OpenTrials

OpenTrials
Name	OpenTrials
Type	Open data project
Founded	2016
Founders	Evidence Based Medicine DataLab
Location	Oxford
Products	Clinical trial registry aggregation

OpenTrials OpenTrials is an open data initiative that aggregated information about clinical trials, trial registry entries, journal articles, regulatory documents, and patient-level results to promote transparency in medical research. It was developed to collate disparate records from sources such as ClinicalTrials.gov, the European Medicines Agency, the World Health Organization, and academic publishers to make trial data more findable, accessible, interoperable, and reusable. The project intersected with institutions including the University of Oxford, non-profits like Open Knowledge Foundation, regulators such as the Food and Drug Administration, and advocacy groups like AllTrials.

Overview

OpenTrials sought to link trial registry identifiers, publications in journals such as The Lancet, The New England Journal of Medicine, and BMJ, and documents from regulatory bodies including the Medicines and Healthcare products Regulatory Agency and the European Commission. The platform aimed to support stakeholders like clinicians affiliated with NHS England, researchers at Johns Hopkins University, policy makers in the House of Commons, and patient advocates from PatientsLikeMe. It engaged with bibliographic databases including PubMed, indexing services such as Scopus, and citation networks exemplified by CrossRef and ORCID to reconcile authorship and trial provenance.

History and Development

The initiative emerged in the context of campaigns led by organizations such as AllTrials, investigative work by journalists at ProPublica, and reproducibility efforts at institutions like the Max Planck Institute for Psycholinguistics. Early development was influenced by methods used by projects at Open Data Institute, datasets curated by Wellcome Trust, and policy discussions involving the European Parliament. Collaborators included academics from University College London, data scientists with ties to Imperial College London, and contributors associated with Kaiser Permanente research programs. Funding and pilot phases involved partnerships with foundations such as the Laura and John Arnold Foundation, coordination with registries like ISRCTN, and contributions from open science advocates at Mozilla Science Lab.

Data Sources and Methodology

OpenTrials drew on registries including ClinicalTrials.gov, EudraCT, and the WHO International Clinical Trials Registry Platform, literature from publishers like Elsevier and Wiley-Blackwell, and regulatory submissions to agencies such as the European Medicines Agency and the Food and Drug Administration. It applied entity resolution techniques similar to projects at Google Research and methodological standards advocated by Cochrane. Data cleaning used tools and ontologies promoted by DBpedia, metadata schemas from DataCite, and identifier systems from ORCID and DOI Foundation. Natural language processing methods reflected approaches developed at institutions like Stanford University and Massachusetts Institute of Technology to extract outcomes, interventions, and adverse events.

Features and Tools

The platform offered searchable trial profiles akin to interfaces provided by ClinicalTrials.gov but enriched with linked documents such as protocol PDFs from European Medicines Agency assessment reports and journal publications in Nature Medicine. It incorporated visualization techniques popularized by projects at Tableau Software and analytic workflows comparable to those used by RStudio and Jupyter Project. Data export options mirrored standards used by Figshare and Zenodo to enable reuse by researchers at Harvard Medical School, librarians at the British Library, and audits by organizations such as Transparency International.

Governance and Funding

Governance arrangements involved academic oversight from the Evidence Based Medicine DataLab at University of Oxford and advisory input from stakeholders including representatives from AllTrials, patient groups like Healthwatch England, and legal experts with experience at Human Rights Watch. Funding streams included grants from philanthropic entities such as the Laura and John Arnold Foundation alongside institutional support from University of Oxford departments and in-kind contributions from collaborators including BMJ Group and The Wellcome Trust.

Impact and Reception

OpenTrials influenced reporting practices referenced in investigations by outlets like The Guardian and BBC News, informed guideline development at NICE, and supported meta-analysts affiliated with Cochrane and Centre for Evidence-Based Medicine. Academics from King's College London and University of Edinburgh cited the resource in systematic reviews, while advocacy organizations such as AllTrials and Sense about Science used its outputs to lobby for policy changes at the European Parliament and within agencies like the Food and Drug Administration. Critics from publishing houses including Elsevier and stakeholders at some pharmaceutical firms such as GlaxoSmithKline raised questions about data provenance and workload implications.

Challenges and Future Directions

Challenges included reconciling conflicting records from registries like ISRCTN and ClinicalTrials.gov, dealing with paywalled publications from publishers such as Wiley-Blackwell and Springer Nature, and legal constraints related to document reuse involving institutions like European Medicines Agency. Future directions envisioned integration with persistent identifier initiatives from DataCite and ORCID, collaborations with open peer review platforms such as PubPeer, and interoperability with trial transparency efforts at organizations like AllTrials and regulatory modernization driven by European Commission policy proposals. Continued sustainability depended on support from research funders including Wellcome Trust, philanthropic partners such as Laura and John Arnold Foundation, and academic hosts like University of Oxford to ensure the preservation of linked clinical trial evidence.

Category:Clinical trials