NIH Seeking Information To Help Form Million Member Cohort

Part of the Precision Medicine Initiative is the establishment of a research cohort.  Intended to be a million strong, the voluntary cohort would contribute a breadth of data to help extend the understanding of diseases.

As part of this process the National Institutes of Health (NIH) is seeking information from the public about the cohort.  Comments are due on May 7.  Specific questions the NIH is interested in are:

A. General topics on the development and implementation of this large U.S. cohort.
1) The optimal study design and sample size for a large U.S. precision medicine cohort.
2) Data to be collected at baseline and follow-up, including mode of collection and frequency and length of follow-up.
3) Potential research questions that could be uniquely or more efficiently and effectively pursued in a large U.S. precision medicine cohort.
4) Any other suggestions for NIH to consider in the development and implementation of such a research cohort.

B. Suggestions for existing or potentially new research entities (a health care system, research network, cohort study or consortium, or other entities such as longitudinal studies using digital-based platforms) that might be combined into a large U.S. cohort.  Providing the following information would be useful when suggesting research entities.
1) The capability of the existing or potentially new research entity to efficiently identify and follow 10,000 or more participants who are likely to consent to providing their medical and other health-related data, biospecimens, and genomic data for broad research use, including in sub-group analysis that could help assess various treatment effects and outcomes.  It would also be useful to provide the rationale that potential participants are likely to consent, as well as experience with and ability to participate in central IRB and a master contract agreement to streamline enrollment of the precision medicine cohort.
2) The capability for the research entity to provide individual-level participant data, particularly those from electronic health data (including both electronic health record and payer data), that can be integrated into a standard format to create a combined large longitudinal precision medicine cohort.
3) The capability for the research entity to track and retain the participants for several years of follow up.  The race/ethnic composition, sex, and age distribution of participants from the research entity likely to consent, by standard U.S. Census categories, would also be helpful. The NIH especially seeks information about studies of populations underrepresented in research and those with phenotypes or disorders of high public health and human impact. Additional information that would be of use includes: for health care systems, the current patient turnover rate and efforts that can be made to capture longitudinal data from clinical visits outside of the system and to continue follow participants who leave the system entirely; and for ongoing cohort studies, the retention rate to date.”

This strikes me as uncharted territory, depending on how many recruits can be found to participate in this cohort.  Should it truly be a million strong, there will be new questions that we don’t necessarily have answers for right now.  They include how to manage the study(ies), maintain the anonymity and privacy of the medical information, and simply how to analyze such massive amounts of data.  There’s a lot that can go wrong here, with unclear benefits on the horizon.  Personally, I consider this a risk worth taking.  Hopefully it will be remembered that there are risks involved.

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