- A Clinical Research Professional may serve as a clinical investigator, sub-investigator, clinical researcher, research nurse, administrator, coordinator, data manager, project manager, IRB coordinator, Quality Assurance specialist, regulatory affairs specialist, research pharmacist, consultant, or educator in clinical trials management.
- A Clinical Research Professional is involved in one or more aspects of clinical trials (GCP) research, including data collection, analysis, or monitoring; case management of protocol participants; recruitment and enrollment of human subjects; protection of subjects and subjects’ rights through IRB relations; development of informed consent documents; preparation of adverse event experience reports; construction or monitoring of case report forms; maintenance of drug accountability records; grant and budget development; report preparation; education of other health-care professionals, patients or families regarding clinical trials, protocol development, program administration; and research program audit.
Clinical Research:
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
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 on a long term usage of the drug.
The clinical trial market in India looks very lucrative. The country promises to be one of the hottest destinations for conducting global clinical trials, owing to a huge patient pool representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings. Moreover, the market is getting boost from improved IPR protection with changed rules and also from reduced taxes and duties.
According to our new research study on the sector called “Booming Clinical Trials Market in India”, the clinical trial outsourced market in India is forecasted to grow at a CAGR of around 31% during 2010-2012. Presently, the market is characterized by the dominance of phase III and phase II trials, which currently hold more than 80% of the market. This scenario is expected to remain intact in future as well. In terms of competitive landscape, the market is characterized by many small CROs, with certain companies like Syngene, Quintiles, Lambda therapeutics, Vimta labs doing better in comparison of the rest.
Our report has found that one of the biggest reasons attracting drug manufacturers and CROs to India is the country’s vast patient pool. The number of patients for chronic and infectious ailments in India surpasses that of nearly any other country. Moreover, clinical trials for drugs related to central nervous system and cancer have been mainly outsourced to India in recent years. Backed by this factor, the number of clinical studies in India is expected to grow at a CAGR of over 14% during the forecast period. In this regard, the report provides rational analysis of the factors which are supporting the forecast.
Our report provides extensive information on the clinical trial market in India, with detailed description of the regulatory environment and cost factors promoting the market. It also highlights several emerging market trends like clinical data management, pathology and diagnostic market, etc. It contains all the requisite information that will help clients to draw up market strategies and assess opportunity areas in India’s clinical trial market.
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 is innovation and to introduce new drugs, clinical trials are mandatory. They are to be conducted as per ICH GCP norms. 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 are projecting that total Clinical Research spending in India will increase by more than 30% annually through 2010.
The Clinical Research industry in India has grown from Rs 20 crores to Rs 100 crores in the last three years. As per a recent McKinsey report, it is expected to touch Rs 5,000 crores by 2010 and will employ 50,000 people in the next five years.
India is increasingly being recognized as a hub for global clinical trials as it has several prized attributes:
- Large and diverse patients' pool for conducting clinical trials
- Availability of Medical, Pharmacy and Science graduates
- Excellent infrastructure facilities
- Comparative cost advantage
- Changes in the Patent Laws
The Clinical Research industry in India has grown from Rs 20 crores to Rs 100 crores in the last three years. As per a recent McKinsey report, it is expected to touch Rs 5,000 crores by 2010 and will employ 50,000 people in the next five years.
"
There will be a huge demand for qualified and trained clinical professionals"
The following pharmaceutical organizations and Clinical Research organizations have already come forward to unlock the vast potential that India has, and are conducting Clinical Trials in India.
• Abbott Labs
• Allergan
• Amgen
• AstraZeneca
• Baxter Healthcare
• Bristol- Myers Squibb
• Covance
• Cephalon
• CSP
• EmpiriStat
• Genzyme
• Gilead Sciences
• GlaxoSmithKline
• GlobeImmune
|
• Hill-Rom
• InNexus Biotech
• Isotechnika
• Lundbeck
• Medarex
• Merck
• Millennium
Pharmaceuticals
• Neurogen
• Nycomed
• Onyx Pharmaceuticals
• Ortho-McNeil Janssen
• PDL Biopharma
• Pfizer
|
• Pharma Consulting Solutions
• PPD
• ResearchLink
• Sanofi-Aventis
• Schering-Plough
• UCB Pharmaceuticals
- Quintiles
- Manipal Acunova
- Parexal
- Omnicare
- Clintec
- Clinirax
- Cliniegen
|
|
|