Pfizer starts first US “virtual” clinical study; pill for ‘frequent urination’ is pilot project
TRENTON, New Jersey — Drugmaker Pfizer Inc. is running the first U.S. clinical study in which patients participate by using mobile phones and the Internet, rather than repeatedly visiting a participating hospital.
The study announced Tuesday is a pilot project, approved by the Food and Drug Administration and known by the acronym REMOTE. The 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 check-ups.
If it works, it could mean that patients all over America 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.
“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 email.
The agency has an initiative to improve the quality and efficiency of patient studies.
The study by New York-based Pfizer, the world’s biggest drug maker by revenue, will test the safety and effectiveness of its blockbuster pill for overactive bladder, a condition in which patients have sudden, frequent urges to urinate.
The drug, Detrol Louisiana, was approved in December 2000 and goes off patent next year. The long-acting version of Detrol, it requires only one pill a day.
About 600 patients in 10 states will enroll over the Internet 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, as in a traditional study.
All the participants will submit information online frequently, directly to one of the study investigators, noting when they take the medicine, how often they urinate and details on symptoms and side effects.
The study acronym, REMOTE, stands for Research on Electronic Monitoring of OAB Treatment Experience. Overactive bladder was widely publicized in TV ads after Detrol and rival drugs such as Flomax came on the market.
Many medical studies require patient blood or urine samples, and sometimes X-rays or other imaging. Researchers would have to work out a system for specimen collection by local doctors or clinics, and for access to imaging facilities, for any virtual studies needing such data.
