The Future of Clinical Trials is Decentralized

Investing in Medable’s $77 Million Growth Round

By Tina Hoang-To & Chris Cheng

Let’s start with the basics: a clinical trial is the research process for advancing medicine and the path to unlocking cures to diseases. They help us to determine whether new therapies work (or don’t work) to address illnesses of all kinds, and if they are safe for us to use across the population.

Unfortunately, until recently clinical trials have been a broken process:

• 37% of trials are terminated before testing even starts because of under enrollment*
• 85% of trials fail to retain enough patients*
• 70% of potential patients live more than two hours from a research site*

With over 50% of the cost and time associated with bringing a drug to market residing in the clinical trial operations, the ripple effects are real: it can take up to 10 years to bring a new therapy to market, only 7% of clinical trial drugs actually make it, and when they do, the cost can reach upwards of $1 billion dollars.

When the pandemic set in last year, the fragility of site-based, in-person clinical trials was laid bare to us all — most trials were cut to “near zero” for non-COVID-related work, and thus completely stalled innovation in medicine.

Running Clinical Trials Like It’s 1999

Let’s paint a picture of the typical clinical trial process. Clinicians first go through the arduous process of finding the right patients for the study. In the case of rare diseases, it is like finding a needle in a haystack. At the later stages of a clinical trial, thousands of patients worldwide are needed — and the more diverse the population, the better. Before a trial even starts, all of these potential patients need to be identified, qualified, and enrolled.

For the most part, clinical trials remain an analog business (aka “pen and paper”), with much of the process to determine a patient’s eligibility involving onsite interviews and filling out countless forms. In global trials that require thousands of patients, people are often flown to sites for qualification. This process alone could take up to two years.

Once patients are selected and the trial is underway, investigators will typically see patients on a bi-weekly basis to measure health outcomes and responses to a drug. As mentioned before, 70% of patients live more than two hours from a research site. Imagine, as a patient with compromised health, having to repeatedly drive hours to a site to measure drug responses.

It’s easy to see why there is massive patient drop-off, enormous costs, and most importantly why trials fail so often.

Technology + Telemedicine = Resilient, Effective Clinical Trials

As investors, we believe that some of the most valuable companies are not only the best at responsibly aggregating data, but they also leverage technology to transform this data into actionable insights that drive better outcomes and superior user experiences.

In this new world of decentralized clinical trials (“DCTs”), one of the major challenges we will face is having multiple access points and the massive amounts of data that is now flowing through the platform. With adoption of wearables (e.g. Apple watches), and a myriad of intake channels such as in-person visits, online questionnaires, remote monitoring devices, virtual consultations, and electronic health records, there’s an increased frequency and volume of data being captured at the patient level. This is a good thing for improving the quality of a research study, but it creates new challenges of making sense of all this data.

Medable Is Leading the Evolution In Clinical Trials

Unlike many competitors that have built technology for a single part of the value chain, Medable addresses every part of the clinical trial tech stack: screening, consent, virtual visits, remote monitoring, electronic data capture, and clinical outcomes assessment — enabling its customers to run trials anytime and anywhere on a single platform.

When we met them, the team and product stood out immediately.

Medable was founded in 2015 by a team of entrepreneurs and engineers led by CEO and Co-Founder, Michelle Longmire, M.D. Michelle was raised by scientist parents, and as a resident and doctor at Stanford University, trained and worked with leaders in the field of genetics and epigenetics.

Medable’s inspiration came from Michelle’s personal challenges when she cared for patients with autoimmune disease at Stanford. Patients were not healthy enough to travel to a hospital and participate in a trial, resulting in weak clinical data, and preventing their ability to find a cure. Michelle set out to solve this by applying mobile technology to trials to collect better patient data and founded Medable.

In speaking with pharma and biotech companies that were operating DCTs, we found that the two things that customers valued the most were: 1) clinical expertise and 2) global presence.

Deep knowledge of different therapy areas matters significantly in the successful design of a research study. There is no one size fits all for trials. A cancer trial will have very different requirements from a cardiovascular trial — different recruiting, tests, processes, check-ins, hardware, etc. Pharma sponsors need a DCT solution that they can trust to provide the same standard and quality across any type of trial, which is why sponsors trust Medable. Guided by Michelle’s expertise and vision, Medable has assembled a team of experts across therapeutic areas from leading companies such as Covance, ERT, and AstraZeneca. Medable isn’t just a technology company — it’s a partner for adopting virtual or hybrid clinical trials.

Navigating global regulations is a big challenge for clinical trial startups. Trials often require thousands of patients across multiple countries, and with more diverse patient populations comes a higher conviction for the drug’s efficacy when used globally. Feet on the ground and local presence is important because every state and country has their own set of regulatory requirements. For example, at the surface e-consent may appear to be simple document e-signing, but in practice, different states have different consent forms that are constantly modified by regulators, which makes document management and version control critical. When dealing with patients outside of the U.S., it can be more complicated (e.g. some countries don’t yet accept electronic signatures). With presence and leadership in 60+ countries, Medable is emerging as the global leader in DCTs.

Obvious & the Promise of Full-Stack Healthcare

Obvious has been backing companies reimagining all aspects of our healthcare system, rooted in full-stack approaches that are tech-enabled, more personalized, and purpose-built for better healthcare outcomes.

Recursion is rapidly accelerating drug discovery at dramatically lower costs. Virta is scaling its clinically validated Type 2 diabetes reversal program while extending to other conditions. Devoted Health is growing its Medicare Advantage programs with an outcome-aligned business model. Galileo’s platform is making healthcare more accessible to more people, 24/7. Inato is streamlining the inefficient marketplace of clinical trial site selection, while removing bias and expanding access for participants. Tomorrow Health is also modernizing the marketplace for durable medical equipment, making it more patient-centered and set to deliver better outcomes for care in the home. And Incredible Health is helping healthcare professionals find and do their best work while reducing time-to-hire for hospital systems.

We are humbled to now have Medable in this family of companies, leading the charge in the future of clinical trials.