‘We need to change the current clinical trial infrastructure’: Medable
Patient-focused drug development tech firm Medable has named Pamela Tenaerts as its new chief scientific officer. Tenaerts brings to the company more than 3 decades of research experience to the firm; she most recently served as executive director of Duke University’s Clinical Trials Transformation Initiative.
Outsourcing-Pharma connected with Tenaerts about her new position, her record of broad clinical research experience, and her enthusiasm about fostering innovation in clinical research.
OSP: Can you share some of the reasons you decided to join Medable?
PT: I passionately believe we need to change the current clinical trial infrastructure to better answer vital medical research questions in ways the current system cannot – after all, the life expectancy rate in the US has declined for the last couple of years in a row when it should be increasing. Decentralizing clinical trials is key to evolving medicine; Medable is the leader in DCTs so it was naturally alluring.
While I strongly believe in the need for multi-stakeholder groups to come together and create recommendations as I was doing for the past nine years at CTTI, there was something exciting about being part of architecting a novel clinical trials technology solution where patients are at the center and sponsors can access clinical trial data faster and more reliably.
OSP: How did your work with Duke and CTTI help lead you to your new gig with Medable?
PT: I have been working on improving the quality and efficiency of clinical trials for almost 10 years, developing a strong foundation for building evidence and trust in new systems. At Medable, I will be continuing that work to ensure DCTs are deployed in a way that instills trust and accelerates drug development so breakthrough treatments get to patients faster.
OSP: Do you have any personal goals on what you want to achieve, or maybe more accurately, what you want to help Medable achieve?
PT: From a young age, I knew that I wanted to become a physician to help patients and this aspiration has never wavered. As a mission-driven person, I have always worked in organizations where I could amplify that drive to help patients.
The decentralized model allows industry to bring trials responsibly to any patient, anywhere, anytime which will drive medical treatments to everyone faster. In that way, my goals align closely with Medable’s goals, as set forth by a fellow female physician with a similar passion.
OSP: According to the company announcement, you’ll be focused on a number of things, starting with DCTs. Could you please share how the industry’s understanding and acceptance of the decentralized model has evolved in recent years?
PT: One of my goals is to advance DCTs through evidence and best practice. Before COVID (BC) there was a perception that DCTs were risky, even as companies had been piloting and using them for almost 17 years; when COVID hit, DCTs went from high-risk to low-risk when compared with the alternative. Many trials were closed or interrupted but then adopting elements of decentralization, especially in therapeutic areas where critical trials are considered highly critical such as oncology.
Now, as we are starting to see a light at the end of the COVID darkness, the industry is becoming much more comfortable with DCTs. Familiarity is removing many of the fears across sites, clinicians, CROs, and patients.
In fact, Medable is seeing patients and doctors of all age groups demonstrate a remarkable comfort level with using new systems and technology – presumably because the benefits of handling a large portion of the trial from the comfort of one’s home outweigh any learning curve.
OSP: Could you please talk about Medable’s digital biomarker work to date, and what lies ahead for your efforts in this area?
PT: Medable has engaged in digital biomarker work with the National Institute of Health (NIH) funding, and directly supports life sciences companies for their specific digital biomarker needs in clinical trials. Most importantly, we are leading with what matters to patients while following FDA regulatory guidance.
Digital biomarkers offer a revolutionary opportunity to measure and alleviate the symptoms that trouble patients the most, not just the symptoms that we can easily measure with traditional tools. Drs. Ingrid Oakley-Girvan and Reem Yunis lead this effort at Medable to include digital biomarker work in their scientific development process. We have a robust understanding of this process and support SaMD efforts for customers.
OSP: What can you tell us about the master protocol approach you’ll also be working on?
PT: Master protocols are an interesting strategy to improve clinical trial efficiency and decrease the number of participants needed in a control group or standard of care arm. With master protocols, you can test multiple drug or medical products at a time rather than just one. In this way, they are a great way to maximize efficiency and find answers about the medical product faster. At Medable, we will be looking into how to deploy those in a decentralized model.
OSP: Then, patient engagement—why is this an important area to center your efforts on, and what are some of the challenges trials face with patient engagement, recruitment, and other aspects of patient-centric trial operation?
PT: Much work has been done, especially at CTTI, to demonstrate that when you engage patients in the design of clinical trials from start to finish, early and often, those trials will be designed to include the most important stakeholders’ voices. When you are designing a DCT, it is particularly critical to deploy technologies in ways that work for the participants living with the disease.
Medable is committed to include patients in the design and user experience of its DCT solution and has put that into action with its novel Patient Advisory Council (PAC) and broader Patient Champion Network.
Established in 2020, the PAC advises Medable and its customers on ways to improve patient access, experience, and outcomes in clinical trials. It played a vital role over the past year advising Medable teams on product development, patient preferences, and key performance indicators.
The PAC also advised Medable’s pharma and biotech customers on clinical trial deployments – providing advice, evaluating workflows, reviewing communication, testing usability, and improving retention for specific trials. Members are long-time advocates, patients, and caregivers dedicated to making trials accessible and inclusive for all. I am proud to build upon that important work.