Pfizer has announced the first “virtual clinical trial” pilot in the US that will utilize mobile and web technology to assess the safety and efficacy of Detrol LA, Pfizer’s extended release treatment for overactive bladder.
With this pilot, Pfizer hopes to improve the efficiency of clinical trials while cutting costs by having participants report results remotely, without having to visit trial sites. The REMOTE project (Research on Electronic Monitoring of OAB Treatment Experience) will attempt to replicate results of a traditional Phase IV study that Pfizer completed on the same drug.
A mobile based clinical trial has the potential to greatly improve the drug testing process for both patients and pharmaceutical companies. Recruiters could target much more diverse populations, including those who have traditionally been excluded because of factors such as travel to and from clinical appointments.
Theoretically, participant retention will also increase as patients can report results from the comfort of their own home. Researchers can receive valuable realtime data from participants – this electronic process can speed up the clinical trial process, while making it more cost-effective for pharmaceutical companies. As traditional clinical trials are a long and expensive ordeal, trials like the REMOTE project have the potential to revolutionize how pharmas bring new drugs to the market.
Electronic monitoring does, however, raise important questions in terms of patient reporting and safety. Without a face to face appointment with a clinician, will patients actually be thoroughly monitored throughout the trial? If patients report only via an online form, there is potential for investigators to miss important details on individual reactions to the drug.
In addition, the reliability of the collected data must be assessed thoroughly to ensure that it lives up to the strict standards of traditional trials. With these preliminary concerns in mind, Pfizer’s REMOTE project should be an excellent way to compare this novel clinical trial process with their already existing Phase IV results of the same drug.
REMOTE, and other trials like it, should elucidate the advantages and challenges of a “virtual clinical trial.”
Source: Pharma Times Online