What is Clinical Research?

Clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These are carried out prior to the release of the medicine in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use.

Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with the objective of determining safety and efficacy of the new drug.
Clinical Research is conducted in 4 Phases:-

Phase I trials

This is the first time the new drug is administered to a small number, around 20-80 healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.

Phase II trials

In this phase, the medicine is administered to a group of approximately 100-300 informed patients to determine its effect and also to check for any unacceptable side effects.

Phase III trials

In this phase, the group is between 1000 and 5000, for the company to use statistics to analyze the results. If the results are favorable, the data is presented to the licensing authorities for a commercial license.

Phase IV trials

This is a surveillance operation phase after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.

A clinical research associate (CRA) is a profession defined by Good Clinical Practice guidelines (ICH GCP). The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer  or for a Contract Research Organization  (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs)  (CRFs) and communicates with clinical research investigators. A clinical research associate is usually required to possess an academic degree in Life Sciences and needs to have a good knowledge of Good Clinical Practice  and local regulations.

CRAs also assist in communicating findings to the research community.
Significant advancements in these areas and expanding regulatory requirements have increased the demand for trained CRA's.

The global pharmaceutical market is estimated at US$ 427 billion and Research & Development cost is estimated at US$ 60-65 billion annually. Two thirds of this amount is spent on Drug Development, ie, approximately US$ 40 billion. Clinical Trials involve almost 70% of time and money of new Drug Development. Cost of conducting Clinical Trials for a new drug is approximate US$ 200-250 million.