The pharmaceutical industry has not escaped the impact of the COVID-19 crisis.
Every phase of drug development has felt far-ranging and long-term effects, including significant disruption to the R & D pipeline. Clinical research organizations (CROs) around the globe have had no choice but to alter their clinical trial plans—slowing or even shutting down many (if not all) of their studies. The shift is unprecedented, as manufacturers turn their attention to coronavirus therapies and vaccines—and away from drug development programs targeting other indications.
Even though the clinical trials for many of these programs are ready to begin, there’s a significant shortage of participants available. The main reason is the legacy approach taken to conduct clinical trials. Enrollment typically takes place onsite within a healthcare system, and participants are required to visit a clinic or other site of care in person for therapy administration.
Because of the pandemic, patients have been unwilling or unable to visit their clinicians in person, so the opportunity to enroll in a clinical trial has vastly declined. For those patients who had been participating in a trial prior to the pandemic, many have simply stopped participating.
Turning concept into action
Well before the pandemic began, there were efforts underway throughout the pharmaceutical industry about how to improve the clinical trial process. The key challenge has always been recruiting and retaining an adequate number of participants, based on FDA requirements.
Achieving the right number of participants has always been especially difficult for rare and orphan drug trials. Because there are so few patients, they’re not geographically clustered. They may have to travel a great distance to visit a clinical trial site. When you consider that there are other in-person visits required as well for lab work and other support, the logistics can be too difficult for many patients to overcome.
I know of one patient living on the West Coast whose clinical trial site was in New York. Pre-pandemic, she traveled there once a month. Today, she doesn’t travel at all—especially because she is immunocompromised—and is no longer taking her medication. There’s no trial site near where she lives—and because of the way the trial protocol was designed—she can’t switch to a new trial.
A solution that Optime Care had been developing pre-pandemic is now gaining more traction than ever: conducting clinical trials in patient homes. With this patient-first approach to clinical trials:
- The product is delivered directly to the patient’s home
- Nursing staff gather clinical data in-home and liaison with the clinical trial site
- Blood draws for lab work are gathered in-home as well
- Clinical monitoring and consults are conducted via telehealth
At the heart of it all is the patient care coordinator, who organizes the activities around a patient’s trial participation—such as scheduling visits from the nursing agency, arranging for lab work and reviewing clinical notes before sending to the CRO.
Improving enrollment and retention
This model is not just a theory. The in-home clinical trial model works: With one particular trial conducted by the manufacturer and Optime Care, we expected we would enroll about 50% of the total patient population targeted. The results were far different: more than 99% enrolled in our in-home trial, demonstrating the patient-first value of the model. It’s simply more convenient for patients and helps put their minds at ease during the pandemic.
Even the speed to achieve the required number of participants can accelerate when taking a patient-first approach. Patients in small populations know each other and share information about the clinical trials available. If patients are having a positive experience with one—particularly during the pandemic—the word will spread and manufacturers can have an easier time rounding out their participation goals.
Retention throughout the study has been equally impressive. Clinical trials can vary in length, from six months to two years; manufacturers naturally want to retain patients through all three phases—as well as during expanded access and compassionate use periods—to demonstrate the value of the therapy.
The pandemic has made retention even more problematic for traditional clinical trial models, which hope to achieve retention rates in the neighborhood of 70%. Our patient-first, in-home approach achieved 95%.
Taking the shorter path to profitability
Because of improved retention, manufacturers can compress the timeline to trial completion—which can lead to faster FDA review, approval and commercialization. Once a drug is greenlighted by regulators, the traditional transition time from Phase III clinical trial to commercialization can be cut by half or more, from 90 days to 45—or even 30. That’s because trial participants are already in the distribution and care coordination system and ready for the commercial product.
The key is to design the study from the very beginning for a seamless hand off between clinical trial and commercialization efforts. By having the same team in place for both, Optime Care Coordinators know each patient well and can help smooth the transition. That includes collecting not only medication data, but also understanding and reporting on the patient’s journey throughout the clinical trial.
It all adds up to more control over costs and a faster return on investment for manufacturers. This is especially critical for rare and orphan drugs, given their comparatively high cost. Indeed, manufacturers should put more effort into understanding the economic consequences of a therapy during the clinical trial stage, according to Ken Greathouse, a Director of Zosano Pharma and the co-founder of Valcrest Pharmaceuticals.
“Our industry needs more non-traditional thinking,” he said. “Manufacturers should spend more time defining the value proposition for a therapy during clinical trials.” The economic impact should include not only the cost of care (which is where traditional thinking ends), but also looking at the social consequences of a disorder and the opportunity cost of a patient being unproductive because of illness.
By taking a patient-first approach to clinical trials, manufacturers are better equipped to define this more comprehensive value proposition. They have a more holistic view of the patient journey and are better able to understand the impact on quality of life.
Changing the paradigm
COVID-19 has driven significant and lasting change in how healthcare is delivered today. For example, telehealth has made it possible for more patients to visit their doctors without ever leaving home. The concept of the traditional doctor visit is evolving.
The way to conduct a clinical trial can adapt as well. As an industry, we must come together to seek new and creative ways to bring rare and orphan drugs to market. Taking a patient-first approach to clinical trials by conducting them in patient homes is proving to be a viable alternative for overcoming the barriers to treatment created by COVID-19—and perhaps just as meaningful, becoming the new standard of care after the pandemic has subsided.