A clinical trial is a research study for which patients voluntarily consent to participate. Participating patients or research subjects who qualify for a study are assigned by chance to receive an investigational study medication for their specific medical condition (such as asthma or allergies). The investigational medication could be either the active (real) drug studied or a placebo (no active drug). The patients who agree to participate are carefully followed during the clinical trial by our physicians and the research staff.
Most clinical studies involve receiving an investigational drug. An investigational clinical study drug is a drug that has not been approved by the United States FDA and is not available for treatment on the market. The purpose of such studies is to determine if the new drug should be approved for the market to treat other patients. Sometimes the study involves medications that are approved by the US FDA but not for the medical condition studied. Some studies are observational and simply involve collection of medical information or tests and no study medication is given to the participating patients.
Subjects who participate in clinical trials can play a more active role in their own health care, gain access to new investigational treatments before they are widely available, have additional medical screening, test and procedures, learn more about their medical condition. In addition, your participation may lead to new treatments that could help other patients in the future.
All clinical trials have guidelines or “criteria” about who can participate. Each clinical trial is unique and all patients need to qualify based on the specific inclusion and exclusion criteria, stating which patients can and cannot participate. Our research staff will ask questions such age, gender, the severity of disease, previous treatment history, and ask about other medical conditions to determine which patients are eligible. All study participants must pass the history, physical exams and screening tests before determining if they qualify for a clinical research trial.
Each clinical trial is different but directions for all studies are written down in a detailed study plan or “protocol” that has already been approved for use in the research study by the US FDA and an Institutional Review Board (IRB). The IRB is responsible for reviewing the study information and ensuring patient safety. Our board certified doctors who are known as the investigator and study nurse (research coordinator) have been specially trained on how to conduct the study protocol.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant will receive detailed information about the study tests and procedures, medical exams, and study stipend payments for time and travel.
Informed consent is the process of learning and identifying the key facts about a clinical trial before deciding whether or not to participate. The doctors and coordinators involved in the study explain the details of the study and answer all patient questions and concerns. The informed consent form document 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. The participants should receive a signed and dated consent form document and should not have any test, procedures or study related events occur prior to completing the informed consent form. The participant can only volunteer for one study at a time and will need to wait 30 days between participating in clinical studies.
If the participant is a minor (under the age of 18) the child signs and dates the Accent Form and the legal guardian signs and dates the informed consent form. The Accent/informed consent form process is the same as stated above.
Benefits:
- Subjects play an active role in their own health care.
- Subjects receive patient education about their medical condition.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care during the clinical trial.
- Receive study related test and procedures that might not normally receive during a usual doctor visit.
- Have easy access and scheduling for sick visits with minimal wait times.
- Receive financial reimbursement for time and travel.
- Help others by contributing to medical research findings that could eventually lead to more effective medical treatments.
Risks:
- There are potential risks to participating in clinical trials.
- There may be unpleasant, unexpected events and possibly serious side effects related to the investigational medication treatment.
- The investigational treatment may not be effective for the participant and the subject may need to be withdrawn from the clinical trial.
- The study may require more time and attention than would be expected during a normal doctor visit.