Pfizer is taking the randomised clinical trial further than ever into the digital age by announcing the first such study conducted under an US 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 address concerns around the cost-efficiency and accessibility of clinical research by using mobile phone and web-based technology to collect data on the safety and efficacy of Detrol LA (tolterodine tartrate), Pfizer’s extended-release treatment for overactive bladder (OAB).
The REMOTE project has been cleared by the US Food and Drug Administration as well as two institutional review boards.
Pfizer, which has been ratcheting up its efforts to improve research productivity and innovation, hopes to determine whether the results of the pilot ‘virtual trial’ can replicate those of a previously completed Phase IV study with Detrol LA, “and in this way begin to validate virtual, patient-centered approaches to clinical research”, it noted.
Speed, access, compliance
Billed as a “US-based Participatory Patient-Centred clinical trial”, the REMOTE study has the potential to widen the available trial population, speed up clinical development while cutting costs (which weigh heavily in patient recruitment and retention), improve patient compliance, reduce withdrawal rates and deliver better-quality, more reliable ‘real-time’ data.
It is also in line with efforts to improve the transparency of clinical trials and the resulting data. Researchers managing the conduct of the study remotely will share trial data and results with patients, enabling them to add these to their personal health records.
Pfizer said the REMOTE trial was the first-ever randomised ‘virtual’ clinical trial under an IND application to secure patient consent online using video/multimedia and online testing. As a financial incentive, the company is offering participants US$25 for each online assessment and/or laboratory visit completed, up to a total of US$175.
The plan is to enroll some 600 patients from around 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.
The investigators will deliver all of blinded study medication to patients’ own homes, rather than dispensing it at a clinic.
More diverse populations
Pfizer executive vice president and chief medical officer Dr Freda Lewis-Hall announced the REMOTE study at the National Library of Medicine Clinical Trials Conference in Bethesda, Maryland.
“Studies like REMOTE could make biomedical science much more accessible to people who have long been excluded from or under-represented in clinical trials,” Lewis-Hall commented. “Putting research within reach of more diverse populations has the potential to advance medical progress and lead to better outcomes for more patients.”
The REMOTE trial pilot is also consistent with the aims of the FDA’s Clinical Trials Transformation Initiative (CTTI) to improve the quality and efficiency of clinical studies, noted Pfizer, adding that it has been “an active participant in multiple CTTI projects”.
Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research at FDA, said the agency commended Pfizer’s progress with the REMOTE pilot and encouraged “all manufacturers considering other novel ideas in advancing clinical trials to have prospective discussions with the Agency regarding trial design and oversight”.
