Cynthia J. Girman expands real-world evidence work into substance use research

Cynthia J. Girman, a longtime leader in pharmacoepidemiology and real-world evidence, is using her new BeatSUD Foundation to fund decentralized trials for substance use disorders and brain health. The effort reflects a broader push to apply rigorous clinical research methods to underserved conditions while highlighting the growing role of patient-centered outcomes in healthcare decisions.

Why it matters: - Cynthia J. Girman is extending more than four decades of work in real-world evidence and patient outcomes into substance use disorders and brain disorders. - BeatSUD Foundation aims to build a stronger evidence base for nontraditional, additive neuromodulating tools that could eventually inform clinical practice. - The effort targets conditions where rigorous evidence is limited and treatment needs remain high.

What happened: - Influential Women highlighted Girman as a global leader in real-world evidence, pharmacoepidemiology, and patient outcomes research. - Girman founded BeatSUD Foundation, Inc. in 2024 as a 501(c)(3) nonprofit. - The foundation plans to conduct 30 decentralized, pragmatic randomized controlled trials over the next five years. - The first trial will study people with opioid use disorder in outpatient programs over 24 weeks. - Girman also founded CERobs Consulting LLC in early 2015. - She serves as founder and CEO of CERobs and as co-principal investigator for the BeatSUD program.

The details: - Girman has more than 45 years of experience in study design, randomized trials, observational studies, and methodological rigor. - Her career has focused on generating fit-for-purpose evidence for healthcare, regulatory, and payer decision-making. - At Merck & Co., Inc., she helped lead epidemiology, observational research, patient-reported outcomes development and validation, and data analytics initiatives. - She helped shape strategies for integrating real-world evidence and patient outcomes into drug development and regulatory submissions. - She served 11 years on the Methodology Committee of the Patient-Centered Outcomes Research Institute. - Girman is an adjunct professor of epidemiology at the University of North Carolina at Chapel Hill. - She is an elected Fellow and former Board member of the International Society of Pharmacoepidemiology. - She co-edited the 2021 Elsevier publication, Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic. - She is an award-winning co-author of A Voice from Heaven, written with her late son, Alexander V. Girman. - The BeatSUD studies will test specially designed music, guided meditation, and educational inspirational recordings against control recordings. - The first opioid use disorder trial will test music with tonal frequencies, binaural beats, and a steady tempo tailored to emotional state, alongside usual care. - The foundation operates on donations and grants, and more information is available online. - Girman also shared profile links for her Influential Women page and CERobs Consulting.

Between the lines: - Girman’s career shows how real-world evidence has moved from a niche research discipline to a central input for regulators, payers, and clinicians. - Her shift into substance use research reflects a belief that the same methodological standards used in pharmaceutical evidence can be applied to underserved behavioral health problems. - The BeatSUD model also shows a preference for collaboration over hierarchy, using a remote-first network of consultants and volunteers. - Girman’s comments on AI point to a broader tension in research: speed and convenience are rising, but scientific validation and confidentiality still matter most in high-stakes work.

What's next: - BeatSUD Foundation is expected to begin or continue trials across substance use and mental health populations. - The research program is expected to expand into autism, ADHD, PTSD, anxiety, and depression. - Trial results will help determine whether the tested tools should be integrated into clinical practice. - Girman’s consulting network and nonprofit work will likely continue to center on methodological rigor, interdisciplinary collaboration, and patient-centered evidence.

The bottom line: - Girman is applying a career built on evidence standards to a new mission: testing whether unconventional supportive tools can earn a place in care through rigorous trials.