In an article for Applied Clinical Trials, Bass, Berry & Sims attorney Clint Hermes examined the dramatic impact of the COVID-19 pandemic on clinical trials in low- and middle-income countries (LMICs). According to clinical trial registrations on the WHO International Clinical Trials Registry Platform and clinicaltrials.gov, there has been a significant and growing number of clinical trials conducted in LMICs, with major centers in Eastern Europe, the Middle East, Brazil, China, India, and South Africa.
Even without the COVID-19 pandemic, LMICs face many challenges in conducting clinical trials. In the article, Clint outlines five critical challenges faced by researchers conducting clinical trials in LMICs, including:
- Regulator guidance.
- Unavailable participants.
- Monitoring visits.
- Informed consent and ethical issues.
In addition, Clint points out that “For those LMICs without regulatory guidance, following the general principles articulated in FDA’s guidance is advisable to the extent possible. Participant safety must be the priority, so when trials are started or ongoing during the pandemic, decreased in-person study visits and monitoring should be implemented wherever possible.”
The full article, “Five COVID-19 Related Challenges for Trials in Low-to-Middle Income Countries,” was published by Applied Clinical Trials on May 27 and is available online. The content is scheduled to publish in the June 2020 print issue. For additional information about conducting research during the COVID-19 pandemic, please read the resource authored by Clint and fellow Bass, Berry & Sims attorneys, “Resource for Organizations Conducting Research in the Developing World Amid COVID-19 Pandemic.”