Exploring 5 types of clinical trial data sharing platforms

Trial Registries

Trial registries are one type of clinical trial data-sharing platform. According to the Clinical Trials Transformation Initiative, they aim to collect data to understand long-term trends in specific populations. Researchers can use information from data registries to guide future studies, improving clinical trial efficiency and reducing expenses.

These platforms serve as central repositories for information about ongoing and completed clinical trials, including study design, enrollment, and summary results. The HHS notes that, in 2004, the International Committee of Medical Journal Editors instated a policy requiring all published studies to be listed in a public registry. Following that initiative, regulatory organizations began enforcing similar requirements.

The World Health Organization Trial Registration Data Set requires the following components to be included in clinical trial registries:

• Primary registry and trial identifying number
• Date of registration at primary registry
• Secondary identifying numbers
• Financial or material support sources
• Primary and secondary sponsors
• Contacts for public and scientific queries
• Public and scientific titles
• Recruitment countries and recruitment status
• Health conditions studied and interventions
• Inclusion and exclusion criteria
• Study type
• Date of first enrollment
• Target sample size
• Primary and secondary outcomes

Some of the most well-known clinical trial registries include clinicaltrials.gov (United States), the WHO International Clinical Trials Registry Platform (ICTRP) (global), the European Union Clinical Trials Register (EU), and the Australian New Zealand Clinical Trials Registry (Australia and New Zealand).

Result Repositories

Another type of clinical trial data-sharing platform is results repositories. These platforms allow researchers to request access to individual patient-level data and supporting documents from completed clinical trials. The primary goal of these platforms is to enable secondary analyses and facilitate the reuse of clinical trial data.

According to an article in Trials, “Data repositories have the potential to play an important role in the effective and safe sharing of clinical study data because they can provide a stable, long-term home for the data, improve the security and quality of archiving through active data curation, increase the discoverability of data through the application of metadata schemes, and facilitate the processes of request and transfer of data from generators to users, as well as tracking data utilization.”

ClinicalStudyDataRequest.com, the Yale Open Data Access Project, Project Data Sphere, and the Syneos Health Shared Clinical Trial Data Portal are some examples of clinical trial result repositories.

Open Data Platforms

Open data platforms are online repositories that provide free and publicly accessible access to a wide range of clinical trial data, including summary-level results, individual patient-level data, and supporting study documents.

Key features of open data platforms include unrestricted data access, diverse data offerings, standardized data formats, metadata, and documentation.

These platforms may also be clinical trial registries or qualify as other clinical trial data-sharing platforms. For example, the Clinical Study Data Request, Project Data Sphere, Vivli, and the Yale Open Data Access Project are open data platforms.

Open data platforms are crucial in promoting transparency and the secondary use of clinical trial data. By providing unrestricted access to diverse data, these platforms enable researchers to conduct independent analyses, validate previous findings, and explore new research questions that may have yet to be addressed in the original studies.

Sponsor-Specific Data-Sharing Platforms

Sponsor-specific data-sharing platforms are online repositories established and maintained by individual pharmaceutical or biotechnology companies to share data from the clinical trials they have sponsored.

These platforms may take on different forms, but their common factor is that they are associated with a specific pharmaceutical company or sponsor. For example, the GlaxoSmithKline (GSK) Clinical Study Register, the Roche Clinical Study Data Request Site, and Pfizer Clinical Trial Data and Information Sharing are sponsor-specific clinical trial data-sharing platforms.

Consortium-Based Data-Sharing Platforms

Consortium-based data-sharing platforms are another clinical trial data-sharing initiative involving collaborations among multiple organizations. These platforms are typically developed and maintained by consortia or partnerships of pharmaceutical companies, research institutions, and other stakeholders in the clinical research community.

Consortium-based data-sharing platforms can provide researchers access to a more diverse and comprehensive collection of clinical trial data, fostering collaboration and enabling secondary analyses that can lead to new insights and advancements in clinical research.

These platforms' collaborative nature can also help address some of the challenges associated with data standardization and interoperability that may be more prevalent in single-sponsor or open-data platforms.