What are clinical trials?
A clinical trial is a research study to answer specific questions about vaccines, new treatments or new ways of using known therapies. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find new treatments that work in people.
What are phases of clinical trials and what do they mean?
Phase I- Earliest stage of human subject research of an experimental treatment completed in a small group of healthy subjects for the first time. The purpose is to discover safety and side effects.
Phase II- Treatment is expanded to a slightly larger group of people. The purpose is to see if treatment is effective and further study side effects.
Phase III- Treatment given to large groups of people, in many locations. Purpose is to confirm effectiveness, compare to other treatments, and collect additional information that will allow it to be used safely.
Phase IV- Study after the drug has been approved and all physicians can prescribe. Purpose is to find out about additional benefits, risks and optimal use, especially after long term use.
What is an Informed Consent?
An informed consent is a document that contains details about the study, such as its purpose, what’s going to happen, potential risks and benefits. An informed consent is more than just a document, it is a process. At Christie our research coordinators thoroughly review and discuss the informed consent document with each person, prior to their decision to participate in the study. We welcome a person bringing a trusted family member or friend with them when talking about the study, or taking the document home to review. Once the decision is made to join a study, the person and study coordinator sign the document, and participation in the trial may begin. An informed consent is an ongoing process throughout the entire time you are part of the study, as research coordinators and providers will continue to give information and answer questions. If at any time during the study a person decides not to participate anymore, all he/she needs to do is sign a request to be taken out of the study. Withdrawing from a study will not affect any of the medical care a person receives at Christie Clinic.
How am I protected?
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board to make sure the risks are as low as possible and are worth any potential benefits. Clinical research involving investigational products or devices are also federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details everything a researcher will do during the study. This is also described in the consent form. Throughout a clinical trial and at the end, researchers report the results at scientific meetings, to medical journals, and to various government agencies but we take special precautions so that information that could identify you is not reported. Any new information that is received from the sponsor about the study that may affect your decision to participate will be shared with you.
Will my protected health information be kept safe?
During a trial, information about a person’s health will be collected, stored and analyzed. To keep the information safe, we “de-identify” it before we share it with the sponsor. This means we remove any specific information about you, such as your name or address.