This is an area I’ve been looking into (personal interest) – Clinical Research utilizing more of healthcare IT, especially PHR technologies.
The original article can be accessed here.
Pfizer Inc. is conducting a drug trial in which patients participate from their homes using computers and smartphones rather than visiting a clinic.
The company plans to compare the results to those obtained from a previous, traditional trial of the same drug. The study involves the company’s overactive-bladder drug Detrol.
If successful, the methods used in the study might eventually be used to help drive down the high cost of bringing new medicines to market.
The Food and Drug Administration recently signed off on Pfizer’s study, which is believed to be the first all-electronic, home-based study of a drug to receive agency approval.
It is designed to replicate the results of a 600-patient study conducted in 2007 through traditional methods comparing Detrol to a placebo over a four-month period. Pfizer will announce the launch of the study at a National Library of Medicine clinical trials-conference on Tuesday.
Study participants are being recruited through Internet advertisements and directed to the study’s website, which explains the study and allows enrollment.
Patients who enroll in the study will be required to have blood drawn at a local clinic or during a home visit. Medications will be mailed to participants, something that’s rarely, if ever done in clinical trials. Patients will keep diaries using a mobile phone that has an application specifically designed to track symptoms of overactive bladder. Patients will fill out assessments on a secure website four times throughout the study.
Although a home-based, electronic approach won’t work for all drugs in clinical trials, the company and the FDA are looking to see if the technology can be integrated into more studies to make it easier to recruit patients and allow them to participate in clinical research. Now, patients usually need to live near a study site to participate.
Recruiting patients through sometimes dozens of study sites is among the most expensive parts of clinical research. The cost of bringing a new product to market is estimated at $1 billion, with much of that related to trials. Efforts to recruit patients more quickly could help drive down some of these costs.
The study is also being overseen by a single group of doctors and nurses at the University of California, San Francisco, rather than at the numerous sites employed in most clinical trials.
“This frees us from bricks-and-mortar sites,” said Steven Cummings, an emeritus professor of medicine at the University of California, San Francisco and the co-founder of the company Mytrus, which developed the technology being used in the Detrol study.
Freda Lewis-Hall, Pfizer’s chief medical officer, said the methods used in the study, if proven successful, would likely be used to complement current clinical-trial infrastructure, particularly for experimental drugs that aren’t yet on the market.
Take-Home Drug Test
Pfizer’s Detrol study, dubbed Remote, uses Internet ads to recruit participants.
- The 16-week study compares Detrol to a placebo.
- Potential participants are directed to the study’s website to enroll.
- Laboratory supplies are sent to a participant’s home so blood can be drawn at a local clinic or during a home visit.
- Eligible subjects are sent the medication and a smartphone with an application to track overactive-bladder symptoms.
- Patients complete periodic assessments on the Internet.