Veritas Research Foundation
OUR STORY
Veritas Research Foundation (VRF), a non-profit established in 2022, was founded to complement pharmacovigilance and drug safety research efforts conducted by the Food and Drug Administration (FDA). In 2023, VRF launched Pharmacovigilance 2.0 – a research program focused on detecting, confirming, and ultimately preventing drug-related harm focusing on commonly used medications by elderly patients in the United States. In partnership with Rutgers University's Center for Pharmacoepidemiology and Treatment Sciences (PETS), VRF ushers a new era in 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 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.
Mission Statement
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 in vulnerable patients
Background Statement
Veritas Research Foundation (VRF) is an independent non-profit research organization dedicated to safeguarding public health by transforming pharmacovigilance and the drug safety research paradigm. Our cutting-edge initiative - Pharmacovigilance 2.0 - uses a novel approach to detect, quantify, and confirm drug-related harm. Further, it emphasizes safer medication prescribing practices, particularly aimed at protecting vulnerable populations and promoting safe and equitable healthcare.
Pharmacovigilance 2.0 is a transformational endeavor to elevate from the inadequacies of the current drug safety paradigm, which relies on voluntary or “passive” adverse drug event (ADE) reporting, incomplete patient details and case narratives, and the absence of contextual understanding. The realization of Pharmacovigilance 2.0 innovation will strengthen awareness regarding medication safety concerns, ultimately resulting in improved (safer) prescribing practices and optimized patient care.
The study population for Phase I of Pharmacovigilance 2.0 includes older patients in the United States. Addressing drug safety issues of this vulnerable population using systematic, innovative, and robust methodologies not only has the potential to significantly enhance the overall well-being of this demographic but also plays a pivotal role in mitigating health disparities and ensuring equitable healthcare.
Impact Statement
Pharmacovigilance 2.0 will generate the first comprehensive, actionable evidence base on adverse drug events associated with the medications most used by older Americans. Using a longitudinally stable cohort of 9.8 million Medicare beneficiaries and sequential target-trial emulations, Veritas Research Foundation will detect, confirm, and externally validate medication-related harm that passive reporting systems miss. Results will inform safer prescribing, more accurate product labeling, and refined treatment guidelines—equipping clinicians, regulators, and manufacturers to reduce preventable hospitalizations and improve equitable medication safety for older adults, including disabled and dual-eligible patients who depend most on pharmacotherapy.
Needs Statement
Older adults carry the highest burden of adverse drug events yet remain underrepresented in pre-approval trials and underserved by postmarketing surveillance. Age-related pharmacokinetic change, multimorbidity, and polypharmacy elevate risk, while U.S. systems such as FAERS rely on voluntary reports that undercount events and lack a defined denominator—so incidence cannot be measured. In VRF’s Medicare fee-for-service cohort of 9.8 million beneficiaries (mean age 76; 17% dual Medicare–Medicaid), 89% used at least one of the 50 most common oral outpatient medications (mean 6.4 agents per person). Without proactive, population-based analyses, preventable drug-related harm in this high-need group will remain hidden and unaddressed.
Geographic Areas Served
United States, nationwide: older Medicare fee-for-service beneficiaries aged 65 and older in all 50 states and U.S. territories. External validation among adults aged 65 and older in the United Kingdom using the Clinical Practice Research Datalink. Organization based in San Clemente, California, in partnership with Rutgers University (New Jersey). Findings are intended to inform medication safety nationally and, through publication, globally.
Top Three Populations Served
- All Populations
- People with Disabilities
- Seniors/Older Adults
Statement from the CEO/Executive Director
I founded Veritas Research Foundation to close a gap I have seen throughout my career: older adults use the most medicines and face the highest risk of harm, yet our safety systems still cannot reliably tell us which commonly prescribed drugs hurt them. Pre-approval trials exclude them; passive reporting undercounts their injuries. Pharmacovigilance 2.0 is how we answer that question—independent, population-based research that detects, confirms, and validates adverse drug events using real-world Medicare data. As President and Principal Investigator, I am accountable for the science, the CMS data use agreement, and the transparent publication of results that clinicians, regulators, and patients can use.
Statement from the Board Chair/President
As President of Veritas Research Foundation, and on behalf of the Board, I affirm that our sole purpose is independent research that protects the public from medication-related harm. We do not accept funding from pharmaceutical manufacturers or other conflicted sources. Pharmacovigilance 2.0 is the Board’s priority because it converts a national Medicare cohort into confirmed, publishable evidence on the medicines older, disabled, and disadvantaged Americans use every day. The Board will oversee scientific integrity, data stewardship, and responsible use of grant resources so that findings reach clinicians, regulators, and patients without delay or distortion.
CONTACT
Veritas Research Foundation
4030 CALLE MARLENA
SAN CLEMENTE, CA 92672-4514
Christopher G. Rowan
Phone: 3109186530