New Reality
While the drug testing is real, the recruitment, the screening and the venue are changing the way clinical trials are conducted, reported an article by Barbara Mantel in Undark and reprinted by Fast Company.
Mantel described a clinical trial conducted by AOBiome Therapeutics, a life sciences company in Cambridge, Massachusetts, in which a topical spray was deemed “safe and effective in reducing the severity and number of acne lesions.” The study was a 12-week clinical trial. The drug, which contains beneficial bacteria, has to pass another round of testing in a Phase III trial prior to AOBiome’s application to the Food and Drug Administration for marketing approval, but the procedure for testing so far has been a bit unusual.
Instead of having clinical trial participants visit a site for screening, make repeated visits to that site to gauge the effects of a drug or placebo and spend many hours driving and waiting, AOBiome recruited the participants via social media and internet advertisements. More than 8,000 people were screened online to determine eligibility. The 372 people who were deemed eligible got the drug or a placebo in the mail and used AOBiome-issued iPhones to take pictures of their acne, a phone app to remit the photos to physician-investigators to be evaluated and video conferencing to “talk” to study staff.
The trial had no in-person screening interviews, no doctor visits and no waiting time. It was completely “virtual.”
According to Dr. Belinda Tan, co-founder and chief medical officer of Los Angeles-based Science 37, which uses proprietary software and wireless devices to help drug companies conduct virtual clinical trials, “Because we bring trials to patients in their homes, we remove barriers, whether geography or time and inconvenience, that are preventing them from participating,”
Many experts believe that these innovations are much needed, because less than 5 percent of Americans participate in clinical trials, and many fail to complete them. Statistics say that 30 percent of clinical trial participants drop out, nearly 20 percent of trials end before completion because of participation shortfalls and many trials take two or three times as long to complete as anticipated.
Industry analysts point to a number of challenges that have to be overcome before virtual clinical trials, a small percentage of the 100,000 registered clinical research studies in the United States, can become a regular procedure. Some of those factors are “overcoming a conservative corporate culture, ensuring that the technology is easy for patients to use, managing and analyzing the enormous amount of data that round-the-clock sensors generate and proving the data’s reliability and validity to regulators,” Mantel said.
In spite of the challenges, there is a critical need to make clinical trials more appealing and convenient to people who might be thinking about participating in them. As Ken Getz, a research associate professor at Tufts University School of Medicine and founder of the Center for Information & Study on Clinical Research Participation (CISCRP) in Boston, a non-profit that educates the public about clinical research participation, explained, making it simpler for volunteers to enroll in clinical trials is vital to future drug development. Recent research by his organization has noted that the top five reasons for leaving a trial “are all associated with the inconvenience of having to go to a physical location to participate in the trial,” he explained. “What’s at jeopardy is the ability to bring new treatments into the marketplace efficiently, yet in an affordable way — and quickly.”
According to Todd Krueger, AOBiome’s president and CEO, the virtual nature of his company’s clinical trial yielded important benefits. As he explained, “Online recruitment was relatively fast, dropout rates were lower than expected and compliance was better than expected. Once you develop a relationship with somebody online, it’s not particularly difficult to send them emails to remind them to take the product.”
