On June 7, Pfizer Inc., under the investigational new drug application, conducted first in the history electronic clinical trial. This trial is unique because it will allow patients to participate in the trial using electronic tools, which means patients, who are located far away from clinical sites, are able to participate as well. Pfizer’s project will use web-based and mobile technologies to collect data. Food and Drug Administration announced a following review of the product.
Pfizer hopes, that so-called “virtual trial” can demonstrate the same result as the previous clinical trial (Phase IV Detrol LA trial), which was conducted to check if Detrol LA medication is effective and safe in the case of overactive bladder (OAB) treatment. For those purposes, the Research on Electronic Monitoring of OAB Treatment Experience (REMOTE) trial was designed. As a previous trial, the current one is also using Participatory Patient-Centered (PPC) approach.
There are about 600 patients from 10 states will be enrolled in REMOTE clinic trial. Investigators wish to collect the data in real time since everyone who takes part in the program will manage their activity and send reports directly to trial investigation specialists through the Internet. Investigators will receive the data, check it and track patients’ compliance, changes in health condition and their safety. As the part of the program, patients also should not go to a pharmacy for their medications, because REMOTE investigators will medications to the patients (this should be done in order to make results more clear and avoid other factors to affect on the study). After obtaining the data, researchers will share trial data and medical results with patients. Those records could be included in their personal medical records.
This trial pilot is also consistent with Clinical Trials Transformation Initiative by FDA and Pfizer is actively participating in CTTI programs. The main goal of CTTI is to increase the efficiency of clinical trials and achieve a higher quality of them.
Pfizer’s senior vice president of Worldwide Medical Excellence, Briggs W. Morrison, M.D., said that the approach was proven successful and would increase the quality of clinical trials and decrease the time spent on them. He pointed out the program may lead to the entirely new way of patients’ participation in such kind of trials.
Freda Lewis-Hall, M.D., Pfizer Executive Vice President, and Chief Medical Officer, said that with REMOTE program it was very convenient to patients take part in research without the necessity to visit medical facilities in person. This study could lead to higher accessibility for patients and will let those who did not participate in the clinical trial to take part in them in future. Also, it will cause an advance of medical progress. Lewis-Hall announced the new trial at the National Library of Medicine.
Director of Center for Drug Evaluation and Research at FDA, Janet Woodcock, M.D., said that modernization of clinical trials was a key initiative of the U.S. Food and Drug Administration and they have commended the progress of Pfizer on REMOTE trial and so, FDA would encourage other pharmaceutical manufacturers to provide other ideas in advancing clinical trials. Also, she said that the Food and Drug Administration will have prospective discussions with those companies on oversight and design of clinical trials.
Dr. Steven Cummings, Emeritus Professor of Medicine at the University of California San Francisco, is sure that remote method of collecting data for trials will let scientist conduct trials in a more effective way and also include border patient population in a trial, since it will be more convenient to participate without a need of living home.
The Pfizer’s study has been reviewed by the FDA and it was approved by two institutional review boards. Patients will have an ability to interact with study any moment and physicians will look after patients data and safety all the time during the REMOTE.
Pfizer states that their global resources and science were applied to improve health at every stage of life and they wish to set higher quality, value and safety in development of medications for people and animals that is why there are a log of human and biologic molecule medications, vaccines and nutritional products and some other products were released by Pfizer. Pfizer is also collaborating with many of health care providers to support and expand the access to affordable health care for more than 150 years. To learn more about Pfizer, their production, development, collaboration with health care providers or their participation in Clinical Trials Transformation Initiative and other initiatives, visit their site at www.pfizer.com.