Temple University is on a mission to not only accept the standard of care but to forge ahead not just settle for the status quo. After all, many patients are diagnosed with serious illness every day in a big city such as Philadelphia and they often commence an urgent search for their best care. Clinical trials advance medicine—in fact there wouldn’t be any advances without clinical trials. Dr. Jonathan Galli, a lung specialist at Temple, knows this all too well. The lung physician recently conveyed to ABC 6 News that hospitals such as Temple Health are constantly probing the market for new clinical trials that may benefit their patient population.
Maximize Potential for Patient while Minimizing Risks
Recently Dr. Galli educated ABC 6 News on the importance of clinical trials. Dr. Galli emphasized the levels of review and scrutiny that a clinical trial must pass by the Food and Drug Administration (FDA) before approval to test a drug in patients. He noted that clinical trials are” carefully designed and controlled studies, comparing a new test or treatment to the standard approach.” He continued that clinical trials exist in order “to try to minimize risks while maximizing scientific discovery.”
The Research Coordinator at Temple
Carla Grabianowski serves Temple as a research nurse coordinator—tracking and working with patients from study start up through till completion. When it comes to enrolling patients Grabianowski connected that they must understand a patient’s condition and understand what clinical trials are available and if there is a potential fit they will share the study information with the patient.
Questioning is Key
Grabianowski declared that patients should question away! No question is a bad question. For example she noted patient’s should ask, “How many times do I have to come here? What’s involved in each visit? How long am I going to be here.” How long is this study? Will I get reimbursed for any of my travel or my time? Is this going to be billed to my insurance company? What protections do you have?”
She emphasized that the hospital (research site) must go through the informed consent process with the patient. TrialSite News reminds patients that in the informed consent process (which the site must go through with you) they must explain what the clinical trial is for; why is the patient a potential fit for this trial; what are the potential risks, etc. Grabianowski reminded patients that they can always drop out of the trial.
Temple Clinical Trials
6 ABC News reported that at any given time Temple’s Lung Center alone may have 20 or 30 studies underway. As it turns out some of the studies Temple’s Lung Center participate with during the past led to approvals by the FDA where new treatments are now on the market, such as lung coils and valves for emphysema.
Any number of investigational trials is ongoing at Temple such as one current study where the procedure involves deadening of the nerves to ease breathing.
Benefits to Patients
Dr. Galli reminded the audience that clinical research is not just about a patient potentially finding an advanced new treatment but securing access to the drug before it is generally available. In some cases, this can literally mean saved lives.
Temple Clinical Trials Office
The Temple Clinical Trials office oversees clinical trials at Temple University. They conduct numerous clinical trials in an ongoing effort to discovery and deliver more effective medical treatments. Their goal—quickly translate discoveries made in the lab to the patients who will benefit from them.
Each and every clinical trial at Temple is approved by their Institutional Review Board, a panel of healthcare professionals and interested community members, to ensure that risks are monitored and federal guidelines are involved and followed. It is critically important to understand that institutions that conduct clinical trials, such as Temple, must ensure the rights and welfare of people participating in clinical trials both before and during the trial.
The Office of Clinical Research Administration supports the schools of Medicine, Dentistry, Podiatric Medicine, Pharmacy, and the College of Public Health. It helps plan, implement and financially manage clinical trials.
The Temple Clinical Research Institute (TCRI)
The Temple Clinical Research Institute (TCRI) was established within the Lewis Katz School of Medicine at Temple University in May 2014. The Institute’s mission is to provide a transformative infrastructure of expertise and resources designed to enhance and accelerate multidisciplinary clinical research of the highest quality throughout Temple Health.
Based on the article, we include:
Dr. Jonathan Galli, Assistant Professor, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University
Carla Grabianowski, Nurse Coordinator