Dr Ingrid Oakley-Girvan

Dr Ingrid Oakley-Girvan

Dr. Oakley-Girvan received her Ph.D. from the Stanford University School of Medicine and her M.P.H. from Tulane University School of Public Health and Tropical Medicine. She is affiliated with the Stanford Cancer Institute, the Canary Center at Stanford for Cancer Early Detection, and is SVP of Research and Academics at Medable Inc. Key accomplishments include clinical trials and research on mobile and digital technology, particularly in oncology, device utilization, and behavioral health interventions. She has documented disparities in breast and prostate cancer in addition to investigating new biomarkers – both digital and lab bench based. A hallmark of her work is combining multi-disciplinary studies and technology with business partnerships to more rapidly advance a direct-to-patient approach for impactful work that improves population and individual health.

Recent posts by Dr Ingrid Oakley-Girvan

2 min read

The language of eCOAs

By Dr Ingrid Oakley-Girvan on Jan 28, 2021 2:41:06 PM

What do patient’s care about most and what do clinicians consider essential to assess regarding their patient’s health and wellbeing while participating in clinical trials? These are commonly referred to as clinical outcome assessments (COAs). 

The four categories of COA

In patient-centric clinical trials, COAs are essential to understand the impacts of a drug on certain endpoints, for example, whether it is improving or diminishing quality of life and everyday activities that matter to patients. The FDA, signaling the importance of COAs and the need to develop additional ones, has even created specific guidance and pathways for their development and validation.  

Fortunately, one of the lessons from COVID-19 is that we can be flexible and efficient and conduct a multitude of COAs remotely, or what we call eCOAs. No longer do patients need to come into the clinic for every assessment:

  • ClinROs can be measured over a televisit
  • PROs can be measured through patient directed surveys on a mobile app
  • ObsROs can be measured on mobile apps with care partners assistance at home
  • And device data can be used to generate PerfOs

Not only can we collect these at standard times as if patients were “in clinic” but we can collect them even more frequently adding critical new data to better assess health related quality of life impacts that patients often highly value. If the most important thing to a patient is being able to remain mobile, feel less foggy or fatigued, we can incorporate additional time points to better understand the effects of a trial medication or concomitant meds on outcomes and endpoints.

Furthermore, in many cases longitudinal data collection may be analyzed to monitor participants for simmering adverse events and provide early warning of declining health with which clinical teams can act quickly.

Technology enables this to now be done at scale in a modular fashion which not only helps protect patients but also prevents trial drop out and can encourage retention as patients may feel they are receiving better care.

There is a freedom created by these discoveries and solidification of approach. Patients are no longer tethered to a clinical site, this means patient travel burdens are reduced and distance is of diminishing importance when making a decision to participate or remain in a clinical trial. At the same time, in a decentralized clinical trial model, facilitating remote data capture that occurs at greater frequency in an easily scalable approach will enable statistical assessments that are reliable and allow for new COAs to be developed that can support labeling claims and improved patient health. In sum, the language of eCOAs is a win-win for pharma and patient health.

Learn more here: https://www.medable.com/products/ecoa-epro

Topics: decentralized trials Hybrid Trials TeleCOA clinical trials eCOA
2 min read

Why I Joined Medable

By Dr Ingrid Oakley-Girvan on Dec 2, 2020 2:04:50 PM

Can you imagine waiting around in the kitchen for the phone to ring so you could do just one thing – talk to someone? Some of us remember when we had no choice because it was attached to the wall and we didn’t imagine all that a phone could be but then, that all changed. 

Smartphones untethered us and opened up incredible freedom with 3-D global video calls, digital maps and spoken directions, social and shopping apps, an embedded personal assistant, instant food delivery to our doors, endless internet searches no matter where we were, tagging and sharing of photos and information, calendars and health data at our fingertips, and so much more. 

This type of revolution is why I joined Medable.  When interviewing with the CEO Dr. Michelle Longmire and her co-founder Tim Smith, it was clear – we shared the goal of doing the same for clinical trials. Decentralizing operations, opening up freedom for patients and sites, creating digital therapies that could be delivered anywhere the patient chooses, enhancing robust remote data collection, cutting trial times in half, doing things so differently while maintaining scientific rigor – we were clearly aligned. In retrospect, I think when I joined many of my colleagues thought “wow, that is crazy, truly BHAGs, these guys are a bit nuts!” But now, as we watch vaccine development take place at an incredible pace and necessity forced regulations to facilitate Televisits and therapy development, our BHAGs hatched almost six years ago in the courtyard of a lively watering hole off Sand Hill Road don’t seem that nuts. In fact, they seem entirely achievable. 

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Our early recognition by NIH with two Small Business Innovation Research awards that I lead, work with multiple academic organizations and commercial customers to support their creative efforts to accelerate and provide better health care and trial experiences for patients and sites, and the belief in our goals and approach as documented by our recent $91 million in Series C funding bringing our total capital raised to over $136 million has been incredibly rewarding and validating.

As we work to continue to achieve our BHAGs this includes exquisite longitudinal ePRO, TeleCOA and digital data to help improve patient lives and deliver therapies in half the time, reduced paper and data burdens for sites, rigorous eSource and SaMD regulatory frameworks and metrics, delivery of interim endpoints and digital therapeutics, monitoring for early warning of simmering symptoms that warrant rapid clinical response and so much more all in a space where we re-envision the clinical trial experience. 

No two days in my life at Medable are the same with the exception of always being exciting and building on the team expertise and innovative mindset. I thrive off of being challenged to do more for patients and customers, creatively push harder, help solve disease disparities, and deliver validated solutions all while following our team ethos of Power Hour for self-care and Focused Fridays to thoroughly wrap up each week feeling I’ve made a difference and that my work is incredibly satisfying. The team spirit and energy is infectious and dynamic; we are empowered to have fun and move fast. If you are an expert in your area, hate being bored and share our BHAGs to do more for patients and help our clients deliver treatments sooner, I invite you to view our career opportunities.

Topics: decentralized trials remote trials careers life sciences