Questions About Clinical Trials?
You can find information and participation on clinical trials below.
What are Clinical Trials?
A clinical trial is a type of research study designed to learn if a research medicine works and is safe for people. A government regulator, such as the U.S. FDA (Food and Drug Administration) and others must approve clinical trials before they can start. The data collected from clinical trials are then reviewed by government regulators to see if they help people and are safe before they approve a new medicine for use by the general public.
There Would Be No New Medicines Without Clinical Trials
Clinical trials help researchers find better treatments for people. Before a drug is made available to the general public, it must go through several phases of clinical research and regulatory approvals that show it is safe and works. Most medicines available today are the result of past clinical research driven by patients’ unmet needs and lack of available treatment options. Without clinical trials, there would be no new medications. Clinical trial volunteers play a big role in this process.
Why Diversity Matters in Clinical Trials
Diversity in clinical trials leads to better research, treatments, and health outcomes for all people because drugs can work another way in different people. A person’s age, gender, ethnicity, and genetics contributes data that drives real-world results outcomes, and leads to better research and treatments for all people.
Why Do People Take Part in Clinical Trials?
People take part in clinical trials for many reasons, including potential access to research study drugs or treatments, and helping others by contributing data that is used to expand knowledge about a disease or possible treatment option. It is important to note that participating in a clinical trial may or may not help the person who is taking part in the study.
Your Rights in a Clinical Trial
You have the choice to be in a clinical trial and are given enough time to make that decision without pressure from the study team. Even after joining the study, you have the right to withdraw at any time and for any reason without any effect on your routine medical care.
You also have the right to be told why the clinical trial is being done, what will be required of you, and what the known risks, discomforts, or side effects that may occur during the study. You will be informed of the steps the study team will take to protect your personal health information, and to ensure that personal data collected during the clinical trial will be used only for the purposes explained to you prior to agreeing to take part in the clinical trial.
Clinical Trial Phases
Clinical trials are done in several steps called “phases.” Each clinical phase has a different purpose and helps study researchers answer questions about the drug being tested, such as what is the best dose of the drug to use, and how well does it work?
Pre-Clinical Trials
Before clinical trials can be done with people, researchers study drugs and treatments in the lab. This is called “pre-clinical development.” This research is extremely important in getting information on a drug’s possible benefits and risks before it is tested in people.
Phase I
Phase 1 clinical trials evaluate the safety and possible side effects of a drug being studied in a small group of people.
Phase II
Phase 2 clinical trials further learn about side effects people have while using the study drug and help to determine which dose of the drug works best. Phase 2 clinical trials are usually conducted with a larger group of people than Phase 1 clinical trials.
Phase III
Phase 3 trials confirm that the study drug or treatment helps people who have the disease or condition the study drug or treatment was made for. Phase 3 clinical trials are conducted in an even larger group of people than Phase 2 clinical trials.
Phase IV
Phase 4 trials are done after a study drug or treatment has been approved for all people to use. They are done to learn how a study drug or treatment works when people are taking it as part of their everyday lives. Sometimes these trials are “observational” studies, where people in observational studies are prescribed the drug in the usual manner. They are not assigned to a treatment by the study researchers.
Joining a Clinical Trial
If you are thinking about joining a clinical trial, a team of professionals will assess if you are a good fit for a specific study. Taking part in a clinical trial is different from regular medical care. You will be in contact with the study team that includes the study doctor, nurses, and research coordinators. People of all ages, genders, races, and ethnic groups can participate in clinical trials. This includes healthy volunteers and patients with specific diagnoses.
Pre-Screening
You will answer questions about your health and medical history and make an appointment to learn more. The team will review with you the instructions for taking part in the trial.
Informed Consent
At your appointment, the study team provides you information to review about the details of the clinical trial, including possible risks and benefits, so you know what to expect. If you decide to participate in the clinical trial, you will sign an “Informed Consent” document giving permission for additional screenings and access to your health records.
Screening Visit
This visit will confirm that you meet the clinical trial requirements. It includes a more detailed review of your medical history and a physical exam. It may also include additional tests related to your condition.
Study Participation
The study team will tell you what will happen, how the process works, and will answer any questions you have. They will be clear about how much of your time is required during study participation. The study team will also check in with you regularly to ask questions and see how you are doing.
Follow Up
The study team may call you or require additional visits after the clinical trial ends to check on your health and write down any changes that may have happened. The study team will tell you before you join the study if you will need to do any follow-up.