By Carolyn Crist
NEW YORK (Reuters Health) - The number of oncology clinical trials that launched globally during the first half of 2020 declined by 60% as compared with previous years, according to a new study.
The findings add to evidence that the pandemic may have long-term indirect effects on cancer treatments, drug development and new therapies, researchers write in JAMA Network Open.
"The pandemic's enormous, immediate direct impact on global health and welfare is tragically clear. It is also clear that the immediate impact is compounded by less direct or collateral effects," said lead author Dr. Elizabeth Lamont of Acorn AI by Medidata, a Dassault Systemes company in Boston.
Researchers have already seen that people are delaying care for cancer, heart attacks and strokes, she said. Delayed research and development could extend the negative consequences of the pandemic for years to come.
"It's important to understand the size of the pandemic's impact on non-COVID-19 clinical trials initially and over time," she told Reuters Health. "Beyond its immediate threat to public health, the COVID-19 pandemic exerted additional health threats through decreasing the pace of scientific research in oncology, an area separate from infectious disease."
Dr. Lamont and colleagues at the Johns Hopkins Bloomberg School of Public Health compared the number of trials launched during the beginning of the pandemic with the number of trials launched before the pandemic. They analyzed clinical trial data from the Medidata Enterprise Data Store, which includes studies that use the RAVE electronic data capture platform. About 29% of the world's industry-sponsored interventional trials for oncology drugs are hosted on the RAVE platform.
The research team included launches for phase-1 through -4 oncology trials of drugs or biological agents that opened for patient recruitment between October and May over five years. They considered January through May 2020 to be the pandemic period and the 35 months before that to be the pre-pandemic period.
During the five-year span, more than 7,500 trials were hosted on the RAVE platform, including 1,440 oncology trials in 91 countries. In 2015-2016, 229 trials were launched, followed by 304 in 2016-2017, 340 in 2017-2018, 376 in 2018-2019 and 191 in 2019-2020.
Overall, the research team calculated a 60% decrease in oncology trial launches during the January to May 2020 pandemic period.
A limitation of the study is that the research team couldn't pinpoint the exact reasons why the number of trial launches decreased, though it was likely due to travel restrictions and public-health measures to prevent the spread of the virus. Based on Medidata's ongoing surveillance, trial launches are increasing again.
"The good news is that research and development in oncology and other areas appears to be rebounding following the initial COVID-19 wave, with more trials opening and increased numbers of patients enrolling in them," Dr. Lamont said.
Researchers adapted during the second half of 2020 by collaborating with new partners and using telehealth technology to work with clinical trial participants through virtual trials, she said.
"It's expected that these novel approaches will outlive the pandemic to improve patients' experience with clinical trials more broadly," she said.
In 2021, researchers will also look at the other factors that affected cancer trials and drug development during the beginning of the pandemic, such as the reallocation of hospital resources to care for COVID-19 patients and clinical-trial enrollment.
"Clinical trials have helped to improve the prospect of millions of patients with cancer. For most patients with cancer, participation in a clinical trial is the best option," said Dr. Mustafa Khasraw of the Duke University School of Medicine in Durham, North Carolina. Dr. Khasraw, who wasn't involved in the new study, has written about the changes in oncology clinical trials during the pandemic.
"We have now learned to adapt better to 'live with the virus,'" he told Reuters Health by email. "The pandemic has taught us how to be more versatile so that we continue to offer patients with cancer the option of participating in clinical trials that not only give hope to patients who participate but also help others to learn more about cancer and to find better treatments and cure."
SOURCE: https://bit.ly/3atxZwj JAMA Network Open, online January 27, 2021.