Independent Drug Safety Research
Veritas Research Foundation (VRF), a non-profit (501(c)(3)) established in 2022, was founded to revolutionize pharmacovigilance and drug safety research. In 2023, VRF launched its inaugural research initiative – Pharmacovigilance 2.0 – a groundbreaking research program focused on detecting, confirming, and ultimately preventing drug-related harm for elderly patients (i.e., Medicare beneficiaries) in the United States. In partnership the Center for Pharmacoepidemiology and Treatment Sciences (PETS) at Rutgers University, VRF ushers a new era in comprehensive, proactive pharmacovigilance and drug safety research, facilitated through access to CMS Medicare data under a dedicated data use agreement (DUA).
By transcending the limitations of the current drug safety paradigm – characterized by passive (voluntary) adverse drug event (ADE) reporting, incomplete patient narratives, absence of population context, and causal uncertainty - Pharmacovigilance 2.0 represents a sea change in the field. By seamlessly integrating longitudinal real-world data, it captures critical details regarding medication exposure over time, reveals unreported adverse drug events, and provides comprehensive patient narratives. The transition from passive ADE reporting to active safety signal surveillance dramatically amplifies safety signal detection, exposing otherwise hidden patient harm. Moreover, rigorous methodology is employed to contextualize, quantify, and confirm bona fide ADEs, generating robust inferences about medication-related harm.
This transformative paradigm shift brings forth remarkable strides in optimizing safe prescribing practices and enhancing patient outcomes, ultimately benefiting vulnerable populations deeply dependent on pharmacotherapy. Further, it fortifies healthcare providers, drug regulators, and pharmaceutical manufacturers with precise information, enabling them to minimize future adverse outcomes and potentially contribute to the development of tailored treatment guidelines, refined product labeling, and personalized medication management.
Pharmacovigilance 2.0 is structured into a five-phase plan spanning the next decade, with each phase designed to adapt to new drug approvals and emerging safety signals. Dr. Christopher G. Rowan, the principal investigator (PI) of Pharmacovigilance 2.0 and founder of VRF, brings nearly two decades of expertise in drug safety research using real-world data (RWD). His visionary approach centers on harnessing comprehensive RWD to transform drug safety research, with the goal of safeguarding public health and preventing drug-related harm.
For more information please visit the VRF website Veritas Research Foundation. You may also contact Dr. Rowan at crowan@veritasrf.org.