Research is going mobile. For the first time in America’s history and an innovative advancement in clinical study approach, Pfizer is running the first U.S. clinical study pilot project, approved by the Food and Drug Administration and known by the acronym REMOTE, in which patients participate by using mobile phones and the Internet, rather than repeatedly visiting a participating hospital. Welcome to the mobile community, medicine.
The study acronym, REMOTE, stands for Research on Electronic Monitoring of OAB (over active bladder) Treatment Experience. Approximately 17% of women suffer from overactive bladder (OAB) also known as urge urinary incontinence. Chances of getting OAB increases with age and many women have symptoms of OAB but are not being treated.
A common cause of Overactive Bladder (OAB) is due to frequent bladder muscle spasms known as detrusor overactivity.
Dr. Freda Lewis-Hall, Pfizer’s chief medical officer stated:
“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. 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.”
The ultimate goal is to determine whether such “virtual” clinical studies can produce the same results as traditional ones that require patients to live near and regularly visit a hospital or clinic for an initial screening and multiple checkups. This breakthrough could mean that patients all over the country could participate in many future medical studies, allowing under-represented groups to take part, speeding up data collection and likely reducing costs and the rate of participants dropping out.
Dr. Steven Cummings, M.D., Emeritus Professor of Medicine at the University of California San Francisco continues:
“This virtual method enables scientists to conduct trials more efficiently. Additionally, as more people participate in trials conveniently from home, the results of trials may apply to a broader patient population.”
About 600 patients in 10 states will enroll over the Internet (https://oab.mytrus.com/home) after watching a video explaining the study and any risks, and then filling out a questionnaire. They will then have medication, either Detrol or dummy pills, mailed to them, not knowing which they are taking, the same as a traditional or “old school” study.
The drug, Detrol (tolterodine) was approved in December 2000 and goes off patent next year. The long-acting version of Detrol, it requires only one pill a day. Tolterodine is used to relieve urinary difficulties, including frequent urination and inability to control urination. Tolterodine is in a class of medications called antimuscarinics and works by preventing bladder contraction.
Janet Woodcock, M.D., director, Center for Drug Evaluation and Research at FDA comments:
“Modernization of clinical trials is a key initiative of FDA. We commend Pfizer’s progress on the REMOTE pilot and encourage all manufacturers considering other novel ideas in advancing clinical trials to have prospective discussions with the Agency regarding trial design and oversight.”
Researchers would have to work out a system for specimen collection by local doctors or clinics, but the REMOTE study is a step in a forward moving direction.
Source: Pfizer
Written by Sy Kraft