Apply Remotely for Decentralized Clinical Trials

Inspiration

The clinical trial for COVID vaccines have come into the spotlight, with some patients experiencing serious adverse events. This also brought to light the real impact that diversity of patients can have in testing the effectiveness of a drug across different populations, and underscored why diversity and inclusion matter in the COVID-19 vaccine trials.

It turns out that "Decentralized Clinical Trials" (DCT) have been a necessary but effective way to conduct research and reduce both patient and sponsor burden, among other benefits, which has to a greater push to further reap the benefits, as described by the Clinical Trials Transformation Initiative project on DCT.

Affinidi's Verified Credential tools can help with patient recruitment in this new landscape of telemedicine and Decentralized Clinical Trials, by allowing patients to check if they are elligible to participate and remotely share their credentials with those who are conducting the research. Especially when vaccine trials fail to report ethnicity data, having patients participate in trials using verified credentials with such information can help us understand how diverse a trial was, and increase confidence that a drug is effective for everyone.

What it does

A POC involves tools for 3 parties:

the healthcare provider / authority who issues credentials claiming medical data
- a dashboard for patients to request information from their medical reports
- admins can log in to issue credentials and send emails containing links for patients to add to their Affinidi allet
the patient who holds the credentials in the Affinidi wallet
- a chrome extension which adds a button for ongoing trials on clinicaltrials.gov open to recruiting patients
- basic validation for whether a patient's credentials match inclusion-exclusion criteria
the researcher, coordinator or clinical/contract research organization who carries out the research protocol of the study, verifies the patient's medical data
- a dashboard to view verified credentials shared by the patient and email to follow up with the patient

How we built it

I used the driving license POC as a base and added example patient data from FHIR (Fast Healthcare Interoperability Resources) schema.

I then added a Chrome extension to show how easy it is to integrate Affinidi solutions into an existing site, clinicaltrials.gov, where participants can search for clinical trials being run all over the world.

Challenges we ran into

Ensuring that the new medical data conformed to the Affinidi data model, and used examples found on FHIR examples and the typescript interfaces to ensure that the right fields were present.