The COVID-19 pandemic has turned our world upside down. Every aspect of our ways of life are experiencing unprecedented disruptions.
For the clinical trials community, we are seeing steep declines in patient enrollment and, in some cases, complete pauses of trials. A report from Medidata showed an 83 percent decrease in new patients entering trials in China in February 2020 compared to February 2019 and similar trends have been seen in other countries. In the first half of March this year, the U.S. has had a 62 percent decrease in new patients entering trials.
This pandemic has thrust clinical research into the limelight like never before and – while daunting and challenging – the scientific community is answering its collective call-to-duty with impressive vigor and determination. COVID-19 is literally changing the way the world does science.
Researchers and scientists are saying, according to the New York Times, “Never before have so many experts in so many countries focused simultaneously on a single scientific quest with so much urgency – exchanging information as it becomes available and launching clinical trials that rely on laboratories and hospitals from around the world.”
Developing a vaccine against COVID-19 and new treatments for those infected with the novel coronavirus is of paramount importance and we applaud those efforts. We must also do what we can to advance new and ongoing clinical trials for all medical products across all diseases and therapies in the age of the coronavirus pandemic. For some patients, participation in a clinical trial may be their last chance at extending or even saving their life. We owe them that chance.
On March 18, the U.S. Food and Drug Administration (FDA) released guidance “to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.” The European Medicines Agency (EMA) and Medicines & Healthcare products Regulatory Agency have also released similar guidance documents.
In response to the FDA’s new guidelines, the Clinical Trials Transformation Initiative, a leader in driving change across the clinical trials ecosystem, surveyed the research community about experiences and best practices on the conduct of clinical trials of medical products during the current COVID-19 crisis. The survey’s findings were presented along with shared experiences from a patient representative, academic medical center and independent IRB on a CTTI-hosted webinar on Mar. 31.
The survey’s findings, along with additional learnings from the webinar, identified the following best practices for conducting clinical trials during this pandemic:
- Keep Participants Informed
- Perform Ongoing Risk-benefit Assessment
- Communicate with IRB/IEC and Regulatory Authorities
- Pause (Most) New Study Starts & Enrollment
- Pivot to Remote Study Visits
- Switch to Remote Monitoring
- Document all changes with COVID-19 Tag
These best practices were released by CTTI this week as a free online resource.
During this pandemic, the clinical trials community is rising to meet the challenge upon us. Most immediately, we must respond to the urgent public health need to prevent, diagnose and treat COVID-19 and we must seize the unprecedented opportunity to collaborate and conduct clinical trials for a vaccine against this disease in the most efficient way possible. The clinical trials enterprise can also use this experience to adopt these more collaborative and innovative approaches as routine on a wider scale moving forward. Our ultimate goal is that we will drive for change that leads to further development of medical products currently under investigation and, as a result, saves lives.
This article was originally published by CTTI Executive Director Pamela Tenaerts on LinkedIn on 4/20/20.