Big Pharma is turning into Digital Pharma. Drug company Pfizer is about to pilot a clinical trial program, but rather than have patients come to them, they’re bringing the trial to the patient digitally.
The program will allow Pfizer to perform clinical drug trials outside of clinics, with participants using smartphones or computers to remotely send results, in an effort to bring drugs to the market faster. The virtual trial will test the safety and efficacy of a drug called Detrol, which is intended for the treatment of overactive bladders.
Approved by the FDA, the program is named under the acronym REMOTE (Research on Electronic Monitoring of OAB Treatment Experience) and is being used to determine whether “virtual” clinical studies can produce the same results as traditional ones.
“Putting research within reach of more diverse populations has the potential to advance medical progress and lead to better outcomes for more patients,” Dr. Freda Lewis-Hall, Pfizer's chief medical officer, said in a statement.
FDA spokeswoman Karen Riley confirmed that this is the first such study in the country.
“We approved this concept and were supportive,” she wrote in an e-mail.
“With the REMOTE virtual trial pilot, for the first time we can make it possible for patients to participate in clinical trials without having to visit physical sites,” Dr. Lewis-Hall was quoted as saying in the press release.
“Studies like REMOTE could make biomedical science much more accessible to people who have long been excluded from or under-represented in clinical trials. Putting research within reach of more diverse populations has the potential to advance medical progress and lead to better outcomes for more patients,” she added.
Researchers plan to enroll approximately 600 patients from 10 different states across the U.S. Researchers will ship the study medication to participants at their homes. The participants will then manage their own trial activity and report results directly to a researcher, thereby saving time and producing more reliable data, researchers hope.
“This approach, if proven successful, holds considerable promise in speeding up clinical trials while improving their quality,” Dr. Briggs W. Morrison, Pfizer’s senior vice president of Worldwide Medical Excellence, was quoted as saying in the press release.
Pfizer hopes that, if successful, the trial will validate virtual, patient-centered approaches to clinical research.
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Michelle Amodio is a HealthTechZone contributor. She has helped promote companies and groups in all industries, from technology to banking to professional roller derby. She holds a bachelor's degree in Writing from Endicott College and currently works in marketing, journalism, and public relations as a freelancer.Edited by
Jennifer Russell
