Clinical research is a broad term that includes biomedical research including clinical trials. The research helps in the development of diagnostic methods and modern drugs for the treatment of diseases.

In its scope, there are clinical trials, packaging and labelling for single blind and double blind studies, conduct of trials, quality Control (QC ) and Quality Assurance ( QA ), bio-statistical analysis, data management, report writing and periodic safety update ( PSUR ) and pharmacovigilance — reporting of adverse events for new chemical entity ( NCE ) and generic products.

To develop new drugs, there are clinical trials. For generics there are bio-equivalence studies where generic product is compared with innovator and for new chemical entities, there are bio-availability ( BA ) studies to determine the pharmacokinetic profile during Phase I, and for generics there are studies of availability by assessing the co concentration of drugs in blood and other body fluids such as urine, CSF, vitreous humour, salive etc.

Clinical research started in India since 1980 when Ciba-Geigy evaluated nitroxazepin. GSK, Ciba Geigy, Hoechst, were the pioneers of Phase I clinical trials. Dr. Reddy’s Lab, Biocon were involved in late phase clinical trials. CDSCO published in 2005 good clinical practices ( GCP ) that includes World Medical Association declaration of Helsinki as appendix I and Schedule Y giving requirements for clinical trials for import and manufacture of new drugs appendix II. This paved the way for clinical trials. ICMR issued guidelines on biomedical research but CDSCO guidelines are more popular.They are mandatory for clinical trials of drugs, vaccines, surgical procedures, medical devices, diagnostic agents, herbal remedies and medicinal plants.

A clinical pharmacologist is engaged in clinical trial conduct and is either a doctor with pharmacology qualification or a paramedic with pharmacology qualification. A doctor happens to be a principal investigator and a paramedic plays a supportive role.