The following are questions that people frequently ask about clinical research studies.
Q: What is a medical research study?
A medical research study is a carefully designed trial that is done with volunteers who receive investigational treatments under supervision by a physician and other research professionals to try to determine the safety and effectiveness of a drug. The clinical testing of an investigational drug is a step-by-step process that ensures volunteers receive medical attention. All medical research studies are reviewed by Institutional Review Boards (IRBs) and must obtain ethics approval. Sometimes volunteers in one study group will receive an investigational treatment or study drug, while other volunteers receive a placebo or a treatment already available. A placebo is a sugar pill that looks like the study medication, but has no medical effect. Whether you receive the placebo or the investigational drug, you will receive the same medical tests and evaluations.
Q: What are the benefits of participating in a medical study?
People volunteer to participate in a medical research study for a number of reasons, including being a part of the advancement of science or hope for a treatment that doesn’t currently exist. They also may seek improved medical care or desire to be involved in research that could help many others. As a volunteer in a medical research study, a patient helps in the possible development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases.
Q: What can a volunteer expect?
Volunteers can expect to receive comprehensive information on their disease and available treatments as well as support for coping with their symptoms. They will be given a detailed outline of the study procedures, which may include physical exams, questionnaires, and blood work among other tests specific to the trial. The volunteer will receive study medication or placebo according to the trial. The patient must feel free to discuss their medical treatment with the investigator or any research staff member at any time during the course of the research study. The expectations of the volunteer will be clearly described and may include taking study medications as instructed, keeping all scheduled visits, and telling the study physician about any symptoms they have had, no matter how minor they may seem. As a volunteer, the patient has the right to leave the study at any time.
Q: What happens after the study?
When a medical research study ends, several things might happen. For a serious illness, a pharmaceutical company may or may not continue to provide the study medications to those patients that are responding well. After a study is complete, all of the information is collected and analyzed to help determine the study drug’s safety, efficacy, and side effects. FDA medical advisors and specialists closely review this data before considering any new investigational drug for approval. Even if an investigational drug is approved, pharmaceutical companies will continue to conduct studies that compare the new drug to other drugs already on the market. These continued research studies may determine if a therapy can be administered to children or special populations, its long-term effectiveness, and its impact on the quality of life.
Q: What is an informed consent form?
An informed consent form is basically a detailed and comprehensive information package. It contains information on the study medication, the required test procedures, expectations of the volunteer, possible risks and benefits as well as a visit schedule. Before beginning a trial, the study nurse will go through the informed consent form with the volunteer. The volunteer will be encouraged to take this form home to review and discuss with family, friends and/or their family physician. The informed consent form also addresses confidentiality. Information about your personal health is very private and researchers are extremely sensitive to volunteers’ need for confidentiality. With the volunteer’s permission, the personal information will not be disclosed to anyone outside of the medical research study group without consent. By signing an informed consent form, a volunteer is giving permission to the study staff to administer study medication and conduct the necessary study test procedures, however, this permission can be withdrawn at anytime for any reason.
Q: Do the volunteers receive a copy of the study results?
Once the study has been completed, the sponsor compiles the data from each individual and publishes the results. The reports are not normally sent to the volunteers, however, if they are interested in learning the results of the trial, they can be obtained from the site once they have been received.
Q: What is the Government of Canada’s involvement?
Before any study is conducted, the Government of Canada requires that the sponsor file an Investigational New Drug Application (IND). The IND includes all information regarding the scientific development of the compound, the safety of the drug, and all results from previous studies. The study design and protocol, and the qualifications and experience of all study staff must also meet stringent FDA and International guidelines for human research. As well, approvals must be received from independent Research Ethics Boards who review all aspects of the study and personnel qualifications.