Frequently Asked Questions Regarding Clinical Trials

Q: What is a clinical trial?

A: Clinical trials are also known as clinical studies or research studies. Clinical trials help doctors and researchers find ways to improve health and health care. Information is gained on the possible benefits and applications of new drugs, the combinations, different doses and indicated uses of drugs already approved, and side effects.

Q: What are the phases of clinical trials?

A: Phase I studies are the first steps in using a new drug or a new drug indication in people following animal studies. The safety of the study drug is tested, as well as determining the best way to give the study drug, the best dose, and are there any side effects. There are a limited number of patients accepted to participate in Phase I trials.

Phase II studies are initiated if the Phase I trial shows safety. Phase II trials look at the dosage data, how well the drug works, and other less common side effects.

Phase III studies compare the value of the new drug with existing standard therapy. It uses two groups of people: the intervention group: this group takes the study agent, or the control group: this group takes either the standard treatment or a look-alike pill that contains no active ingredient, called a placebo. The purpose of the Phase III trial is to determine the value of the experimental drug in comparison to the standard therapy and whether it is more beneficial than or adds any benefit to the standard treatment.

Phase IV studies are post marketing studies to continue the evaluation and generate additional information of the safety and efficacy of the therapies which are already FDA approved and commercially available.

Q: What are the benefits of participating in a clinical trial?

A: Your participation in a clinical trial will contribute to gaining knowledge about a disease and the potential treatments. You may experience positive results from the new treatment. You will also receive high-quality care. Sometimes the study drug is provided for the patient free of charge by the sponsor. On the other hand there are no guaranteed benefits from participating in a clinical trial. It is possible that the new treatments aren’t any better than the standard care and unknown side effects may be worse than those known with standard treatment. Like the flip of a coin, you may be placed in a control group that receives the standard treatment instead of the study treatment. You should be aware of these pros and cons before you decide to participate in a clinical trial.

Q: What are the financial benefits?

A: As a patient you may be responsible for routine costs such as hospital fees, lab tests, and doctors visits. This will be discussed during the informed consent process. The costs covered depends on what is written in the study procedures covered in the informed consent. Regular treatment not covered in the study will be your responsibility or the responsibility of your insurance company.

Q: What are the patient’s rights participating in a clinical trial?

A: Clinical trials have several procedures to protect the safety of the people participating in clinical trials. One group includes the Institutional Review Board. A patient also signs an informed consent.

Institutional Review Board (IRB): All research centers have an Institutional Review Board (IRB) which reviews the actions and documents related to the specific clinical trial. The IRB group includes doctors, other health care providers, consumers, and sometimes clergy who don’t have any personal interest in the results of the study which would bias them. They take the responsibility of ensuring the study is being managed safely, fairly, ethically, and with the patient’s full consent.

Informed Consent Process: Before any patient is enrolled in a clinical trial an informed consent is signed. You will first meet with a member from the research team who will talk to you about the trial, and provide you with written information about the trial (Informed Consent document). Details include safety issues, purpose of the study, duration, alternative procedures, benefits, and risks. You will have time to review the document, and think over your decision. If you decide to participate in the trial, you will sign the informed consent verifying that you understand and agree to the conditions of the clinical trial. During the informed consent process, this is the time for you to ask questions on any part of the consent you do not understand. A copy of the signed consent will be given to you for your reference.

When you are enrolled in a clinical trial you will receive updates on any new information gained during the study, which may reasonably influence your desire to continue participation in the study. You will be encouraged to ask questions at any time during the study. Participating in a trial is voluntary. You are free to leave a trial at any time, for any reason. If you decide to leave, you will have the chance to talk about alternative options with your own doctor, or with a doctor from the study.

Q: Should I participate in a clinical trial? Is it right for me?

A: You should always explore and discuss your interest to participate in a clinical trial. You should talk to your doctor and gain a better understanding of the benefits and risks of a clinical trial. Sometimes it is helpful to speak with patients who have participated in clinical trials. Also, if you and your doctor find a clinical trial that could be beneficial, take the time to think about your commitment to the trial. Clinical trials require a commitment from both the researchers and patients. You will need to be able to have time to come in for treatments, appointments, monitoring, and follow-up. If you cannot fulfill these requirements at this time, you may want to reconsider entering a clinical trial. Remember joining a clinical trial is voluntary. You have the right to drop out at any time if you feel it isn’t right for you.