The purpose of this Request for Information (RFI, NOT-HG-16-001) is to solicit input regarding future opportunities in clinical sequencing. The National Institutes of Health is seeking input from researchers, academic institutions, professional societies, patient advocacy groups, health practitioners, payers, policymakers, and other stakeholders on strategies for maximizing the impact of a potential future clinical sequencing research program. Comments are invited on any or all of the following areas:
- Ideas for engaging payers, patients, professional societies, regulatory agencies, and policymakers to work with researchers on optimizing the design of future studies, so that outcomes of value to these groups can be measured as part of a potential future clinical sequencing program and used for decision-making by payers and policymakers. Examples of outcomes, scientific questions, or regulatory issues of interest to these stakeholders, approaches to coming to consensus on these outcomes or scientific questions, or ongoing collaborations with researchers, are encouraged.
- Strategies that leverage existing infrastructure for data sharing, e.g., resources such as dbGaP or ClinVar, in combination with additional data resources to facilitate the development of a shared evidence base for clinical decision-making. Additional data resources might include, but are not limited to: types of outcomes, such as health utilization data; descriptions of resources, such as case-level resources tailored to clinical data; or heterogeneous data sources, such as laboratory and pharmacy data. Strategies for individual sites to develop their own model(s), as well as those for which sites can work together to develop common models for sharing, are encouraged.
- Areas broadly related to the integration of genomic sequencing into clinical care in which special emphasis on either an investigator-initiated approach or a consortium-based approach is needed. For the purposes of this RFI, investigator-initiated research should be regarded as research in which the aims are determined by the investigator and carried out independently. Consortium-based research should be regarded as research in which the aims are best accomplished collaboratively among multiple sites, potentially trying diverse approaches and identifying the pros and cons of each, where collective output is more than the sum of its parts. Responses can include a justification for why the proposed area falls under investigator-initiated or consortium-based research and would not likely be adequately addressed without the need for a targeted funding announcement.
- Other issues relevant to National Human Genome Research Institute (NHGRI) desire to maximize the impact of a potential future program in clinical sequencing.
Responses will be accepted through 5:00 pm EST on December 7, 2015, and should be submitted via email to Lucia A. Hindorff.
Please also direct all inquiries to Dr. Hindorff, NHGRI, phone: 240.271.1509, email: hindorffl@mail.nih.gov.