Premier Medical Group’s Research Division continues to be one of the Hudson Valley’s largest centers for gastroenterological and urological clinical trials. Under the leadership of principal investigators Evan Goldfischer, M.D., Medical Director for the Urology Research Division, and Peter Varunok, Medical Director for the Gastroenterology Research Division, Premier has participated in more than 300 clinical trials over the last 20 years. These studies have contributed to the approval of such drugs as Viagra, Cialis, Levitra, Detrol LA, Vesicare, Rapaflo, Mirabegron, Firmagon, Pegasys Pro-Click, Toviaz, and Xgeva, Myrbetriq, Zytiga, Xtandi, Viekira, Addyi, Trulance, and Stelara.
While Premier’s clinical research program offers patients the opportunity to receive the newest treatments, there may be risks and side effects associated with any procedures performed and drugs investigated in the study.
Why take the chance? Patients who participate in research trials have different reasons for doing so. Some have exhausted all other treatment options, while others do it out of the goodness of their hearts and their desire to advance medicine.
Still others participate because they like the special flexible scheduling, the interaction with the research team and the fact that most study-related procedures—including lab work, physical exams, EKGs, and imaging studies—are conducted at no cost. During the course of a study, Premier’s physicians and research staff are always available to answer any questions for research participants.
The willingness to participate in a trial does not, however, guarantee that a patient will be enrolled. Before patients can even begin the screening process to see if they meet the unique protocols of each study, they must meet with one of Premier’s clinical research staff—doctors, mid-levels, coordinators—to review the informed consent form. These forms detail the nature of the study, the risks/benefits involved, and outline the study procedures and schedule of events that occur during the duration of the study. During this review process, the patient has a chance to ask questions, to take the form home and discuss it with their family. The informed consent form is the most important procedure in a research trial.
Patients who agree to the terms of the informed consent form can then begin the study’s screening process. During this phase, health histories and medications are reviewed, lab work and other tests can be conducted. The data collected is carefully reviewed and patients who meet the study’s protocols will be enrolled. Some trials are “open label” studies, in which both the researchers and the patients know if they are receiving “real” medication or placebo. Others may be “double blind” studies, in which neither the researchers nor the patients know if they are receiving “real” medication or placebo. Still others may be “single blind” studies, in which the patients do not know if they are getting medicine or placebo, but the researchers do. The frequency of patient visits with their research coordinators and doctors to dispense medications, conduct tests or lab work is based on each trial’s protocols. The length of the trial may also vary as well. Some studies have a specific end-point, while others may continue for the entirety of the patient’s life. Patients have the right, however, to leave a clinical trial at any time.
For information on current clinical trials please visit www.clinicaltrials.gov