Date Submitted: June-2024
Authors: Anastasios Moresis and Eoin C. O’Connor c/o F. Hoffmann-La Roche, Basel, Switzerland.
Idea Originators (and Companies): See https://www.nature.com/articles/s41684-024-01335-0
Other supporting Individuals/Companies : Stefano Gaburro – Tecniplast S.p.A., Italy
Problem Statement
In the field of biomedical in vivo research, data sharing and repurposing are not commonly practised. One critical element for enabling data sharing and repurposing is the provision of metadata that well describes the raw or primary data. However, there is currently no established minimal metadata set (MNMS) that can be used in a domain-agnostic way across various biomedical research fields. Solving this problem could bring new scientific insights, enable opportunities to reduce or replace animal experimentation through data reuse and the generation of virtual control groups, and bring gains in research efficiencies.
Idea Proposal and Value Proposition:
To address the problem of non-harmonized, non-standardized data sources that prohibit repurposing of biomedical research data from animal studies, we propose a minimal metadata set (MNMS) designed to enable the repurposing of in vivo data. MNMS would align with existing validated guidelines for reporting in vivo data (e.g. ARRIVE 2.0) and would contribute to making in vivo data FAIR-compliant.
An effective solution could positively impact multiple stakeholders across academia, pharmaceutical and contract research sectors and regulatory bodies, in the following ways:
- Enhanced Data Sharing & generation of Virtual Control Groups: The use of Virtual control groups, made possible through data sharing and repositories that follow MNMS guidelines, can benefit various stakeholders by providing a robust framework for comparative studies. This approach has been demonstrated in projects like the IMI eTRANSAFE, which collected extensive preclinical drug safety and toxicology
data. - Incremental Knowledge: A standardised MNMS would facilitate data sharing and repurposing, leading to new insights and discoveries by enabling researchers to
effectively interrogate and utilise existing data sets, such as in the context of meta-
analyses. - Ethical Use of Animals: By promoting data sharing and reuse, MNMS helps advance the ethical use of animals in research. This is particularly important in ensuring that the maximum scientific value is obtained from each animal study, thereby justifying their use.
- Operational Efficiency: A well-defined MNMS can streamline data management processes, reduce administrative burdens on researchers, and ensure high-quality data reporting.
Collectively, we believe the MNMS approach brings greater transparency, accountability and helps to address concerns about reproducibility of animal research. Ultimately, if used effectively and at scale, MNMS would result in more efficient and ethical research practices,concomitant with significant time and cost savings.
Targeted Outputs
Key deliverables from this project are likely to include:
- Tools and Infrastructure Development:
– Joint development of tools to support integration with existing data infrastructure.
– Creation of new documentation and materials to support uptake of MNMS.
- Policy and Frameworks:
– Harmonisation of terminologies and controlled vocabularies to support MNMS adoption.
– Development of comprehensive legal frameworks and policies for data sharing across multiple industries.
- Pilot Projects and Validation:
– Performing pilot experiments to demonstrate the utility of MNMS in common settings, potentially result in joint publications or consensus statements by involved collaborators.
Critical Success Factors
Several factors are anticipated to be important to ensure the idea is successful:
- Harmonisation of Terminologies and Controlled Vocabularies:
Aligning MNMS with existing terminologies, controlled vocabularies, and ontologies is essential. This harmonisation will facilitate the adoption of MNMS by key stakeholders, including companies providing scientific research equipment and software. - Stakeholder Engagement and Collaboration:
Engaging primary stakeholders (scientists, regulatory bodies, and statisticians) through co-creation and community-consensus processes, will help refine and validate MNMS. This collaborative approach ensures that the MNMS meets the needs of diverse research fields. - Policy and Legal Frameworks:
Developing and refining legal frameworks and policies to support data sharing across multiple industries is necessary. This includes joint development of tools for data integration and alignment with existing 3Rs initiatives and regulatory requirements. - Education and Training:
Providing comprehensive documentation and educational materials for non-technical users is crucial. This includes training on how to integrate MNMS into existing workflows and demonstrating its utility through pilot experiments - Incentives for use:
To ensure the successful adoption and implementation of a Minimal Metadata Set (MNMS) in biomedical research, it is crucial to establish incentives that encourage researchers and institutions to embrace this framework.
Why this is a good idea / Why Now
The adoption of a Minimal Metadata Set (MNMS) in biomedical research is particularly
timely and beneficial for several reasons:
- Advancements in Data-Rich Technologies
Biomedical research is currently experiencing a surge in data-rich technologies that can be rapidly deployed at relatively low costs. However, without effective tools to reintegrate the vast quantities of data generated into the research cycle, there is a risk of massive resource inefficiency with minimal scientific gain. MNMS provides a structured framework to describe raw data effectively, facilitating its reuse and integration into new research efforts - Enhancing Reproducibility and Transparency
Reproducibility is a significant challenge in biomedical research. MNMS builds upon existing guidelines like PREPARE and ARRIVE to increase transparency in data generation andreporting. Transparent reporting of methodology and data is a fundamental step for
enabling and ensuring reproducibility. By adopting MNMS, researchers can ensure that their studies are more transparent and reproducible, which is crucial for scientific progress - Ethical Considerations and the 3Rs Principles
The ethical use of animals in research is a critical concern. MNMS aligns with the principles of Replacement, Reduction, and Refinement (3Rs) by enabling the repurposing of data from animal studies. This can reduce the number of animals needed for new experiments and, in some cases, replace the need for new animal studies altogether. The use of Virtual Control Groups (VCGs), facilitated by MNMS, is an underexploited opportunity that could substantially reduce the number of animals used in biomedical research when applied at scale - Support for Existing Initiatives
MNMS complements and builds upon existing initiatives and guidelines, such as PREPARE
and ARRIVE. This synergy can enhance the quality and reproducibility of research, making it easier for researchers to adopt MNMS without having to overhaul their existing workflows entirely. The alignment with these initiatives also facilitates broader acceptance and integration within the research community - Facilitating Meta-Research and Data Sharing
The adoption of MNMS could facilitate data sharing through large, publicly accessible data repositories or streamline data sharing between collaborative research partners. In the first case, this would enable complex meta-analyses that are currently prohibitive due to the absence of raw or primary data. Such work could generate novel scientific insights without additional use of laboratory animals.
In summary, the adoption of MNMS is a timely and strategic move that addresses current challenges in biomedical research, enhances reproducibility and transparency, aligns with ethical standards, and leverages existing initiatives to facilitate data sharing and meta-research. These factors collectively make MNMS a compelling and necessary advancement in the field.
Other Relevant Information
A full discussion of MNMS was recently published in Nature LabAnimal, and featured also on the front page. https://www.nature.com/articles/s41684-024-01335-0