REMOTE: The Revolution in Clinical Trials
In 2011, Pfizer pharmaceuticals launched the Research on Electronic Monitoring of OAB Treatment Experience (REMOTE) study, the first direct-to-patient clinical trial. The trial was a pilot study to confirm data from a previous phase IV of the drug Detrol LA to treat overactive bladder symptoms. What made this trial revolutionary was the design of the study. Instead of having the patients work with a clinic or hospital, the patients received the drug directly and recorded the data using Smartphones and Web-based technology. The revolutionary direct-to- patient design eliminated the cost of establishing capable sites and working with a contract research organization. The patients did have their blood drawn at a clinic or during home visits.
The clinical trial community was optimistic about what studies like REMOTE could do for the industry. Anthony Costello, chief operating officer of Mytrus, a clinical research technology company stated, “There is a massive cost savings to the pharma industry in not having to start up dozens or hundreds of sites to enroll patients. It’s not hard to imagine. If you take a trial that has 50 sites and cut it down to a trial that uses one site, you get away from contracts, multiple IRB submissions, site initiation visits, trainings, and payments with 50 organizations and do it with one instead.” (Korieth, K., CenterWatch, June 2011).
However, REMOTE, like many initial pilot efforts, did not run perfectly. Pfizer admitted in early 2012 that the enrollment goal of 600 patients was not being met. The study was stopped. Despite this setback, Pfizer is taking what it learned and is launching a second virtual trial, REMOTE 2, with plans to address the enrollment issues that affected the initial study.
REMOTE was revolutionary not only in its approach to clinical trial design and logistics, but it also introduced new technology. The study made use of a diary application for Smartphones to collect data that tracks the symptoms of overactive bladder. Prior to using Smartphones or other mobile devices, the data was entered after a scheduled visit by the site data coordinator into a Web-based electronic data capture system. The cellphone allows the participants to enter data at any time or place. REMOTE’s app is an example of this; it allowed patients to enter data when they experience any distress related or unrelated to the drug.
While REMOTE may have not achieved its initial goal, due to the unsustainable costs of clinical trials, similar studies must be implemented. The amount spent on clinical trials has gone from $10 billion in 2000 to $24 billion in 2010, and is estimated to reach $28 billion in 2014 (BCC Research Forecast, 2011 report, #PHM027C). We are reaching a point where promising drugs and medical devices will not be tested because the trials cannot be funded by industry or government.
KAI has been pioneering the use of Smartphone technology in clinical research. We are working with this technology for both standalone data collection and in combination with standard Web-based data capture. KAI believes as the capability of the Smartphone increases, it will not just serve as a data entry device but will be integrated with various diagnostic devices, such as EKG and labs on a chip. This will allow increased real time evaluation of drugs and medical devices.