By Benjamin Ross 

August 31, 2020 | The COVID-19 pandemic has forced clinical trial sponsors and sites to think outside the box, offering innovative services to help patient recruitment, sample collection, and other phases of clinical research. Industry leaders and CEOs are stepping up as well, offering their services to the community and sharing their perspective on how the industry can manage its way through the murky waters of quarantines and social distancing. There’s also another voice that needs to be considered: namely, that of the patient. 

It’s a topic TJ Sharpe has been concerned with for years. A survivor of Stage 1 melanoma, Sharpe is now a patient advisor for TransCelerate, working with both patients and researchers to find ways to improve the patient’s experience in research. Sharpe tells Clinical Research News that COVID-19 has exposed some warts in the industry, such as regulatory hurdles that would slow down innovation and the adoption of tools that could change the industry, like decentralized trials or telemedicine. 

“It takes $1 billion and more than 10 years to get drugs to market,” Sharpe says. “Now [with COVID-19], we’re talking about getting a drug to millions of people in the span of months.” 

The industry has been hesitant to adopt new approaches because they were viewed as either too risky or there was pushback from a compliance perspective, Sharpe explains. “Those hurdles have been significantly reduced because the urgency is here to get something done. I’ve seen a number of places in the industry that have been affected to where we can more quickly and effectively bring medicine to the patient faster.” 

Sharpe says innovation is something the patient advocacy community has been seeking for years with little headway. It’s been encouraging to see the industry adopt new ways to run clinical research: ways that accommodate the patient’s needs. 

“We, as patient groups and advocates, have seen them respond to a different type of pressure besides patients just shouting at them,” Sharpe says. “They’ve responded to a global crisis in ways they didn’t before: patients talking with sponsor companies and sites about ways to make their trials more patient-friendly, how to encourage enrollment. All of those things have been laid bare a little bit, and you see that, yes, we can recruit for a trial in a matter of weeks instead of months or years. And when hurdles are removed and the public is educated about clinical research, guess what? We have enough infrastructure and certainly interest to move the needle to change how effective medicine can be and how important clinical research can be in offering something to a patient.” 

Sharpe says the patients he’s spoken with in the last few months have noticed the industry’s efforts. 

“One of the big things I’ve seen is the number of patients who have posted on social media how their healthcare provider has so quickly adapted to telehealth and has gotten over the initial speed bumps of  measuring safety when bringing someone into a risky environment,” he says. “This has almost become the essence of what patient centricity should have been.” COVID-19 has taught the healthcare ecosystem to really respond to patient needs and desires and the overall patient experience within clinical research, he says.  

The real concern is that these patient-centric efforts could be short-lived, Sharpe says. “The fear is this is just the means to an end and a stop gap measure and when this threat subsides, we’re really going back to where we were before,” he says. “I think a lot of us will up in arms if it does.” 

Sharpe says we shouldn’t let a good crisis go to waste. “The biggest thing I’ve seen from all this is we’ve learned that it’s possible to bring the trial to the patient instead of the patient to the trial,” he says. “Let’s not let that go; let’s build on that. Let’s make that the baseline model of what we should be doing for clinical research, that we bring the trial offerings and different healthcare options to the patients where they are.” 

This boils down to options for the patient, Sharpe says. The best thing the industry can do for the patient is provide them with the most appropriate options so they can make informed decisions about their treatment. The COVID-19 pandemic has forced researchers to give patients those options. 

“That’s a point that gets overlooked at times,” says Sharpe. “Most patients don’t see all their options, unless you have a dedicated patient or a dedicated healthcare provider (HCP)... The hope is that this paradigm is replaced with a plethora of clinical options so that you can make the best decision for yourself. I think we can get there. There’s a strong motivation within the industry to build on the model. The concern is whether it will trickle down to the people on the ground giving the diagnosis and guiding the patients to the treatment options.”