Virtual trials are growing in acceptance. The patient-centric aspect of these trials makes them easier to recruit and retain patients and accelerate timelines, while also providing patient data to researchers in real time. But will virtual trials also mean the end of CROs?
Josh Rose, VP of clinical development strategy and innovation and global head of virtual trial operations at IQVIA, smiles when he hears that question. In response, he likes to show a photo of Times Square from around 1948. It looks the way you would expect: Grainy, black and white, trolley cars, old building facades, and people walking in the streets.
“If you look at statistics in the industry, less than five percent of patients participate in clinical research,” says Rose. “One in two studies under-enroll the patients needed, and 50 percent of investigators that conduct clinical research will not do it a second time. Those are alarming statistics.”
“I like to share that photo of Times Square because 1948 was the year researchers conducted the first randomized controlled clinical trial,” states Rose. “It was a site-based trial conducted in a hospital. It was also a trial where patients had to have all their assessments performed in the hospital. That was 71 years ago, and in the past 71 years, little has really changed.”
Times Change, Trials Don’t
Although trials have not changed much in 71 years, everything else has. We are more connected than ever before. People are more geographically distributed. In 1948 most people lived in a city or a very rural setting. That is no longer the case. Most people have active professional lives and no longer live in cites. That is part of the problem with trials today. Although the rest of the world has changed, the clinical model remained somewhat ‘frozen-in-time’ and has not adapted to the way people live today.
“The model we use today still revolves around opening a physical site and hoping patients live near and travel to that site,” states Rose. “Oftentimes that is not the case. In the U.S. today, on average, patients travel more than 50 miles for a site visit. Seventy percent of them live two hours away from the site. Most people do not want to travel that distance. That is the primary contributor to low participation rates and why so many trials fail to meet enrollment goals. Selecting sites and hoping they can recruit the patients needed is an antiquated model.”
The industry clearly needs to change the model. This is where virtual trials enter the picture. Rose describes this new model as taking the old paradigm, breaking it apart, and putting it back together in a way that moves the trial as close as possible to the patient’s location. Virtual trials allow the industry to take the trial to the patient, instead of making the patient come to the trial.
With this new model, a patient can go into their office at work or find a private room in their house, close the door, log into their computer or smartphone, and connect with the primary investigator (PI). If a blood draw is required, a home health nurse can show up at the patient’s home or office.
“The whole idea is that patients can go on with their lives and not have to deal with the challenges of visiting a physical site,” says Rose. “A heart rate can be obtained right from a wearable device. We live in a connected world, but sometimes the new technologies we have available seem to be impacting many facets of our lives, but not clinical trials. We need to change the entire paradigm.”
Pharmacies Become Sites
With virtual trials, the possibilities are endless. Pharmacies will play a role in this new paradigm. For patients who are mobile but can’t get to a clinic, a visit to Walmart, CVS, or Walgreens might be a more convenient alternative. These outlets may not be the PI, but they will be a location the patient can visit if they wish to participate in a study. The PI can interact with a location that is close to the patient’s home using telemedicine, connected devices, or some other networked communication. These visits will replicate everything that used to be done in a clinic and be far less inconvenient to the patient.
This new paradigm also flips the old recruitment method on its head. Instead of establishing sites and hoping they can find patients, pharma can now go out and recruit patients directly.
“Pharma can now use direct-to-patient recruitment methods, digital marketing, social media, and other means of reaching patients,” notes Rose. “Those patients no longer have to be in that narrow geographic region around the site. We can reach out to patients regardless of where they happen to be located.”
Making Trials More Diverse
In addition to enrolling more patients, pharma also needs to make trials more diverse. Currently, trial participants tend to be white, male, urban, educated, and affluent. Unfortunately, that is not an accurate representation of the entire population. Populations are highly varied with people of all races and education levels.
“We still seem to be missing too many demographics,” says Rose. “The real promise of taking trials to the patients is that they will allow us make trial populations more diverse. When we get greater diversity in our trials, the drugs we bring to market will be better represented by the population that’s using it.”
Virtual trials can also change the investigator paradigm. Right now, most physicians who participate in a trial tend to never do so again. Rose believes that is because they’re essentially signing up to run a clinical research business. That is hard to do without hiring coordinators and patient recruitment experts and having enough research business to sustain that infrastructure.
“Virtual trials are like Uber for investigators,” adds Rose. “If you’re a physician, all you need is a medical degree and the interest in participating in a trial. We can enable all the technology for them. They can worry about treating the patient, and we can worry about all of the other components.”
CROs Are Not Going Away
Rose notes that many people believe virtual trials are all about leveraging technology. Get the technology, and you can get rid of CROs is how the thinking seems to go. But Rose suggests we put the brakes on that misconception.
Virtual trials certainly involve technology, but there are many components of clinical research that also become more complicated. There is interaction with patients, scheduling, medical reviews, gathering and understanding of data, home health nurses, and connected devices. Someone still needs to oversee and manage those processes and relationships.
“All of those things still need to be enabled with a virtual trial solution,” says Rose. “Conducting a virtual trial goes beyond just creating an app that enables telemedicine and patient-reported outcomes. For that reason, I see the role of CROs growing and changing. A pharma company can conduct an entire virtual trial themselves, just like they can today for a traditional study. Some might opt to do that, but most companies won’t.”
Outsourcing decisions have always been based on preference. Currently, Rose does not see a clear trend toward more companies deciding to outsource or bring their trials back in-house. Still, he doesn’t believe virtual trials will lead to CRO-less trials. The decision to go siteless should have no impact on whether a sponsor company will decide to use a CRO.
“When you move to a more digitally connected, data-driven, technology-enabled world, the role of the CRO changes,” he states. “CROs have to make that transition, and those that don’t are not going to be around in 5 to 10 years. But these are two separate discussions. They are not related.”
CROs Of The Future
The role of CROs has certainly evolved over the years. The service providers started off as an alternative to hiring additional full-time CRAs. That evolved to outsourcing data management and other trial functions, leaving only study design and oversight in the hands of pharma. The big change currently going on in the industry is the proliferation of technology. Clinical research that had been paper-based and manually-driven is now much more digital and technology-enabled.
As a result, Rose believes CROs need to be able to morph and change their model to meet current expectations of clients. “It’s another paradigm shift,” he says. “We have devices that can take a patient’s blood pressure. The Apple watch can do an EKG reading. CROs need to be able to leverage that.”
In order to succeed, CROs will need to continue to be impactful to their pharma partners.
“There is a tendency in pharma to be attracted to new and interesting technologies,” says Rose. “Sponsors want to implement and leverage these technologies, but there is a lot that has to go into making that happen. Working with a startup technology company can be difficult. They have the technology but can lack the domain expertise that’s associated with clinical research. Pharma needs to provide that, and it’s not easy to do.”
That’s where CROs come into play. CROs can act as a clearinghouse for new technologies if a sponsor likes certain technologies but doesn’t want to manage one-on-one relationships with startup companies. Even the small- to mid-sized companies are jumping into some of the emerging technologies.
“Many companies used to play follow the leader,” adds Rose. “They would wait for Big Pharma to adopt new technologies before wading in themselves. That’s no longer the case. Emerging biopharma and biotech companies are not content to sit on the sidelines. With the emergence of virtual trials, they have an opportunity to take advantage of lower costs, faster timelines, better quality, and improved relationships with patients. They are not waiting for these benefits to become mainstream within large pharma companies.”