Cynthia J Girman

I am a goal-oriented woman, and throughout my 45-year career, I was always pursuing more publications, presentations, symposia, and funding for studies. I was active in the methodology space and in real-world evidence for regulatory purposes, which gave me visibility within the professional societies of our field and for my employer. I organized countless symposia, spoke at conferences, moderated sessions, led working groups and delivered a plenary talk at an annual meeting and was on the Board of our international professional society in pharmacoepidemiology. I also served on the methodology committee of PCORI for 11 years, always maintaining a focus on improving methods and study design. My constant drive to improve methodology and study design in epidemiology and outcomes research led me to the success I've had. However, I now know that true accomplishment is not about how much you achieve in your job, what accolades you have, how many publications you have, or how much money you make. It's all about the peace you feel, how much love and compassion you have for others, and how much you give to others. I learned that the hard way, when we lost our son.

Professionally, the best advice I received was to 'tell a story'. Storytelling is what we should be doing with statistical reports, epidemiology reports, and reports for regulators. It's not just about presenting facts - we need to tell a story to convey what the data are really saying. Personally, the most meaningful advice came from my son after he died, when we were co-writing a book together. He said, 'Don't let life just happen to you. Make life happen for you.' He repeated this to me on several occasions. We all tend to get up and just go through the routines all day long and then collapse into bed - that's letting life happen to us. But we really need to grasp it, we need to make things happen for us, we need to make the life we want, and we need to do the things we enjoy. It's your life, not anybody else's. You are meant to enjoy it.

I would say stay true to yourself, and stay true to what you know is right, and also to have the confidence to speak up, even in a still male-dominated world. But most importantly, don't just strive for work-balance, make it happen. If your employer expects you to work 50-60+ hours a week, find another job. If your employer doesn't expect that but you still work those hours, think hard about what your prioritizing in your life. After 45 years, I look back with 20/20 hindsight and regret the hours that I spent working on weekends and evenings instead of being with our kids, one of whom we lost. You are meant to enjoy this life not work all the time. The lessons that you were intended to learn in this life, won't be learned on the job. Make life what you want it to be, and enjoy most of it with family and friends.

The biggest challenge in my field is that it's evolving so fast. The FDA and payers are changing requirements and guidance constantly. For example, they went from requiring two well-controlled randomized clinical trials for approval to requiring one with confirmatory evidence, which is a huge change, making real world evidence potentially more acceptable for product approval. AI is changing the way everybody works. At CERobs, we can't yet trust AI for deliverables for my clients because AI truly hallucinates a lot - it makes up references and makes up data, so we have to be very careful. I use it daily in my personal life for things like getting organized or creating tables, but I don't use it for deep research from a medical point of view because I don't trust it quite yet. For regulatory-related or publication-related work, we have to do so much checking of AI after we use it that it actually takes more time. Our clients are using AI when they shouldn't and not using it when they should, so things are rapidly evolving. We also have to be careful about confidentiality agreements with our clients - if we use AI that learns from the information we're giving it, we could breach those contracts. AI is improving and our prompting is improving, but we're not quite there yet.

Collaboration is the most important value to me in my work and personal life. People look to me as a leader, but I consider myself a collaborator because that's how I treat everyone that works with me. We're all a team working together to accomplish some goal or project. When you do that, I really think you get the most out of people because they want to work and they want to achieve as a team, as opposed to being told what to do or trying to compete with other team members. My business model in the consulting firm I run reflects this - I bring people in as collaborating consultants with no hierarchy. They all come in as contract employees, they're all part-time, they're all remote, and it's basically a network of expert collaborating consultants. We form a team when we get a project from pharma to consult on. I hope that I bring that collaborative spirit over to our marriage as well, and I think we are very much partners.

BeatSUD Foundation is completely about collaboration and giving. I've been fortunate to have some wonderful volunteers helping me planning and launch of our first clinical trial. We rely solely on donations (www.BeatSUD.org) and will be seeking funding over the next few years to launch clinical trials using music and guided meditation in various substance use disorders, after which we hope to launch trials in other brain disorders like autism, ADHD, post-traumatic stress disorder, anxiety, and depression.