MODIFICATION
B -- Quantitative Imaging Biomarkers (QIBs)
- Notice Date
- 4/24/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-SBSS-EB-15-CDB
- Archive Date
- 5/19/2015
- Point of Contact
- Chris Bocus, Phone: 3014027888
- E-Mail Address
-
chris.bocus@nih.gov
(chris.bocus@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under NAICS code 541690 should not submit a response to this notice. 1. Background. Healthcare research and delivery in the modern era of molecular and personalized medicine requires reliable quantification of biomedical imaging data. Achieving reliable extraction of quantitative results from imaging scans requires a standardized approach to data acquisition, process and interpretation. Broad multidisciplinary stakeholder collaboration is needed to achieve cross-industry consensus on and adoption of quantitative imaging biomarkers, and this can only be achieved through a multi-stakeholder coalition supported by an entity recognized and trusted nationally and internationally as objective and balanced. Once achieved, reliable imaging quantification will lead to validation and qualification of imaging biomarkers for use in clinical trials, drug development and clinical decision-making. 2.1 Specification: Acquisition purpose. The molecular bases of health and disease have become increasingly well understood in the past 20 years and suggest that each patient is likely to have a unique combination of genotypic, epigenetic, and phenotypic profiles for their disease. Healthcare delivery is now focused on trying to determine the most appropriate therapy for any patient's molecularly-unique version of disease. This concept is referred to as Precision Medicine, and it has been identified as a national priority, leading to the need for tests that can provide objective, reproducible information for clinical research and practice. Standardization of test performance and implementation will be absolutely essential in order for Precision Medicine to become reality. Imaging biomarkers are of considerable interest in evidence-based clinical decision-making and for therapeutic development. The demand for quantitative results from imaging studies will increase as treatment decisions are driven by such results. Yet there remain substantial barriers to reproducible QI measures in clinical trials and clinical practice. There are several sources of bias and variance in the quantitative results obtained from clinical images. Thus the entire chain involved in producing a clinical image must be approached from a systems engineering perspective. Considerable work is needed to validate specific metrics, improve standardization across vendor platforms, and educate imaging physicians about the reliability of QI. An additional challenge confronting efforts to improve reproducibility in quantitative clinical imaging is the continual state of technological advancement that occurs in medical imaging hardware and software. Thus the quantitative accuracy of medical images has to be continually reassessed and the standardization requirements have to be periodically updated. This continuous, systematic appraisal of accuracy and precision is crucial to maintain confidence in quantitative interpretations. Although there is widespread acceptance of the idea that biomarkers are increasingly important in drug and medical device development as well as in clinical decision-making, there is also broad concern that biomarker evaluation and implementation are not optimal. This concern is manifest in several current government activities including the: • 21ST Century Cures bill, • FDA Request for Comments on Biomarkers, and • Senate white paper "Innovations for Healthier Americans". To be clinically useful and valuable, it is essential that quantitative results from imaging scans be reproducible. Major impediments to reproducibility of QI results are the current differentiation in imaging vendor products and image analysis tools, as well as the independent activities of imaging physicians. Because the process of acquiring a clinical imaging scan is complex, the goal of improved reproducibility requires much coordinated activity among many stakeholders. What is needed is a collaborative organization uniquely poised to convene the relevant stakeholders to address the complex, inter-related issues involved in extracting quantitative results from images. Why is a collaborative approach supported by the Public Sector needed? Efforts by individual manufacturers to establish quantitative imaging parameters as biomarkers are often more costly and time-consuming than the effort needed for traditional device clearance or approval. This is because biomarker validation requires data from clinical trials to demonstrate the imaging biomarker of interest correlates with a meaningful clinical endpoint. Individual companies are constrained by their business model to pursue only activities that can be justified in the short-term with respect to that company alone. Furthermore, individual manufacturers do not commonly address the need for cross-vendor standardization, which would enable a level of clinical effectiveness not currently possible when a given quantitative parameter depends in part on non-biological factors, such as vendor differences. Therefore, the standardization needed to minimize variation in multi-center studies and allow comparability of results from different trials necessitates a cooperative structure. With such standardization in place, it would be possible to perform multiple studies and pursue objectives that would not be feasible for individual sponsors of clinical research alone. Although many stakeholders are interested in this goal, none can accomplish it alone. Appropriate deliverables from the envisioned collaboration of multiple stakeholders would be standards documents, groundwork activities to inform the specifications within those standards documents, test objects (physical and digital) to test some of those specifications, and datasets (image archives) to assess compliance with other specifications. The result of this data-driven, expert-consensus-guided activity would be a set of standardized specifications for image acquisition, collection, post-processing, and analysis. These standards documents should start with an imaging performance Claim stating what will be achieved by complying with the specifications in the document. Claims should focus on a specific clinical application and be written using a statistically rigorous framework and language. Specifications dictate what must be achieved and/or what technical capabilities must be demonstrated in using the imaging device to realize the Claim. There must also be a compliance strategy to allow vendors and users to determine whether equipment manufacturers and other "actors" along the imaging chain are compliant, using required or recommended phantoms (test objects), data sets, software, and other tools. Compliance programs might span a spectrum from self-attestation to formal third-party certifying programs. To develop these standards documents, data relating to bias and variance of the biomarker measurement (referred to as groundwork data) will be extracted from the literature, and gaps in the published data necessary to understand the sources of variability will be noted. These gaps will lead to projects to obtain such missing data. All data created by the consortium shall be made available to the public, either for secondary analyses by other investigators, or to allow others to check and validate the conclusions drawn by the collaborative participants. Thus, the collaborative enterprise constructed to improve the accuracy and precision of QI must be stable and have policies and procedures for periodic updating of standards documents to reflect the emergence both of new data relevant to reducing bias and variability and also the introduction of new, complex technologies. The standards documents should go through a series of maturation phases including a Public Comment phase. When the public comments have been documented and addressed, the document would be in a Publicly Reviewed phase, where it is considered reasonably stable and ready for trial implementation. Why is all this effort necessary? In order to build trust in QIBs: • Vendors must understand and trust the clinical interest/value to implement • Regulators must understand and trust the claim, mechanisms, safety and effectiveness to approve • Imaging Physicians must understand and trust the performance and clinical relevance to use in their findings and conclusions • Payers must understand and trust the patient impact and cost effectiveness to reimburse • Clinicians must understand and trust the meaning and reliability to use QIBs in their clinical decisions The collaboration described here is the necessary forum to address these challenges. The purpose of this Acquisition is to maintain the multi-stakeholder coalition already developed to achieve cross-industry consensus on and adoption of QIBs. The coalition must be supported by an entity recognized and trusted nationally and internationally as objective and balanced. Achieving reliable extraction of quantitative results from imaging scans requires both scientific understanding of the sources of bias and variance and multidisciplinary consensus around how best to minimize and compensate for such sources. Broad multidisciplinary stakeholder collaboration is needed to establish standardized approaches to data acquisition, process and interpretation. Once achieved, reliable imaging quantification will lead to validation and qualification of imaging biomarkers for use in clinical trials, drug development and clinical decision-making. The required activities are not well-supported by traditional NIH grant award processes, and, therefore, this contract mechanism is needed.   2.2 Statement of Objectives (SOO) 2.2.1 Objective 1. Create and disseminate new Protocols and QIB Profiles each year that address diseases of significant burden to the US population. 2.2.2 Objective 2. Perform field tests and revise existing QIB Profiles as needed. 2.2.3 Objective 3. Perform individual groundwork data collection and analysis projects to fill gaps identified during work developing QIB Profiles covering the four major imaging modalities, CT, MRI, radionuclides and ultrasound. 2.2.4 Objective 4. Develop and employ physical and/or virtual (digital) reference objects needed for assessment of imaging biomarker variability and/or to demonstrate compliance with QIB Profiles. 2.2.5 Objective 5. Develop procedures and processes for hardware and software manufacturers and users to demonstrate compliance with QIB Profiles. 2.2.6 Objective 6. Collect images and associated data for a quantitative imaging data warehouse or other public data repositories, and perform analyses on the data to serve QIB committees and the broader imaging community. 2.2.7 Objective 7. Provide support for the QIB Collaboration program staff, Key Personnel, project management, meetings, travel, and conference calls. 2.3 Performance Work Statement (PWS) 2.3.1 Objective 1. Create and disseminate new Protocols and QIB Profiles each year that address diseases of significant burden to the US population. The following are likely candidates: 2.3.1.1 CT volumetry Profile for lung masses smaller than 10 mm 2.3.1.2 CT volumetry Profile for hepatic masses and lymphatic metastases 2.3.1.3 CT densitometry Profile for COPD 2.3.1.4 fMRI Profile for pre-operative evaluation 2.3.1.5 ADC measurement (DW-MR) Profile for tumor detection and treatment monitoring 2.3.1.6 Ultrasound shear wave speed (SWS) measurement Profile for fatty/fibrotic liver infiltration assessment 2.3.1.7 PET-amyloid Profile for brain imaging 2.3.1.8 MR diffusion tensor Imaging (DTI) Profile for brain imaging 2.3.1.9 MR elastography (MRE) Profile for liver evaluation 2.3.2 Objective 2. Perform field tests and revise existing QIB Profiles as needed. The following are likely candidates: 2.3.2.1 Extend the DCE-MRI Profile to incorporate the following: 3.0T field strength specific issues, effects of parallel imaging, effects of B1 inhomogeneity and coil sensitivity corrections 2.3.2.2 Revise the advanced lung cancer CT volumetry QIBs Profile 2.3.2.3 Revise the FDG-PET SUV Profile 2.3.2.4 Perform field test of CT volumetry Profile 2.3.2.5 Perform field test of FDG-PET SUV Profile 2.3.2.6 Complete field test of DCE-MRI Profile (ACRIN 6701 clinical trial) 2.3.2.7 Complete field test of DW-MR Profile for liver (IMI/EORTC clinical trial) 2.3.2.8 Complete field test of DW-MR Profile for brain (São Paulo clinical study) 2.3.2.9 Perform field test of fMRI profile using digital phantoms at multiple sites. 2.3.3 Objective 3. Perform individual groundwork data collection and analysis projects to fill gaps identified during work developing QIB Profiles covering the four major imaging modalities, CT, MRI, radionuclides and ultrasound. The following tasks are examples: 2.3.3.1 For CT-volumetry: Using scans of liver phantom with lesions inserted, assess algorithm performance. 2.3.3.2 For CT-volumetry: Using hybrid clinical data sets of lung and liver (with synthetic lesions inserted), assess algorithm performance. 2.3.3.3 For DW-MR, Collect phantom groundwork data for precision 2.3.3.4 For fMRI: Continue to develop and test digital phantoms to refine the fMRI Claims and release the first fMRI profile. 2.3.3.5 For the PET-Amyloid Profile: perform meta-analysis of reported precision data. 2.3.3.6 For SWS Ultrasound Profile: Complete and scan physical phantoms for bias and precision. 2.3.3.7 For SWS Ultrasound Profile: Complete clinical data collection and analysis. 2.3.3.8 For COPD Profile: Harmonize reproducibility of lung density and airway size measures across different CT scanner platforms through experiments in phantoms. 2.3.3.9 For COPD Profile: Use existing test data sets from the National Lung Screening Trial (NSLT) and COPD gene studies to test best approaches for volume adjustment using pulmonary function testing as a gold standard. 2.3.3.10 For COPD Profile: Use phantom, NLST and COPD gene data to examine the consequences of dose and slice thickness on lung density measurements and develop a model to correct for systematic errors in density between scans acquired at higher dose (100-200 mAs) vs. lower dose (~50 mAs). 2.3.4 Objective 4. Develop and employ physical and/or virtual (digital) reference objects needed for assessment of imaging biomarker variability and/or to demonstrate compliance with QIB Profiles. The following tasks are examples: 2.3.4.1 For the PET-Amyloid Profile, construct complementary physical and digital phantoms. 2.3.4.2 For the MRE Profile, determine the appropriate phantom to harmonize results from MRE and SWS measurements. 2.3.5 Objective 5. Develop procedures and processes for hardware and software manufacturers and users to demonstrate compliance with QIB Profiles. The following are example projects: 2.3.5.1 Complete compliance checklists for CT volumetry, FDG-PET and DCE-MRI Profiles. 2.3.5.2 Develop and test a self-attestation compliance program. 2.3.5.3 Test algorithm comparison software systems to determine most suitable infrastructure for future compliance program use. 2.3.5.4 Discuss options for integrating QIB compliance into existing accreditation programs run by various professional organizations. 2.3.5.5 Develop compliance guidelines for fMRI software manufacturers to test their products using fMRI digital reference phantoms on the QIDW. 2.3.6 Objective 6. Collect images and associated data for a quantitative imaging data warehouse or other public data repositories, and perform analyses on the data to serve QIB committees and the broader imaging community. The following are likely candidates: 2.3.6.1 Make available to the imaging community image data from all QIBs physical and digital reference objects (phantoms), and phantom analysis algorithms. 2.3.6.2 Solicit clinical trial images and associated clinical data from pharmaceutical companies and cooperative clinical trial groups. 2.3.7 Objective 7. Provide support for QIB Collaboration program staff, Key Personnel, project management, meetings, travel, and conference calls. 2.3.7.1 Project Management: Implement and oversee QIB project-funding-request applications, review and selection processes. Create and maintain tracking process for all selected projects/subcontracts Solicit and consolidate information/data from QIB committees to support online, semi-annual and annual government reporting 2.3.7.2 Conference Call support: Schedule calls, disseminate information, and prepare meeting materials and summaries for the teleconference meetings of all of the QIB collaboration committees 2.3.7.3 Communications Create and update collaboration Web and Wiki pages, rosters, and governance documents. Produce QIB collaboration Newsletter 2.3.7.4 In-person Meeting Support Procure meeting space and negotiate contracts for services. Create registration mechanisms for all in-person meetings of the QIB collaboration. Provide logistical support for speakers and attendees, including travel and hotel arrangements, and onsite support. Create and maintain meeting Websites. 2.3.7.5 Quantitative imaging data warehouse. Coordinate and manage support and operation of the image archive. Implement and monitor application and review processes for upload and access to data Coordinate and assist with curation of data Scope and Requirements: The contractor shall supply all labor, materials, facilities, equipment, and supplies to perform the task outlined in the Performance Work Statement (PWS). Scope of Work: As an independent contractor and not as a Government employee or representative, the Contractor will perform the tasks and/or projects necessary to (1) implement a validated model for QIB development to meet the requirements of clinical trials, and (2) following the model, develop and disseminate QIB Profiles for imaging biomarkers in active clinical trials and/or clinical practice. It is anticipated that actual projects to be funded will be selected by the QIB Steering Committee. In addition, the Contractor shall continue to manage a coordinated process structured to meet the scientific needs for QIBs, thereby enabling users and developers of healthcare imaging technology to achieve reproducible and accurate quantitative imaging results through the precise definition of clinical contexts, delineation of standards-based equipment specifications and protocol designs, and the conformance testing of systems to determine they adhere to the specifications. The Contractor shall determine the methodology to be followed, the specific work plan, and the administrative management requirements for performing these tasks and projects. The work plan shall address imaging biomarkers in those areas already under development and/or identified as high priority by the broad, inclusive membership of the QIB consortium. The Contractor shall submit the proposed methodology and work plan(s) according to the Schedule of Deliverables shown below. QIBs deliverable report: a.) Proposed Project Methodology; b.) Preliminary Workplan; and c.) Ad hoc Reports Proposed Project Methodology: The proposed project methodology should be detailed enough to answer such questions as the following: - How will the Contractor develop a process for relating biomarkers to disease areas, setting the clinical context, and identifying and prioritizing what biomarker to pursue; - How will the Contractor identify and/or develop a coordinated model for quantitative imaging biomarker development, including the structure and operation of the QIBs infrastructure; - What are the potential solutions for error mitigation in imaging biomarker measurements such as PET-amyloid for brain imaging, Ultrasound shear wave speed (SWS) and/or MR elastography (MRE) for liver imaging, fMRI for pre-operative evaluation, and DW-MRI for tumor treatment response; - How will the Contractor develop methodology or a paradigm that can be used to test hypotheses about the technical feasibility and medical value of these imaging biomarkers; - How will the QIBs profiles' efficacy be assessed by vendors and researchers; and - How will the QIBs solutions be disseminated? Preliminary workplan: For the purposes of this deliverable, the Contractor should excerpt this portion of the proposal, retitle it as Preliminary Workplan, and submit as a separate document for the COTR's review. We expect the preliminary workplan to be the same for all Biomarkers; however, in cases where the workplan differs substantially for a particular Biomarker, this Biomarker's workplan should be addressed in a more specific manner. This document should be organized so that there is an index identifying the overall workplan, the specifics for each Biomarker that will be developed differently, and a proposed timeline for achieving project goals and milestones. Ad hoc Reports: By their very nature, Ad hoc reports are not known in advance and would be related to a particular issue that might be of significant interest. It is envisioned that NIBIB would ask the Contractor to provide brief reports in defined formats (normally narrative with limited graphics) that would address such issues as: - What are the scientific highlights achieved in a particular period, such as for a periodic report to the Congress or to the National Advisory Council; - If a particular biomarker, in the process of assessing its efficacy, is found to be remarkable such that it needs extremely wide information dissemination in a very fast manner, a report might be requested to provide the noteworthy facts and scientific results for media release purposes; or - Another reportable situation might arise if there were a major disagreement within the QIBs infrastructure that could impact the outcome of the entire project. Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each project requirement separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The capability statement must not exceed 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Chris Bocus, Contract Specialist, at chris.bocus@nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by 12:00 PM EST, May 4, 2015 in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate approximately one (1) firm-fixed price contract, for a period of twenty four (24) months with an approximate award date of September 15, 2015. Original Point of Contact Chris Bocus, Contracting Specialist, COAC Service Branch, Phone (301) 402-7888, Fax (301) 480-3338, Email: chris.bocus@nih.gov. Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6701 Rockledge Drive RKL2/6207 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES
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