Clinical drug trials have long required biomedical companies to recruit patients willing to trek to medical offices and be examined by teams of research scientists.
Science 37 Inc., a mobile tech and clinical trial company based in Playa Vista, wants to change that.
The company announced the completion last week of a clinical drug trial conducted entirely with an iPhone app – no office visits required.
“We are so thrilled about this,” said Dr. Belinda Tan, Science 37’s co-founder and chief medical officer. “There are so many wins in this. For patients, it’s clearly demonstrated a new way of administering treatment.”
The virtual drug trial for an acne treatment is the latest in a movement towards site-less clinical trials, researchers, biotech advocates and U.S. Food and Drug Administration officials said.
“It’s definitely a trend,” said Dina Lozofsky, executive director of the Los Angeles office of Biocom, an advocacy trade group for California life sciences companies. “One of the things companies struggle with during a middle-phase clinical trial is finding the right people. By moving to virtual trials, it means you can find your patients anywhere.”
The FDA, which regulates clinical trials, by law cannot comment on developing drugs or specific drug trials, but the agency did acknowledge the emergence of virtual clinical drug studies.
“The FDA is aware of interest in non-traditional clinical trial design,” Lauren Smith Dyer, a spokeswoman for the FDA, said in an email. “In a traditional trial, a site with an investigator carries out the study using data collected specifically for the purpose of the study. (But) there is growing interest in possible other sources of trial data, including but not limited to: use of data already collected in the health care system on such events as heart attacks, strokes, deaths, hospitalizations, use of data from a smartphone of exercise trackers to measure activity, and perhaps other data sources.”
Science 37 conducted the study in tandem with by AOBiome of Boston. The companies claim their acne trial was the first successfully completed Phase 2b drug study done solely via telemedicine. The companies recruited 8,000 participants with mild-to-moderate acne via Facebook, Instagram and Google ads and then whittled the pool down to 372 patients in 10 states through video chats conducted by doctor researchers. Consent was obtained electronically.
Patients were then mailed a rented iPhone and an acne drug spray produced by AOBiome and studied by Science 37.
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