A consortium of experts in precision medicine, cardiometabolic diseases, and statistics, alongside patient advocates, has released new guidelines aimed at enhancing patient access to precision medicines worldwide. Published in Nature Medicine, these guidelines were developed by the BePRECISE consortium (Better Precision-data Reporting of Evidence from Clinical Intervention Studies & Epidemiology), which includes members from various income-level countries.
The guidelines emphasize transparency, accuracy, safety, and equity in precision medicine, establishing standards to better compare findings across different studies. Paul Franks, a professor at Lund University in Sweden and chair of the guidelines committee, highlighted the challenges posed by the heterogeneity of diseases and varied research methodologies in precision medicine. He emphasized the need for standardized reporting to facilitate comparison and implementation of research findings.
The guidelines include a 23-item checklist addressing key sections of scientific publications: title and abstract, background, methods, results, and discussion. Researchers are advised to specify if the study involves prevention, diagnostics, treatment, or prognostics, and to detail the population or subgroup analyzed. The methods section should explain the rationale for tracking certain outcomes, and define biomarkers, molecular markers, and clinical characteristics, as well as societal, economic, geographic, and cultural factors used for patient stratification or outcome prediction.
A significant focus of the guidelines is on health equity. Researchers are urged to consider under-represented and underserved groups in their studies and to discuss the impact of their inclusion or exclusion. The checklist includes a specific section on health equity to ensure inclusivity in precision medicine research.
Michèle Ramsay, director of the Sydney Brenner Institute for Molecular Bioscience at the University of the Witwatersrand in South Africa and consortium member, stressed the importance of including African ancestry in precision medicine research. She highlighted Africa's unique genetic diversity and challenging environments as valuable contributions to global precision medicine solutions. Ramsay noted that the BePRECISE checklist is crucial for generating and sharing research data, ensuring studies can be accurately compared, and avoiding a one-size-fits-all approach that may not suit African populations.