Pfizer, FDA approved

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Pfizer Running First Virtual Study

A.

Drug Discovery & Development - June 08, 2011

TRENTON, New Jersey (AP) - 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 checkups.

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 -Hall, Pfizer's chief medical officer,

said in a statement.

FDA spokeswoman 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 LA, 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.

Date: June 8, 2011

Source: Associated Press

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

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