Wikidata:WikiProject Clinical Trials/criteria project
The WikiProject Clinical Trials Criteria Project is the effort to include inclusion and exclusion criteria in Wikidata items for clinical trials. For context, this is a difficult undertaking. There is no obvious dataset to import so someone has to produce the data. It is not obvious how to model this in Wikidata. Some criteria are more difficult to model in Wikidata than others. Besides Wikidata, there are other stakeholders for such a dataset.
What are inclusion and exclusion criteria?[edit]
Clinical trials recruit human research participants. To join a trial, the participants must meet all of the inclusion criteria, and must not match any of the exclusion criteria. Clinical trial registries require researchers to list inclusion and exclusion criteria as part of the clinical trial record. Humans write these criteria as prose, and different researchers may list the same criteria in different ways.
As an example, consider Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men (Q61981063)
For this study, the inclusion criteria are
- HIV (Q15787) negative
- good health (Q12147)
- has circumcision (Q83345)
- certain kinds of anal intercourse (Q63781172) in the past 6 month
- certain levels of glutamic-pyruvic transaminase (Q305481) (stated as Alanine aminotransferase)
- certain levels of Ad5 neutralizing antibody (no Wikidata item for this antibody as of September 2022)
- must be willing to travel to research site (Q57951700)
- demonstrate understanding (Q46744) of the research
- willing to receive tests which provide diagnosis of HIV/AIDS (Q337517)
- willing to participate in AIDS education (Q29957539)
- will not join another clinical trial (Q30612) while participating in this one
- if trans woman (Q1052281) meet additional criteria
and the exclusion criteria are
- previously received an HIV vaccine (Q1479804)
- current or recent use of anti-retroviral agent (Q50430310)
- circumcision (Q83345) was within past 90 days
- use of immunosuppressive drug (Q249619) within past 168 days
- use of blood product (Q886722) within past 90 days
- use of antibody (Q79460) within past 90 days
- use of attenuated vaccine (Q1810913) within past 30 days, except universal flu vaccine (Q25326661) is allowable
- use of research intervention (Q106486555) within past 90 days
- universal flu vaccine (Q25326661) within past 14 days
- use of antigen (Q103537) within 30 days
- having a significant disease (Q12136)
- having a medical, mental, or career-related responsibility (Q1274115) that conflicts with the study
- researcher (Q1650915) objection
- prior history of vaccine adverse event (Q445335)
- receiving tuberculosis management (Q1189184)
- using autoimmune disease (Q8084905)
- has immunodeficiency (Q641307)
- has blood coagulation disease (Q890200)
- has malignancy (Q1483951)
- has seizure (Q6279182)
- has asthma (Q35869) which is either severe or not controlled
- has hereditary angioedema (Q2096745)
Research and resources[edit]
- datasets
- ClinicalTrials.gov (Q5133746) is the original source for United States data
- The AACT Database (Q76654384) is a curated version of clinicaltrials.gov with more structured data
- research
- Formal representation of eligibility criteria: a literature review (Q33886631)
- The Leaf Clinical Trials Corpus: a new resource for query generation from clinical trial eligibility criteria (Q114065565)
- A knowledge base of clinical trial eligibility criteria (Q111224624)
- Knowledge Services Using Rule-Based Formalization for Eligibility Criteria of Clinical Trials (Q56840094)
- Classifying Clinical Trial Eligibility Criteria to Facilitate Phased Cohort Identification Using Clinical Data Repositories. (Q55114539)
- Classification of Clinical Research Study Eligibility Criteria to Support Multi-Stage Cohort Identification Using Clinical Data Repositories. (Q47220168)
- free and open platforms for sharing
- Clinical Trials Transformation Initiative (Q76654258)
- Semantic Scholar (Q22908627)
- WikiProject Clinical Trials (Q21829773)
Project goals[edit]
- structure inclusion and exclusion criteria for all trials in Wikidata
- describe the strengths and limits of structuring this data in Wikidata
- discuss how structuring clinical trials data in Wikidata can help modeling inclusion and exclusion criteria in other contexts
Thanks[edit]
There is no particular sponsorship or commitment to this project from any organization. Thank you to organizations below who have someone who made useful contributions to this project.
