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Pfizer to conduct 'virtual' trial

Pfizer has launched pharma's first 'virtual' clinical trial, allowing patients to participate in a study to assess overactive bladder treatment, Detrol, using only mobile and online technology

Pfizer has launched pharma's first 'virtual' clinical trial, allowing patients to participate in a study to assess overactive bladder treatment, Detrol (tolterodine tartrate), using only mobile and online technology.

Around 600 patients from ten US states are expected to enrol in the REMOTE trial, with participants signing up and giving consent online, before having medication shipped to their home.

Patients will manage their trial activity by email and phone rather than in a physical, clinical setting, with results reported directly to a trial investigator who will oversee patient eligibility and safety.

A YouTube video has been developed by Pfizer's partner, Mytrus, to explain the process of participating in the trial. A dedicated website has further information too.



YouTube video for Pfizer's REMOTE trial

Dr Freda Lewis-Hall, executive vice president and chief medical officer, Pfizer, explained the benefits of trials which don't demand patients to visit a clinic: "Studies like REMOTE could make biomedical science much more accessible to people who have long been excluded from or under-represented in clinical trials."

She continued: "Putting research within reach of more diverse populations has the potential to advance medical progress and lead to better outcomes for more patients."

The trial was approved following a US Food and Drug Administration (FDA) review, with Pfizer aiming to replicate the results of a previously completed phase IV Detrol LA trial.

It is hoped a successful trial will begin to validate virtual approaches to clinical research to be used in future studies.

"Modernisation of clinical trials is a key initiative of FDA," said Dr Janet Woodcock, director, Center for Drug Evaluation and Research at the 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."

8th June 2011

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