Understanding the difference between research on cancer and COVID treatments
By Kathryn E. Vinson, MS, CCRC
What About Us? The novel coronavirus. SARS-COV-2. COVID-19. “The Rona.”
Unless you’ve been hiding under a rock for the last couple of months, you’ve undoubtedly heard of the virus that has wreaked havoc on not only our health and medical facilities but also our economy. Every day our social media feeds are full of articles describing research that is being fast-tracked through trials all over the world. The data coming out of some of these studies seems phenomenal. Some of these claims are legitimate, some are misleading, some are just straight up bogus.
But with all of these news reports, many cancer patients (and folks with other life-altering medical conditions) are thinking, “Uh, why is this being fast-tracked? What about the disease that I have!?” There isn’t a simple answer to this, so let’s take some time today to talk about what is involved in fast-tracking drug/device approvals, what is happening in COVID-19 research, and how cancer research has been impacted by this fiasco.
What is fast-tracking?
Under FDA guidance, fast-tracking is “…a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.” With that definition in mind, we can see that the novel coronavirus fits this to a T.
A quick perusal of clinicaltrials.gov shows that a great number of trials for COVID-19 treatments are already in phase 3 studies. I know – I’ve mentioned before how long it takes to get drugs through clinical trials to the approval stage, and phase 3 is the last stage before approval. What you have to understand about this is that a large number of these trials that are already in late-stage are on medications that have already been approved for other indications. These drugs have already been tested in pre-clinical and clinical settings for safety and tolerability. They are simply seeing if they can use it to treat COVID-19. Are they on a fast track? Probably so – but, they didn’t skip the line, so to speak.
We hear a lot about vaccines being developed for the prevention of COVID-19 as well. These studies are definitely in phase I status, with a couple that has progressed to phase II. A vaccine is where herd immunity will come from. To have the beautiful thing known as herd immunity, we need 92% of the population to have antibodies to the virus – that level of immunity isn’t seen often, or at all in many cases, without a vaccine. So, to protect immunocompromised individuals, we really need a vaccine for this nasty monster.
Cancer research in the times of COVID
Clinical research has really taken a hit during this pandemic. Both the FDA and the EMA (and other regulatory bodies around the world) have issued guidance to clinical research sites and sponsors on continuing ongoing research and on whether new trials should commence. The biggest thing that I got out of reading both documents is that safety remains our first priority. The safety of our volunteers/participants, the safety of the trial staff, and the safety of the community. There are a lot of changes that have been approved for use during this pandemic, including allowing participants to utilize video conferencing/telehealth instead of going into a clinic for scheduled appointments; using home delivery services for distributing study medications; allowing home healthcare service providers and local labs or imaging services.
One of the biggest issues that are coming up is that in many locations, the trained study staff have been pulled to work as essential service providers (think research nurses, physicians, and physician extenders). With the loss of trained study staff, many trials have had to be put on hold. Rest assured that if you are currently enrolled in a clinical trial, that the study staff is making informed decisions about how to most safely proceed with your care – whether to continue the trial in a modified format or how to safely withdraw you from the study. None of these decisions are made lightly.
With that being said, many cancer-related clinical trials are still ongoing – with the drugs listed as a priority under “breakthrough therapy” status. This is a study designation where the investigational medication is thought to offer better outcomes than existing therapies.
My message today is this: don’t lose hope. Researchers are still working on trials. There are over 74,000 cancer clinical trials for various types of cancer that are being conducted worldwide. You are not forgotten in this pandemic. Also, remember that the research on the pandemic will help protect you.
As always, much love, many prayers, and abundant blessings to all of the warriors out there!!