Fast-Track proposals will be accepted. Direct-to-Phase II proposals will be accepted. Number of anticipated awards: 3-5 Budget (total costs, per award): Phase I: up to $400,000 for up to 12 months Phase II: up to $2,000,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary There is an urgent need to spur innovation in developing unbiased medical technologies to reduce disparities in cancer outcomes. Structural inequalities in health and medicine, including in cancer control, have garnered the attention of leading clinicians, researchers, and journals. One insidious symptom of, and contributor to, structural inequalities in cancer outcomes is biased medical technology. For example, existing pulse oximeters overestimate oxygen saturation when used by people with darker skin, and particularly women of color. This is consequential for cancer, given that pulse oximeters are an important prognostic tool for lung cancer. Similarly, Black, Indigenous, or other People of Color (BIPOC) individuals are at risk of getting inaccurate readings from smartwatches and fitness trackers that monitor heartbeat, due to increasing inaccuracy in darker skin. This is consequential for cancer because activity guidelines for cancer prevention recommend the use of heart rate monitors. Algorithms and machine learning-informed artificial intelligence (AI) used to guide clinical cancer decisions are often adjusted for race/ethnicity (with no explanation or explanations based on outdated/biased data); such algorithms guide decisions in ways that direct greater resources to white patients, compared to BIPOC patients. Similarly, computer-aided cancer diagnostic tools (e.g., for medical imaging) may be biased because the datasets they are developed on are imbalanced with respect to race/gender. If underlying data informing algorithms, AI, and imaging reflect structural inequalities, these will perpetuate bias and widen existing cancer disparities. As such, there is a critical need to develop unbiased medical technologies to improve cancer disparities. Project Goals The goal is to create scalable health IT-based informatics tools that measure care coordination in order to assess and improve quality of care and patient outcomes, assist the ongoing healthcare delivery system transformation and improve research efficiency. The tools will help managers and clinical teams realistically assess the effectiveness of existing care coordination and patient engagement processes and help identify areas for improvement, which will help their efforts to transform delivery systems to meet the triple aim objectives of improving patient experience, improving population health and reducing costs. The researchers will gain access to tools that measure the variability in cancer care coordination and patient engagement in diverse settings, which will help identify the characteristics of clinical teams, processes and health systems associated with delivery of high-quality care and to test interventions based on these characteristics. Proposals should identify existing, racially/ethnically biased medical technologies integral to cancer prevention and control; identify the mechanisms contributing to such bias (e.g., targeted development and testing, inability to work effectively with a variety of skin tones, biased data inputs or outcome measurements); and develop new, unbiased replacement technologies. Potentially biased technologies could be identified in the existing literature or by the applicant. Activities that fall within the scope of this solicitation include development of unbiased medical technologies to replace existing bias in technologies that contribute to disparities in cancer control outcomes. Proposals should target existing technologies integral to cancer control and with demonstrated bias, including (but not limited to): pulse oximeters or other measures of blood oxygen to be used at home or in clinical settings; heart rate monitors to be used at home to guide appropriate intensity exercise for weight loss and maintenance; and algorithms and artificial intelligence (AI) designed to inform clinician decision making individualized to the patient, such as those used for diagnosis, prognostic prediction, distribution of medical resources, and assessment of patient-reported outcomes (including pain). Projects could also involve integration of large biomedical data sets containing genomic, proteomic, histological, and clinical information to develop Page 73 new technologies or algorithms, as prioritized in the Cancer Moonshot Blue Ribbon Panel. Activities can involve the development of any medical technology that could complement or replace existing, racially/ethnically biased technologies that are widely employed in the medical care system or recommended for at home use. Phase I Activities and Deliverables: • Establish a project team including personnel with training and research experience in the specific type of medical technology targeted, knowledge of the relevant area of cancer prevention and control, and expertise in structural inequalities/health disparities; • Provide a report including a detailed description and/ or documentation of: o Existing racial/ethnic bias in the targeted medical technology; o The role of such biased technology in perpetuating or exacerbating disparities in cancer prevention and control; o Potential mechanisms underlying biases in the target medical technology; o Description of the technical strategy that would be used to correct the bias in the existing technology or develop a new technology that could replace the cancer prevention and control function of the target biased technology; o Analysis of the cost-effectiveness and ability to disseminate/ implement/ integrate technology into standard cancer prevention and control practices or healthcare settings; o A detailed plan of methods that will be used to validate and evaluate the acceptability of the new technology in performing requisite cancer prevention and control strategies among the racial/ ethnic group for whom the initially targeted technology produced biased results; o A detailed plan of methods that will be used to validate and evaluate the efficacy of the new technology in performing requisite cancer prevention and control strategies among the racial/ ethnic group for whom the initially targeted technology produced biased results; o A detailed plan of methods that will be used to examine the reliability of the new technology in performing requisite cancer prevention and control strategies among the racial/ ethnic group for whom the initially targeted technology produced biased results across time; o A plan for marketing and distribution of the novel medical technology after it has passed cost-effectiveness and efficacy/ acceptability tests described above; o Any original data collected to demonstrate the bias in the target technology; and o A list of all references and research informing the description and documentation outlined above. • Develop a functional prototype of the newly developed technology; • Provide preliminary evidence for potential efficacy for newly developed technology in reducing or eliminating bias; Phase II Activities and Deliverables: • Evaluate and document cost of and time to development of technology, compared to the existing biased technology; • Scale the production of the technology, if necessary, to accommodate efficacy/acceptability research as described in the plan requested above; • Conduct studies of acceptability, efficacy, and reliability, based on the detailed methodological plan outlined as described above; • Prepare a report describing the cost-effectiveness and acceptability/efficacy/reliability findings; • Execute marketing and dissemination/ implementation plan; • In the first year of the contract, provide the program and contract officers with a letter(s) of commercial interest; and • In the second year of the contract, provide the program and contract officers with a letter(s) of commercial commitment.