An Open Data API for Clinical Trials

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myTomorrows is a global healthcare platform for clinical trials and early access programs, and facilitates access to drugs in deelopment for physicians and their patients.

www.mytomorrows.com

@mytomorrows

API Documentation:

https://mytomorrows.app.box.com/v/public-api/1/11231216095/94441848186/1

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Clinical Trials API

The myTomorrows clinical trials API is an online service providing access to a central database of worldwide medical trial and study data.

The API is provided as a public web service and research tool for application developers, healthcare professionals, and domain experts working with clinical trials.

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Agenda

Trial API Overview

What, Why, How?

API Goals and Solutions

API Design Principles

Trial Search Engine (MeSH)

Examples

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API Fact Sheet

Public & Accessible: no registration required; get started with a web browser

Open web technology: HTTP + REST + JSON + Schema

Cloud infrastructure: hosted on Amazon Web Services for uptime and autoscaling

Versioned: legacy support for API clients; no surprises, no breaking changes

Comprehensive Data: 16 WHO global trial databases- 300k Clinical Trials- 447k Interventions- 275k Contacts, Sponsors, and Facilities- 21k Diseases- 185 Countries

Fresh Data: full Imports run on daily basis

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The myTomorrows Mission

Short Term:

Improve access to treatment options Improve standards of care

Long Term:

Understanding the worldwide landscape of clinical trials is a necessary condition for these goals.

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How Can an API Help?

Access to global, harmonized, healthcare data is a catalyst for research and new insights.

Search trends reveal interest in unmet medical needs and unknown patient populations.

Technical support for “Meaningful Use” policies and practices.

An API is a way to give a much wider group of people access to and information on clinical trials and population health trends.

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What is an “Open” API?

Non-commercial and free to use.

Datasets can be republished downstream.

Based on open community standards and conventions.

The myTomorrows clinical trials API promotes several open data principles:

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Use Case: Trial Discoverability

Clinical trials suffer from major discoverability problems.

Solving these problems means doctors can consider more treatment options for their patients.

An openAPI is a means to generally improve discoverability.

An API is a solution for access to information.

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Master Data Management

Schema Mapping

Data Consolidation

Source Identification & Attribution

De-duplication

Error Detection & Correction

The medical trials API provides a standards-based model for formalizing trial registration data. Various techniques are used:

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Industry-Level Pressure on Data Exchange

Trial Reporting in ClinicalTrials.gov — The Final Rulehttp://www.nejm.org/doi/pdf/10.1056/NEJMsr1611785

US toughens rules for clinical-trial transparencyhttp://www.nature.com/news/us-toughens-rules-for-clinical-trial-transparency-1.20616

NIH aims to beef up clinical trial design as part of new data sharing ruleshttp://www.sciencemag.org/news/2016/09/nih-aims-beef-clinical-trial-design-part-new-data-sharing-rules

New federal rules target woeful public reporting of clinical trial resultshttps://www.statnews.com/2016/09/16/clinical-trials-reporting-rules

Especially in the US there is pressure to improving clinical trial studies and data publication.

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Design Principles

Favour human-readable content (optimize for access, scrutiny, portability)

Decompose data models and schema (optimize for loose coupling, small interfaces)

Model schemas on conventions in active use, e.g. PDED, TRDS (optimize for collaboration, familiarity)

Provide simple query model (optimize for common use cases, still allow difficult queries)

Interoperability between healthcare systems and data these systems contain still a primary challenge.

The myTomorrows clinical trials API is heavily informed by domain-driven design principles and pragmatic interests, e.g.

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Use Case: Active Trials

The simple question - “what are the active clinical trials in the world?” - is not possible to answer without interpreting trial register data.

For example, some trial statuses found in registers which could be construed to mean that a given trial is currently running include:

“active”, “available”, “on-going”, “completed, no longer recruiting”, “underway”, “in practice”, “recruitment completed”, “inclusion stopped”

The myTomorrows API provides an abstraction layer that normalizes concerns like model schema and vocabulary.

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Leaky Abstractions

1. Be as clear and familiar as possible while remaining general enough to be broadly applicable.

2. Be as specific as possible without compromising future change.

Due to various kinds of fragmentation (market, geographic, stakeholders, etcetera) this is one of the dominant problems of healthtech.

Some level of leaking is necessary due to focus and specialism, and some level generalization should be avoided due to verbosity, complexity.

Developing the clinical trials API, our middle-ground approach was to:

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Data Mapping

1. ClinicalTrials.gov Protocol Data Element Definitionshttps://prsinfo.clinicaltrials.gov/definitions.html

2. WHO Trial Registration Data Sethttp://www.who.int/ictrp/network/trds/en/

Two prevailing schemas for trial register data that inform the API design:

API schemas extended to support custom trial register datasets:

3. Trial Register Custom Datasets (e.g. study design, data monitoring and ethics committees, etcetera)

PDED + TRDS + WHO Partner Network

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The Importance of Data Mapping

1. Data outlives APIs

2. APIs outlive applications

The most important design decisions happen close to the data. Leaky abstractions addressed on this level.

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Clinical Trial Datasources

Medical trial data is imported daily from the 16 World Health Organization Primary Partner registries:

http://www.who.int/ictrp/network/primary/en/

The Australian New Zealand Clinical Trials Registry (ANZCTR), The Chinese Clinical Trial Register (ChiCTR), The Clinical Research Information Service (CRIS), The Clinical Trials Registry- India (CTRI), The German Clinical Trials Register (DRKS), The EU Clinical Trials Register (EudraCT), The Iranian Registry of Clinical Trials (IRCT), The International Clinical Trials Registry Platform (ICTRP), Japic CTI (JAPIC), ClinicalTrials.gov, The Nederlands Trial Register (NTR), The Pan African Clinical Trials Registry (PACTR), The Brazilian Clinical Trials Registry (ReBec), The Sri Lanka Clinical Trials Registry (SLCTR), The Thai Clinical Trials Registry (TCTR), and The University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR).

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Clinical Trial Search

Main API use case is searching trials, e.g. eligibility matching, medical research.

Two core search features:

Easy to filter patient options with general information, possible to explore related treatments

MeSH (Medical Subject Headings) condition search

Trial search filters (gender, location, dates, etcetera)

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MeSH

“The Medical Subject Headings (MeSH®) thesaurus is a controlled vocabulary produced by the National Library of Medicine and used for indexing, cataloging, and searching for biomedical and health-related information and documents.”

https://www.nlm.nih.gov/mesh/

The API links clinical trial data through diseases as identified with MeSH terms.

Searches can be more or less specific depending on disease area.

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Trial Search Filters

Study design, intervention model

Titles, medical codes, universal trial number, secondary ids

Inclusion / exclusion criteria

Country, study sites

Interventions, drug codes

Ethics committees, review boards

Use cases include: trial eligibility and availability, finding specialist practitioners and clinics, upcoming enrollment, etcetera

Example searchable data (from 30+ distinct filters) includes:

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URLs: The Bridge Language

1. REST is over-engineered, FHIR is over-engineered!

2. Every healthcare knowledge worker knows how to manipulate URLs

Be like the Elasticsearch of healthcare data, but with *meaningful* schema and query models

Make the API accessible to domain experts:

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Ideal API Users

Physicians / Medical Institutions

Clinical Scientists

Academic Researchers

Patient Advocates

Healthcare Technology Developers

Contract Research Organizations

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Example 1: Pediatric Medicine

Status of the Pediatric Clinical Trials Enterprise

http://pediatrics.aappublications.org/content/early/2012/09/26/peds.2011-3565

Performing study with clinical trials API query:

https://api.mytomorrows.com/api/v1/medical_trials.json?max_age=16&country=US&type=interventional&max_enrollment=100&sponsor=NIH

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Example 2: Meaningful Evidence

Large-scale analysis finds majority of clinical trials don't provide meaningful evidence

https://www.sciencedaily.com/releases/2012/05/120501162702.htm

Performing study with clinical trials API query:

https://api.mytomorrows.com/api/v1/medical_trials.json?max_enrollment=100

VS.

https://api.mytomorrows.com/api/v1/medical_trials.json?max_enrollment=1000

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Example 3: Compliance With Mandatory Reporting

Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

http://www.bmj.com/content/344/bmj.d7373

Performing study with clinical trials API query:

https://api.mytomorrows.com/api/v1/medical_trials.json?country=US&type=interventional&end_from=2009-01-01&end_to=2009-12-31&fda=true&phase=-1

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Questions?

Please get in touch if you have any feedback, feature requests, data exchange proposals, datasource recommendations / requests, or bug reports. Thanks!

tech@mytomorrows.com

API Documentationhttps://mytomorrows.app.box.com/v/public-api/1/11231216095/94441848186/1

Terms of Servicehttps://mytomorrows.app.box.com/v/public-api/1/11231216095/94310908387/1