What is Clinical Research?
A clinical research study or trial is a scientific investigation to determine how or verify if a new medication, medical device or treatment works in people. It is through clinical trials that doctors can find new and better ways to diagnose, treat, control and prevent illnesses. Clinical research studies are an important part of the advancement of medicine.
Why Should I Volunteer to Participate in a Clinical Trial?
There are a number of reasons why people decide to volunteer to be in clinical trials. For some people, being a part of the advancement of science and the contribution to that it makes to society is reason enough. Others suffer from conditions for which no treatment exists or the currently approved treatment could stand to be improved upon. Most volunteers get involved to learn more about their own condition through screening examinations and evaluations throughout the clinical trial. In addition to the reasons listed above, participants can potentially receive promising new treatments at no cost to them, before they are available to the general public.
How Do I Know if a Clinical Trial is Safe?
There may be some risks to participants in a clinical trial. However, the Food and Drug Administration (FDA) has mandatory safeguards and regulations that they require all doctors (Investigators) involved in clinical trials to follow. Our doctors are committed to following all FDA guidelines in order to ensure that a person’s safety is not put at risk. In addition, all clinical trials must be approved by an objective group of independent experts known as an Institutional Review Board (IRB). The IRB reviews and approves the study design and monitors the trial’s progress to ensure that the risks to participants are as low as possible and worth the potential benefits of participating.
What is Informed Consent?
“Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.” (ICH E6: GCP Guidelines; 1.28) As Investigators we take our responsibility to provide you with all of the information that you need to make an informed decision very seriously. If there is a study that you may qualify for, you will be presented with an Informed Consent Form containing this information prior to any study related procedures taking place. If new information about your trial becomes available, you will be provided with that information and be presented with a new, updated Informed Consent Form. We understand that informed consent is an ongoing process and you have the right to withdraw your consent at any time.
Who Pays for Clinical Trials?
Clinical Trials are usually sponsored by either the federal government (through the National Institute of Health or NIH), pharmaceutical companies or by device manufacturers. The investigator is reimbursed for all study related procedures through grants by the sponsoring entity.
We encourage you to ask questions. We want you to feel confident and secure in your decision to participate throughout the study. Make sure that you know the answers to the following questions before making your decision: