Pre-clinical, Clinical Research, Biostatistics and Data Management

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INTRODUCTION:

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 which are Phase I trials,Phase II trials,Phase III trials,Phase IV trials.

Clinical Research Industry - A Global & indian Perspective

The projected market of global pharmaceutical is US$ 427 billion and Research & Development cost is estimated at US$ 60-65 billion annually. India has become a signatory to TRIPS. Consequently, a new patent law has come into effect from January 2005. The new keyword for the pharmaceutical industry after recession is innovation & cost reduction and to introduce new drugs, clinical trials in low cost destination are mandatory. The clinical trials that have been conducted in India till date have gone well. For majority of the studies, patient enrollment is a key advantage. This helps compress the development timeline and data quality is excellent. Numerous audits in India are a testimony to level of quality. And data from clinical study in India have been successfully filled with international regulatory agencies. The potential realized at present is a fraction of the possible in India. Consistent with WTO guidelines effective from 2005, India will also offer 10-year tax concessions on revenue to companies making Research & Development (R&D) investments here. These incentives are expected to substantially increase R&D activities of both multinational and domestic biopharmaceutical companies.

Analysts projects that clinical trial outsourced market in India is forecasted to grow at a CAGR of over 30% during 2010-2012 to around US$ 600 Million by 2012. With this anticipated growth, India will become one of highest growing clinical trial destinations in the world.

Various Types of Clinical Trials being conducted in India

Trials are on for drug which is indicated for reduction of mortality in adult patients and can be used for sepsis. Clinical Trials have already been held on more than 600 patients for human insulin and insulin. Clinical Trials are being conducted on oncology and developing a new molecule for lung cancer.

Clinical trials are on 300 patients on a new malaria 'cocktail' drug that combines chloroquine (to which Indian malarial strains have developed resistance) and azithromycin, an antibiotic. Clinical Trials are also being conducted for drugs to treat osteoporosis, breast cancer and schizophrenia involving new drugs and therapies for treatment of different variants of blood cancer and colorectal diseases. The trials in India are mostly in different areas like oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, paediatric diseases, and infectious diseases. The largest Clinical Trial outside US for a drug delivery device has been conducted in India.

Major players in Clinical Research in India:

The major global players that have started operations in India are Quintiles,Paraxel,Icon,Wyeth,BMS,Novartis, Novo-Nordisk,GSK,Pfizer .There are now quite Indian CROs who are in involved in CR and CDM operations such as TCS,CTS,Clinigene etc.