New drugs and treatments have to travel a long road before they can be made ready for public use. Beginning with discovery, it typically takes approximately ten years of clinical trial and research, to get the treatment approved for the market. Clinical trials alone can take six to eight years to conduct successfully. Clinical trial supply companies, like Client Pharma, help ensure that this time is not wasted by providing effective clinical trial services around the world.
Let’s examine in greater detail the journey and timeline of a new drug from discovery to trade.
Table of contents:
- The pre-clinical stage
- Phase 1
- Phase 2
- Phase 3
- Obtaining approval
- Post-approval and monitoring
The pre-clinical stage
Research and planning for a drug or treatment begin much before clinical trials are initiated. Researchers conduct extensive research to figure out whether or not a drug should be introduced to the clinical trial cycle. During this research, the drug is subjected to three types of testing:
In vitro– where the testing occurs in a test tube or cell culture.
In vivo– the drug is used in experiments with animals.
Model testing- For some drugs, computer models can be developed to develop a drug profile and demonstrate the way it will potentially interact with human biology.
The pre-clinical stage can take anywhere between one and six years to complete. Because of the high rate of failure for new treatments in the pharmaceutical industry and the high cost of conducting clinical trials, researchers only select the most promising treatments to take to the clinical trial stage. After being approved in the pre-clinical phase, the treatment is then tested for efficacy and safety through five clinical trial phases.
Phase 1
The first phase of the trial begins with the enrollment of patients. The trial will enroll around 20 to 100 people and will extend over several months. The objective of Phase 1 is to test the safety of the new treatment by administering it and then monitoring for any unexpected or adverse side effects. This phase could involve healthy volunteers or individuals who have the condition being researched. Phase 1 does not test for the effectiveness of the treatment.
Phase 2
Phase two carries on testing for safety while also beginning to test for effectiveness and measuring side-effects. Phase 2 also ramps up recruitment to include many hundreds of patients actively living with the condition being treated and can take two years to complete. It is estimated that up to 70% of new clinical treatments make it past the first phase of the trial.
Phase 3
Phase 3 increases the volume of patients participating in the trial even further, occasionally recruiting thousands of people to participate in the trial. The objective of Phase 3 trials is to test the effectiveness and safety of the drug in as wide-spread a cross-section of the population as possible. As such, Phase 3 rials last from 1 to 4 years to complete. Because the next stage in the life-cycle of most clinical trials involves a rigorous examination by regulatory bodies, only a third of clinical trials make it to this stage.
Obtaining approval
In this stage, pharmaceutical companies conducting the clinical trial will submit the new treatment to the local regulatory body, for example, the Food and Drug Administration in the U.S., for approval. The regulatory body will then examine the results from each stage of the trial to decide whether or not to approve the treatment for public use. This could take anywhere between six to ten months, sometimes more, depending on the rules of the regulatory body.
Post-approval and monitoring
Once approval from the regulatory body is obtained the pharmaceutical company may choose to continue monitoring their patients for an extended period to watch for any delayed side effects or new symptoms that may arise through continued treatment. This phase can last for several years, depending on the nature of the drug or treatment.
For more information on how your medicine is made, check out the infographic below!
Infographic provided by The Emmes Company, a biostatistics organization
