Multi-domain Drupal 8 platform including a new theme to modernize the look-and-feel and integration with external data sources such as clinicaltrials.gov to import and display clinical trials data for patients.
- Drupal 8 implementation
- Multi-domain configuration using Domain Access module, for 3 domains
- Content migration from Drupal 7 to Drupal 8
- 3rd party theme implementation and customization
- Integration with clinicaltrials.gov to import and display clinical trials data for patients
- Implementation of custom Company Directory and Expanded Access listings using Solr search
- Aggregation of FDA RSS Feeds
- Requirements Definition
- Technical Specifications and Implementation
- Front-end Development
- Drupal site-building and Webform implementation for multi-domain site
- Custom development for integration with external data sources
- Content migration
- Quality Assurance
- Deployment and Hosting support
- Support and maintenance
The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) is a non-profit 501 (c)(3) created by Congress to advance regulatory science critical to helping the FDA meet its mission. The Foundation works collaboratively with stakeholders including academia, patient groups, industry groups, and FDA scientists.
The Expanded Access Navigator, or EA Navigator, represents a unique partnership between the Reagan-Udall Foundation for the FDA, patient advocacy organizations, the pharmaceutical industry, and the federal government for helping patients and physicians understand the Expanded Access process.
The Navigator website, www.navigator.reaganudall.org, provides step-by-step guides to assist patients, physicians, and companies in understanding expanded access and how to navigate the process. The Navigator website includes a Company Directory that allows users to search by company for investigational drugs, read that company’s policy, and easily locate contact information.
Reagan-Udall was looking to extend the use of the Navigator, by including data from clinicaltrials.gov within the Company Directory itself, rather than redirecting patients and physicians to the separate clinicaltrials.gov website. This enhancement would allow patients and physicians to see if there are Expanded Access programs currently in place and what the parameters (such as age or location) of those programs are. In addition, rather than browsing only by company name, Reagan-Udall was looking to provide a free text search, allowing patients to search by medical condition or drug name.
To meet Reagan-Udall's goals, TrazerEdge upgraded the existing website from Drupal 7 to Drupal 8, implemented a new theme to modernize the look-and-feel and enhanced the platform to import and display clinical trials data for patients.
TrazerEdge began the engagement with a basic audit of the Drupal 7 production environment. The initial navigator.reaganudall.org Drupal 7 website included a Company Directory with links out to clinicaltrials.gov for each company’s expanded access listings. TrazerEdge was tasked with importing and then displaying this data within the company directory information.
For Reagan-Udall to present clinicaltrials.gov data within the website itself, TrazerEdge created a new content type and then built a custom import to parse XML feeds from clinicaltrials.gov based on company, expanded access type, availability and status. Each record imported from clinicaltrials.gov was programmatically associated with a Company in the directory, so that when users browse the directory they can quickly view the expanded access listings for that Company, without ever leaving the navigator website.
In addition to browsing Expanded Access listings by Company, Reagan-Udall wanted to provide patients with a way to search by medical condition or drug name. To meet these goals, TrazerEdge added Solr search to the Drupal environment. Patients can quickly locate expanded access listings using the free text search. From the search results, users can view the brief title of each expanded access offering that matches the search term, and then click on a program of interest to view the full details. The details page presents up to 18 different fields of information about the selected program.
With the upgrade and enhancement of Reagan-Udall’s multi-domain Drupal website, the Foundation now has a fresh and modern tool to communicate with patients, physicians and companies about its programs. The EA Navigator Company Directory is now a one-stop resource for expanded access programs. The data import from clinicaltrials.gov extends the use of the Company Directory by allowing patients and physicians to see if there are Expanded Access programs currently in place and what the parameters of those programs are. In addition, rather than searching only by the company name, patients now have the ability to search by medical condition or drug name (intervention) using free text search.
For the first time, those who need quick access to drug availability and expanded access options can find it all in one place, without having to visit site after site or sift through thousands of studies that don’t meet their needs," says Amar Bhat, PhD, interim executive director of the Reagan-Udall Foundation for the FDA.
TrazerEdge continues to provide Drupal technical and user support as well as all site maintenance and feature enhancements for the collection of Reagan-Udall Foundation websites. Read more about the clinicaltrials.gov integration project here.