A Prospective U. S. Cohort set within Health Care Systems to Study Cancer
Added: Jul 27, 2017 2:05 pm
The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) focuses on research to discover genetic and environmental determinants of cancer and identifying new approaches to cancer prevention. DCEG plans to build a new prospective multi-center adult cohort study of 150,000-200,000 adult participants enrolled through U.S. Integrated Health Care Systems (IHCS) to study the causes of cancer and the means of its prevention. The goal of this acquisition is to work with selected IHCS sites to recruit health plan members from selected IHCS sites into this complex, intensive, prospective cohort study, to collect serial biospecimens and longitudinal data, and to follow participants for disease outcomes, with a primary focus on cancer.The IHCS sites will work with NCI, other NCI third party contractors (support service and study information technology [IT] platform contractors), processing labs, central repository, various oversight committees, and researchers to recruit health plan members, collect serial biospecimens and longitudinal data, and to follow participants for disease outcomes.The project will require multiple contractors to perform the following:• Provide site-specific estimates as necessary for study planning and implementation purposes e.g. median duration of membership within health plan, estimated number of eligible participants by demographic characteristics, estimated number of projected incident cancer cases, participation rates of screening, number of known and potential cancer precursors by demographic characteristics.• Coordinate and integrate all of the Task Order activities including staffing decisions, prioritizing support for projects, preparing required reports, deliverables and other official documentation, and managing subcontracts. The Contractor shall ensure quality assessment and quality control of the work performed, fostering internal/external communications, tracking projects, and monitoring the budget.• Work cooperatively with the NCI, support services contractor, study IT platform contractor, and other IHCS sites in all relevant aspects of study development and execution to maximize cost-effectiveness and efficiency of the study. Obtain and maintain Institutional Review Board (IRB) approval(s) as necessary.• Use the cohort IT study infrastructure to enter all data related to the study and to manage and coordinate all study activities at the IHCS site.• Develop/customize and maintain the necessary infrastructure to identify and recruit eligible individuals (e.g. develop algorithms, data programs, databases), collect, process and track biospecimens, and follow-up participants (e.g. email).• Serve as the point of contact to health plan members and participants to answer questions for all stages of the study (e.g. host a toll-free telephone line) and contribute information (e.g. for a newsletter or study updates) to be included in study website. Study related questions and issues raised by members and participants should be collated and shared with NCI and third party contractors. This information will be reported to NCI as described in the reporting requirements of the Solicitation. While consent will be obtained electronically and questionnaires will be completed online and both activities will be managed by the NCI and third party contractors, the IHCS site will serve as the point of contact for individuals and participants who would like additional information or have questions related to the study. If a participant leaves the health plan their primary point of contact will be the support services contractor, managed under a separate contract. Responsibility for follow-up activities will also transfer to the support services contractor.• Provide services as necessary to enable electronic submission of standardized data from various data sources such as the EMR to the study IT platform, and expert review of clinical events by IHCS sites. Perform regular routine updates of data as well as for ‘new' data abstraction. All electronic submissions should be fully annotated and deposited in a central repository for future reference.• Collect, process, and transfer biological specimens and data from participants according to SOPs provided by NCI.• Perform administrative, operational, and technical duties to support productive collaboration among the study personnel at all sites, NCI, support services contractor and platform solution contractor.• Participate collaboratively in study committees.• Host one site visit per year or as otherwise required by each Task Order at each IHCS site, attend an annual meeting for all stakeholders, and participate in regular meetings with NCI and third party contractors and consultants as required.• Provide data verification for collaborative publications with the IHCS site investigators, NCI, support services contractor, and platform solution.• Ensure data security and confidentiality requirements are met.• Prepare and submit technical and financial reports.• Adapt and integrate any modifications to study protocol as needed.• Work cooperatively with the NCI, support services contractor, study IT platform contractor, and other IHCS sites in all relevant aspects of study development and execution to maximize cost-effectiveness and efficiency of the study. NCI will prioritize the order of tasks and activities.Specific Task areas include:1. Task Area 1: Study Planning and Preparation. Task Area 1 shall encompass all activities necessary for preparing for participant recruitment, follow-up, and biological specimen and data collections.2. Task Area 2: Pilot Studies. Task Area 2 will include performing a run-in pilot phase for recruitment and data and specimen collection to identify and resolve any barriers to successful implementation of the full study. This task area will also encompass pilot efforts as required for new or additional specimen and data collections.3. Task Area 3: Recruitment, Follow-up and Retention. Task Area 3 will involve full-scale recruitment and follow-up of participants. Eligible health plan members will be invited to participate and enroll; baseline collections will include completion of an online questionnaire and donation of biological samples (including, but not limited to, blood,urine, and an oral sample), and collection of discard clinical samples. This task area will also include activities specific to participant engagement and retention. Task Area 3 shall also encompass development and/or modification and validation of algorithms to abstract exposure, confounder, and disease outcomes data from electronic medical records, administration of online follow-up questionnaire(s), and collection of serial biospecimens.4. Task Area 4: Ancillary Data and Biospecimen Collection. Task Area 4 will involve additional collection of biological specimens and data collection (e.g. physical activity measured by smartphones or wearable devices) and/or ancillary studies on all participants or a subset of participants.5. Task Area 5: Contract Closeout/Transition. Task Area 5 will include all study closeout and transition activities.The Government anticipates awarding a multiple award IDIQ with a base period of ten years. The NAICS Code is 541990.The RFP will be available electronically at a later date and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL, WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFEROR'S RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.
N02CP71009-58 Department of Health and Human Services National Institutes of Health
7/27/17, 2:05 PM