Testing a cheaper way to do clinical research, Pfizer ($PFE) has stumbled in a journey to complete what's been called the first completely virtual clinical trial. But the drug giant has fixed some of the bugs in the study and is expanding the pioneering trial from the U.S. to Europe.
After launching the trial last year to test the drug Detrol for overactive bladders, the company found that its online recruitment effort fell way short and stalled the progress of the trial, InPharm reported. According to the article, Miguel Orri, senior director of clinical science at Pfizer, said that the study "didn't recruit" because patients felt uneasy about sharing their health info online, they struggled with a tricky sign-up process and many targeted subjects are elderly and don't spend as much time online as young people.
Pfizer has taken steps to fix the problems. For instance, the company introduced a call center to the study to aid patients in the sign-up process. And the drugmaker aims to tap a contractor to boost recruitment for the European edition of the study and give patients simplified tablets that allow them to self-report data without needing their own Internet setup, Outsourcing-Pharma reported.
If Pfizer failed in it's initial stab at online recruitment, the failure is hardly a major setback for the company. For one thing, the clinical results of the study won't make or break the world's largest drugmaker, and even most conventional clinical studies don't meet recruitment deadlines. Also, Pfizer appears to be figuring out where the ruts in the road lie in the course of conducting its virtual trial, which will tell the company and regulators what has worked and what has failed during planning of future studies that involve elements of the virtual trial.
Pfizer's virtual study is an "…important [and] promising new direction in clinical trials," Daphne Zohar, managing director of PureTech Ventures, a Boston-based company that has taken innovative approaches to commercializing biotech discoveries in academia, wrote on Twitter. And the drug giant is "working out the kinks" in the trial.
Zohar is hardly the only one to endorse the virtual trial model. Last year when the study launched, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said that the agency "commend[s] Pfizer's progress on the REMOTE pilot and encourage[s] all manufacturers considering other novel ideas in advancing clinical trials to have prospective discussions with the Agency regarding trial design and oversight."
Pfizer isn't the only outfit traveling the virtual trial road. In January New York-based drug developer Transparency Life Sciences unveiled its plans to take the virtual strategy even further than Pfizer, using online crowdsourcing to gather feedback from clinicians on the design on the virtual trials that the company plans to conduct.
- read the InPharm post
- and the Outsourcing-Pharma article