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BePRECISE Consortium Publishes Checklist for Reporting Precision Medicine Research Findings

NEW YORK – A consortium of experts in precision medicine, cardiometabolic diseases, and statistics, and patient advocates on Friday released guidelines for reporting research findings that they hope will improve patients' access to precision medicines around the world.

The inaugural guidelines, published in Nature Medicine, were developed by the BePRECISE consortium, which stands for Better Precision-data Reporting of Evidence from Clinical Intervention Studies & Epidemiology. The consortium comprises members from low-, middle-, and high-income countries.

In issuing these guidelines, the consortium aims to promote transparency, accuracy, safety, and equity in precision medicine and establish standards that allow the field to better compare the findings from different precision medicine studies. "Precision medicine seeks to tailor healthcare to individual characteristics, accounting for the heterogeneous nature of diseases," Paul Franks, a professor at Lund University in Sweden and chair of the guidelines committee, said in a statement. "However, this heterogeneity, combined with varied research methodologies, has created challenges in comparing studies and implementing findings across the field."

The Nature Medicine paper includes a 23-item checklist of topics that investigators should address in the five sections typically included in a peer-reviewed scientific publication — title and abstract, background on the reason for the research and the objectives investigators hope to achieve, methods used to conduct the study, results, and a discussion of the relevance of the findings to the field. 

For example, the consortium recommends researchers describe in the title and abstract if the study relates to prevention, diagnostics, treatment, or prognostics, and describe the population or subgroup that's the focus of the analysis. And in the methods section, the consortium recommends investigators provide a rationale for why they chose to track the impact of a treatment on certain outcomes and define any biomarkers, molecular markers, and clinical characteristics, as well as societal, economic, geographic, and cultural factors they used to stratify patients or predict outcomes for a subgroup. 

The consortium also advises investigators to incorporate information in their publications on health equity. The consortium tells investigators to pay special attention to groups that are under-represented in precision medicine research or underserved by health services, and describe the impact of including or excluding these people in their research. Within the checklist, "a specific section about health equity serves to encourage precision medicine research to be inclusive of individuals and communities that are traditionally under-represented in clinical research and/or underserved by health systems," the authors led by Franks wrote in their paper.

Michèle Ramsay, director of the Sydney Brenner Institute for Molecular Bioscience (SBIMB) at the University of the Witwatersrand in Johannesburg, South Africa, and member of the BePRECISE consortium, in a statement highlighted the importance of including people of African ancestry in precision medicine research. SBIMB is part of a broader effort to create an African genomics research hub with the capability to analyze large genome, transcriptome, and epigenomic datasets, which, in turn, would support development of precision medicines for people in Africa.

"Africa and its people will contribute to global solutions in the field of precision medicine by virtue of their unique genetic diversity and challenging environments. They should not be left behind, but potential benefit will require generating and sharing research data and reporting outcomes according to international best practices," Ramsay said. "The BePRECISE checklist is an important tool to ensure that research studies can be compared, and similarities and differences accurately evaluated, to avoid a one-size-fits-all misfit for African populations."