S. Harachand11.06.09
India is making rapid strides to claim a larger portion of clinical trials run across the globe. Along the way, a question is also looming large. It is the question of manning the rising multitude of trials with the right sort of trained professionals.
India's potential to speedily deliver any number of patients in most therapeutic areas continues to be an allure for the clinical research community worldwide. Finding and recruiting patients well within the time-frame is often the toughest part of trials.
Clinical studies cost less in India compared to that in the West, at the moment. A huge pool of competent medical professionals and hospital staff who can communicate in English - the universal language of clinical research - is also in waiting.
India got its GCP guidance (Schedule Y of Indian Drugs and Cosmetics Act) revised as per ICH norms and regulatory framework streamlined, enforcing compulsory registration of CROs, clinical trials, etc. Efforts have been underway to make IP laws like data protection on par with the global standards; India only started following laws protecting product patents in 2005.
Data submitted by Indian CROs as part of the global trials are also "getting noticed" by leading regulatory agencies, including the FDA and EMEA.
Various industry analysts also forecast India's clinical research market could well become a success story growing manyfold in the coming years. McKinsey projects it will occupy nearly 5% of the global marketshare by 2010, with a value of as much as $1.5 billion.
India's clinical trials industry is growing two-and-a-half times faster than the overall market, according to a recent survey findings from Federation of Indian Chambers of Commerce and Industry (FICCI)-Ernst & Young Report.
Multi-national companies account for more than 50% of the total trials in India, with a focus on specific therapies such as oncology, CNS, CVS and diabetes, which require higher mean patient enrollment. Nine of the top 15 global pharmaceutical and biotech companies and seven of the top 10 global CROs have set up captive clinical research centers in India.
The number of clinical trial investigators has also grown faster in India compared to other Asian, Latin American and Eastern European countries, according to the report. But despite its enormous supply of specialized physicians, India still finds trained clinical research professionals are very much in short supply.
Qualified professionals are plentiful. There are even more research enthusiasts. CROs are flooded with their rsums. "But where are those 'soft' skills?" asked Dr. S. M. Sapatnekar, dean of the Clinical Research Education and Management Academy (CREMA) in Mumbai.
"These aspirants do not have domain knowledge; if they have, it is theoretical," pointed out Dr. Sapatnekar, whose academy conducts courses tailored to the needs of clinical research industry from several centers in India.
There is zero tolerance for mistakes when it comes to clinical research. Professionals need to acquire new knowledge independently. Moreover, global trials have become so complex and demanding today that only specialists can become investigators. So where can a CRO or a trial manager find specialists trained in clinical research?
"Most specialists are very busy with patient care and do not have time to devote to clinical research," opined Dr. Arun Bhatt,chief executive officer of ClinInvent, a full-service CRO from Mumbai, which runs nearly a dozen Phase I to III studies in immunology, CNS, oncology, CV, and urology.
Training ofprofessionals in GCP requirements is also lacking in many respects. There are few serious players in this field. Clinical research has not been a part of doctors' training in India.
Including clinical research and ethics as a subject in undergraduate medical curriculum could go a long way in addressing the gap. In addition, the post-graduate students of medicine should undertake a clinical research project as part of obtaining a degree, according Dr. Bhatt.
India's clinical research industry risks falling a victim of its own success as demand outstrips supply. Only a greater number of research-active physicians will help it meet this challenge.
Meanwhile, quite a few prefer to believe that such a crisis is far off. By the time it comes to a head, the industry will be ready to cope with the load factor, said Dr. Deven Parmar, vice president, Clinical Research, Wockhardt Ltd, Mumbai. "Clinical trial sponsors can also consider expanding to tier 2 and 3 cities from the current urban-centric approach to widen the investigator base," Dr. Parmar noted.
Along with pervading optimism, a larger dose ofenthusiasm seems to fuel the rather nascent clinical research sector. "It is not because Indians are better, but just because they go that extra mile," asserted Dinesh Jain, founder and chief executive officer of Chicago, IL-based Aagami Inc., which offers drug development and consulting services for biotech and pharmaceutical companies.
India's potential to speedily deliver any number of patients in most therapeutic areas continues to be an allure for the clinical research community worldwide. Finding and recruiting patients well within the time-frame is often the toughest part of trials.
Clinical studies cost less in India compared to that in the West, at the moment. A huge pool of competent medical professionals and hospital staff who can communicate in English - the universal language of clinical research - is also in waiting.
India got its GCP guidance (Schedule Y of Indian Drugs and Cosmetics Act) revised as per ICH norms and regulatory framework streamlined, enforcing compulsory registration of CROs, clinical trials, etc. Efforts have been underway to make IP laws like data protection on par with the global standards; India only started following laws protecting product patents in 2005.
Data submitted by Indian CROs as part of the global trials are also "getting noticed" by leading regulatory agencies, including the FDA and EMEA.
High Demand, Short Supply
Various industry analysts also forecast India's clinical research market could well become a success story growing manyfold in the coming years. McKinsey projects it will occupy nearly 5% of the global marketshare by 2010, with a value of as much as $1.5 billion.
India's clinical trials industry is growing two-and-a-half times faster than the overall market, according to a recent survey findings from Federation of Indian Chambers of Commerce and Industry (FICCI)-Ernst & Young Report.
Multi-national companies account for more than 50% of the total trials in India, with a focus on specific therapies such as oncology, CNS, CVS and diabetes, which require higher mean patient enrollment. Nine of the top 15 global pharmaceutical and biotech companies and seven of the top 10 global CROs have set up captive clinical research centers in India.
The number of clinical trial investigators has also grown faster in India compared to other Asian, Latin American and Eastern European countries, according to the report. But despite its enormous supply of specialized physicians, India still finds trained clinical research professionals are very much in short supply.
Wanted: Research-Active Physicians
Qualified professionals are plentiful. There are even more research enthusiasts. CROs are flooded with their rsums. "But where are those 'soft' skills?" asked Dr. S. M. Sapatnekar, dean of the Clinical Research Education and Management Academy (CREMA) in Mumbai.
"These aspirants do not have domain knowledge; if they have, it is theoretical," pointed out Dr. Sapatnekar, whose academy conducts courses tailored to the needs of clinical research industry from several centers in India.
There is zero tolerance for mistakes when it comes to clinical research. Professionals need to acquire new knowledge independently. Moreover, global trials have become so complex and demanding today that only specialists can become investigators. So where can a CRO or a trial manager find specialists trained in clinical research?
"Most specialists are very busy with patient care and do not have time to devote to clinical research," opined Dr. Arun Bhatt,chief executive officer of ClinInvent, a full-service CRO from Mumbai, which runs nearly a dozen Phase I to III studies in immunology, CNS, oncology, CV, and urology.
Training ofprofessionals in GCP requirements is also lacking in many respects. There are few serious players in this field. Clinical research has not been a part of doctors' training in India.
Including clinical research and ethics as a subject in undergraduate medical curriculum could go a long way in addressing the gap. In addition, the post-graduate students of medicine should undertake a clinical research project as part of obtaining a degree, according Dr. Bhatt.
India's clinical research industry risks falling a victim of its own success as demand outstrips supply. Only a greater number of research-active physicians will help it meet this challenge.
Meanwhile, quite a few prefer to believe that such a crisis is far off. By the time it comes to a head, the industry will be ready to cope with the load factor, said Dr. Deven Parmar, vice president, Clinical Research, Wockhardt Ltd, Mumbai. "Clinical trial sponsors can also consider expanding to tier 2 and 3 cities from the current urban-centric approach to widen the investigator base," Dr. Parmar noted.
Along with pervading optimism, a larger dose ofenthusiasm seems to fuel the rather nascent clinical research sector. "It is not because Indians are better, but just because they go that extra mile," asserted Dinesh Jain, founder and chief executive officer of Chicago, IL-based Aagami Inc., which offers drug development and consulting services for biotech and pharmaceutical companies.