COVID-19 Clinical Trials Offer Optimistic Glimpse of the Future of Drug Development
Clinical trials were notoriously difficult to execute well before COVID-19 shocked the healthcare system and the global economy. Historically, about 80% of clinical trials fail to meet their recruitment deadlines and only 32% of trials ever make it to Phase 3. Overall, on average 9.6% make it all the way through to FDA approval, meaning that roughly 90% of trials are expected to fail under ideal circumstances.
Add the COVID-19 pandemic into the equation and it seems the whole process could collapse under its own weight. Indeed, a recent analysis conducted by NPR identified 440 different clinical studies that have been suspended since March 1st.
Among the many headwinds confronting life sciences teams right now, the pandemic poses yet another challenge to patient recruitment and site identification. As reported recently in Reuters, Komodo Health identified steep drops in testing rates for key cancers. How can companies recruit patients under shelter-in-place orders through much of the U.S., or engage physicians who’ve been dispersed and reassigned to deal with COVID-19? This doesn’t even begin to take into account the huge capital outlays required to launch a trial at a time when budgets are already strained.
COVID-19 as a Catalyst for Change
Yet, amid these challenges, a renewed focus on technological advances provides a significant reason for hope. Motivated by the opportunity to save lives and emboldened by the need to overcome the obstacles, medical affairs teams are leveraging COVID-19 as a catalyst to innovate, using new technologies to improve the speed and efficiency of their trials.
One of the best examples of this is Karyopharm Therapeutics, which launched a clinical trial last month for its cancer medicine, selinexor, to determine whether the medication’s potential antiviral and anti-inflammatory properties could also be effective in treating patients with severe cases of COVID-19. Karyopharm needed to quickly and accurately identify hundreds of providers and institutions with the highest at-risk populations to target for participation – at the height of the COVID-19 crisis response.
Launching a trial the old way – using outdated methods for identifying and recruiting patients as an example – simply wasn’t a viable option. How, for example, would Karyopharm find patients when testing was nearly non-existent in some parts of the country, and when new medical codes to specify COVID-19 diagnoses were not being applied consistently? How could its medical affairs team launch a physician research initiative when the providers they needed to urgently engage were serving on the front-lines of the pandemic, and in many cases, working outside their specialties as part of their institution’s COVID-19 crisis response?
Real-World Patient Data Unlocks New Approach
Karyopharm found the solution by working with Komodo Health to flip the traditional patient recruitment model upside down, focusing on using state-of-the-art, real-time patient-level analytics and insights to drive recruitment. By tapping into our real-time patient data tracking the healthcare experiences of over 320 million individuals, Karyopharm was able to identify diagnoses of coronavirus and coronavirus-like symptoms – including pneumonia, bronchitis, and other variants – in a matter of hours.
Those insights were used to identify top primary care physicians, top specialists, including internal medicine, pulmonary disease and infectious disease providers, and the top healthcare organizations, for immediate engagement. Karyopharm was then able to rapidly help accelerate the patient recruitment process in lockstep with the trial launch, speeding the process dramatically and improving its accuracy at a time when speed and efficiency have become precious commodities. Our partners at Karyopharm informed us that “first patient in” took place less than two weeks after the launch of their trial.
It would be hard to overstate the challenges that COVID-19 has introduced to healthcare and the broader economy. Recovery will not be easy. But, for all of the painful lessons learned and serious battles still left to fight, the experience is also forcing a hard look at the status quo, and introducing new tech-enabled approaches to drive solutions.
The traditional model for running clinical trials wasn’t working great before COVID-19. The fact that new innovations can enable the process to function at all during the crisis is a testament to what will be possible once we reemerge from the pandemic.