Patient Safety First
Patient safety has always and will always continue to be Allergan’s main focal point in its research and development program. We take great pride in our ability to discover and manufacture products with the hope and expectation that they will make a meaningful difference in the lives of patients like you; but this comes with the vital responsibility that to make a difference, we must look out for the patient’s well-being at every stage of the product’s development. Our mission – “Our Pursuit. Life’s Potential.” – begins with a close look at product safety from the earliest stages of research and development. That’s why before any microscope is focused in our laboratories, decisions are made on whether a potential new treatment will add a significant and safe contribution to patient care.
Safety in Clinical Trials
Patient safety is paramount in the way clinical trials are designed and carried out. We want to ensure that our studies are conducted in the highest ethical manner and in accordance with U.S. and international guidelines, including Good Clinical Practice (GCP) and the Declaration of Helsinki.
In addition to the required Governmental oversight, we implement our own checks and balances in the form of stringent internal committees for ensuring patient safety during Allergan-sponsored clinical trials. These committees include: the Pre-Clinical Group, which sets the high safety bar before an Allergan product ever reaches the first patient, and the Protocol Review Group, which ensures that regulated safety criteria has been met in the trials and that the patients being studied are appropriately informed of the risks that may come with using the product.
Next, when engaging patients to enroll in clinical trials, we begin with the Informed Consent process. The Informed Consent is a document which details patient rights, confidentiality and the potential risks associated with the drug being studied, to help the patient make the appropriate decision to participate, continue or disengage from the trial. We strictly adhere to this Informed Consent protocol, which is closely regulated by authorities both in the United States and internationally to preserve the rights of patients. For further reference, in case interested, the Department of Health and Human Services’ Office for Human Research Protection (OHRP) provides guidance for the Informed Consent process and lists some frequently asked questions.
Once a clinical trial starts, Allergan puts additional internal committees in place, including the Safety Committee, which takes a 360° view of all treatments being studied from the standpoint of safety and efficacy; and the Real-Time Safety Monitoring Group, which continuously monitors data for any potential safety signals. A medical monitor, who is a physician, is involved in each clinical trial and has the final say on safety issues, is unfettered by timelines and acts independently, creating an atmosphere of uncompromised safety which is so key. The physician monitor has the authority to make a determination about whether a patient needs to be discontinued from the study for safety reasons – and his or her decisions are incorporated into the study protocol. If a safety issue with the product is observed, it is reported to health agencies and the ethics committees of the clinical trial sites.
Often times, we focus on trials that study vulnerable patient populations. In this event, Allergan may secure additional clinical experts in the field to make certain that the safety of these patients is never compromised while participating in the trial.
A list of Allergan’s current and past clinical trials can be accessed by visiting the U.S. National Institutes of Health’s Clinical Trials Web site located at www.clinicaltrials.gov.