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To sustain changes from COVID, Ken Getz says we need to think about study complexity, customization and fragmentation

Experts in the clinical research industry are now turning their attention to investigating the long-term effects of the COVID pandemic on current drug development processes. At The Chief Medical Officer Summit 360°, Kenneth Getz, Deputy Director and professor at the Tufts Center for the Study of Drug Development, provided an overview of the pandemic response, shared new data on trial performance and efficiency, and offered insights on how operations may be transformed.

According to Getz, there are three factors that impact the efficiency and speed of a trial: 1) Complexity, 2) Customization and 3) Fragmentation. Each factor affects one another and every decision that is made in designing a protocol has downstream effects on study performance. Complexity and customization can be defined across several dimensions such as the number of endpoints, study visits or operating dimensions (e.g., number of participating sites, target enrollment, number of countries). According to data from the past 10 years, Getz says that the number of endpoints has risen by about 90%. This means that both volume and diversity of data collected has also significantly increased. Looking at eligibility criteria, the number of inclusion and exclusion criteria per trial has increased by about 60%. This is because pharmaceuticals have moved towards rare diseases and working with more stratified patient populations. Complex protocols are associated with frequent protocol amendments, longer cycle times and higher levels of inefficiency. With respect to fragmentation, data shows that the research industry is an incredibly fragmented ecosystem. There is still much work to be done to improve the kind of study visibility and partner collaboration that will speed up trial execution.

In order to see any long-term changes to current drug development processes, Getz says that we need to tackle these three factors. In other words, we need to reduce or limit protocol complexity, allow for needed customization and increase industry wide collaboration.

Over the past nine months, all players within the research industry have been forced to rapidly modify and adopt new practices so that research could proceed during the pandemic. In analyzing industry responses to the pandemic, Getz found that…

1. The most disrupted part of clinical research has been execution of ongoing trials
Six weeks after the widespread lockdowns occurred across the United States, only 45% of clinical trial activity continued with the original executional model. This 45% is likely from studies looking at therapies in areas such as oncology, infectious disease, immunological disease and rare diseases as there was too much risk in transitioning to a virtual model.

About 30% of clinical trial activity shifted to a remote model. Experienced investigative sites and those in site management organizations were able to migrate to a remote model. With more research experience, there is more familiarity with remote technologies.

The remaining 25% of clinical trial activity was suspended or delayed. In an unprecedented pandemic, there were many research sites that did not have the capability to shift to a remote or virtual model and there were many sponsors that did not feel comfortable operating in this manner.

2. Collaborations have drastically increased
Collaborations came in many forms — sharing of data, sharing of talent or personnel, sharing of IP, sharing of risk. There has been a tremendous increase in the number of co-developments, collaborative approaches to scaling and sharing of technology platforms.

3. A shift to remote/virtual approaches is more nuanced.
The most common approach was the use of telemedicine. The second was a shift to using eConsent. While implementation of these two approaches is relatively easy, adoption of others such as home visits, direct to patient shipment of IP/supplies to patients, pushing lab-work to local providers and use of electronic/health medical information can be difficult.

4. There was rapid growth in use of some form of remote monitoring.
For decades, there were obstacles that prevented the widespread use of remote monitoring due to challenges with infrastructure or technologies. The pandemic facilitated the rapid growth of remote monitoring at larger sites.

5. There are more than 450 treatment and vaccine trials in the pipeline specifically targeting COVID.
This means that there are many many programs working to create therapies and that they are moving at record speeds. The typical duration for an antiviral or anti-infection therapy to move through all phases is 74 months. Looking at the latest drug candidates and announcements from sponsors, there has been about a 70% reduction in duration. In other words, there has been a compression from 74 months to 20 months.

By combining lessons from the pandemic with an understanding that we should not add to what is already a complex, highly customized and fragmented industry, Getz says that it is possible to create long-term and sustainable changes to drug development processes. Furthermore, he explains how critical it is that any changes seen during the pandemic are treated differently than the usual “proof of concept” programs. Rather than piloting activities once as one-and-done, we must integrate the lessons learned to allow continuity of innovation.

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