What are the 3 types of clinical trials?

Types of clinical trials

  • Interventional trials aim to find out more about a particular intervention, or treatment.
  • Observational studies aim to find out what happens to people in different situations.
  • Feasibility studies are designed to see if it is possible to do the main study.

What are registrational trials?

Registrational Trial means a Clinical Trial that is designed to obtain sufficient data and results to support the filing of an application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals).

What is a phase2 3 trial?

Listen to pronunciation. (fayz … KLIH-nih-kul TRY-ul) A study that tests how well a new treatment works for a certain type of cancer or other disease and compares the new treatment with a standard treatment.

What are Stage 3 trials?

A study that tests the safety and how well a new treatment works compared with a standard treatment. For example, phase III clinical trials may compare which group of patients has better survival rates or fewer side effects.

What is a non registrational study?

Non-Registrational Trial means a Clinical Trial for a particular indication that (a) is initiated or ongoing after completion of the first Phase III Trial for such indication, and (b) is not conducted to obtain, maintain or expand Regulatory Approval of the Product being tested.

What is a Phase 4 clinical 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. These trials look for side effects that were not seen in earlier trials and may also study how well a new treatment works over a long period of time.

What are Phase 4 clinical trials?

How long do Phase 3 trials last Covid?

Phase 3 trials can sometimes take years. But Janssen hopes to get results much sooner—in a year or less—by creating as large a trial as possible, with up to 60,000 people.