What is the timeline for a drug development?

On average, getting a potential drug candidate from the laboratory to the pharmacy takes about 14 years, costs more than one billion dollars, and has a low success rate. A successful drug will pass through all five stages: drug discovery, pre-clinical research, clinical trials, FDA approval, and post-market monitoring.

What is late stage drug development?

Late Stage Development means the development activities that are conducted in connection with a Development Compound during the period of time beginning on the date a Development Compound enters Phase IIb Clinical Trials up to and including Regulatory Approval.

How many phases are there in drug development?

four
The drug development process can be broken down into four key stages. These stages cover everything that needs to be done to put new drugs on the market, from the initial research to it being approved by the FDA. Here’s a breakdown of what the four stages of drug development covers.

How long do Phase 3 trials last?

one to four years
This phase typically lasts several months to two years. Phase 3: Just 33% of drugs make it to Phase 3, which tests the potential treatment in the largest number of people. This phase measures both safety and effectiveness with many volunteers, sometimes thousands. Phase 3 trials last from one to four years.

What are late phase clinical trials?

Late-phase studies (phases IIIb and IV), also known as post-approval or observational studies, are conducted to evaluate a drug’s long-term effectiveness and impact on a patient’s quality of life over a longer period of time.

Why do drugs in development fail in clinical trials?

Six Key Drivers of Failure Insufficient assessment of the current standard of care and disease area landscape. Flawed study design. Flawed data collection/analysis. Study operations problems.

What is late stage clinical trials?

Late-stage clinical development primarily aims at demonstrating efficacy, safety, and cost-effectiveness. It corresponds to Phases 2b and 3 confirmatory studies. The product is tested in larger clinical studies, often as compared with the therapeutic ‘gold standard’ or standard-of-care (SoC), if any.