Pfizer’s “virtual” clinical trial intrigues, but leaves lots of questions
June 9, 2011 Leave a comment
Clinical trials are the backbone of the new drug development process. Without them, you can’t get FDA approval to market your drug. Pharmaceutical companies spend millions, of dollars designing, recruiting for and executing even a single clinical trial, and you need at least three, if not more, to get approval.
Recruiting for clinical trials is challenging. Getting enough patients to completely adhere to the clinical trial’s protocol to have a sufficient data pool may be even more challenging. All of this makes Pfizer’s starting of the first “virtual” clinical trial in the United States an intriguing story, although one that still leaves questions to be answered.
Instead of residing in or regularly visiting a research facility for the entire length of the trial, patients would administer the study drug (Detrol LA, Pfizer’s long-acting formulation of its overactive bladder treatment), as well as monitor and report the necessary vital signs and results, on their own. Pfizer’s project, which goes by the acronym “REMOTE,” is aimed at expanding access to clinical trials, and therefore diversifying the pool of participants, which currently is limited to whoever happens to live near the participating research facilities.
It’s a very interesting idea. And if it works, it could have some very positive results. In addition to improving access to clinical trials, it could save trial sponsors money by not having to compensate participants to repeatedly travel to the research facility.
But there are some very important questions that need to be answered:
- How many drugs will this type of clinical trial be able to be used for? I imagine that drugs that need to be administered by a medical professional (such as intravenous chemotherapy drugs for cancer) won’t work for virtual clinical trials.
- How do you go about training participants to correctly monitor and obtain the required data on their own?
- Do they need to use exactly the same equipment to monitor and obtain vitals?
- How do you protect the blinding and the confidentiality of the patient data when conducting a trial virtually? Blinding is vital to clinical trials. And patient data must be kept confidential to comply with HIPAA and FDA policy.
- Would a virtual clinical trial shut out demographic groups that don’t have easy access to the necessary technology? How would this affect the reliability of the data?
I’ll be very interested to see how this project turns out. It could present a major revolution in the pharmaceutical research and development process. Or it could be yet another idea that sounds good in theory but doesn’t work in reality. We’ll see what happens.