiving older radiotherapy plans. The Contractor shall provide support for centers to upload these plans for transfer to the Contractor’s system.

6.0 CONTRACTOR QUALIFICATIONS:

The Contractor shall have at least 3 years of experience managing a pediatric proton consortium registry including collecting clinical data from pediatric cancer patients treated with protons from multiple treatment centers and maintaining a database of clinical and treatment data.

7.0 TYPE OF ORDER

It is anticipated that this requirement will be a firm fixed price purchase order.

8.0 ANTICIPATED PERIOD OF PERFORMANCE

The period of performance is anticipated to be twelve (12) months from the effective date stated in the award.

9.0 PLACE OF PERFORMANCE

Services shall be performed at the contractor’s facilities.

10.0 SOLE SOURCE JUSTIFICATION

The tasks outlined in the Contract Requirements require that the contractor has experience managing a pediatric proton consortium registry and maintaining a database of clinical and treatment data including collecting clinical data from multiple treatment centers providing proton or photon radiotherapy to pediatric cancer patients. A contract is currently in place (Purchase Order 75N91022P00918 with Massachusetts General Hospital (MGH); period of performance September 15, 2022 to September 14, 2023), under which the team at MGH has been coordinating data collection from nine proton and photon centers. Further, the coordinating center for the PPCR is at Massachusetts General Hospital. The PPCR is uniquely qualified to coordinate data acquisition from proton and photon centers because they have been collecting data from multiple US proton centers for the past 11 years and have the infrastructure and knowledge in place to manage similar data acquisition from proton and photon centers. As the coordinating center for the PPCR, MGH is the only group that is collecting data from all 18 major proton centers participating in the registry, and they are the only group that has sole access to the data collected from these 18 major proton centers. The epidemiologists and dosimetrists in REB have built a collaboration with MGH and the MGH team has successfully served as the data coordinating center for data collected from nine participating centers to date. It is anticipated that this acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1)(i) to Massachusetts General Hospital.

11.0 SUBMISSION INSTRUCTIONS

This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Information furnished must not exceed 5 pages (12-point font minimum) and should include an outline of previous or similar projects performed. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov.

All capability statements sent in response to this notice must be sent electronically (via email) to Michelle Nguyen, Contract Specialist at michelle.nguyen2@nih.gov and Linda Park, Contracting Officer at linda.park@nih.gov in Adobe Portable Document Format (PDF) by June 28, 2023; 2:00 PM Eastern Daylight Time. All responses must be received by the specified due date and time to be considered. Capability Statements received after that date and time will not be considered.

12.0 DISCLAIMERS AND IMPORTANT NOTES

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality:

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.

mailto:michelle.nguyen2@nih.gov mailto:linda.park@nih.gov