Clinical trialshelp test new methods or drugs or devices for diagnosis, prevention or treatment of various health conditions or diseases. Clinical trials are conducted to understand the safety and efficacy of a new drug or device that undergoes different stages of approval before it is sold in the market. The extensive research for the drug or device involves years of experimentation in animals and humans. The experimental drug or device is subjected to human testing which consists of four phases. After completion of each phase which is considered a separate trial, the investigators submit their results or data to national authority for approval before starting with the next phase.
Different Phases Of Clinical Trials
Phases of clinical research trials investigate a health intervention and collect sufficient evidence to declare it safe and efficacious. The process starts withdrug designanddiscovery followed by animal testing and then proceeds to human trials. The clinical trial initiates with safety tests followed by efficacy studies in human subjects.
Phase 0 or micro-dosing or pre-clinical studies are used to determine pharmacokinetics, oral bio availability and half-life of the drug in animals. Initially pre-clinical studies are conducted in-vitro or in-vivo experiments in animal with different doses of investigational drug to obtain safety, efficacy and pharmacokinetic information. Phase I involves testing multiple doses of the drug on healthy volunteers for safety while phase II tests the product on patients to assess efficacy and side effects. Phases 0, I and II are also used to determine the safety and efficacy of devices in animal and human subjects. Phase III studies determines therapeutic effect of the drug or device by randomized and blind testing in large number of patients. Phase IV studies also called Post Marketing Surveillance Trials, determines long term effects of the drug or device.
Multi-arm trials are used to compare different treatments delivered to the subjects in random groups. The whole process of developing a device or drug from pre clinical studies to marketing takes more than 10 years and is very expensive. The drug or device that clears all phases of clinical trial is available for public use after approval from national authorities like FDA i.e. Food and Drug administration.
The process and phases of clinical trial are pictorially described.
Scope of Clinical Trials
Clinical trials are conducted to collect information and data pertaining to the efficacy and safety of a new device or a new drug developed. To confirm the efficacy and safety, extensive and rigorous laboratory tests or experiments are conducted on the new device or drug in animals and humans, which progresses for many years. The result of pre-clinical trials in animals determines the future of the clinical trials. The national authority needs to be informed on the success of the research experiments conducted at every stage. Every phase is a separate trial and investigators submit the collected data and results for approval before proceeding to the next phase. This process though extensive confirms and instill confidence in the end users on the efficacy and safety of the new product. Clinical research is faster and cost-effective in developing countries in comparison to developed nations. The scope for clinical research activities is increasing, thus, providing better job opportunities in this field across the globe.
Online Course in Clinical Trial Management
James Lind Institute (JLI) provides an online program in Post Graduate Diploma in Clinical Research that helps to understand in detail the various phases involved in clinical trial and the management practices related to the clinical trial process.
For more information please visit: www.jliedu.com
