Confidently detect more abuse-related events with the industry’s best standardized approach.
Clinical trials are designed to evaluate whether a treatment is effective, but it’s just as critical to assess a treatment’s negative effects.
WCG’s Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®) rapidly identifies and assesses potential abuse-related events so sponsors and regulators can accurately evaluate abuse potential – expediting approval, labeling, and scheduling. It’s the world’s first and most widely used standardized system to assess potential drug abuse in late-phase trials.
Support informed scheduling and labeling
Send contextual information about events of interest to the FDA to better document abuse potential and support appropriate scheduling and labeling.
Stay ahead of regulatory requirements
Create a proactive approach: MADDERS is based on FDA guidance for assessment of abuse potential in CNS trials.
MADDERS is as easy as it gets. Add the system to any ongoing trial with minimal effort; simple setup, low-impact integration, and no IRB approval needed.
Lead Solution Functions
Expert identification of potentially abuse-related events by trained investigators and site staff
Seamless, real-time data collection using standardized forms
Formal event adjudication by substance-abuse experts
Seamless data reporting
MADDERS fills a need for standardized approaches to quantifying potential abuse in clinical trials and should be used for any trial medication that crosses the blood-brain barrier.
- Initially developed in collaboration with the public-private FDA-ACTTION initiative (learn more)
- Prevent overestimation or underestimation of abuse potential by focusing on those for whom the drug was designed
- Get to the bottom of whether triggering events are attributable to non-medical use of study medication or false positives
Phase II through IV multicenter clinical trials
Average clinical trial acceleration across the board
Risk management when it matters most.
Greater effort is needed to identify inappropriate use events occurring in clinical trials and categorize these events based on the underlying intent. Collect and assess the right information to minimize unnecessary risk and stay ahead of regulatory requirements with ease.
The finish line is in sight
Don’t risk your drug’s approval. Protect research participants, minimize the risk of late-stage failure, expedite regulatory approval, and reduce trial costs. MADDERS is the only system to comprehensively capture data on abuse-related events in clinical trials per FDA guidance.