The Department of Otolaryngology—Head and Neck Surgery conducts ground-breaking research in cochlear implants, laryngology, otology, and more. Clinical trials help us translate our research into patient care.
For a complete list of available clinical trials, visit Columbia RecruitMe.
What is a Clinical Trial?
A clinical trial is a research study that uses human volunteers to determine whether a specific intervention is safe and effective. Clinical trials are the best way to understand the risks and benefits to humans of a given medical strategy, treatment, or device. A clinical trial is one of the final stages of a long research process, which may have begun in a laboratory and involved testing on animals.
The trial must follow strict scientific standards that protect participants and help produce reliable results. It also has to undergo rigorous review and approval by the Food and Drug Administration (FDA) and an Institutional Review Board (IRB), an independent committee of physicians, researchers, and community members charged with ensuring that the study is ethical and that participants are protected.
The trial usually begins with a small group of participants who have undergone a thorough informed consent process. The trial may include several phases before determining if a new strategy, treatment, or device improves outcomes, offers no benefits, or causes unexpected harm.
Why Enroll in a Clinical Trial?
The benefits of participation in a clinical trial include:
- Access to innovative treatments before they are widely available
- Opportunities to take a more active role in one’s own health care
- Regular medical care and close monitoring during the study
- Contribution to advancements in medical research
How to Enroll in a Clinical Trial
Clinical trials have eligibility criteria that may include age, gender, medical history, or medical conditions. A candidate must match all the specified criteria to participate.
Once eligibility has been confirmed, our research coordinator begins the informed consent process by providing information to help patients decide whether they want to enroll in the study. This information includes:
- Reason for the trial
- Expected length of the trial
- Eligibility criteria
- Number of participants needed
- Schedule of tests, procedures, or drugs and their dosages
- Risks and benefits
- What information will be gathered about the participants
Once all information has been reviewed, the patient is 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.
Resources and Contact Information
To learn more about participating in a clinical trial, please contact Jessica Campbell, research coordinator (212-305-2298; firstname.lastname@example.org).
Columbia Otolaryngology puts the newest science and most advanced technologies to work for our patients.