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Rita Banzi, Head of the Center for Health Regulatory Policies

Center for Health Regulatory Policies, Mario Negri Institute

Rita Banzi is the Head of the Center for Health Regulatory Policies at the Mario Negri Institute. Her main fields of expertise are drug regulatory policies, health research methodology and ethics, evidence synthesis, data sharing and transparency in research. Within the EU-funded CORBEL project, she was involved in the definition of standards for sharing individual-participant data from clinical trials. From 2010 to 2014 she was the European Correspondent for Italy of the European Clinical Research Infrastructure Network (ECRIN) and involved in the activities of its Scientific Board. She is involved in post-graduate training programmes on clinical research methodology, systematic reviews and clinical guidelines at the University of Milan and Modena and Reggio Emilia.

She is author of 65 scientific papers in international journals (Medline/PubMed).

Rita Banzi holds a doctoral degree in Pharmaceutical Sciences (University of Bologna, Italy) and a post-graduate specialisation in Clinical Pharmacology (University of Milan, Italy).

 


Abstract

Quality criteria for repositories hosting clinical trial data 

Data sharing is increasingly being recognised as a key requirement of scientific research. Sharing and re-use of data generated by clinical trials can enhance reproducibility and the generation of new knowledge; it is also ethically valuable as to respect the generosity of study participants by increasing the utility of the data they provide.

Data repositories have the potential to play an important role in the effective and safe sharing of individual-participant data (IPD) from clinical studies. We assessed repositories that enable storage, sharing, discoverability, re-use of the IPD and associated documents from clinical studies and provided a detailed description of available repositories. Although certification systems for data repositories exist, such as the CoreTrustSeal certification, none was deemed sufficiently specific for health research data. Therefore, we proposed an indicator set to capture the maturity of the repositories’ procedures and their suitability for the hosting of IPD. The indicators cover guidelines for data upload and data deidentification, data quality controls, contracts for upload and storage, flexibility of access, application of identifiers, availability of metadata, and long-term preservation.

We analysed 25 repositories, from an initial set of 55 identified as possibly relevant. None of the repositories completely demonstrated all the items included in the indicator set, but three repositories (Dryad, Drum, EASY) met – fully or partially – all items. Flexibility of data-access modalities appears to be limited, being lacking in half of the repositories.

Within the CORBEL project activities, a discussion about the reference implementation to provide best practice, concrete examples, and administrator advice on how to develop a repository is currently ongoing. The indicator set is currently being tested in the establishment of a pilot repository based upon a widely used repository system (DSpace). This pilot repository should be able to provide access to IPD from clinical trials and be compliant with current requirements and recommendations for each defined quality criteria. The services any repository provides should conform to specified quality standards, to give its users confidence that their data and documents will be stored securely and in accordance with the specific data transfer agreements they have agreed.

References

Banzi R, Canham S, Kuchinke W, et al. Evaluation of repositories for sharing individual-participant data from clinical studies Trials. 2019; 20:169.

Ohmann C, Banzi R, Canham S, et al. Sharing and reuse of individual participant data from clinical trials: principles and recommendations. BMJ Open. 2017;7:e018647.

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