A clinical trial is a research study to answer specific questions about new therapies or new ways of using known treatments. Clinical trials in Columbus 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 treatments that work.
The clinical trial process depends on the kind of study you participate in. The team will include doctors and nurses as well as other health care professionals. They will check your health at the beginning of the study, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study.
All clinical trials have guidelines about who can get into the program. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. Before you join a clinical trial, you must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers.
Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or medical devices.
Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
Some clinical trials will pay you for joining the trial. In some studies, researchers will reimburse you for expenses associated with participating in the study. Such expenses may include transportation costs, child care, meals and accommodations.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
A placebo is an inactive pill, liquid, or powder that does not contain study drug. Treatments are often compared with placebos to assess the treatment's true effectiveness. In some studies, the participants in what is called the control group will receive a placebo instead of an active drug or treatment. In a cross-over design study, after a period of time, patients may receive the study drug after placebo treatment is given without the patient knowing.
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
Each clinical trial lasts a specific amount of time, depending on the medicine and/or treatment being tested. You will be informed of the specific time requirement before you agree to enter a study.
Aventiv has conducted phase I, II, III, and IV clinical studies with over 55 different pharmaceutical companies and clinical research organizations.