Digital Pharma: Pfizer’s mobile-powered ‘virtual’ clinical trial
pharmafile | June 8, 2011 | News story | Research and Development | Digital Pharma blog, Pfizer, clinical trials
In an industry first Pfizer is to use mobile phone and web-based technology to collect study data for pharma’s first ‘virtual’ clinical trial.
The US Research on Electronic Monitoring of OAB Treatment Experience (REMOTE) study has FDA backing and aims to increase patient compliance, lower withdrawal rates and gather real-time data collection.
It will allow patients suffering from overactive bladder (OAB) to participate in the study to use electronic diaries and avoid having to travel to clinics during the trial.
Pfizer’s chief medical officer Freda Lewis-Hall said: “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.
“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.”
The 16-week trial will assess the safety and efficacy of the company’s OAB treatment Detrol LA (tolterodine tartrate) and will involve around 600 patients from 10 states across the US.
Patients will participate in the study screening process through the internet, manage their own trial activity and report results directly to trial investigators.
Pfizer’s technology partner Mytrus has a dedicated website for the trial and has produced a YouTube video to explain to patients how the study will work.
The REMOTE trial is the first-ever randomised ‘virtual’ clinical trial under an IND application to secure patient consent online using video/multimedia and online testing, and has been reviewed by the FDA.
Janet Woodcock, director, Center for Drug Evaluation and Research at FDA, said: “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.”
Pfizer said the REMOTE trial is a consistent fit with the FDA’s Clinical Trials Transformation Initiative (CTTI), which aims to improve the quality and efficiency of clinical trials.
Investigators will post to patients’ home address an electronic bladder diary and all the blinded study medication needed for the study rather than dispensing it at a clinic visit. Patients will also receive email reminders about the trial and a personal webpage to track their progress and provide guidance.
Researchers, contactable via email or phone, will manage study conduct remotely, and share clinical trial data and results with patients, enabling them to add them to their own personal health records. Once completed the trial will be one of the first to send patients their own study results.
By running the trial virtually Pfizer expects to save time and obtain better quality, more reliable data through increased patient compliance, lower withdrawal rates and real-time data collection.
The company hopes to use to the trial to see if it can replicate the results of a previously completed traditional phase IV study of Detrol LA, and thus begin to validate virtual, patient-centered approaches to clinical research.
Dominic Tyer is web editor for Pharmafocus and InPharm.com and the author of the Digital Pharma blog He can be contacted via email, Twitter or LinkedIn.
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