The health care research ecosystem has shifted into overdrive in response to Covid-19, sparking unprecedented speed and agility. The economic and public health burdens it has generated demand that we rethink our approach to developing new vaccines and therapies. Researchers are now examining what we can learn from these experiences and more broadly apply this innovation to research and development in the future.
As we look back at the past few months, I see three lessons that health care researchers can take from our experience so far:
More collaboration. In nearly every case, meaningful progress against Covid-19 has been the result of multiple organizations working together with a unified mission. While partnerships have long been a facet of drug development, the intensity and scale of recent collaboration is unprecedented.
Competition and intellectual property incentives remain vital to fuel the innovation engine that positions the pharmaceutical industry to help address this and other crises. However, the pandemic is catalyzing conversations about expanding partnerships in ways that can mutually benefit all players.
Rethink clinical trial design. Patients frequently cite barriers to access as a reason they don’t participate in clinical trials. In cancer research, for instance, more than half of patients don’t have a trial available to them at a nearby institution.
The widespread adoption of telehealth services spurred by recent social distancing measures is a significant step forward, as it allows geographically diverse patients to access trials where clinical sites aren’t available. As these capabilities continue to expand, it is imperative that we capitalize on their potential.
Covid-19 has had a devastating impact on nursing home residents, with more than 40% of coronavirus deaths in the U.S. linked to long-term care facilities. The existing logistical challenges in managing clinical studies in such facilities have been amplified by social distancing restrictions.
An approach taken by my company, Lilly, offers an example of rethinking clinical trials in the age of coronavirus.
Given the pressing challenges caused by the pandemic, we needed an innovative solution to fast-track potential Covid-19 treatments for this vulnerable population. So when we launched a trial for our lead investigative neutralizing antibody against the novel coronavirus, we did so in a way that did not require residents to travel. The first-of-its-kind study design relies on mobile labs built from custom retrofitted recreational vehicles that can be brought directly to residents and staff, while trailer trucks transport the supplies needed to create on-site infusion clinics.
Better integration of digital technologies. Until recently, most of Lilly’s clinical sites relied on a manual screening process in which we worked with investigators to individually review applications and ensure that patients met the qualifications to take part in a trial. An internal assessment we performed found that because these were not tracked effectively, our sites were screening an average of 20 patients for every one enrolled, which extended timelines beyond what we felt was appropriate.
The innovation here was adopting a cloud-based process that allows sites to enter and track prescreening information. That helps us quickly analyze trends in how patients are getting accepted or rejected. If more patients are being screened out than expected, we can reexamine and possibly update the enrollment criteria. This change has not only helped reduce the time required to enroll patients, but has also informed decisions about where to open new sites for trials.
Digital solutions in clinical trials continue to rapidly evolve, and it is the pharmaceutical industry’s responsibility to lead the way in implementing them. It is also up to us to communicate the benefits these tools can offer to help overcome status quo biases that may hinder progress. For instance, we found that the clinical trial sites that implemented a cloud-based system enrolled 23% more patients than those that did not.
I often hear from physicians and patients who are eager for updates as a new treatment nears the finish line. When you’re dealing with diseases like cancer, getting a treatment to market just three or six months sooner can save lives. During the fight against Covid-19, it is crucial that we understand, implement, and share what we’ve learned from innovations and failures across the health care system so we can continue to improve the way all companies discover and distribute new medicines to people in need.
Patients regularly face the unexpected with resilience and strength. Our industry must do the same.
Anne White is the president of Lilly Oncology.
Thank you, Anne, for such a clear and constructive distillation. I especially appreciated your innovation of the patient clinic visit using the retrofitted RVs- both creative and solutions-focused! To extend the point made by another commenter below, it is really rather staggering how quickly we in industry go from being greedy profiteers, ranking “as the most poorly regarded industry in the eyes of Americans” (in the words of Gallup)— TO: white knight saviors whose work holds the promise of saving the world from the current scourge— TO: politically motivated safety risk “deniers” racing to deliver a vaccine prior to the election! Wow!
“All in a day’s work,” the wiser among us might say!
Great piece- thanks again!
How about rethink the definition of fair or affordable pricing? WIth the current clarion call by media, activist groups and health economists all demanding minimal profit and/or cost based pricing for therapies and vaccines, where is the incentive for biopharma to innovate for coronavirus treatment? Saving lives alone is one thing, but doing it for free is ridiculous.
Heck, why not ask first line workers treating Coivd-19 patients to do it all on a volunteering basis with no compensation? Why not require wildfire fighters to do I with so compensation? Research scientists need to get paid too, and biopharma companies must keep a lot of them on payroll too for future R&D.
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