Over the past year, the pharma industry has been in overdrive. The best of the best around the world – biochemists, scientists, doctors, researchers, and the like – came together to develop a COVID-19 vaccine in record time. Several vaccines have been approved for emergency authorization; manufacturing, distribution, and inoculation efforts are happening at rates never seen before. Despite the countless obstacles and dangers, the pharma industry managed to remain steadfast and put one foot in front of the other to get to where we are today – hopefully with COVID-19 in the rear-view mirror..
Let’s take a closer look at the numbers. We at ISR like to keep an eye on some specific core industry metrics. The line graph below puts the past year in perspective – the bottoming out of Q1 2020 to the explosive ramp-up between Q2 and Q3. Between Q1 and Q4, the number of industry-sponsored submissions for Phase 1 studies rose from 246 to 420. That’s a 70% increase. The number of submissions for Phase 2 and Phase 3 studies doubled: Phase 2 rose from 237 to 464; Phase 3 rose from 119 to 238. For an industry not known for its speed, this snapshot proves otherwise.
Sponsors can’t churn out the work alone. We know many companies turn to CROs for the heavy lifting of their clinical development programs. Finding the service provider best suited to meet trial needs and ensuring that provider can meet performance expectations constitutes the onerous and time-intensive decision-making process that companies take on if they need to outsource any or all components of their clinical trials. Every year, we survey hundreds of clinical development outsourcers to share their perspectives and experiences regarding Phase 1 and Phase 2/3 outsourcing activities and provider usage.
Add in the complexities of conducting trials during COVID-19 and you’ve got sponsors looking for providers who can pivot to nontraditional methods and solutions. One element we explore per our annual CRO benchmarking survey is outsourcers’ future expectations for their clinical development programs. How much deviation from the traditional clinical trial infrastructure do sponsors anticipate? And while we are hoping COVID-19 is in the rear-view mirror, this does not suggest that sponsors want these new tools to fade into the sunset with it.
Something still very much on the radar is remote/risk-based monitoring. Trials traditionally assess site performance via on-site monitoring, and they rely heavily on source data verification. Risk-based monitoring reduces the volume and frequency of source data verification, and is designed to focus on high-risk sites — those that flag with potential issues requiring verification. We asked 272 outsourcers their levels of agreement with the statement below. More than four in five respondents (87%) agreed that their organizations’ use of this type of monitoring will increase over the next two years. Sponsors want to have this at the ready in the future, regardless of a pandemic bearing down or not.
One respondent gave this complimentary reason for their overall satisfaction rating regarding the recent use of a Phase 1 provider: “Regulatory expertise, risk-based monitoring expertise, great clinical operational support, data management and biostats, and offering hybrid approach in terms of virtual trials, especially during COVID-19. Global knowledge of Phase 1 units and SME database.”
Conversely, others were not as fortunate with their Phase 1 provider experiences. One respondent shared: “Although the performance was quite good, they were not able to quickly adapt to COVID-19, and we had to move the trial.” And this respondent noted a change in performance: “The site has historically executed well, with quality project management. The site is experiencing turnover (likely due to COVID-19), which is understandable; however, scheduling of bed space has been problematic of late.”
In another ISR study looking at the use of EDC systems, we asked respondents what improvements they would like to see made to today’s systems. One suggestion was the addition of or enhanced remote monitoring capabilities to accommodate decentralized trials during the pandemic. Indeed, sponsors want the right tools for this new breed of trials.
We also learned whether virtual clinical trials and home-based trials will be a consideration for outsourcers two years from now. The interest in these types of decentralized or hybrid trials continues to hold. We speculate the effects of the pandemic on human interaction will not be short-lived. Undoubtedly, the terms “contactless” and “social distance” will linger in our lexicons for a while. And that’s OK. The cautious restoration of “normalcy” will be a marathon, not a sprint.
The charts below compare findings between the past two benchmarking studies (2021 n=272, 2020 n=329). This year, 58% of respondents slightly to strongly agreed with the statement that virtual clinical trials will be a major component of their organizations’ clinical portfolios within two years. This is an uptick of 10 percentage points since 2020.
Likewise, 48% of respondents slightly to strongly agreed with the statement that their organizations will run a trial within two years where the majority of activities occur in the participant’s home — an uptick of 11 percentage points since 2020.
These findings tell us that companies expect to break as needed from their traditional blueprints to pursue new ways of managing their clinical development programs. If they were not delayed or pulled due to the pandemic, clinical trials needed to go on during the past year. Patients and volunteers still needed to be recruited. Data still needed to be collected. Results still needed to be delivered. Phase 1 outsourcers gave more commentary on the effects of the pandemic on their trials and provider experiences compared to Phase 2/3 outsourcers. Perhaps this has to do with the timing of data collection (November-December 2020). Even so, CROs were presented quite a challenge this year — keeping all things and humans connected, even when it seemed impossible.