At Eastern Carolina Women’s Center, PA, we believe that the best medical care for tomorrow can only be developed by studying the care we give today, learning from it, and proposing improvements to it. This is the essence of clinical research. Eastern Carolina Women’s Center, PA participates in many clinical research trials, and offers the opportunity for our patients and members of our community to participate in them.
All participation in clinical research is voluntary. Our physicians and clinical trials staff actively search for studies specific to women’s health that prevent, detect, diagnose and offer possible treatment to our patients. The majority of studies we offer are nationwide studies involving a large number of participating research centers from across the United States. Some studies also enroll patients in other countries.
Understanding Clinical Trials
Clinical trials are research studies involving human volunteers to answer specific health questions. They are conducted to see if a new drug or device is effective for people to use, compare existing treatments to determine which is better, and they study different ways to use approved treatments, so they will work better, be easier to use, and/or decrease side effects.
Before a clinical trial can be offered to volunteers, it must pass through several phases and receive approval to be studied from the Food and Drug Administration (FDA). The trials have many phases, in early phases, medications and devices are tested on animals and healthy volunteers to determine they have no significant adverse effects. Then, there are phases done to see if there is a benefit to the medical condition being studied. If the medication or device is determined to benefit a medical condition and not cause significant adverse effects, the study enters another phase. This phase tests a larger population of patients with the medical condition to confirm the medication is safe and effective. Most of the studies done here at Eastern Carolina Women’s Center, PA are these studies looking at safety and efficacy. Once these phases are completed, a medication or device may then receive approval from the FDA to be available to the general public. Sometimes, the FDA will want more information and additional later phase trials can be done. Lastly, after a medication or device receives FDA approval, the sponsor of the product may perform a post marketing study to compare their product against another product or prove their product could be beneficial in another medical condition.
Clinical trials are also evaluated by Independent review boards (IRBs). An IRB is a group of people that meet to review a clinical trial to determine if the trial will be performed in an ethical manner. This group of people has both scientific and non scientific members. This is to ensure the clinical trial will be performed in a setting that will protect the rights of the volunteer and not expose them to unnecessary risks. Here at Eastern Carolina Women’s Center, PA we use multiple IRBs, we prefer to use the same IRB as the study sponsor for each trial since they will be more familiar with the trial and the expectations of the volunteers.
The possible benefits of participation include access to potentially new research treatments, and medical care for the condition being studied.
The possible risks of participation may include unpleasant, or serious side effects resulting from the treatment, the treatment may not be effective, and the treatment may be demanding or time consuming.
Clinical trials are conducted according to a plan called a protocol. A protocol describes what types of patients may enter the study, the types of tests and procedures required, drug dosages, length of study and what outcomes are to be measured at the end of the study. Participants in clinical trials are given informed consent documents to read and review prior to study entry and when changes are made to the protocol. These informed consents are used to ensure that the participant understands the study, its requirements, desired outcome, risks and benefits.