Clinical Trial
Volume of Distribution (V)
Do we know that one of the most misunderstood pharmacokinetic (PK) parameters is volume of distribution (V)? This is especially exacerbated by the many terminologies of V. Letโs start with a simple yet important understanding that V is a proportionality factor that relates the amount of drug in the body ... Read More
Clinical Trial Terminologies | Part-2
KAPLAN-MEIER CURVE A graphical representation of survival probabilities over time in a clinical trial. HAZARD RATIO A measure comparing the risk of an event occurring in two groups over time. COX PROPORTIONAL HAZARDS MODEL A statistical method to explore the relationship between variables and time-to-event outcomes. DOSE-RANGING STUDY A study ... Read More
Clinical Trial Terminologies | Part-1
BLINDED ADJUDICATION A process where an independent committee reviews and classifies study outcomes without knowing which treatment group the participants belong to. SUBGROUP ANALYSIS An analysis conducted on specific subsets of participants (e.g., by age or gender) to explore differences in treatment effects. NON-INFERIORITY TRIAL A trial designed to demonstrate ... Read More
Clinical Trials with Decentralized Elements
The U.S. Food and Drug Administration (FDA) issued final guidance titled โConducting Clinical Trials with Decentralized Elements.โ This guidance provides recommendations for sponsors, investigators, and other stakeholders on implementing decentralized elements in clinical trials. A decentralized clinical trial (DCT) is defined as a trial where trial-related activities occur outside traditional ... Read More
FDA Clinical Study Requirements for IND
Clinical study requirements for an Investigational New Drug (IND) application are designed to ensure the safety and efficacy of the investigational drug during human trials. Here are the key aspects and requirements: Clinical Study Protocol A detailed clinical study protocol must be included in the IND application. This protocol should ... Read More
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. ๐๐ฑ๐ฒ๐พ๐๐ฎ๐๐ฒ ๐ฎ๐ป๐ฑ ๐ช๐ฒ๐น๐น-๐๐ผ๐ป๐๐ฟ๐ผ๐น๐น๐ฒ๐ฑ ๐ฆ๐๐๐ฑ๐ถ๐ฒ๐: ๐ง๐ต๐ฒ ... 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