The Future Feature, with Brenda Yanak | Read now
Medable, Inc caught up with the Founder and Precision Medicine Expert, Brenda Yanak , from Clinical Transformation Partners, to discuss what she perceives as the biggest breakthroughs in clinical research to date, & what she thinks our industry should strive towards in the future.
What’s one thing you wish everybody knew about your job.
People associate me with specimen management and think specimen management is “putting tubes into a box and shipping them”, whereas in reality, specimen management is a critical enterprise function with equal status to data management. People may not realize that 60-70% of medical decision-making (and therefore 60-70% of a trial’s clinical study report) comes from results of clinical assays performed on specimens. The industry only ever talks about data, yet without quality specimen management, data integrity is compromised – period. In an age of AI and automation, I think most people would be shocked to learn that specimens in a clinical trial – and their allowable uses as described in the informed consent document - are being managed using excel spreadsheets. Excel spreadsheets! Because a research experiment or clinical trial is only as fast as its slowest step, correcting this imbalance will be critical to advancing precision medicines and ensuring patient safety. In addition, people have a tendency to think only of specimens as biological, despite the surge of digital sampling that is now being explored, thanks to various remote technologies and wearables. The combination of longitudinal biological and digital sampling is going to create datasets large enough to much more fully characterize disease, accelerating precision medicine. Now more than ever, excellence in bio - and digital specimen management - is going to be a key enabler of both quality and speed in clinical trials. The people who hold these jobs have a special skillset - I call them ‘unicorns’. They are key not just for quality and speed purposes, but also because they have key knowledge to enable Digital Data Workflows for precision medicine.
In an ideal world, how would clinical research be done?
Ideally, clinical research would be done as an integrated part of clinical practice, embedded into routine medical care. I envision a healthcare world in which physicians could take a person’s biospecimen and send it not for testing, but for characterization – ex, growing patient cells into an organoid, whose profile could be then matched against a library describing disease characteristics of that patient’s particular tissue microenvironment; or sending out a set of digital recordings of a patient’s speech, gait, balance, whatever - and similarly, having that recording scanned against a library of digital phenotypes of disease for diagnostic or prognostic purposes. An AI assistant could then help the physician identify which companies are conducting trials for patients with this set of biological/digital characteristics, and the physician could then present the patient with options of ‘current treatment’ or ‘clinical trial x’ . I can see a world in which every clinical practice, with these tools, could make clinical trials far more accessible. It’s very exciting to see future clinical practice poised to readily integrate deep molecular science directly into more standard observational (phenotype- based) clinical practice, thanks to access to Big Data, AI, and connectivity.
What’s one barrier that’s not being talked about enough?
Digital health is sometimes referred to as a means to increase inclusivity in healthcare, since many of these advancements are from devices that can be accessed remotely (smartwatch, phone, etc). While geographic differences in access are noted, access is a much larger problem than some may realize. I had occasion to attend the Pennsylvania Farm Bureau meeting last year and there I learned from one member that during COVID, even though he lived only one mile outside of his town, connectivity was so poor, both of his children could not be on Zoom simultaneously, so he had to home-school them. This is a stark reminder that people do not have access to infrastructure to enable digital health just down the street, all over the US, the wealthiest country in the world. I have heard this example time and again – a clinical coordinator in West Virginia, whose client had to drive 10 min away to the top of a hill to access bandwidth for a video call; a clinical research associate who said radio was a more effective recruitment tool because it reached more of her rural patient population. Collectively, we need to talk more about how to ensure that digital health does not inadvertently widen the disparity and cause exclusion, vs inclusion.
What’s one consumer experience you wish you could bring to clinical research?
I would love to see USPS-like tracking be associated with a patient’s specimens and data. “I gave this specimen for testing. Where is it? (Enroute to the lab, at the lab, tested, destroyed), when will my results be back? Where are my specimens and data being used for research? For what purpose? What is the outcome of that research?” Right now, people only ask, “When will the results be back? " and the rest is pretty much a black box. Improvements in specimen management practices will not only reduce medical error (by increasing transparency and ensuring data integrity), but ethically, what could be more patient-centric than knowing where a patient’s specimens and data are and that they are both being used with consent?
If the industry could do _____, things would work much better and why?
If the industry could focus on how the clinical trial process framework needs to change to support Precision Medicine, the industry could accelerate digitization and automation. Currently, scientific and technological advancements are being discussed, without enough consideration on how operations need to change to support these advancements. In essence, right now many efforts appear to be digitizing broken, out of date blockbuster processes vs framing how precision trials are run, and working to automate that. The companies that transform the process piece will be able to scale digitization faster and, in the end, be able to create big datasets for AI mining, discovery, and creation of digital twins. They will be the winners in the data race because they will be able to scale. Without this, companies will be creating a lot of disconnected digital processes which could actually decrease quality and increase risk for patients in the short term.
In your view, what’s the smartest/best advancement in clinical trials that’s happened in the last 5 years?
Of course all the technology that enables remote monitoring is a huge step forward. That’s a give. We all know this. One thing that may not be on people’s radar screen, though, is microsampling. With the FDA approving Tasso’s at home sampling device last year, I am thrilled to see microsampling becoming a reality and in doing so, opening up a whole world of longitudinal bio- sampling that, with continuous digital sampling from wearables, will help construct far more accurate models of disease. Sampling has been done in a decentralized way for many years now (blood spots, buccal swabs, stool samples), however with microsampling and advancements in liquid biopsy, we will soon have the ability to offer more accessible multi-cancer screening for early detection. Just as women now go annually for a mammogram, in the near future, insurance could cover annual liquid biopsy analysis from blood collected at home. This could save lives and allow significant health care dollars to be focused on prevention and management vs hospital stays. It’s important to note that microsampling started as a DARPA effort about 10 years ago. The innovation cycle is long but we are finally at an inflection point. There are several companies in this space now. Woohoo!