More Than 200 International Cancer Trials Suspended Due to COVID-19

Roxanne Nelson, RN, BSN

May 22, 2020

Editor's note: Find the latest COVID-19 news and guidance in Medscape's  Coronavirus Resource Center.

The COVID-19 pandemic has disrupted clinical research across the globe and has had a significant impact on patient enrollment in oncology clinical trials in the US and Europe, and to a lesser extent in Asia.

An analysis of data from ClinicalTrials.gov showed that more than 200 interventional oncology studies were suspended in March and April as a result of the COVID-19 crisis.

Plus, results from a new survey showed that 60% of institutions in the US and 86% in Europe are enrolling new patients at a lower rate. Several barriers to enrollment were cited, including access during lockdown, investigator concern about patient safety, potential lack of research staff, and cancer treatment type/route of administration.

The findings were published May 18 in Nature Reviews Drug Discovery.

"We wanted to look at and understand what was happening in clinical trials across the country and bring to it a third-party, unbiased viewpoint," said coauthor Vanessa Hubbard-Lucey, PhD, MBA, director of the Cancer Research Institute (CRI)'s Anna-Maria Kellen Clinical Accelerator and Venture Fund programs. The CRI is a nonprofit organization that exclusively funds innovative clinical and laboratory research in cancer immunotherapy.

"This is a snapshot of the situation ­— enrollment went down or was suspended and we wanted to understand what the impact was, and what people were doing to mitigate those impacts," she said. "Our hope was to try and provide a guidepost or blueprint for the future."

Facing Challenges

For their study, Hubbard-Lucey and colleagues conducted a survey of 36 investigators (between March 23 and April 3) who are conducting cancer-related clinical trials at institutions in several countries. In a separate analysis, IQVIA, a healthcare data analytics firm, examined a subset of more than 200 of its oncology clinical trials to identify major risks that may be affecting the trials.

At the time their survey was conducted, patient enrollment in clinical trials had significantly declined, especially in the United States and Europe. Only 20% of institutions in the US, and 14% in Europe, continued to enroll patients at the usual rate. In contrast, the situation in Asia was considerably different, with 60% reporting that enrollments rates had not changed.

Among institutions that continued to conduct trials with lower enrollment rates, 23% cited patient care (as reflected by a comparison between in-patient and outpatient settings) and the type of cancer therapy, including route of administration, as two of the top key considerations negatively affecting patient enrollment. Other concerns included those about patient safety and a potential lack of research staff and resources.

Investigators also emphasized that assessing the risk vs benefit was the fundamental consideration for patients in ongoing trials, the authors note.

For initiating new trials, similar trends were noted, with patient care, cancer therapy type, and route of administration of the therapy being at the top of the list of considerations. Investigators were also concerned about therapy that required intravenous administration as compared with oral therapies, because oral drugs could potentially be self-administered at home.

Regulatory/Operational Considerations

The authors also looked at how investigators were dealing with new regulatory and operational challenges, as patients with COVID-19 illnesses began to overwhelm medical infrastructures. They found that almost 60% of investigators reported that COVID-19 had "moderate" or "high" impact on causing delayed or cancelled patient visits, and about 80% stated that they anticipated protocol deviations would cause unresolved queries, such as incomplete patient visit data.

Investigators reported using different tactics in order to work around operational challenges while ensuring patient safety. These included adopting or planning to adopt technology-based interventions that could decrease on-site monitoring visits and in-person patient visits, such as telemedicine (82%), alternative locations for assessments (73%), remote electronic health record access for monitors, and virtual monitoring of data and study documentation (73%). Others reported approaches such as shipping oral drugs directly to patients (64%) and avoiding immunosuppressive treatment regimens (73%).

IQVIA Analysis

The separate analysis of a subset of IQVIA-run oncology clinical trials showed that milestone delays (16%) were the most reported risk as a result of the COVID-19 pandemic. Causes of these milestone delays are predicted to be delays to site activation, enrollment, patient visits, and/or data collection and cleaning.

In addition, data from ClinicalTrials.gov revealed that more than 200 interventional oncology studies were suspended in March (n = 62) and April
(n = 139). Of these trials, 29 were phase I, 72 phase II, 11 phase III, and the remainder classified as other.

"Maybe we can learn something from this for the future," said Hubbard-Lucey. "From a clinician point of view and from the hospital's viewpoint — what can we do to make it easier to get patients into trials? I hope that there is a positive twist to all this, and maybe we can learn how to improve trials."

Hubbard-Lucey is a scientific advisor and has equity interest in Fx Biopharma. The other authors have disclosed no relevant financial relationships.

Nat Rev Drug Discov. Published online May 18, 2020. Full text

For more from Medscape Oncology, join us on Twitter and Facebook

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....