A clinical trial is a scientific study involving medicines, new treatments and new medical devices involving patient and non-patient human volunteers. They are necessary for collecting clinical data to demonstrate the safety and effectiveness of a new therapeutic, an existing therapeutic or a medical device.
Before commencing clinical trials on human subjects, extensive pre-clinical testing is performed on non-human subjects such as animals. This is necessary to determine whether the therapeutic has any merit as an investigational new drug and to obtain preliminary efficacy, toxicity, and pharmacokinetic information.
There are four different phases of clinical trials that a therapeutic can progress through during its development.
- Phase I: Involves testing on healthy volunteers for dose ranging purposes. These clinical trials also identify preferred routes of administration – eg. tablet, injection, liquid, etc.
- Phase II: This is the first stage that involves testing on patients to assess efficacy and safety. These clinical trials involve a smaller group of patients that are closely supervised.
- Phase III: This involves testing on larger groups of patients. The purpose is to determine whether the therapeutic confers clinical benefit. A trial will only proceed onto Phase III, if Phase II demonstrated benefits that outweigh the risks. Potential side effects are also identified during this phase.
- Phase IV: Gathers data for post-market surveillance. These trials are undertaken to further investigate the use of the medicine in a normal clinical setting and may involve comparisons with existing medicines.
Medical devices are not classified via phase but involve similar concepts in demonstrating safety and efficacy. Pre-clinical testing may involve bench testing, biomaterial testing, immunogenicity and carcinogenicity testing. The new device may also be tested in animals. Initial clinical testing involve pilot studies on small groups of patients before commencing onto larger studies. Studies may also be performed to confirm the performance and safety of changes in design, materials or components of the device.
At Inner Maven we have assisted in the drafting of study protocols, determining ethical and regulatory requirements and in the general management of clinical studies in hospital, research institutions and independent laboratories.