Table of Contents
What is the purpose of clinical trials?
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.
How are clinical trials designed to give valid results?
Most clinical trials use comparison groups to compare medical strategies and treatments. Results will show if one group has a better outcome than the other. This is usually conducted in one of two ways: One group receives an existing treatment for a condition, and the second group receives a new treatment.
What you should know about clinical trials?
Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. It is important to remember that the FDA does not conduct Clinical Trials.
What are the main objectives of the pre clinical phase?
The main goals of preclinical studies are to determine a starting, safe dose for first-in-human study and assess potential toxicity of the product, which typically include new medical devices, prescription drugs, and diagnostics.
Why is preclinical testing important?
The ultimate goals of preclinical studies are to accurately model, in animals, the desired biological effect of a drug in order to predict treatment outcome in patients (efficacy), and to identify and characterize all toxicities associated with a drug in order to predict adverse events in people (safety) for informed …
What type of research is a clinical trial?
Clinical Trials A clinical trial is a type of clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new drugs or treatments are safe and effective.
What is the purpose of pre clinical drug development studies What information does it provide and what information does it not reveal?
What is a clinical trial and why are they conducted?
Clinical trials are conducted for many reasons: to determine whether a new drug or device is safe and effective for people to use. to study different ways to use standard treatments or current, approved treatments so that they will be more effective, easier to use, or decrease certain side effects.
What happens in a Phase 1 clinical trial?
Phase 1 Trials This phase occurs directly after lab testing. Based on the lab testing, researchers have determined that the drug, device or other treatment may provide a benefit to humans. However, at this point, it has not yet been determined how the drug will affect or react to a human’s biology, or whether it’s safe or even effective.
Why do people volunteer to participate in clinical trials?
People volunteer to participate in clinical trials for different reasons. Some volunteer because they want to help advance medical knowledge. Others have tried all available treatments for their condition without success.
How can research data be collected for clinical trials?
For example, researchers may collect data through medical exams, tests, or questionnaires about a group of older adults over time to learn more about the effects of different lifestyles on cognitive health. These studies may help identify new possibilities for clinical trials.