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What is clinical research?
Clinical research is medical research that involves people like you who volunteer to participate in carefully conducted investigations that uncover better ways to treat, prevent, diagnose, and understand human disease. This research includes clinical trials that test new treatments and therapies which can provide valuable information about the disease process, improving the quality of life for people with chronic illnesses and to help researchers find better treatments for others in the future.
All trials follow a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. The clinical trial is then reviewed by an Institutional Review Board (IRB) in order to ensure that the risks are minimal and is worth any potential benefits.
Once approved, members of the research team explain the details of the study, purpose of the trial, required procedures, risks and potential benefits, and who to contact for further information in order to help you decide whether or not to participate. This is known as the informed consent process and continues throughout the trial. Before you participate in a trial, you must give your consent by signing a document known as an informed consent form.
Types of trials
Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
Treatment trials test new treatments, new combinations of drugs or new approaches to surgery or radiation therapy.
Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
Who participates in clinical trials?
Men and women of all ages, races and ethnic groups take part in research. Each trial has guidelines that determine if a person can participate. One set of guidelines is called “inclusion criteria”. These are criteria that must be met in order to be a part of the trial and may include age, sex, and specific type of disease. The other set is called “exclusion criteria”. These would prevent you from participating. Examples would be other medical conditions or other treatments you may already be taking.
If you are eligible to participate, the choice remains yours. Participation in a clinical trial is completely voluntary and you can change your mind at any time.
Is a clinical trial right for me?
Choosing to be part of a clinical trial is a personal decision. You should discuss the option with your doctor and loved ones. Remember that if you participate:
- You have rights and protections.
- Your safety and well-being are always your doctor’s top priority
- You will be treated with the same respect as all other participants
- You can stop participating at any time.
Your decision to participate will not affect your care. We will continue to care for you no matter what your decision.
Your doctor or their staff may not mention clinical trials to you during your visit. This does not mean that you cannot join one. Ask your doctor about clinical trial options. Learning about all your treatment options is important. Be sure to have all the information you need before making a decision. You can ask questions at any time.
For more information regarding these trials, call our Clinical Research Center at 937-771-2287 or email DPNresearch@daytonphysicians.com or go to www.clinicaltrials.gov and enter the NCT number.