The College of Dental Medicine is improving the health of its patients through ground-breaking, multidisciplinary research that involves developing and testing new treatment strategies for patients with dental issues. Clinical trials help us translate our research into patient care.
What is a Clinical Trial?
A clinical trial is a research study using human volunteers. Participants receive a specific intervention such as a medical therapy, treatment, or device to determine whether it is safe and effective for humans. Clinical trials are the best way to understand the risks and benefits to humans of any given medical strategy, treatment, or device.
A clinical trial is one of the final stages of a long research process, which may begin in a laboratory and sometimes involves testing on animals.
The trial must follow strict scientific standards which protect participants and help produce reliable study results. It also has to undergo a rigorous process of review and approval by the Food and Drug Administration (FDA) and by an Institutional Review Board (IRB). An IRB is an independent committee of physicians, researchers, and members of the community charged with ensuring that the study is ethical and that the rights and welfare of participants are protected.
The trial usually begins with a small group of participants who have undergone a thorough process of informed consent. The trial may go through several phases. Ultimately, the trial will determine if a new therapy, treatment, or device improves patient outcomes, offers no benefits, or causes unexpected harm. Each of these results is important because it advances medical knowledge and improves patient care.
Why Enroll in a Clinical Trial?
Benefits of participation in a clinical trial include:
- Access to innovative treatments and state-of-the-art care before it is available outside the clinical trial setting
- Opportunities to take a more active role in your own health care
- Regular, consistent medical care and close monitoring by a team of health professionals during the course of study participation
- Important contribution to medical research
How to Enroll in a Clinical Trial
Clinical trials have specific criteria, called inclusion and exclusion criteria, which are used to determine your eligibility for a trial. These criteria may include age, gender, medical history, or medical conditions. You must match all of the specified criteria in order to participate in the trial.
Once your eligibility has been confirmed, a research coordinator will begin the informed consent process. This is the process by which researchers provide potential participants with information about a clinical study to help them decide whether they want to enroll in the study. This information includes:
- The reason for the trial
- The number of participants needed
- Length of the study
- Who may participate in the study (the eligibility criteria)
- The schedule of tests, procedures, or drugs and their dosages
- Risks and benefits
- Information that will be gathered about the participants
You will also have the opportunity to ask questions about the study. Once you have reviewed the information and have all of your questions answered, you will be asked to sign a consent form. The consent document is not a contract. Participants may withdraw from a study at any time, even if the study is not over.