What is a Clinical Trial?
Clinical trials are research studies. The information gained from clinical trials is crucial in the progress of finding a better way to treat diseases, including Sepsis, infections cancers and many other ailments that effect human beings. Infections like influenza, pneumonia, urinary tract infections, and skin infections. Through the use of clinical trials, researchers are able to learn which treatment approaches may be more effective than others.
A clinical trial is usually based on standard treatment with the addition of some newer elements. It may be antibiotics, antiviral mediation, or wound care to mention a few. A participant may receive advanced treatment before it is available to other patients.
Physicians with patients in clinical trials follow a carefully designed treatment plan called a protocol. The protocol dictates exactly how your treatment will be administered. This protocol has been reviewed and approved by the FDA and an Institutional Review Board (IRB). The IRB reviews all clinical trials to be certain they are safe before the trial is offered as a treatment option to patients. The Joint IRB of St.Rita’s Medical Center, Institute of Orthopedic Surgery, West Ohio Surgery and Endoscopy Center and Triumph Hospital – Lima is the board which reviews clinical trials performed by our site.
What kind of information will I get about the trial?
Once your physician determines there is a suitable clinical trial for your participation, a clinical research coordinator
will meet with you. The research coordinator will provide you an informed consent. This consent will give a detailed description of the exact treatment you will receive and the potential side effects.
All participants must sign the informed consent in order to participate. Your signature signifies you understand the treatment and any potential risk involved. Even if you have signed the informed consent, you may withdraw from a clinical trial at any time.
If you withdraw you will continue to receive the same level of high quality care from your physician with no bias.
What are the benefits of participating in a clinical trial?
Participation in a clinical trial offers patients a very structured treatment program which some patients like. As a participant you may receive cutting edge treatment for yourself while also getting satisfaction others may benefit in the future.
Do I have to participate in a clinical trial?
No. Participation is voluntary and is considered a treatment option. You and your family have the ability to ask questions about your treatment throughout your participation in the trial. And again may withdraw at any time.
A few sample questions a potential clinical trial participant may ask:
- What is the purpose of this trial?
- Who reviews patient safety?
- What are the possible short term and long term risks?
- What are my other treatment options?
- Who is charge of my care if I participate?
- Will this cost me anything or will I get paid to participate?
- Who gets to see my information?
- Do I need to be in the hospital?
The informed consent potentially contains the answers to most questions a participant has.
BUT ALWAYS REMEMBER : Write your questions down.
Ask all of your questions until you are comfortable with the answers.
Regional infectious diseases and infusion center is currently doing multiple clinical trials and appropriate patients will be presented with an option to participate.