Clinical Trial by Pfizer Conducted Remotely

A clinical trial being conducted by Pfizer is the first-ever randomized “virtual” trial under an investigational new drug (IND) application that uses electronic tools to manage study participation, the company announced Tuesday in a press release submitted to Business Wire.

The clinical trial, known as Research on Electronic Monitoring of OAB Treatment Experience (REMOTE), uses mobile phone and web-based technology to collect data from trial participants without the need to visit a clinic.

The purpose of the clinical trial is to assess the safety and efficacy of Detrol LA, a drug used to treat overactive bladder.

“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,” Dr. Freda Lewis-Hall, Pfizer Executive Vice President and Chief Medical Officer, was quoted as saying in the press release.

“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,” she added.

Researchers plan to enroll approximately 600 patients from 10 different states across the U.S. Researchers will ship the study medication to participants at their homes. The participants will then manage their own trial activity and report results directly to a researcher, thereby saving time and producing more reliable data, researchers hope. “This approach, if proven successful, holds considerable promise in speeding up clinical trials while improving their quality,” Dr. Briggs W. Morrison, Pfizer’s senior vice president of Worldwide Medical Excellence, was quoted as saying in the press release. Pfizer hopes that, if successful, the trial will validate virtual, patient-centered approaches to clinical research.
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