4_Attachment 3 Sole Source Justification (SJJ) 25K-250K MGH_Redacted.pdf

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 concern has been raised about whole-body scatter doses from neutrons, a by-product of the proton therapy, brain stem 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, including second cancers. To date, no studies have directly evaluated the potential benefits or risks for children, but some case series have raised concerns about some serious unanticipated side-effects, such as brain necrosis. There is widespread agreement among the clinical and scientific community that large-scale collaborative efforts are urgently required to address these questions.

NCI proposes to create the first prospective cohort study by expanding the US Pediatric Proton Consortium Registry (PPCR) to add patients treated at photon therapy centers and systematic follow-up. The state-of-the-art registry run by Massachusetts General Hospital (MGH) currently includes 13 US proton centers and has enrolled 2000 pediatric proton patients since 2012. REB’s market reseachs supports the proposed cohort study and the suitability of the intramural research environment for this high-risk, long-term effort. In addition, the market research also showed the justification for urgent development of the addition of photon treated patients due to the impending transition from photon treatment to proton treatment despite the absence of direct evidence of benefit. NCI’s primary aim will be to add a photon component in order to quantify the subsequent cancer risks after proton compared to photon therapy. Second cancers are the most common and serious adverse-effect of pediatric radiotherapy.

The PPCR is the only known compmphrehensive source in the US, because they have been collecting data from the major US proton centers for the past 7 years and have the infrastructure and knowledge in place to support the assembly of a photon comparison cohort.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. US Pediatric Proton Therapy Study

b. Project description. See the attached Statement of Work the only group that is collecting data from all 13 major proton centers participating in the registry, and they are the only group that has sole access to the data that are collected from these 13 major proton centers.

The data are captured via REDCap, a secure web-based data collection platform with online survey capabilities. Currently, there are data on over 2000 potential data fields collecting information on demographics, diagnosis, baseline treatment and health details, as well as follow up health information for 2000 pediatric cancer patients. The MGH research team continuously evaluates and updates the registry keeping current with the changing disease-specific paradigms. The data are regularly monitored for completeness across all participating sites. Participating sites receive quarterly reports identifying missing data fields that highlight the study’s critical data points. MGH is uniquely positioned collect data for photon-treated pediatric patients at multiple hospital centers that match the characteristics of the proton patients, because they have sole access to the collected data from all 13 major proton centers. It is important to the integrity of the study that the photon patients have characteristics similar to the proton patients, such as age age at diagnosis and type of cancer. Further, MGH has the necessary radiation oncology contacts and relationships in place to conduct the study required by the statement of work.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A Small Business Sources Sought (SBSS) notice was posted on FedBizOpps on November 4, 2019 with a response date of November 13, 2019. No responses were received in response to the Sources Sought notice.

The Contracting Officer (CO) also conducted several Small Business Dynamic Searches. The CO searched the following combinations: NAICS Code 541990 and th term “radiation”; NAICS code 541990 and rthe term “cancer”; and NAICS Code 541990 and the term “proton” with no results. The results of those searches are part of the market research package.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The CO will consider the independent government estimate and the previous purchase order prices as a determining factor for reasonableness. The CO will also conduct a price analysis. Based on the aforementioned, there is no reason to believe that price will not be fair and reasonable to the Government. A final determination will be conducted prior to the award of any resultant contract.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The NCI program staff obtained knowledge of the technical and scientific market place based on multiple factors. The Program Staff organized meetings of leaders in the field of pediatric radiation oncology in order to understand how patients are selected for proton or photon therapy as well as obtaining information on capabilities for long-term follow up of these patients. NCI program staff also participated in professional scientific meetings that focused on pediatric cancer and types of radiation treatments, read the relevant scientific literature as well as consulted with experts in the field of pediatric radiation oncology. The program staff wrote a commentary on the lack of information on second cancers following pediatric proton therapy (Berrington et al., IJROBP 2017) that attracted a lot of attention in the pediatric proton community because of its timely and important message that a study is needed to determine the risks and benefits associated with proton therapy. Program staff also conducted and published an international survey of proton centers to understand the patterns of proton therapy use in children around the world (Journy et al, Radiotherapy and Oncology, 2018 ).

Based on these sources of market research, the Program staff determined that the PPCR at MGH has the infrastructure in place and sole access to the combined pediatric proton data that is needed by the Government, and was identified as the unique source that will fulfill the Radiation Epidemiology Branch, DCEG, requirements in the SOW.

9. Any other facts supporting the use of other than full and open competition.

Given the accelerating transition from treating pediatric cancer patients with photons to treatment with protons, this study needs to be conducted as soon as possible in order to enroll an adequate number of photon patients. The PPCR at Massachusetts General Hospital has the experience enrolling patients and has the infrastructure in place to start the study immediately without a lot of lead time.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed any interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

NCI will continue to seek new sources of data for both photon and proton. It will treat market research as on ongoing process for future acquistions.