Clinical drug trials enter electronic world

Pfizer is conducting what it calls the first-ever all-electronic drug trial, in which patients at home will report outcomes to the company through the Internet.

The testing patients' individual physicians will not be hired as investigators. Instead, the patients will report and manage their trial activities to a central physician investigator who will oversee the entire process.

The drug being tested, Detrol LA (tolterodine), prescribed for overactive bladder, already has completed a Phase IV, post-market clinical trial and has been on the market for 10 years.

But Pfizer wants to repeat the testing in a Web-based, patient-centered model to see if it replicates the results of earlier trials, and whether this process could be used for future trials -- perhaps changing the clinical drug trial process and potentially saving drug companies a lot of money. The Food and Drug Administration has approved Pfizer's electronic study.

Pfizer said it hopes to enroll 600 patients from 10 states who will receive the blinded study medication -- and a smartphone -- in the mail. The patients will manage all their trial activities on their own using Web-based tools. Results will be reported directly to trial investigators through the Internet. Patients will receive trial data and results back from investigators and have the ability to record their data in their own personal health records.

"We think this model creates new engagement opportunities for patients to participate in research," said Craig Lipset, head of clinical innovation in research and development at Pfizer.

Lipset said another advantage to all-electronic clinical drug trials is having one investigator manage the trial from a central location, as opposed to several investigators spread throughout the country.

"Physician recruitment has always been an issue," he said.

Doctors hired as investigators rarely come back a second time, Lipset said. This model will open up opportunities for physicians to participate by working with patients involved with the trial without taking on the burden of becoming an investigator.

Jonathan Seltzer, MD, president of the Academy of Pharmaceutical Physicians and Investigators, said although he agrees that investigative recruitment can be long and expensive for drug trial sponsors, there are APPI members who believe they are not recruited enough. This virtual model could eliminate even more opportunities, he said.

Lipset said there are limitations to using the virtual model in clinical trials. Trials that involve IV therapy, for example, could not be managed solely by the patient and would need to be done using the traditional model. But as health information technology advances and use of electronic medical records rises, Lipset expects there will be more opportunities for patients to share records with clinical trial researchers and become involved in more drug development activities.

Dr. Seltzer sees additional limitations. "From a regulatory perspective, the integrity of data is not as high," he said. Patients, for example, could report a drug-induced rash, which a physician could determine is actually something else.

But for certain types of studies, such as post-marketing, to get the patients' point of view and find out how they are using the drug, "it's great," Dr. Seltzer said.

Though this is the first known virtual clinical drug trial under an investigational new drug application, it's a concept that is expected to gain traction.

Paul Pomerantz, worldwide executive director for the Drug Information Assn., said the idea of using technology to better engage patients involved in clinical drug trials will be a focal point of the annual DIA meeting, at which Lipset will be presenting. DIA is a professional organization for all stakeholders, including patients and clinicians, involved in the development of pharmaceuticals and medical devices.

Jeffrey Ventura, press officer for the FDA, said the agency also sees value in a virtual clinical trial model.

"This trial, for example, includes people who might otherwise not participate in a trial, enriching the potential patient population and potentially making it easier and quicker to recruit trial participants," he said.