Clinical Trial
Effective Design of Clinical Trials | FDA
The 1962 FD&C Act Prior to 1962, drug safety was the primary concern, but the act revolutionized the landscape by demanding substantial evidence of a drug’s effectiveness. This shift led to the requirement of “adequate and well-controlled studies” – a cornerstone of modern clinical research. 𝗔𝗱𝗲𝗾𝘂𝗮𝘁𝗲 𝗮𝗻𝗱 𝗪𝗲𝗹𝗹-𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗱 𝗦𝘁𝘂𝗱𝗶𝗲𝘀: 𝗧𝗵𝗲 ... Read More
Different Phases of Clinical Trials
Pre-clinical (or laboratory) Studies Clinical trials are done only after preclinical findings suggest that the new drug or treatment is likely to be safe and will work in people. Pre-clinical studies, also called laboratory studies, include: Cell Studies Animal studies Phase 0 Studies The IND application must contain certain information, ... Read More
Different Types of Clinical Research Studies
Clinical research studies come in many different forms, each with its own purpose and unique approach. Let’s take a look at some of the most common types of studies: Prevention trials are like superheroes, working to prevent the development of a particular condition or disease. Researchers test a variety of ... Read More