What is Clinical Trial?

Clinical trial (also clinical research) is a research study in carried out in human volunteer in order to answer specific health questions. Carefully conducted clinical trials are the fastest

and safest way to find treatments that work in people and ways to improve health.

Interventional trials determine whether experimental treatments or new ways of using

known therapies are safe and effective under controlled environments. Observational

trials address health issues in large groups of people or populations in natural settings.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being  conducted. The clinical  trial team includes doctors and nurses as well as social workers and other health  care  professionals. They check the health of the participant at the beginning of the  trial, give specific instructions for participating in the trial, monitor the participant  carefully during the trial, and stay in touch after the trial is completed.

What are the phases of clinical trials?

Clinical trials are conducted in phases. The trials at each phase have a different

purpose and help scientists answer different questions:

In Phase I trials, researchers test a experimental drug or treatment in a small group  of

people (20-80) for the first time to evaluate its safety, determine a safe dosage range,

and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of

 people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of

people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to

commonly used treatments, and collect information that will allow the experimental

drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the

drug's risks, benefits, and optimal use.

Global Scenario

The global clinical trials industry is currently worth an estimated $10 billion and has the potential for considerable growth in the future. Global revenues from clinical trials have increased by almost 15% in the last year and the industry is prepared for an extended period of healthy growth (Source: The Clinical Trials Market 2006, Lead Discovery Ltd, UK).

The clinical trial market in Asia is booming. The pharmaceutical market grew by seven per cent on a global level to US $ 600 billion while sales in Asia grew by about nine to ten per cent. Looking ahead to the next five years, the Asia Pacific region is expected to grow by up to 12 per cent annually. To this end, we will see a corresponding growth of 20 per cent in the clinical trial market. Recent revisions to the pharmaceutical industry’s regulatory laws as well as improved patent laws in countries such as Japan, China and India, have led to the burgeoning clinical trials market in Asia (Source: Lim Bee Koong, Director Life Sciences, Clinical TNT Asia, Pharma Focus Asia July, 2006).

Indian Scenario

Nearly 30 per cent of the clinical trials will be outsourced to developing countries in the near future. The clinical research industry in India has been growing rapidly. During the last 3 years it has increased from Rs. 20 crores to Rs. 100 crores. According to a recent McKinsey report, by the year 2010 the industry is expected to grow up to Rs. 5,000 crores. India will play an increasingly important role in the clinical trials segment given its genetically-diverse population, abundant technical talent, low costs and sound infrastructure, among other reasons.

Clinical Research Training

Most medical schools lack a formal course in training for clinical research, and investigators have relied on mentors to learn how to conduct clinical trials. There is a shortage of trained manpower. India has about 500 - 1000 investigators in the country, as compared to United States that has 50,000 investigators. With the projections made for the industry in 2010, India would need about six times its present number of investigators. (Source: FICCI white paper on clinical trial scenario in India Friday, November 18, 2005)