Veritas Research Foundation
Independent Drug Safety Research
VRF Mission
To serve the needs of public health in the United States and globally, VRF is an independent, nonprofit research organization aimed to detect, confirm and ultimately prevent medication related harm
The Problem VRF is Trying to Solve
Serious and life-threatening adverse drug events (ADEs) may not be detected or adequately quantified in small scale clinical trials and may only be illuminated after many thousand or millions of patients are treated with a new medication. This is especially true for high-risk, vulnerable patients (including the elderly) with the greatest therapeutic need, but who are often excluded from new medication trials. Thus, medication safety must be critically evaluated following regulatory approval; however, the current paradigm of post-approval pharmacovigilance and drug safety research is notably deficient.
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New medicine clinical trials are primarily designed to assess efficacy (not safety)
PROBLEM: Serious and life-threatening adverse drug events (ADEs) may not be detected or adequately quantified in small scale clinical trials and may only be revealed after many thousand or millions of patients are treated
New medicine clinical trials often exclude the sickest patients
PROBLEM: Pre-approval medication safety is often not established for high-risk, vulnerable patients with the greatest therapeutic need. Thus, medication safety must be evaluated and established following regulatory approval
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Reliance on passive or “spontaneous” ADE reporting
PROBLEM: This paradigm leads to substantial ADE underrepresentation, as most ADEs remain unreported, thus impeding the capacity to pinpoint true safety signals. Additionally, passive reporting is inherently biased due to lack of systematic ADE ascertainment.
Inadequate ADE report quality
PROBLEM: ADE report content variability obstructs the precise quantification and contextualization of potential ADE signals
Absence of critical data to assess causality
PROBLEM: Spontaneous ADE reporting systems lack the true number of patients with an ADE and the number of patients treated with a medication. Therefore, causal ambiguity results, thereby making it impossible to estimate a robust casual association between medication use and ADEs
Innovation in Drug Safety Research
VRF’s innovative approach to drug safety research - Pharmacovigilance 2.0 - employs systematic strategies to proactively detect “known” and “unknown” medication-related safety signals and confirm the causal association between medication exposure and adverse drug events (ADEs) among vulnerable patients heavily reliant on pharmacotherapy.
Pharmacovigilance 2.0 empowers patients, healthcare providers, and drug regulators with critical information aimed to:
Reveal true ADE risk
Mitigate future ADE risk through safer medication prescribing practices
Improve the accuracy of medication labeling with respect to ADE risk
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Objective
To prevent medication-related harm, cultivate safer medication practices, and ensure equitable access to safe pharmacotherapy and optimal outcomes
Primary research question
What serious adverse drug events are associated with commonly used medications among elderly patients?
Real World Data Integration
Transitioning from the inherent biases of voluntary or “spontaneous” adverse drug event (ADE) reporting systems, Pharmacovigilance 2.0’s integration of comprehensive real world data (RWD) captures critical details pertaining to medication exposure, reveals unreported ADEs, and includes detailed patient narratives. This novel utilization of RWD signifies a sea change in safeguarding public health.
Surveillance Amplified
A departure from passive safety signal surveillance, Pharmacovigilance 2.0 actively detects medication-linked safety signals exposing otherwise concealed patient harm using systematic and innovative methods.
Contextual Understanding
Elevating from isolated safety signals devoid of context, Pharmacovigilance 2.0 employs rigorous methodology to identify, contextualize, and confirm adverse drug events thereby generating robust inferences regarding medication related harm.
Research Principles & Scientific Leadership
The Veritas Research Foundation is guided by a world-class cadre of epidemiologists, biostatisticians, and clinical experts committed to safeguarding public health. We possess a relentless commitment to methodologic innovation using fit-for-purpose data to detect, quantify, and confirm medication related harm. This commitment further extends to transparency, where the facets of our research methodology and findings are presented and published with unwavering candor.
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Dr. Rowan is the Principal Investigator of Pharmacovigilance 2.0. He is an Adjunct Associate Professor at Rutgers University Center for Pharmacoepidemiology and Treatment Science (PETS) and a pharmacoepidemiologist, biostatistician, and drug safety researcher by training.
His research vision is to employ an innovative approach using comprehensive real-world data (RWD) to improve drug safety research and safe guard public health.
Through his nearly two decades of drug safety research, he has extensive experience using comparative methods to estimate causal relationships between medication exposure and a variety of adverse drug events. Additionally, Dr. Rowan has conducted and published many burden of illness, drug utilization, comparative safety and predictive modeling studies.
Dr. Rowan has extensive experience designing and executing drug safety research studies using large electronic health record (EHR) and administrative claims data – in a variety of disease and therapeutic areas. His recent publications include comparative safety research, predictive modeling studies, methodologic investigations, and health services research.
His research proficiencies include study design, statistical analysis, interpretation of research findings, and dissemination through peer reviewed publications (abstracts and manuscripts) and presentation. Dr. Rowan has a strong publication track-record and conducted a pre-doctoral fellowship at the FDA to study drug safety signals as part of his dissertation research.
Research Funding
VRF’s independent drug safety research is sustained through donations from concerned citizens, ensuring independence by not accepting funds from pharmaceutical manufacturers or other sources with conflicting interests. We are currently seeking donations to support Phase I of Pharmacovigilance 2.0, focusing on detecting, quantifying, and confirming serious adverse drug events associated with the top 50 most commonly used medications by Medicare beneficiaries.
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VRF’s drug safety research is sustained through generous donations from concerned citizens who are dedicated to enhancing the understanding of and ultimately preventing medication-related harm.
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Committed to maintaining our integrity and independence, VRF consciously avoids accepting donations or grants from pharmaceutical manufacturers and any other funding agency that might present a conflict of interest. This approach ensures that VRF can operate transparently and continue its critical research without external influence and bias.
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We deeply appreciate your support with a donation to help fund independent drug safety research. We are currently seeking to raise $1.58 million to support Phase I of Pharmacovigilance 2.0 (3 years), which will focus on the detection, quantification, and confirmation of serious adverse drug events (ADEs) associated with the top 50 most commonly used medications used by Medicare beneficiaries in the United States.