By now, the novel coronavirus (COVID-19) has completely taken over news outlets, social media, and even our daily conversations. As the coronavirus makes headlines, it continues to raise more questions, especially for people with colorectal cancer on a clinical trial or those hoping to enroll in one.
What Does COVID-19 Mean for Colorectal Cancer Patients on Clinical Trials?
Because there are many uncertainties surrounding COVID-19, we reached out to Dr. Scott Kopetz, M.D., Ph.D., FACP, at MD Anderson to provide his thoughts on what patients on clinical trials can expect in the coming weeks and months, and how it will ultimately affect the course of treatments.
As a Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, Texas, Dr. Kopetz provided wonderful insight into what patients can expect, and advice moving forward. Watch the interview below to hear what he has to say.
For a full overview on colon and rectal cancer and coronavirus, make sure to read more here!
According to STAT news, the novel coronavirus will likely impact over one-third of clinical trial sites. Barriers that could affect typical trial operations include site closures, supply chain interruptions, and site personnel becoming sick with COVID-19.
Additionally, those running clinical trials are concerned that due to quarantines or not wanting to leave their homes and travel to a site, patients will be less likely to enroll in a new clinical trial, or that patients already enrolled will be more likely to drop out.
Recognizing the challenges that the coronavirus may cause, the Food and Drug Association (FDA) released a guidance statement on COVID-19 for clinical trial sites on March 19, 2020. Their recommendations stress that the main goal of trial sites should be the safety of all trial participants. Knowing that sites will likely encounter a range of difficulties, the FDA suggested the following:
- Keep patients informed of any and all changes.
- Trial sponsors may decide to continue/discontinue trials based on safety.
- Explore alternative visit methods (phone/virtual). Are in-person visits necessary?
- For those who cannot access their trial, there should be additional safety monitoring.
- Document everything! Alternative processes, restrictions that led to changes in the study, who and how patients were impacted, and describe any missing data.
- Sites should engage as soon as possible with the Institutional Review Board (IRB) if any trial protocol changes.
- Consider virtual assessments; are there alternative ways to collect specimens?
- Establish policies and procedures to describe approaches to manage the study during COVID-19.
How Have Sites Been Affected Already?
UPDATE: May 1, 2020 – Certain companies are beginning to start clinical trial recruitment, including new studies, on a site-by-site basis where health authorities allow recruitment to continue. This is based on the observation that disease burden varies from state to state and even within counties.
Many pharmaceutical companies are continuing clinical trials for patients that have already been enrolled but pausing additional recruitment for the time being and/or delaying the start of new trials. Other companies are making exceptions for trials that target patients with life-threatening diseases who have no additional treatment options, and others are continuing to recruit new patients that meet specific criteria.
Last week, James Doroshow, MD- a Senior Investigator at the National Cancer Institute (NCI) spoke on the NCI Board of Scientific Advisors meeting and said that clinical trial enrollment has fallen off between 30 to 50 percent for a range of government-sponsored clinical trials.
UPDATE 4/17/20 – In response to the effects COVID-19 has had on clinical trials, the NCI has begun to make modifications in the last two weeks including:
- Patient care can be transferred to other sites (so patients don’t travel for treatment on trial)
- Local healthcare providers can provide oversight
- Shipping patients their pills instead of having patients pick them up
- Allowing local providers to provide infusions, collect biospecimens and do lab work
In addition, the Central IRB is now allowing remote informed consent for patients enrolling on trials.
As news of the coronavirus changes daily, we will continue to update our resources to bring you the most timely and relevant information. We know that these are unprecedented times, but Fight CRC and our medical community will remain here for you.
To learn more about the policies that affect COVID-19 and cancer, check out our blog.