Ovarian Cancer and a New Era for Clinical Trials

April 20, 2021 9:00 am

The following article is provided by The Clearity Foundation to support women with ovarian cancer and their families. Learn more about The Clearity Foundation and the services we provide directly to women as they make treatment decisions and navigate emotional impacts of their diagnosis.

Clinical Trials

At Clearity we are intent on bringing the future of ovarian cancer treatment to women today. It’s exciting to have the opportunity to work with other organizations who share our vision. Teckro’s goal is to make clinical trials more accessible, transparent and simple through their suite of clinical trial software. In this blog post Brendan Buckley, MD, DPhil, Teckro’s CMO, shares his thoughts on how COVID-19 has shaped clinical trials and why he is hopeful for the future.   

We also invite you to tune in to Teckro’s Women in Leadership podcast series and hear from Clearity’s Executive Director, Hillary Theakston and Board Chair, Sabrina Martucci Johnson about their unique experiences in the biotech industry.

By Professor Brendan Buckley, MD DPhil  Chief Medical Officer,  Teckro

Since COVID-19 was declared a pandemic over a year ago, the need to transform traditional approaches to drug development and clinical trials has never been clearer. When clinical trials couldn’t depend on the physical presence of all participants or indeed staff at trial sites, what was the fall-back plan for those vulnerable patients requiring care?

The reality is that the clinical trials industry (like many industries) wasn’t equipped to handle the level of disruption presented by COVID-19. As a result, we’ve seen the clinical trials industry move quickly to more remote operation. Yet, this forced jump was very needed to push the industry out of the time warp where it has been stuck – to finally move into the 21st Century. Consider that when I became an investigator in my first trial in the early 1980s, I used essentially the same processes that were used up to a year ago. With the exception of electronic data capture systems, trials still rely, now as then, on the same reams of paper documentation, manual processes, laborious weeks-late error detection and slow communication.

It’s such a stark contrast to our normal daily lives, where most of us rely on our phone for instant communication and information. For example, it is wonderful that I can see a video within seconds of a grandchild taking his first steps in a different continent. But if I contrast this to clinical trials, it may be 15 days before I become aware of a suspected unexpected serious adverse reaction that occurred in a trial that I’m supervising. As I am writing from the other side of the Atlantic Ocean in Ireland, it is interesting to note that 15 days is the length of time it took for news of Lincoln’s assassination to get to London in 1865!

Uptake of Technology 

The truth is that old habits die hard. Great upheavals, such as pandemics, drive technological advances that don’t happen during complacent ‘peacetime’. The accelerated development of vaccines over the last year showed what can be done if there is a forced determination to evaluate existing practice and to discard that which is slow, less relevant, bureaucratic and merely customary.

Technology certainly has a role to play in the transformation of clinical trials. There has been plenty of talk in the industry over the last few years about decentralized and hybrid settings for trials.  These approaches can offer a more patient-centric approach with fewer clinic visits, reducing the burden on participants. They may also help to increase diversity.  The pandemic certainly required implementation of much decentralization as a vital response to the existential challenge to many trials, including those of COVID vaccines.

However, the old structures of the ‘clinical trial bureaucracy’ persist and when the pandemic has passed, there is a risk that we see a return to bad old ways. Yet, I’m hopeful that putting a spotlight on the inefficiencies and risks of the “old” ways will encourage a sustained changed and that together we can insist on better when it comes to drug development and clinical trials.

Getting Cancer Trials Back on Track

Of course, with all the talk about COVID, we must not forget about the other ‘Big C’ - cancer. I know this is close to the hearts of those of you involved with the Clearity Foundation. Unfortunately and probably not surprisingly, COVID has had consequences on cancer clinical trials. For example, it’s estimated that in March 2020 around 80% of non-COVID trials were forced to shut down.  Between January and May 2020 new clinical trials for cancer drugs and biological therapies fell by 60% – although thankfully much recovery has occurred.

I probably don’t have to tell this audience that this is a problem. Cancer trials tend to be more complex than non-cancer trials and stringent patient inclusion criteria and slow enrollment mean success rates for cancer that are much lower than the 15% or so for non-oncology trials. A Probability of Success (POS) study by Oxford Academic in 2019, showed success rates for cancer trials as low as 3.4%. And as cancer deaths are the second leading cause of death globally, clinical trials must not be further delayed.

Ovarian Cancer and Clinical Trials

Hard-to-detect cancers, such as ovarian cancer especially require faster and more efficient trials. Ovarian cancer has the lowest survival rate of all gynecological cancers with just 24% being diagnosed early, concealed by “hidden” symptoms. During the pandemic, this is especially a problem with many women suffering from symptoms but putting off getting themselves checked. This means they are receiving diagnosis even later than they would have previously, which can make treatment even more challenging.

Access to clinical trials should be a right of all women, but half of physicians do not offer trials to their patients. The Every Woman Study Summary Report published by the World Ovarian Coalition in 2018 asked 1,500 women across the world about their experiences with clinical trials, discovering that 80% of women would be willing to travel to another hospital to take part in one. This tells me the desire is there among women to participate in clinical research. But there is the other aspect of encouraging more physicians to participate in clinical research so that more women have access closer to them.  There is a concept of “one and done” where half of physicians who run a clinical trial won’t run another one. The reasons why vary, but I would like to think as an investigator myself that if we can make running clinical trials less of a burden with complex, antiquated approaches, it would attract more physicians to participate in clinical research. In turn, this means more trials will be accessible to more women.

I am hopeful for the future. Now we have seen just how quickly clinical trials can adapt, there should be no going back to the old ways. Times have changed and we have seen how the industry can adapt when necessary. We need to focus on getting cancer trials back on track and when it comes to hidden cancers like ovarian cancer, the fast uptake of new technology would be a positive change to propel forward clinical trials that hold the potential for life saving treatments. The good news is that the technology we are talking about to move clinical trials forward isn’t something so futurist or foreign. It exists today. And in fact, we are never really far from it. The key rests with our smartphones and other digital devices that have already been invented.

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