Research Project:
Open Data Sharing for Clinical Food and Nutrition Trials
Brief Summary: Effective January 2023, the U.S. National Institutes of Health will require the open sharing of individual participant-level data from clinical trials supported by public funds. ILSI aims to develop requirements, standards and best practices for managing, tracking and sharing data from clinical food and nutrition trials, with the goal of addressing quality linked to the FAIR (Findable, Accessible, Interoperable, Reusable) attributes of the data. Presented by Michael McBurney.
Rationale and Approach: The U.S. National Institutes of Health is pushing for open sharing of individual participant level data from clinical trials supported by public funds. Researchers with NIH funding will have to submit a Data Management and Sharing Practices (DMSP) and their institutions will have to implement DMSP. To date, a DMSP does not exist. Depositing data in a quality data repository generally improves the FAIR (Findable, Accessible, Interoperable, and Reusableness) of the data. University platforms have not been dependable and are dispersed across unconnected, nonstandard platforms (1-3). An important activity involving a specific open access database was the partnership with USDA in expanding the food composition data base to include branded foods. The USDA Global Branded Food Products Database (Branded Foods) are data from a public-private partnership whose goal is to enhance the open sharing of nutrient data that appear on branded and private label foods and are provided by the food industry (4).
Objectives:
- Review and evaluate attributes of current examples, (EPIC) and (FORCE)
- Develop requirements, standards, and best practices for managing and archiving data including a data sharing template for clinical food and nutrition trials.
- Work toward development of a universal data sharing platform.
- Work with the ILSI federation to determine needs of other regions.
- Work with USDA to determine how to support the USDA Global Branded Food Products Database.
Deliverables:
- Establish the requirements, standards, and best practices for managing, archiving, and sharing data template for clinical food and nutrition studies
- Work with ILSI federation to ensure a universal sharing platform
- Future publication(s), workshop, and presentations/informational work sessions to train and educate
References:
- Waithira, N., et al. (2019) Data management and sharing policy: the first step towards promoting data sharing. BMC Med 17, 80.
- Bezuidenhout, L., et al. (2018) Hidden concerns of sharing research data by low/middle-income country scientists. Glob Bioeth. 29 (1): 39-54. Published 2018 Feb 26.
- Kiley, R., et al. (2018) Data Sharing from Clinical Trials - A Research Funder's Perspective. N Engl J Med. 2017 Nov 16;377(20):1990-1992.
- Keerie, C., et al. (2018) Data sharing in clinical trials – practical guidance on anonymising trial datasets. Trials 19, 25.