Clinical trials are only carried out when there is evidence that it will result in a new medication or treatment that will benefit patients. The procedure can be carried out by either using an in-house research team.
However, most market-leading pharmas prefer outsourcing it to third-party companies like Novotech CRO. This is mainly because professional CRO firms produce a more reliable and robust result compared to conventional in-house practices.
Clinical trials generally consist of 5 phases:
- Phase 0: Only a small number of participants take part in Phase 0 which is entirely focused on learning how a drug is processed in the body. In this initial phase, only a very small dose of medication is given to participants and it determines whether it is worthwhile continuing on with the clinical trial.
- Phase I: This phase includes anywhere from 10-100 participants who have no underlying health issues, and focuses on the drug’s safety and the best way to administer it. Phase I works out the safest dosage of the medication – the highest dosage that can be taken with the least amount of side effects. It also studies how the drug will interact with other medications. Smaller dosages of the drug are given to a group of participants, while a larger dosage is given to another group and so on and so forth, until noticeable side effects take place. This phase takes place over several months.
- Phase II: Includes 100-300 participants and further studies the effects and safety of the drug. The participants in Phase II are living with the condition the medication is supposed to treat (most often Cancer). This phase takes place over several months.
- Phase III: Includes thousands of participants and evaluates how new medication works in comparison to existing medications (side effects and effectiveness). Phase III is carried out by a process of randomisation; participants are given either the standard-of-care drugs or the new treatment. Neither the participants or the researchers know which medication is given to which group which eliminates any bias. Risks are assessed to see if they outweigh the benefits. The information gathered during this phase helps the Therapeutic Goods Administration (TGA) decide whether the new drug should be registered for use in Australia. Phase III can last for several years.
- Phase IV: Phase IV includes thousands of participants and takes place after the drug has already been approved by the Therapeutic Goods Administration (TGA). This phase identifies how well the medication works when it is more widely distributed and monitors the long-term benefits and side effects (more in-depth research). It also establishes how and when the new medication is best used and observes how the medication performs in regular medical settings rather than in a controlled clinical trial.
Each phase in a clinical trial has a crucial part to play in deciding which new medications and treatments get approved.