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Below are commonly used clinical trial terms you may come across.
A blood test, scan, or procedure used to generate data required by the trial.
The current medication that is typically taken as the standard treatment for a particular medical condition.
A clinical trial design where the participants and/or the research team do not know which treatments, the study treatment or the placebo, are assigned to which participants.
During a clinical trial, your care team consists of the Principal Investigator (PI), Sub-Investigator (Sub-I), Clinical Research Coordinator (CRC), and Patient Educator. Your care team may also include nurses, pharmacists, Patient Resource Partners, and other medical specialists who support the study.
A specialized healthcare professional who supports the Principal Investigator in conducting research and helps trial participants throughout the process.
A clinical trial tests new ways to prevent, detect, or treat disease, so we can create new, safe, and effective treatment options.
The requirements that people who want to participate in a particular clinical trial must meet. Eligibility criteria are based on certain factors like age, gender, ancestry, or medical history.
A federal agency of the Department of Health and Human Services that oversees all clinical trials testing new treatments. The FDA provides guidelines and regulations for clinical research to keep trials ethical and safe.
Informed consent is used by researchers to explain the clinical trial process to new volunteers. Informed consent is meant to empower you to understand everything about the clinical trial before getting started. If you decide to participate, you will sign an informed consent form.
A group of doctors, scientists, researchers, advocates, and community members that review and monitor clinical trials, ensuring the rights of participants are protected.
The treatment or therapy being tested in the clinical trial.
A trial team member who answers your questions and helps you understand all the specifics of the trial.
A care team member who, in some oncology trials, helps you navigate any financial assistance and other non-medical support needs you may have.
Categories created by the FDA for describing the steps of a clinical trial, based on the study's characteristics, such as the objective and number of participants. There are four phases:
Phase I: Focus is on safety. Treatment is tested with a small number of volunteers.
Phase II: Tests for safety, effectiveness and side effects, also with a small number of volunteers, but typically more than in Phase 1.
Phase III: Compares the new treatment to existing treatments available, this time with a much larger number of volunteers.
Phase IV: The treatment has been approved and available but researchers are looking for long-term benefits and side effects.
A placebo is a pill or other substance without any therapeutic effect. It is made to look like the study treatment but doesn’t have any active treatment ingredients in it.
Any steps taken to see if you might be eligible to join a particular clinical study. The process may involve a phone call with a clinical research professional, an online questionnaire, a blood test, or some other basic tests to see if you meet the criteria for the study.
The doctor who is responsible for supervising the clinical trial and protecting the safety and rights of patients.
A written plan on which the clinical trial is based that describes the eligibility criteria, the schedules of visits, the outcomes to be evaluated, and the length of the trial.
The organization or person responsible for the initiation, management, and/or financing of a clinical study.
A doctor on the trial care team who helps the Principal Investigator (PI) with the trial and protects the safety and rights of patients.