Title 2. INTRODUCTION TO CLINICAL TRIALS.pdf ✅

PHARMD GURU Page 2 2) They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial and stay in touch after the trial is completed. 3) For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff. INFORMED CONSENT: Informed Consent is the process of learning the key facts about a clinical trial before deciding whether to participate (or) not. It is also a continuing process throughout the study, to provide information for participants. 1) To help someone decide whether (or) not to participate, the doctors & nurses involved in the trial explain the details of the study. 2) If the participant`s native language is not English, translation assistance can be provided. 3) Then the results team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures and key contacts. The participant then decides whether to sign the document or not. 4) Informed consent is not a contract, and the participant may withdraw from the trial at any time. BENEFITS OF CLINICAL TRIAL: The eligible participants can: 1) Play an active role in their own health care. 2) Gain access to new research treatments before they are widely available. 3) Obtain expert medical care at a leading hospital care facilities during the trial. 4) Help others by contributing to medical research. SAFETY: The ethical and legal codes, that govern medical practice also applies to clinical trials. In addition, most clinical trials are federally regulated with built in safeguards to protect the participants.
PHARMD GURU Page 3 1) A clinical trial follows a carefully controlled protocol, a study plan, which details, what researchers will do in the study. 2) As a clinical trial progresses, researchers report the results of the trial at: scientific meetings, medical journals, and to other various government agencies. Individual participant’s names will remain secret and will not be mentioned in these reports. INFORMATION FOR SUBJECTS BEFORE PARTICIPATING IN A TRIAL: People should know as much as possible about the clinical trial and feel comfortable asking the members of the healthcare team questions about it, the care expected while in your trial and the cost of the trial. The following questions might be helpful for the participants to discuss with the healthcare team. These questions are found in the informed consent document. 1) What is the purpose of the study? 2) Who is going to be in the study? 3) Why do researchers believe the new treatment being tested may be effective? Has it been tested before? 4) What kind of tests and treatments are involved? 5) How do the possible risks, side effects and benefits in the study compare with my current treatment? 6) How might this trial affect my daily life? 7) How long will this trial last? 8) Will hospitalization be required? 9) Who will pay for the treatment? 10) Who will be in charge of my care? IDEAS FOR CLINICAL TRIALS: Ideas for clinical trials usually come from researchers. After researchers test new therapies (or) procedures in the laboratory, and in animal studies, the treatments with the most promising laboratory results are moved into the clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.
PHARMD GURU Page 4 TYPES OF CLINICAL TRIALS: 1) TREATMENT TRIALS: They test new treatments, new combinations of drugs (or) new approaches to surgery (or) radiation therapy. 2) PREVENTION TRIALS: They look for better ways to prevent diseases in people, who have never had the disease (or) to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals (or) lifestyle changes. 3) DIAGNOSTIC TRIALS: They are conducted to find better tests (or) procedures for diagnosing a particular disease (or) condition. 4) SCREENING TRIALS: They test the best way to detect certain diseases or health conditions. 5) QUALITY OF LIFE TRIALS (OR SUPPORTED TO TRIALS): Explore ways to improve comfort and the quality of life for individuals with a chronic illness. PHASES OF CLINICAL TRIALS: Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions: IN PHASE-I TRIALS: Researchers test a new drug (or) treatment in a small group of people (20 to 80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects. IN PHASE-II TRIALS: The study drug (or) treatment is given to a large group of people (100 to 300) to see, if it is effective and to further evaluate its safety. IN PHASE-III TRIALS: