How would you define Phase IV post-marketing surveillance trial?

A type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market. Also called phase 4 clinical trial and post-marketing surveillance trial.

What type of studies may be conducted during Phase IV?

Other phase IV studies could be RCTs, in vitro studies, outcomes research (burden of illness) and pharmacoeconomic studies, drug utilization studies, practical clinical trials, and investigator-initiated research in practice.

What phase of TR are post marketing studies?

The phase 4 trial is also referred to as post marketing surveillance and as the name suggests, it is conducted after the drug is already marketed and available to the general public.

What are Phase IV studies?

Phase IV studies look at drugs that have already been approved by the FDA. The drugs are available for doctors to prescribe for patients, but phase IV studies might still be needed to answer important questions. These studies may involve thousands of people.

What is the main objective of the Phase IV study?

A common goal of Phase IV studies is to provide evidence that the health intervention can be successfully and safely integrated into public health or clinical practice where ‘successful’ means that it is not only feasible to do so, but also that the intervention remains effective and its implementation is not …

What is the difference between pharmacovigilance and post-marketing surveillance?

Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. The process of evaluating and improving the safety of medicines used in paediatric practice is referred to as paediatric pharmacovigilance.

What is a Phase 4 interventional study?

Phase IV refers to large studies, interventional or non-interventional, that are often used to assess serious adverse effects in a sizeable population, but that are sometimes also used to approve additional uses of a drug or to introduce physicians and patients to new treatments [1].

Are registry studies Phase IV?

Registries, while respecting the principles of Phase IV research, cannot be run like a Phase IV study, the same way that Phase IV studies cannot be run like patient registries. Each has its unique role in the evaluation of interventions—both should strive for research excellence.

What is Phase 4 FDA approval?

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

What is the value of Phase IV clinical trials?

Phase IV of clinical trials also named post marketing studies or real world trials, are useful to better understand the true efficacy of medicines. Phase IV could improve scientific knowledge i.e. side effects, use of a drug in special conditions, better precision of the dosage.