Clinical Research & Clinical Trials

Clinical trials conduct

Clinical trials are clinical research observations. Prospective behavioural study on humans to address specific questions about biomedical or behavioural therapies. This generates data on the safety and efficacy of the product. Multiple experimental treatments are tried in only one trial in the master protocol. The clinical trial protocol is used to describe and monitor the trial. This procedure includes a detailed research plan to ensure trail safety and health and to provide inspectors with a proper template for trail behaviour. A clinical trial involving novel medications is divided into five stages. Each stage of drug compliance is regarded as its own clinical study. The drug development process will progress through all four stages. Phase 0 - human pharmacodynamics and pharmacokinetics (testing on 10 to 15 participants). Phase 1 - safety assessment (testing in a small group of 20 to 80 participants). Phase 2 - determining the drug's efficacy (testing with a wider group of 100 to 300 people). Phase 3 consists of final validation of safety and efficacy (testing with a large group of participants ranging from 1000 to 3000). Phase 4 -safety studies during sales (post-marketing studies describe new information such as the treatment's risks, benefits, and recommended use).