Pandemic Causes Drop in New Oncology Trials, But the Tide May Be Turning

The coronavirus 2019 (COVID-19) pandemic caused a 60% drop in the initiation of new clinical trials for anticancer therapies compared with prior years, according to findings recently published in JAMA Network Open.¹ However, lead author Elizabeth B. Lamont, MD, MS, MMSc, said that there is evidence that clinical research is bouncing back.

“Preliminary results suggest that there is a rebound in trial launches, or actually in enrollment and trial launches,” Lamont, an oncologist and senior medical officer of Acorn AI at Medidata, a digital analytics company based in New York, New York, said in an interview with OncLive®.“We think that that's likely due to a very nimble adaptation by the research and development enterprise globally.”

To assess the pandemic impact, Lamont and colleagues from the Johns Hopkins Bloomberg School of Public Health examined patterns from information in Medidata’s Rave electronic database, which includes 29% of all industry-sponsored interventional oncology trials during the 40-month study period. Overall, 7524 phase 1 to 4 clinical trials were launched worldwide during the 8 consecutive months from October through May over 5 successive years. Of these studies, 19.1% were for oncology-directed drugs or biological agents.¹

Investigators analyzed the distribution of trials that started to recruit patients during 5 launch periods, 1 of which included the “pandemic period” from January 2020 through May 2020. The figures for the pandemic period trials were then compared with those of the preceding 35 months.

In all, 191 trials were launched from October 2019 to May 2020, which includes the pandemic period. That was the lowest number recorded during the study period, representing a 60% drop in new trials compared with the prepandemic period (incidence rate ratio, 0.40; 95% CI, 0.28-0.55).¹ (Table)

By August 2020, the research community was showing signs of a recovery, according to a survey of investigators at more than 7000 research sites that Medidata conducted. Overall, 22.9% of respondents said the COVID-19 pandemic was having a “great deal” of an impact on initiating new clinical trials, while 25.2% said the impact was “moderate.”²

Nevertheless, Lamont said the most immediate effect of a reduction in clinical trial launches is likely to be a delay in approvals for new and novel agents, although there have been changes that may mitigate pandemic restrictions.

In March 2020, the FDA allowed investigators to make use of video conferencing to replace some face-to-face visits. Investigators were thus able to use technology to keep their trials going and to initiate new research.³

Clinical medicine was already adopting telemedicine prior to the pandemic, but the practice has skyrocketed during the past year. For example, approximately 13,000 beneficiaries in fee-for-service (FFS) Medicare programs received telemedicine services per week prior to the pandemic. In the last week of April 2020, nearly 1.7 million beneficiaries received telehealth services.⁴

In total, more than 9 million beneficiaries have received a telehealth service from March 17 through June 13, 2020, according to a Centers for Medicare & Medicaid Services internal analysis of Medicare FFS claims data. Services on the Medicare telehealth list including audio-only visits, as well as virtual check-ins and e-visits.⁵

That infrastructure is key to restoring clinical trial initiation, Lamont said. “Those tools existed before the pandemic and were put to use in a meaningful way in order to help facilitate this rebound that early analyses suggest has occurred.”

Like many oncologists, Lamont fears that, in addition to long-term disruptions in research, the pandemic will cause delays in cancer diagnoses that could mean that patients may have noire advanced problems when they do seek treatment. Findings from an analysis of a large medical claims clearinghouse database representing 5% to 7% of the Medicare FFS population published in November 2020 showed that cancer screenings were down 56% to 85% at the initial peak of the pandemic in April depending on the tumor type among older adults in the United States.⁵

Findings from another study found that weekly diagnoses of breast, colorectal, pancreas, gastric, and esophageal cancers were down across the board for March 1 to April 18, 2020, compared with January 6, 2019, to February 29, 2020.⁶ Norman E. “Ned” Sharpless, MD, director of the National Cancer Institute, said in an interview with Managed Healthcare® Executive that new cancer diagnoses in the United States dropped by 50% during the months after the onset of the COVID-19 pandemic.⁷

“Cancer screening has a prevention element,” Lamont said. “If, for example, colorectal cancer polyps aren't being removed, some of those polyps probably will become invasive cancers. Similarly, if a patient had a cancer a year ago, and there was no screening, that cancer could be more severe now than it would have been. That pushes everything in a bad direction.”

Lamont thought that 1 potential long-term benefit of increased use of technology to decrease the burden on patients enrolled in clinical trials would be an increase in participation. If joining a clinical trial requires less of a commitment of time and travel, more people, especially those who can’t drive or who live in underserved areas, may be able to participate.

“The more people we can get on trials, the better,” she said. “The more we can get patients who look like people who get cancer in the US on trials, the better. That makes the results more generalizable.”

References

1. Lamont EB, Diamond SS, Katriel RG, et al. Trends in oncology clinical trials launched before and during the COVID-19 Pandemic. JAMA Netw Open. 2021;4(1):e2036353. doi:10.1001/jamanetworkopen.2020.36353
2. COVID-19 and clinical trials: the Medidata perspective, release 9.0. Medidata. September 21, 2020. Accessed March 16, 2021. https://bit.ly/3tutXKR
3. Conduct of clinical trials of medical products during the COVID-19 public health emergency. FDA. March 2020. Updated January 27, 2021. Accessed March 2, 2021. https://bit.ly/3q8NiPx
4. Verma S. Early impact of CMS expansion of Medicare telehealth during COVID-19. Health Affairs blog. July 15, 2020. Accessed March 2, 2021. https://bit.ly/3e3Cwb8
5. Patt D, Gordan L, Diaz M, et al. Impact of COVID-19 on cancer care: how the pandemic is delaying cancer diagnosis and treatment for American seniors. JCO Clin Cancer Inform. 2020;4:1059-1071. doi:10.1200/CCI.20.00134
6. Kaufman HW, Chen Z, Niles J, Fesko Y. Changes in the number of US patients with newly identified cancer before and during the coronavirus disease 2019 (COVID-19) pandemic. JAMA Netw Open. 2020;3(8):e2017267. doi:10.1001/jamanetworkopen.2020.17267
7. Wehrwein P. U.S. cancer diagnoses fell by 50% in 2020 amid the pandemic, says NCI Director Sharpless. Managed Healthcare Executive.® February 19, 2021. Accessed March 2, 2021. https://bit.ly/2NTZWVz