The coronavirus pandemic has brought much of the world to a near standstill. However, clinical trials cannot afford to slow down, at the risk of delaying or stopping development of much-needed treatments and therapies.
Outsourcing-Pharma (OSP) recently discussed with Fareed Melhem (FM), senior vice president of Acorn AI Labs at Medidata, the ways in which COVID-19 is affecting clinical research, and how pharma companies and their study partners must adjust to keep up.
OSP: Your team has been monitoring the clinical trial landscape since the onset of the pandemic. Could you please share some of the key ways studies have changed since COVID-19 landed?
FM: We’ve seen significant impact on clinical studies. With restricted movements and lockdowns implemented across the globe, patients entering studies dropped from 50% to 80% depending on the indication.
We’ve also seen a significant increase in missed visits; with this impact, clinical trial teams are having to reconsider their approach to trials. This starts with understanding the landscape and the impact study by study and country by country.
We are also seeing a move to technologies that enable virtualization of trials; these include, for example, electronic consent solutions, telemedicine, and data capture for remote visits. We will also need to move to much more centralized oversight and monitoring of trials to appropriately manage patient safety and data quality as monitors have not been able to physically get to sites.
OSP: In your latest update summary, you remark that “the situation is both dynamic and dramatically inconsistent.” Please take a moment to explain and elaborate.
FM: As outlined in the latest ‘COVID-19 and Clinical Trials: The Medidata Perspective’ [page 18] paper, the situation with COVID-19 is ever-changing. This is due to the continuous spread of the disease, differing national and regional governmental responses, and variation in testing and tracing capacity.
Together, this means the ability of patients to participate in trials and go to sites is continuously changing and presents challenges to companies executing trials across the globe.
At Medidata and Acorn AI, we are working to help our customers navigate this pandemic, keep trials on track, maintain the safety of patients and site staff, and ensure high-quality data.
OSP: In what ways do the changes in trials across geographical areas differ—i.e. AsiaPac compared to the US and Europe?
FM: Changes to trials across geographical areas differ for several reasons. First, geographical areas have been affected to different extents, as have the responses to the outbreak; this has led to varying impact on the ability to recruit and enroll new patients, or maintain open sites.
Additionally, there is varying regulatory guidance in countries, which impact the actions companies can take to modify their trials. This means that even within geographic areas such as Europe, the impact on trials differs, with the UK lagging behind other European countries in terms of a recovery for example.
Similarly in APAC, China was the first country to suffer major impacts from COVID-19 and has since been on an upward trajectory, while other countries such Japan were affected later and have only recently started to recover from the impact.
OSP: Please tell us about patient enrollment and retention trends—how has that area changed since the pandemic began?
FM: Given the challenges of the pandemic, it became much harder for new patients to enter studies and make visits. Globally, we saw the largest negative impact on new patients being able to enter trials in April; since then, we have seen a steady aimprovement.
However, this impact varies greatly by geographic region and also by therapeutic area (TA). For instance, oncology has been the least impacted TA - we saw a ~40% decrease in new patients entering study-sites for Oncology in April, as compared to the first half of 2019.
This jumped significantly in June, with a 10% higher average number of new patients entering study-sites in June versus the first half of 2019; this is likely driven by a patient backlog as more sites re-opened. Other TAs have recovered from the April lows but are still performing significantly worse compared to the first half of 2019.
OSP: Please share how different technologies are impacting clinical trials.
FM: We outline four main areas where technology can make a significant positive impact on clinical trials in our White Paper, ‘COVID-19 and Clinical Trials: The Medidata Perspective’:
- Data and analytics that allow companies to better understand the evolving situation and agilely adapt by identifying where to focus efforts, and when / where to engage sites
- Tools to enable data capture through electronic means and increased virtualization such as electronic consent, electronic clinical outcome assessment (eCOA), telehealth, and medical wearables
- Synthetic control arms, i.e. computer simulated control arms derived from clinical data from previous trials, to reduce patient enrollment needs
- Centralized oversight and analytics to maintain the quality of a trial.
OSP: If you could gaze into your crystal ball, please look ahead and share how you think the clinical trial landscape might look different in the near and/or distant future.
FM: Clinical trials are going to continue to adapt to become more patient centric and reduce burden on both patients and sites in a way that will allow research and scientific progress to continue, even in the circumstances of a global pandemic. The pandemic has accelerated the pace of change and adoption of technologies that have existed for several years, and Medidata expects this to continue in the future.
OSP: Similarly, what adaptations to the pandemic’s impact might trial teams forego once the virus is under control, and what do you think might be here to stay?
FM: The likelihood is that this pandemic will continue to have a direct impact on the industry at least for the next year and perhaps longer. Medidata believes that many of the investments that are being made in technology today are likely to stay for some time.