A Collaborative Event
Establishing Best Practices
Integrating Expanded Access Into Clinical Drug Development
WIDENING THE REACH OF DRUG DEVELOPMENT
WideTrial™ is the leading source of regulatory and business knowledge relating to group-level Expanded Access programs in the U.S.
WideTrial™ is the world’s first non-profit platform for sponsoring FDA-authorized Expanded Access programs.
WideTrial is a non-profit company built to make well-designed Expanded Access programs more feasible for those involved in the development of new treatments for serious unsolved diseases. Our platform offers centralized expertise and advisory services to drug companies, clinical research centers, and disease foundations. It also offers direct support by way of multi-party collaborations and sponsorship of large-group Expanded Access trials. WideTrial was founded in 2012 as ALS Emergency Treatment Fund, a 501c3 organization, originally focusing on Expanded Access in neurodegenerative diseases.
WHY EXPANDED ACCESS
Group-level Expanded Access clinical trials (not to be confused with single-patient “compassionate use”) allow meaningful numbers of patients and their physicians to explore a new investigational treatment with a well designed protocol and supply-chain to work in harmony with the continued clinical development of the particular treatment.
When integrated into the drug development cycle, Expanded Access trials bring many benefits to the drug company, including wider patient engagement, increased chances of discovering response-predictive biomarkers, and information that leads to more-highly targeted pivotal trials in historically difficult diseases.
HOW IT WORKS
In each disease area, WideTrial works with leading organizations and pharmaceutical companies to identify trial-stage therapeutics that:
- meet the regulatory criteria for Expanded Access and
- have disease modifying potential in the opinion of key medical leaders
Qualified trial sites are invited to join WideTrial’s network, to be named as investigators on upcoming access trials.
Under collaboration agreement with each drug company, WideTrial conducts some or all components of the Expanded Access trial, including sponsorship of the regulatory filing, protocol, site coordination, monitoring, data collection, and reporting. Operational and patient assistance funds are provided by charitable sources. Product supply is provided by the drug company.
WideTrial has an experienced, knowledgeable team of Expanded Access experts to guide each program.