Clinical Research
Transcript: How Does Clinical Research Make a Difference ? Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following: Who is eligible to participate in the trial Details about tests, procedures, medications, and dosages The length of the study and what information will be gathered A clinical study is led by a principal investigator (PI), who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness. Phase 4: “Post-Marketing Surveillance”, this trial involved the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. After a drug is approved and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use. This Phase designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than possible during Phases 1-3 clinical trials. If harmful effects are discovered by Phase 4 trials may result in a drug being no longer sold, or restricted to certain uses. Thank You! I appreciate you all for listening! Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Clinical trials are a key research tool for advancing medical knowledge and patient care. whether a new approach works well in people and is safe and which treatments or strategies work best for certain illnesses or groups of people. Clinical trials are an important step in discovering new treatments for cancer and other diseases as well as new ways to detect, diagnose, and reduce the risk of disease. Clinical trials show researchers what does and doesn't work in people. Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the agent or intervention because it was unsafe or ineffective. When a phase III trial is completed, the researchers examine the data and decide whether the results have medical importance. Results from clinical trials are often published in peer-reviewed scientific journals. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice. a. Treatment trials: to test experimental treatments, new combinations of drugs or new approaches to surgery or radiation therapy. b. Prevention trials: to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. c. Diagnostic trials: to find better tests or procedures for diagnosing a particular disease or condition. d. Screening (early detection) trials: to test the best way to detect certain diseases or health conditions. e. Quality of Life trials: (supportive care trails) to explore ways to improve comfort and the quality of life for individuals with a chronic illness. f. Natural history studies: provide valuable information about how diease and health progress. As a result, the U.S. Food and Drug Administration now recommends never using HT to prevent heart disease. When HT is used for menopausal symptoms, it should be taken only at the smallest dose and for the shortest time possible. Clinical trials, like these trials, help improve and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments that work best. Outcomes A healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention. Research procedures with healthy volunteers are designed to develop new knowledge, not to provide direct benefit to study participants and also, contribute to moving science forward. A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition. Research procedures with a patient volunteer help develop new knowledge. These procedures may or may not benefit the study participants.
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