Many doctors at Akron General Medical Center study the nature of disease and attempt to develop improved methods of diagnosis and treatment through the clinical trials process. Akron General Medical Center participates in National Cancer Institute sponsored trials, pharmaceutical industry trials and studies initiated by Akron General Medical Center doctors.
Clinical trials, also called research studies, answer specific scientific questions to find better ways to prevent, diagnose and treat disease. Clinical trials test many types of treatments. These may include new drugs or new combinations of drugs, new ways of using known therapies or new approaches to treatments, such as radiation therapy or surgery.
Clinical trials are conducted in four phases. Each phase has a different purpose and answers different questions.
Phase I clinical trials- are usually the first step in treating human participants. Side effects and safe dosage are determined. This phase of a clinical trial usually has a limited number of participants who would not be helped by other known therapies.
Phase II clinical trials- look at whether the new treatment has any effect on a specific disease. Side effects and safety are also monitored. A limited group of people also participate in this phase of testing because risks and unknown side effects are still being established. There is no comparison to a standard treatment in a Phase II trial.
Phase III clinical trials- large groups of people participate in Phase III clinical trials. A phase III trial compares a new way to give a treatment against the standard way. People that participate are assigned at random to either the new treatment or the current standard treatment.
Phase IV clinical trials- these are trials conducted after a treatment has been approved. The goal of these trials is to learn more details about that treatment such as side effects, benefits and how to optimize the use of the treatment.
What happens in a clinical trial?
Treatment is carried out by the doctor according to a protocol. A protocol is a plan, or sort of a road map that the doctor follows. Each doctor that treats participants in a study uses the same protocol or plan. The participant's course of treatment is followed very closely. Once the treatment portion of the protocol is complete, participants may continue to be monitored for other endpoints of the study.
Clinical trials have steps built in to protect participants. One of these steps is the informed consent process.
Informed Consent- is an ongoing process during the course of a trial. The doctor and study coordinator reviews the treatment plan, which includes the potential risks, benefits and all the detailed information about the study with the potential participant. This information is also written in a consent form document, which is presented to the person before any treatment can begin. The potential participant is given time to have all questions answered and understand the treatment plan. A person may choose not to participate in a study and this does not affect their care. If a person decides to participate, the consent form is signed. Signing a consent form does not mean that a person must remain in a study nor are the person's legal rights affected. A person can leave a study at any time without fear of penalty or loss of any medical care. If a person decides to leave a study the doctor will discuss information about other treatment options.
Another step that protects patients in clinical trials is the eligibility criteria.
Eligibility Criteria- these are certain characteristics outlined in the protocol that all participants in the study must have. The criteria differs, depending on what questions the study is trying to answer. Examples are age, gender, type and stage of disease.
Participants' Rights- it is important to remember that participation in a clinical trial is voluntary. The rights of a participant do not change because they take part in a research study.
If you have any questions about participating in a clinical research study please contact an Akron General Medical Center research office.