Quantitative Imaging Biomarkers (QIBs)
Department of Health and Human Services, National Institutes of Health | Published May 28, 2015
The National Heart, Lung and Blood Institute (NHLBI) on behalf of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is seeking qualified sources to perform a follow up to the efforts of the Quantitative Imaging Biomarkers Alliance (QIBA). The purpose of this announcement is to provide a Presolicitation Notice for the release of Solicitation HHS-NIH-NHLBI-CSB-EB-2015-138-CDB. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION.
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. The purpose of this acquisition is to maintain the multi-stakeholder coalition already developed to achieve cross-industry consensus on and adoption of Quantitative Imaging Biomarkers (QIBs). The coalition must be supported by an entity recognized and trusted nationally and internationally as objective and balanced.
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 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 Quantitative Imaging (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.
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.
The QIBs project is expected to fulfill the following:
• Create and disseminate new Protocols and QIB Profiles each year that address diseases of significant burden to the US population.
• Perform field tests and revise existing QIB Profiles as needed.
• 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.
• 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.
• Develop procedures and processes for hardware and software manufacturers and users to demonstrate compliance with QIB Profiles.
• Collect images and associated data for a QI data warehouse or other public data repositories, and perform analyses on the data to serve QIB committees and the broader imaging community.
• Provide support for the QIB Collaboration program staff, Key Personnel, project management, meetings, travel, and conference calls.
This is not a Request for Proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. This advertisement does not commit the Government to award a contract.
The RFP will be available on the FedBizOpps Web page at http://www.fedbizopps.gov. Prospective offerors are responsible for downloading the RFP and all attachments. The offeror is responsible for monitoring the FedBizOpps Web page for the release of the solicitation and any amendments. The RFP will be available from the FedBizOpps on or about June 12, 2015.