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What are the Stages of Clinical Development?
It can take 10 to 20 years to bring a new medicine to patients. Explore the timeline from discovery to distribution, and learn why clinical research is a critical part of the process.
It takes many years to approve a new medication. Clinical development begins in the laboratory before a new medication can be tested in people. Clinical trials are conducted in people to determine the best dose and to assess safety and efficacy. Health authorities such as the US Food & Drug Administration (FDA) and European Medicines Agency (EMA) review all available data to determine if the medication should be approved for use. After a new medication is approved, additional clinical trials and safety assessments may continue per local country requirements. It is common for the process to take 10 to 20 years.
Discovery
New medications are identified from research laboratories based on data from research conducted around the world
Optimization
Chemical and in vitro biological systems, which are tests conducted without animal or human participants, are designed to optimize the intended therapeutic effect
In Vivo Testing
The medications are then tested with in vivo and animal disease models, which are tests conducted in live animals, to assess biological activity
Toxicology Studies
Before testing in human participants can begin, extensive toxicology and drug metabolism studies need to be carried out in many in vitro and in vivo systems according to guidance provided by health authorities or regulatory agencies
Types of clinical trials
Why participate in a clinical trial?
You may want to participate in a clinical trial to help collect information about whether a new medication or medical device not yet on the market is safe and effective. You may get more frequent health check-ups while participating in the study. You may get information about support groups or other treatment options for your medical condition.
Clinical Trials Summary Sources
- https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm
- https://clinicaltrials.gov/ct2/about-studies/learn#ClinicalTrials
- https://www.nia.nih.gov/health/clinical-trials-benefits-risks-and-safety
- https://clinicaltrials.gov/ct2/about-studies/learn
- https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
NPS-ALL-NP-01270 MAY 2024
