The clinical trial process is in desperate need of disrupting.
Before a prescription drug is distributed and sold to the masses, it must go through an often years-long process to ensure usability and safety for users. It’s a timeline that is continually plagued by outdated methods of data management, breakdowns in communication between researchers, clinicians and participants, and other variables that alter from trial to trial.
In 2014, TrialSpark came onto the scene and posed some important questions relating to the problem. First, how could clinical trials be improved with the help of modern tech? And, conversely, how could tech support such an antiquated process?
“Technology tends to make a big impact on problems that require a large volume of repetitive work and with solutions that benefit from network effects — with clinical trials, we have both,” said Rob Murcek, a platform engineering manager at TrialSpark.
In the past six years, the company has built a tool to help healthcare professionals and patients navigate the clinical trial process, which in turn has made ripples for the larger community affected by new drugs.
“Bringing clinical trials into communities allows us to get promising treatments into the hands of a more diverse population of patients and, if we are successful in the long run, will increase the diversity and affordability of treatments that are available to everyone,” said Michelle Lew, the director of product design at TrialSpark.
Through a meticulous roadmap, top-notch UX and a deep sense of empathy, the TrialSpark team is working to make the process efficient. Unlike other industries, the clinical trial space isn’t afforded the luxury of rolling out products with abandon and then fixing issues later — the stakes are simply too high.
“As a platform engineer, I deliver the core technologies that support TrialSpark’s tools, like a secure cloud environment for our applications to safeguard patient data or an automated pipeline to test and deliver software changes quickly to keep our engineers innovating.”
“My job is to design the optimal user experience for TrialSpark’s products. That includes designing digital user interfaces, but it also means helping design operational processes and weighing in on decisions about our product strategy and roadmap.”
“Product managers are problem-solvers: We sit at the intersection of engineering, design, marketing, operations and our users to help deliver outcomes for the business.”
How can tech make clinical trials more efficient?
Frank Wu: Marc Andreessen popularly claimed that software is eating the world, and for many industries, this has absolutely been true. But the cost of running a clinical trial has largely remained unchanged. We believe that we can drastically improve the process by applying tech-enabled and data-driven solutions to problems like matching patients to the best studies for them, collecting and structuring clinical data for real-time biostatistics and easy FDA submission, and automating operational workflows like routing drug deliveries or sending payments to physicians, patients and lab providers.
Michelle Lew: If you think about it, the true product of any clinical trial is the table of data at the end that helps the FDA determine whether the drug is safe, effective and ready to go out to patients – and there are many different people and products involved in making sure that data is accurate, complete and meaningful. Our platform needs to be able to support increasingly complex and powerful developments in study design, like adaptive clinical trials, which essentially allow researchers to do A/B testing with variables like dosage and condition severity.
Rob Murcek: Technology tends to make a big impact on problems that require a large volume of repetitive work and with solutions that benefit from network effects — with clinical trials, we have both. This process requires a huge amount of data capture and repetitive validation which is ripe for automation, a drumbeat for our engineering team. As we scale, we’re able to offer a broader array of potential treatments to patients, and as we serve greater numbers of patients, we’re able to run trials for more types of treatments in more places. This compounding effect is one of the keys to expanding affordable access to quality care.
Your product seems quite complex. How do you build it?
Murcek: Building a product starts with conversations about what problem we’re trying to solve and whether doing so in-house will provide strategic value over an off-the-shelf solution. Product managers, engineers and our potential users iterate on whiteboard sketches, product requirements documents and, eventually, mock-ups as problems evolve toward solutions. We’re not closed to learning from those who have come before us — in fact, we try to learn from every product we can — but we don’t assume that what’s been done before will work for us on our mission to reimagine the clinical trial.
Creativity at work
Wu: Building something meaningful in healthcare is a uniquely difficult challenge where technology alone is often not the solution. We've built a vertically-integrated solution that marries the technology we build with the very patients and physicians that we're looking to serve. At the end of the day, our technology alone is not effective without the partnership of the human side of the business — meaning the workflows and operational pieces of the clinical trial itself.
Lew: One of the toughest things about developing products for clinical trials is something we affectionately call “small data problems.” Unlike products where you can launch features and get feedback and metrics from thousands of users in the matter of a few days, clinical trials often involve a very small number of participants and can last years at a time. That means we have to be especially thoughtful about building to maximize our learning in each product iteration.
How do you consider the unique needs of your users, who are also patients?
Lew: TrialSpark’s look and feel are all about empowering people to make informed choices. The decision to get involved with a clinical trial is never made lightly, whether you’re a patient, a doctor or a pharmaceutical company. When we approach any aspect of TrialSpark's user experience, we ask ourselves: Is this straightforward? Does this demonstrate to users that we understand them and have their best interests at heart? Are we equipping them with everything they need to make decisions that are right for them?
“Most importantly, our managers trust us. That means that we get to fail from time to time and learn in the process.”
Wu: TrialSpark is uniquely positioned to be a consistent, guiding voice for patients throughout their clinical trial journey. From the very first time we meet a patient — perhaps before they are even looking for a trial — all the way through to FDA submission. We ask a lot from our patients: They are people that are struggling with conditions and symptoms that may not even have cures on the market yet. We're asking them to volunteer months and years of their time and energy making visits to our sites. We're asking them to share intimate details about their medical histories. In some cases, we're asking patients to leave their current treatment options and switch onto a new, investigative one. It's our duty and our privilege to partner with our patients and physicians to drive the future of medicine forward.