Pfizer to conduct first ‘virtual’ clinical trial in US

Published: 10-Jun-2011

Will use mobile phone and web-based technology to collect trial data


Pfizer is to conduct the first randomised clinical trial under an investigational new drug (IND) application in which patients will participate remotely without having to visit trial sites.

The pilot REMOTE (Research on Electronic Monitoring of OAB Treatment Experience) trial will assess the safety and efficacy of Detrol LA (tolterodine tartrate), a treatment for overactive bladder.

The pilot project, approved by the US Food and Drug Administration (FDA) and two institutional review boards, will use mobile phone and web-based technology to collect data for the trial.

Pfizer hopes to determine whether the results of the pilot ‘virtual’ trial can replicate the results of a previously completed Phase IV Detrol LA trial, and in this way begin to validate virtual, patient-centred approaches to clinical research.

‘Studies like REMOTE could make biomedical science much more accessible to people who have long been excluded from or under-represented in clinical trials,’ said Pfizer’s executive vice president and chief medical officer Freda Lewis-Hall.

‘Putting research within reach of more diverse populations has the potential to advance medical progress and lead to better outcomes for more patients.’

The plan is to enrol about 600 patients from 10 states across the US. These patients will be screened through the Internet and will actively manage their own trial activity, reporting results directly to a trial investigator who will maintain oversight of patient eligibility and safety.

‘This approach, if proven successful, holds considerable promise in speeding up clinical trials while improving their quality,’ said Briggs W. Morrison, Pfizer’s senior vice president of Worldwide Medical Excellence.

Dr Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, commented: “Modernisation 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.’

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