FBO_Posting_-_preSol_-_NOI.docx

General Information

Short Title: Using Existing Clinical Data to Conduct Large-Scale Research on Treatment Pathways and The Impact of Variations in These Pathways on Outcomes in Cancer Patients: A Feasibility Study Solicitation Number: N02PC72590-88

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E638, Bethesda, MD 20892, UNITED STATES

Description

National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS), plans to procure on a sole source basis services related to a study that will determine the feasibility of using existing clinical data to conduct large-scale research on treatment pathways and the impact of variations in these pathways on outcomes in cancer patients, from the Department of Biomedical Informatics, Columbia University Medical Center, New York, NY 10032.

This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1), using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 541990 and the business size standard is $15 million.

Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract.

The period of performance will be 12 months from the date of award.

It has been determined there are no opportunities to acquire green products or services for this procurement.

The Division of Cancer Control and Population Sciences (DCCPS) is a research program of the National Cancer Institute (NCI), one of the National Institutes of Health (NIH). DCCPS aims to reduce cancer risk, incidence, and death and enhance quality of life for cancer survivors by supporting innovative research and recommending ways to apply that research in quality health care delivery. This research generates basic knowledge about how to monitor and change individual and collective behavior, and to ensure that knowledge is translated into practice and policy rapidly, effectively, and efficiently

The purpose of this contract is to understand the feasibility of conducting large-scale research on treatment pathways using data already collected for delivering care to cancer patients. It is important to understand the sequence of treatments in cancer patients, and the impact on outcomes due to variations in the sequence of these treatments across the U.S. so that NCI can support research to improve patient outcomes. The recent, and near-universal, adoption of electronic health records (EHRs) by hospitals and clinics has made it feasible to use informatics tools to extract data from EHRs, and to link EHR-based data with other databases such as diagnostic, pharmacy and administrative claims. However, it is challenging to link data from EHRs used by different hospitals and clinics due to the tremendous variations in the collection, coding and storage of data across these sites. It is an additional challenge to link data from EHRs to data generated for billing purposes such as for Medicare, Medicaid, and private insurers. Very few data networks have succeeded in creating data linkages across these diverse databases to conduct care delivery research on a large scale. Only one network has demonstrated the ability to conduct large-scale studies on treatment pathways over the course of three years of treatment since diagnosis of a disease, and the variations in the sequence of treatments.

The project has two aims.

Aim 1. Understand the sequence of treatments in cancer patients with diabetes, depression or high blood pressure. The work done under this aim will assemble U.S.-based treatment cohorts of cancer patients with diabetes, depression, or high blood pressure; understand the sequence of treatments in these patients, and assess the geographic variations in these pathways, if there are adequate number of patients to do this analysis.

Aim 2. Understand the feasibility of using existing data infrastructure to conduct cancer treatment and outcomes research. The work done under this aim will clarify the feasibility of using existing data infrastructure to conduct research on cancer treatment pathways, and the impact of treatment variations on outcomes of cancer patients. The work will include assessment of available diagnostic data to assemble cohorts of cancer subtypes, assess the ability to study diagnostic pathways, assess the availability of detailed information on medical, radiological and chemotherapies, ascertain the outcomes that can be analyzed for cancer patients during their cancer care continuum, and to clarify the data infrastructure enhancement needed to overcome limitations in existing data infrastructure.

Contractor Requirements - The Contractor shall conduct the following tasks:

Aim 1:

1. Assemble treatment cohorts of cancer patients in the U.S. with diabetes, depression and high blood pressure.

a) Identify patients with a cancer and with a new diagnosis of diabetes, depression or high blood pressure.

b) Identify the treatments given to the cancer patient to treat their co-morbid condition (diabetes, depression or high blood pressure) for three years after initial diagnosis.

c) Describe the sequence of treatments over the three years for each co-morbid condition.

1. Descriptively summarize the cancers and co-morbidities observed in these cohorts.

a) Describe the types of cancer and numbers of each cancer type.

b) Summarize the number of patients with a co-morbidity within each type of cancer.

1. Create a visualization and a report on the treatment pathways in these treatment cohorts analogous to the Hripcsak et. al. paper published in PNAS in 2016. This will include sunburst displays, graphs, and tables.

1. Assess the geographic variation in the treatment pathways, if there are adequate number of patients in the treatment cohorts to do so.

1. Post the data extraction and analytic algorithms for this aim on a public website owned and operated by the contractor.

1. Present the results to the National Cancer Institute.

Aim 2:

1. Assess the availability of diagnostic data to assemble cohorts of cancer subtypes, and tally the number of patients, geographic variations in distribution of cancer patients (as feasible), the extent of demographic data on patients, and the types of diagnostic data.

1. Assess the availability of temporal information about diagnostic data to understand cancer diagnostic pathways.

1. Assess the availability of information about cancer treatments and our ability to understand the sequence of such treatments. This will include chemotherapy and related medical therapies, radiation therapy and surgical therapy.

1. Characterize what steps in the cancer care continuum are covered by The Observational Health Data Sciences and Informatics (OHDSI) databases: diagnosis, initial treatment, survivorship, relapse, and palliative care.

1. Characterize the types of outcomes that can be assessed in the OHDSI databases.

1. Generate a list of types of research questions that can be answered by OHDSI as it exists today.

1. Describe what enhancements would be needed to answer additional questions.

1. Present the results to the National Cancer Institute.

Deliverables - The contractor shall deliver the following items:

The acquisition is key to help NCI understand how to harness the emerging science of “big data” to the large and diverse data collected during the delivery of cancer care to conduct large-scale research on variations in cancer treatment and their outcomes. This acquisition will also help NCI understand the limitations of existing data infrastructures and analytic methods used to extract information from existing data, which will help guide future investments to improve our nation’s data infrastructure and methods to conduct large-scale cancer delivery research.

The OHDSI collaborative is the first research network to conduct and publish research done on an unprecedented scale by analyzing data from over 250 million patients. This research was made possible by the collective effort, over several years, of more than 100 researchers to map data from more than 50 different databases, including EHRs and claims-based databases, to a single common data model, which was created by OHDSI. Another unique feature of OHDSI is its commitment to open science; it publishes its protocols and software codes on a public website, which improves the transparency and reproducibility of research. The power of OHDSI’s approach was demonstrated in a paper published in 2016 in the PNAS. This paper described the extent of variations in the sequence of treatments, given over three years, to patients with diabetes, depression or high blood pressure by analyzing information from over 250 million patients in four countries, including the U.S.

OHDSI has data from more than 140 million U.S. patients, which is most of the U.S. patient population. Therefore, this network is expected to have data on most of the U.S. cancer patients. No network, including OHDSI, has conducted a large-scale analysis of treatment variations in cancer patients. This acquisition will help NCI understand the feasibility of conducting such research using existing data infrastructure and analytic methods, and the limitations of the infrastructure and existing methods. This knowledge will shape future, competitive funding opportunities to improve our nation’s data infrastructure and methods to conduct large-scale cancer delivery research. OHDSI is the largest source of data of its kind, and the investigators that administer it are the only ones to conduct and publish a study in the manner that NCI is seeking.

Staff at the University of Columbia were first to perform a study that showed the feasibility of doing very large scale observational research on treatment patterns. NCI investigators require that this procurement coincide with the progress demonstrated in that previous work.

This notice is not a request for competitive quotation. However, if any responsible source, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, 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 NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3:00 PM EST, on July 13, 2017. All responses and questions must be in writing and faxed 240-276-5401or emailed to Chad Shearer, Contract Specialist, via electronic mail at chad.shearer@nih.gov. 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. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Awards Management website (sam.gov). Reference: N02PC72590-88 on all correspondence.