Save Sites Now to Preserve the Future of Clinical Trials

Gen Li, PhD, is CEO and founder of Phesi, a clinical development analytical products and services provider, which features a clinical trials database of 330,000 completed clinical trials, 604,000 completed research projects, 4.2 million physicians, and 1.8 million investigator records. Recently, Phesi analyzed data from 300,000 global sites to assess the current COVID-19 situation, which showed a 10% increase in site

Gen Li

222 suspensions over the past two months. This coincides with the effects of worldwide shutdowns, which have seen day-to-day life disrupted beyond recognition. In the following Q&A, Dr. Li shares his insights from the data.

What are the implications of clinical trials sites being suspended for progression of R&D projects?

Gen Li: There are several significant implications. Firstly, the time and money involved-it costs at least $30,000 to activate a site and takes an average of 100 days for an investigator site to be operational. Even temporary closures are an issue because a site continues to incur infrastructure costs without any revenue, which can lead to permanent closure. Secondly, the impact on patients and participants is clear-particularly those with underlying health conditions. Thirdly, there’s the impact on the quality of the study itself -inevitably some patient data or results will be lost, and this data discontinuity will cause additional package approval challenges in the future.

How can biopharmaceutical companies deal with the COVID-19 challenge and why should they keep funding clinical trial sites?

Li: Sponsors need to keep sites operational to avoid the worst of these implications and mitigate the long-term impact of COVID-19. This means continuing to fund even suspended sites. Interim payments will be a relatively small amount of outlay for a large biopharmaceutical company or CRO, but will make a huge difference to the site itself. At the same time, I agree with the call from the ACRP (Association of Clinical Research Professionals) and the SCRS (Society for Clinical Research Sites) for sponsors to relax rules around holdback funds and contracted milestones. While the virus is dominating agendas now, other projects must also be protected, and as the immediate crisis transitions into a semi-permanent state, sponsors must recognize the importance of continued funding of non-COVID-19 related trials.

You recently produced an analysis of the symptoms of 3,395 COVID-19 patients in 10 countries. Though this is a small data set, what can we learn from it when it comes to designing clinical trials?

Li: The key is using real-world data to inform trial design. For instance, it will be of interest to those in healthcare and clinical development, who have a good level of knowledge but sometimes receive confusing and/or conflicting stories, like the risk factors leading to the disease. The data also indicate that a high percentage of patients lack symptoms-only 64% have a fever, despite it being the most prominent symptom of COVID-19. For those ‘in the trenches’ of planning and designing COVID-19 trials, the value of using real-world data to guide protocol design and design optimization is evident.

What does it mean to take a “data-driven” approach to guiding protocol design and design optimization? Why is this important for COVID-19 clinical trials?

Li: We don’t have the luxury of time when it comes to COVID-19, and, indeed, future novel infectious diseases. So, the biopharmaceutical industry must become “data-driven” and make use of the large volumes of data available to it, to minimize inefficiencies and accelerate the time to results. Artificial intelligence will be central to this-automating analyses of large data sets will augment human researchers’ skills and lead to better clinical trials, from protocol and trial design to recruitment and management.

What are your concerns for the long-term impact of COVID-19 on clinical trials infrastructure?

Li: Social distancing in some form will continue throughout 2020 and potentially beyond, so rapid action is needed to minimize the long-term impact of the pandemic on trials infrastructure. 

Drug development sponsors must consider the bigger picture-the impact of COVID-19 is not just a challenge

for the site operator, it is a challenge for the whole industry. 

To avoid even more upheaval in the future, biopharmaceutical companies need to help their partners to keep functioning, protecting trial outcomes, and maintaining their integrity. Safeguarding existing projects by continued funding will be essential for when we do emerge from the other side of the pandemic.