What is a Phase 3 B study?
Phase IIIb: Additional studies that are conducted to increase patient exposure; these additional data are either provided to the authorities at the time of approval or, because the studies are typically not completed at the time of initial filing, will be submitted as a postapproval commitment.
What is Phase 3a and 3b clinical trials?
Main objective of the Phase 3 trials are proving or confirming the clinical efficacy with no unacceptable safety concerns. Phase 3 trials have two sub-phases that is phase 3a and phase 3b trials. Phase 3a trials: With the efficacy and safety data obtained from the phase 2 trials, phase 3a trials are initiated.
What happens in a phase 3 study?
Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. Because doctors do not yet know which treatment is better, study participants are often picked at random (called randomized) to get either the standard treatment or the new treatment.
What is a Phase 3b 4 study?
Once a manufacturer applies for marketing approval on a drug, all subsequent research that is not conducted in-line with the product approval is termed Phase IIIB and all subsequent research that is conducted in-line with the product approval is called Phase IV.
Why do Phase IIIb studies are required?
The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition. To move forward with the trial, investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options.
What are the most common reasons why Phase III clinical trials fail?
Why do phase III clinical trials fail?
- Lack of Efficacy — i.e., failure to meet the primary efficacy endpoint.
- Lack of Safety — i.e., unexpected adverse or serious adverse events.
- Lack of Commercial / financial benefit— i.e., failure to demonstrate value compared to an existing therapy.
What is a Phase 3b clinical trial?
Phase 3b Clinical Trial means a Phase 3 Clinical Trial commenced before receipt of Regulatory Approval in the jurisdiction where such trials are being conducted, but [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.
What is a Phase III study?
Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C. F. R. § 312.
What is the difference between Phase 2a and Phase 2B trials?
Phase2 a is the first trial in patients with several doses and phase 2b is the near final dose. Then you need 2 confirmatory trials of that dose to get the compound registered and on the market.
What is a Phase 4 clinical trial?
Phase 4 Clinical Trial means a product support clinical trial of a Product that is commenced after receipt of MAA Approval in the country where such trial is conducted. Phase 4 Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies and post-marketing surveillance trials.