| PPMD – a Medication Interaction Categorization Resource for Clinical Trials
It is imperative to identify potential mechanisms of harm that could occur during clinical trials to ensure the safety of all participants. One possible such harm is drug-drug interactions (DDIs).
At the Society for Clinical Trials, the University of Buffalo and Frontier Science Foundation presented a quality assurance approach to assist ACTG investigators during protocol development and study enrollment – the ACTG Precautionary and Prohibited Medication Database (PPMD). The PPMD provides mobile-friendly access to current pharmacokinetic (PK) and pharmacodynamic data on DDIs from scientific conferences, peer-reviewed journals, drug manufacturers, and regulatory agency alerts that have been reviewed by clinical pharmacologists. It features all available reported changes in PK parameters (Cmax, AUC, Cmin), physiological effects, recommendations on necessary (if any) action, supporting literature, and safety and efficacy data.
The database currently includes more than 895 interactions (>100 prohibited and >506 precautionary interactions) across more than 358 medications including: antiretrovirals, hepatitis C virus direct-acting antivirals, antimalarial, anti-hepatitis B, and anti-tuberculosis agents, as well as agents for the treatment of coronavirus disease. The database and interface are managed by clinical trial database experts. This program offers real-time information on important drug interactions and access to consultation from clinical pharmacologists. In concert, this database and tool provide critical information that preserves medication-related study metrics and ensures the safety of study participants in large clinical trials and networks.
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