Clinical trials are conducted to evaluate the safety and efficacy of new drugs and medical devices on human subjects. All clinical trials go through four phases. Phase I – Trials test a drug’s safety on healthy volunteers. Phase II and III – Trials test the drug’s efficacy on patients. Phase IV – Trials or pharmacovigilance are conducted once the drug is marketed to monitor for its safety in larger populations.
Most of the clinical trial business in the global market originates from the US, Eastern Europe, India, and China. The global clinical research sector is exploring India by increasingly outsourcing clinical trials. Analysts are projecting that total clinical research industry will grow at an exponential rate especially after post COVID era.
Clinical research holds tremendous scope and opportunities not only for trained medical, pharmaceutical and paramedical professionals, in various organizations like as CRO, SMO, KPOs, and CDM & Pharmacovigilance companies & medical writing organizations.
Clinical trials in India
India has become the most preferred destination for global clinical trials because of significant cost advantage and other resource advantages. The unique advantages that make India so attractive are the 3 ‘P’s— Population, Patients and Physicians
There are many reasons why India is considered as a favorable destination for clinical trials. Some of them are mentioned below:
- Cost advantage in India clinical trials are conducting at a less cost as compared to other countries
- Diversity in Patient pool i.e. diabetes, cancer cardiovascular diseases which will help in achieving the higher enrollment rates at clinical trial site
- Large number of treatment naïve patients
- India has the highest number of English-speaking physicians. We have the trained manpower in medicine and the doctors are MCI qualified.
- Time taken for obtaining the regulatory clearance of clinical trials is relatively less as compared to the other countries.
- Indian regulatory system is much more simplified as the rules and regulations are being amended from time to time by the regulatory system of our country to facilitate the global entry of pharmaceutical countries.
- India has a trained man power in Clinical research and experienced scientists and all these initiatives are boosting the clinical research industry.
- Information technology and IT support –India has the highest number of trained professionals essential for conducting trials.
- Because of the above-mentioned facts India is considered to be as a favourable destination of clinical trials
- Globally, there has been recognition of the Indian advantages which attract pharmaceutical companies to adopt collaborative outsourcing strategies for clinical trials. According to industry estimates, the cost of phase I trial is 50% and phase II 60%, lower in India.
- India has the largest and diverse pool of patients. India is also home to a wide variety of diseases ranging from tropical infections to degenerative diseases. The highest number of cancer and diabetes patients is found in India. It is also home to more than one billion people, including 30 million with cardiovascular diseases and other diseases.
- India has a harmonized regulatory process as with US and international standards.
- Mandatory CTRI registration of clinical trials which allows more transparency of the process
- Licensing requirement of ethical committee also allows the transparency in the conduct of the research process.
- More transparent system for reporting of SAE and for the calculation of compensation in case serious adverse events.
- More accountability of Principle investigators in conduct of safe and ethical clinical trials.
Clinical research industry has grown around the world at an unparalleled rate in the past few years. The clinical trial market worldwide is worth over billion dollar and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK, and they form one-third of the total research and development staff. These large numbers can be attributed to the fact that this industry is fast growing and dynamic and hence offers lucrative job opportunities. Developed markets in the United States, Western Europe, Germany, and Japan still generate the lion’s share of clinical trial activity. However, growth trends in non-traditional regions have been evident. Nearly 31% of the world’s clinical trials are reportedly conducted outside of the United States and 25% of new drug applications (NDAs) include data from international sites. A recent analysis found that from 2007 to 2018, there was a rise in clinical trials registered in emerging countries and a drop in studies registered in the United States and Western Europe According to the latest research , China, India, and Korea re the also considered to be the other sites where Clinical trials are conducted.
Kanishk Dugal is the COO of ICRI.
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