When it comes to patients life, the safety, efficacy and quality of drug, diagnostics, devices and even therapy protocols matters.

Then there comes the role of competent regulatory authorities and ethics committee to ensure that the three things i.e., Safety (S), Quality (Q) and Efficacy (E) are in compliance with the regulatory norms. All this is done to have the confidence that the patient is at no risk. For any new molecule (innovative drug), the clinical trial play a significant role to assure the three (S, Q, E).

Clinical trials take place only after required information has been gathered on the quality of the non-clinical safety, and Ethics committee/ competent health authority approval is given in the country in which these clinical trials are taking place.

Initially healthy volunteers and or patients are enrolled by the investigators in to small pilots, followed by larger studies in patients. The number of patients gradually increases with positive data on safety and efficacy of the new drug that is in question. There are two different sizes of clinical trials that are single center that is in one country and other multi center trials in multiple countries. These volunteers and or patients are subjected to study with this new drug remains on site at the unit for duration from 1 to 30 nights.

The systematic design for any clinical trials include:
* Assessment of effectiveness and safety of new medication or medical device on specific patients
* Dose of the medication is assessed for safety and effectiveness.
* Study and assess new drug for any unknown indication i.e. for the use other treatments for which the drug is not approved by the regulatory bodies.
* To know if the new medicine is more suitable or is more effective for patients conditions than the in-use or standard medication recommended.
* In the patients the effectiveness is compare with a specific disease of two or more already successful interventions for that disease

The concept of clinical trials wherein the new drug is involved uses four different phases. This four phases can be completed over many years, The drug has to pass through phase I , II and III then only it is approved by the national competent regulatory authority for use in general population . Then remains the Phase IV, which are basically "post-approval" studies. In the start, pre-clinical studies are conducted by the inventor before actual clinical trials. Pre-clinical studies are done with test tubes and in animals or cell cultures called as in vitro and in vivo test respectively. Phase I trial uses human for testing within small group of 20-100 volunteers. Phase II are conducted on larger group (20-300). Phase II trials assess the safety as well as how well the drug works. If the phase II studies not work as planned or if shows toxic effects. Phase II studies are then divided into two parts A and B. Phase II A studies specifically dosing requirements while phase II B is specially focused on efficacy. Each phase should pass to go on to next phase studies. In phase III multicenter trials on large patient group (300-3,000 or more if required ) are conducted. It is expected that there be at least successful two phase III trials which assure drug's safety and efficacy, to have the approval from regulatory bodies like FDA (USA) or the EMA (European Union).

Phase IV is also known as surveillance trials or post marketing. It involves the safety surveillance known as pharmacovigilance and ongoing sound technical support of a drug after approval for marketing. This phase also explores the interactions with other drugs in market, or on certain populations such as pregnant women. This is also designed to detect any rare or long term effect in larger patient population. Harmful or toxic effects discovered in phase IV trials results in restriction to certain use or drug being no longer sold. Thus the drug is tested for every aspect to assure safety and heath of patients before it is sold in the market. Simply because drug may have some commercial value but life is precious!

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