The COVID-19 pandemic has shaken up clinical trials around the globe. Medidata recently released its analysis of 4,599 studies and 182,321 study sites to determine just how the effect of the virus has affected research, specifically patient enrollment, in a number of ways.
The results often held potential surprises. For example, China’s studies saw a 68% decrease in new patients entering trials in March 2020, compared to the previous year. However, this March’s new-patient enrollment was 240% higher than February.
The analysis also uncovered marked year-over-year decreases in enrollment by therapeutic area:
- Endocrine – 80%
- Cardiovascular – 70%
- CNS – 68%
- Oncology – 48%
Outsourcing-Pharma (OSP) recently spoke with Fareed Melhem, senior vice president of Medidata’s Acorn AI Labs, about the project, and what the figures might mean for the short- and long-term state of the clinical trial field.
OSP: Could you please tell us a bit about the data analysis—how you decided to tackle this analysis, how you determined the parameters, etc.?
FM: Medidata recognized that we had a unique, on the ground view into the performance of clinical studies and sites because of the number of studies we are running. Since we could track the evolving situation, we also realized that we would be well positioned to identify leading indicators of recovery and, from there, help with recovery planning.
We focused on subject accrual and patient visits first to understand how patients are being impacted. With subject accrual, we are able to track how many new patients are being screened and entering trials, and with visits we can track if patients currently enrolled in trials are making their scheduled visits and maintaining their participation.
OSP: Could you please share some of the things you anticipated you might have found prior to starting the analysis, and how results matched up with expectations?
FM: With the announcements of study starts being halted by major pharma companies, as well as regional lockdowns, we expected that new patients entering trials and visits would drop as COVID-19 spreads across the globe. Our data reflects this – in March we saw an average decrease of 65% in key markets across the globe in subject accrual year-over-year, and a decrease of about 17% in visits per subject.
OSP: Next, could you please share some of the most interesting findings?
FM: We have seen some differences in how therapeutic areas are affected. For instance, in oncology, we saw a less severe drop in subject accrual, down 48% in March year-over-year, compared to the 65% drop we saw across the industry.
But we are also encouraged by how certain areas are showing signs of recovery. China, for instance, went from a significant decline in subject accrual in March compared to the prior year (68%), to a less steep decrease in the first two weeks of April compared to the prior year (39%).
OSP: Looking at the overall findings, how do they point toward a need for solid and rapid solutions for clinical trials?
FM: Due to the recent disruptions and challenges posed by COVID-19, there has been a large increase in activity promoting the use of technology in clinical trials. Medidata has solutions that can be immediately leveraged by our customers to both better understand the impact of the pandemic on their trials, and to mitigate the challenges of patients unable to visit sites for their drugs and protocol-directed clinical and patient-reported data capture.
And, regulators and stakeholder groups are expressing pragmatism and flexibility in terms of mitigating when possible. Common topics include triggers for protocol amendments and deviation processes, risk assessment expectations, continuing or halting a trial, continued subject participation, informed consent – including eConsent (FDA), and remote monitoring.
In addition, eventually sites will have to dramatically accelerate patient enrollment in order to catch back up with the lost time.
OSP: How can Medidata help trials move forward (regarding continuing with existing trials, and to start new ones) in the face of the pandemic?
FM: We see four main categories of challenges facing clinical trials: understanding the evolving situation, reconsidering trial design to enable data capture, maintaining quality and supply, and accelerating study start up. Medidata has solutions to address each of these challenges; from study/sponsor-level dashboards that offer deep insights into metrics and trends, to virtual trial solutions and synthetic controls, to centralized data oversight and monitoring activities.
We can help our customers better understand the ongoing overall impact on their trials, help to identify risk areas, closely monitor patient volume and drug supply to minimize supply disruptions, and safely and effectively accelerate study start up times so cures and treatments can get to market faster.
OSP: In the long term, how do you think lessons learned during the pandemic might impact trials—how they’re operated, designed, how data is collected, patient participation, etc.?
FM: Many of the solutions being deployed today to help virtualize and simplify trials have been in use for a number of years. But COVID-19 is accelerating the adoption of these technologies, and the lessons we’re learning will certainly be valuable and helpful to patients and clinical development well beyond the pandemic.
OSP: What else would you like to add?
FM: At the end of the day, we are all focused on helping patients, and ensuring that they can participate in trials and receive treatment in a safe setting. This means helping pharmaceutical and biotechnology companies get trials back on track as fast as possible, understand and adapt to the evolving COVID-19 environment, and make decisions around where and when to start-up trials again.