Clinical Research : Introduction

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Clinical Research, a branch of medical science and one of the most knowledge intensive industry is emerging as a promising career, with the boom in healthcare sector in India. Indian pharmaceutical industry is growing exponentially and has become a very preferred destination for global pharmaceutical companies to conduct their drug research and development. As a result India, which is considered as the second largest pharmaceutical market in Asia, is becoming a hub for clinical research. The implementation of the General Agreement on Tariffs and Trade (GATT) has opened new opportunities for India to concentrate on the clinical trial market. Moreover, the country has numerous government-funded medical and pharmaceutical institutions with state-of-the-art facilities, which can serve as ideal centers for multi-centered clinical trials. Due to the prevalence of a large variety of diseases such as cancer and diabetes, India is viewed as the ideal location for clinical research trials for the pharmaceutical industry.

Clinical research is an integral part of the drug discovery process to ensure the safety and efficacy of any new drug. It is the complete biography of drug from its inception in the lab to its introduction to the consumer market and beyond. Clinical research can be defined as the systematic and scientific study of effects, risks, efficacy and benefit of a new medicinal product (drug) that may be used for prevention, treatment, diagnostic or for relieving symptoms of a disease. It is the clinical research which determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens that intended for human use.

The Clinical research of the new medicinal product is carried out through an organized Clinical Trial, prior to its release in the market. Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious and effective. These trials are conducted in 4 phases and each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will get approved by the FDA (Food and Drug Administration ) and then marketed for public use. Phase IV are 'post-approval' studies.

Before pharmaceutical companies start clinical trials on a drug, they conduct an extensive pre-clinical studies. These involve in vitro (test tube or cell culture) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. After this, the data obtained from the studies are submitted as an IND (Investigational Drug Application) to take permission for human studies. Then, it enters into clinical trials.

The main four phases in the clinical trails include :

Phase I trials : Phase I trial is designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. In phase I trial, a new drug is administered to a small number around 20-80 healthy, informed volunteers under the close supervision of a doctor.
Phase II trials: Phase II trial is designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. In phase II trial, the medicine is administered to a group of approximately 100 – 300 informed patients to determine the effects and also to check for unacceptable side affects.
Phase III trials: Phase II trials sometimes known as 'pre-marketing phase' are the most expensive, difficult and time-consuming trial which are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. In this phase the group is between 1000 – 3000, for the company to use statistics to analyze the results. If the results are favorable, data is presented to licensing authorities for a commercial license.
Phase IV trials: Phase IV trial also known as Post marketing surveillance Trial involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. The effects are monitored on thousands of patients to help identify any unforeseen side effects.

Clinical research is a very sensitive field and is directly attached to human life. It is a field which demands scientific approach with quality, ethics, emotions and perfection. Future of the medical science is in the hands of clinical research professionals and a single mistake in this field can cost a lot for our upcoming generations. So, those who want to built up a career in the field of clinical research, should be aware of their big responsibility.