...
FAIR implementation is one of the fundamental enablers for secondary reuse of clinical data, thereby realising much greater value from our data assets. . FAIR clinical data and metadata will be findable (discoverable) by both machines and humans, any access restrictions will be determined by open protocol standards and supported by highly expressive FAIR vocabulary or ontology standards, including formats. These attributes of Findability, Accessibility and Interoperability together support Reusability which includes the attributes of data usage, provenance and community standards as illustrated in Figure 10.
...
Registries for clinical interventional and observational studies are important resources for supporting the secondary use of clinical data. Examples include Clinical trial registries such as those provided for the FDA by the NIH (https://clinicaltrials.gov ), the EU (https://www.clinicaltrialsregister.eu ) and Cochrane (https://www.cochranelibrary.com/central) which are within the scope of this guide. For each study, they usually include a study description, the study protocol and summary data for the trial results
...
ClinicalTrials.gov
The NIH funded registry, http https://clinicaltrials.gov is the largest open clinical trials database which has been available online since the year 2000. In the web-based user interface, Basic text search (e.g. see query results for “Diabetes Mellitus, Type 2”), is provided along with the advanced search that provides additional search facets, e.g. eligibility criteria, locations or start and end date of a study.
...
Findable The study identifiers, NCT01020123 and NCT00633464 are global, unique, persistent and resolvable by machine (GUPRI) which has been incorporated into the Uniform Resource Locator (URL: https://clinicaltrials.gov/ct2/show/study/NCT01020123 ) which is discoverable by Google search. This satisfies the four FAIR maturity indicators for Findability (F1, F2, F3 and F4) at the study level (Table X). The same studies can be retrieved as xml which corresponds to the tabular view in html to expose the structured metadata in a machine-readable format.
Accessible The results summary for this clinical trials registry is at the study rather than patient level so access is unrestricted which does not require authentication or authorisation for viewing (Table X4). The persistence policy for the results summary data and study details metadata is likely to be long term although this is not stated explicitly on the history and policies page.
Interoperable.Even though the metadata for the study description is structured (tabular view or xml), it consists of much free text and almost no identifiers for vocabulary or ontology terms can be found. In this regard, the FAIR interoperability of the clinicaltrial.gov registry could be much improved. Further opportunities to make this registry more FAIR include: 1) JSON Linked Data API instead of plain JSON, 2) Adoption of the openAPI/SmartAPI (https://smart-api.info/guide ) specifications for FAIR services and 3) Convert XML based data schema to an ontology powered schemaConvert data schema (XSD) to an Ontology., Tconvert term lists could be converted to SKOS-CVs, align/cross-map to dominant FAIRsharing terminologies. Adoption of the CDISC vocabulary is also likely to improve this clinical trials registry (Table X4).
Reusable. The use of data is described at https://clinicaltrials.gov/ct2/about-site/terms-conditions which is protected by international copyright outside the USA or some third parties. Guidance is given to study record managers on submission to ClinicalTrials.gov using the Protocol Registration and Results System (PRS). This provides the only mechanism for expression of provenance and maintaining the expected standards, policies and legal obligations for this community. This mechanism would benefit from use of the provenance ontology, PROV and by adoption of the major clinical standard, CDISC.
...
FAIR pillars | Simplified FAIR Maturity indicators (MIs) for data and metadata | Formal FAIR MIs | Priority | EU CTR | FAIR Score for study |
Findable | Global Unique Persistent Resolvable identifiers (GUPRI) | F1, F2, F3 | Essential | Identifier for study (how GUPRI?) | 1 |
| Uniform Resource Locator (URL) | F4 | Desirable | URL for study (via query) | 1 |
Accessible | Open standard protocol for identifier resolution to support authentication and authorisation for access to restricted content | A1 | Essential | Unrestricted access to method and results summary (no patient data) |
|
| Metadata has a persistence policy for discoverability independent from the associated data | A2 | Desirable | Legal obligation for retention of the registry | 1 |
Interoperable | FAIR vocabularies or ontologies with external links and language for knowledge representation | I1, I2, I3 | Desirable | Free text, no structure (pdf dump) | 0 |
Reusable | Attributes for consent for data usage (licence and owner), provenance (e.g. PROV ontology) and use of relevant clinical standards (e.g. CDISC, OHDSI, FHIR etc.) | R1, R2, R3 | Essential | Study submitter and registry policy and legislation. No provenance or clinical standards. | 1 |
Score key: 2 is fully satisfied, 1 is partial, 0 is not satisfied | Max possible: | 10 | 4 | ||
...
Findability: The study identifiers, 2009-012612-41 (=NCT01020123) and 2007-005209-23 (=NCT00633464) are unique and resolvable by machine but the globality and persistence of these identifiers is open to question. These identifiers have been incorporated into the URL (e.g. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2009-012612-41 ) which can be found using Google search. This partially satisfies the four FAIR maturity indicators for Findability (F1, F2, F3 and F4) at the study level (Table Y5).
Accessibility: The results summary for this clinical trials registry is at the study rather than patient level so access is unrestricted which does not require authentication or authorisation for viewing (Table Y5). The persistence policy for the results summary data and study details metadata is likely to be long term although this is not stated explicitly. It is notable that CT registry limits user access to a graphical user interface, so there is no programmatic access (i.e. no API) for batch download, unlike http://clinicaltrials.gov .
Interoperability: The study methods and results data and metadata are only available in an unstructured format as plain text or as pdf. The content is identical to that found in ClinicalTrials.gov for the two example trial records. This means there are almost no identifiers for vocabulary or ontology terms. Clearly, the FAIR interoperability of the EU CTR is a massive opportunity for improvement.
...
The European Medicines Agency (EMA) and some national medicines agencies have been investing in access to RWD. Building on this experience, in 2021, the European Medicines Regulatory Network (EMRN) initiated plans to create an EU-wide distributed network of RWD named the Data Analytics and Real World Interrogation Network (DARWIN EU). Similarly, the US FDA has their Real Word Evidence Program which includes documentation for the RWE Program RWE Program Framework, published in 2018. Ideally, such multinational RWD initiatives should be guided by FAIR principles, rather than creating clinical data silos which are all too often lost to secondary reuse.
Other registries and efforts
We just want to briefly mention and link out to other relevant data registries and efforts, without going into further details or FAIR assessments:
...