Clinical Research - A Global perspective
Clinical Research - A Global perspective –
Pharmaceutical industry all over the world has gained an unmatched momentum, making Clinical Research one of the lucrative careers in recent times. Since the niche pharmaceutical products from various pharmaceutical industries have touched down in terms of its time span, the new avenues and new drugs are the order of the day. Clinical Research involves studies world over; the effect as well as the safety of drugs needs to be studied considering the variation in the race, genetic makeup, cultures, food habits, environmental and climatic variations. For e.g the drug which could be safe in African race may not be safe for the Asian origin. Apparently, to gain an approval for new drugs, it has to undergo Clinical Research in multiple centres and multiple countries. In addition, the data generated needs to establish reasonable correlation in safety and efficacy from place to place. The coordination, compliance and the data management requires huge manpower.
There could not be a better time for clinical research. The global market is estimated to be worth over USD 52 billion. There are more than 2,50,000 positions vacant with attractive salaries. Moreover, with a dramatic increase in the number of trials being conducted worldwide; the demand for clinical research professionals is ready to reach an all-time high.
Clinical Research - Advantage India -
India is a multicultural, multi-linguistic, highly populated country with tropical climate. It is a diverse and therapy-naïve population with vast genetic diversity ready to undergo clinical trials. Moreover, India is home to vast reserve of knowledge and resource base and is strategically located in the arena of global clinical research and trials. India's potential as a favorite outsourcing destination has led many global Pharma companies to set up clinical research businesses here. India has emerged as the favorable destination and new global hub for Clinical Research business for a decade and has been tremendously growing for past 2 to 3 years. Contract Clinical Research relatively is a new business and profession in India but according to projections by McKinsey & Company, the Indian Clinical Research Industry could attract US $1.5 billion of revenue from the worldwide Pharmaceutical & CRO Industry creating job opportunities for more than 10,000 Principal Investigators and nearly 50,000 Clinical Research Professionals, who are trained in Clinical Research including ICH-GCP/ FDA guidelines If India's clinical trial business grows to 10% of the scope seen in the U.S. by 2010 according to McKinsey's projections, then the industry will need approximately 50,000 recruits. India has a huge pool of scientific, pharmaceutical, and medical talent, but the supply of trained professionals in India is approximately one-tenth of its demand. Unless research training institutes are established, this huge gap between the demand and supply of trained personnel cannot be bridged. Most global pharmaceutical companies conducting multi-center studies in India have big and small Clinical Research Departments handling regulatory and marketing support, local Pharmaco-vigilance reporting, conduct of local registration, and post-marketing surveillance studies. This team coordinates with its global project management or outsourcing partners to mentor, maintain timelines, ensure checks and balances for regulatory compliance, and collect quality data. The outsourcing decisions for these global studies are mostly made in the U.S. and Europe; however, as India becomes a major hub and contributes further to subject recruitment in clinical studies, Indians will play a much larger role in the outsourcing process. Clinical research is the key discovery of the latest diagnostic methods and to develop modern drug for treating of diseases. Working for the "blockbuster drug" most of pharmaceutical companies invest several hundred million dollars every year; it takes approximately $450-$800 million to bring a drug from a lab to the shelf of pharmacist. Its start from the identification of the lead molecule to the last phase of clinical trial of a single drug would take about 9years on an average, most of the companies would like to reduce this time for profit maximization. According to estimate by PHARMA and ING Barings LLC, outsourced clinical phase I-IV market in 1998 was about US $4.4 billion and is projected to grow to US $7.8 billion in 2002. Around 80,000 clinical trials are being conducted globally each year. Researcher indicates that conducting clinical trials in India would approximately cost less than one-third of the cost which they spend in conducting a clinicaltrials in western countries. Traditionally, Indian pharma companies have been known for its success in generic drug marketing. Now the huge cost of new drug development in western countries is giving a break through opportunity for drug discovery services outsourcing to India, which created the heat in the Indian entrepreneurs and technocrafts.
Developing countries like India are devising tailor -made strategies for catering the needs of the industries. However, India has been a major pit stop for the western pharma industries as the sheer numbers of India's talent force make a compelling case for outsourcing R&D to India. India has some 22 million graduates, including 6million science graduates, 1.2 million with engineering degrees and 600,000 doctors, according to data compiled by The Economic Times Intelligence Group. And by scenes the population is growing rapidly 1 billion plus, with crude birth rate of 26/ 1000 population and increasing life expectancy to 62years, more than 20,000 hospitals, and increasing rate of literates.
Not only these factors have attracted the western pharma industry but the most important factors are:
India has become a signatory to TRIPS; consequently, a new patent law has come into picture which is effective from January 2005(Schedule Y) and also for medical devices effective from March 2006. India has well-defined guidelines for carrying out various phases of clinical trials. These guidelines are in line with the global guidelines on clinical research (ICHGCP).
The various guidelines that govern the conduct of clinical trails in India include: Schedule Y of Drugs and Cosmetics Act, 1940 Ethical Guidelines for Biomedical research on Human subjects, 2000 also known as ICMR code. Good clinical practices, 2001 Looking of these various factors experts in clinical research have varying view on opportunities in India, and no doubt India being the hub for the clinical trails, saying so India has everything it needs to cater the global Pharma market. But the trick is in doing it. Well having said that me being in the family of clinical research, whenever someone gets rapid relief from a severe migraine, severe dental pain, undergoes cardiac bypass surgery without blood transfusion or find helps for a number other problems, I get a warm feeling by knowing I have played an important role in doing so. Advantage India Key factors contributing to India's emergence as a hub for clinical research: • Multi-cultural and multi-linguistic - pool of diverse data under a single umbrella • Local cost of clinical studies – 50 to 70% of costs in the US/EU • Fast recruitment, accelerated approvals and good communication skills • Gigantic pool of dissimilar diseases • English speaking investigators • Regulatory facilitation of parallel phase studies The Future Outlook: Indian CROs v/s Outsourced Projects from Europe & USA: Acceptance of the clinical research profession by young life sciences, Pharma & medical graduates is growing fast. More universities and institutions can be expected to introduce full-time courses for students to help supply the industry's needs on a continuous basis. As has been seen with IT professionals, this resource pool is also becoming source of pride for India that is recognized globally for its sincerity, scientific knowledge, and skills. Although there are often differences between the clinical research professionals of India and western countries in terms of their levels of direct experience in trials and their understanding of the complexities of the drug development process, India is rapidly improving upon this situation as it seeks to one day emerge as a global leader in the CRO industry. Unlike software/ IT industry, which are completely dependent on American and European clients, Clinical Research Industry is not completely dependent. India has major giant pharma companies who themselves have their own CRO establishments. Opportunities, Growth & Career Prospects: Career prospects with CROs and site management organizations (SMOs) in India are quite attractive, considering the number of clinical trials currently underway in India in diverse therapeutic areas. There are more than 360 big and small CROs in Mumbai, Delhi, Gurgaon, Noida, Hyderabad and Bangalore. India has also created a niche for itself in the Bioanalytical and Bio-equivalence business, through cost effectiveness and the ready availability of healthy trial subjects. There are more than 20 big reputed centers for such studies in India, specializing in short-term trials that generate quick revenue. These centers need CRAs, physicians, phlebotomists, nurses, quality assurance auditors, principal investigators, pathologists, biochemists, laboratory technicians, and biostatisticians. Many sponsors have started using Indian centers of excellence to save time and money on their biometrics needs. This has created a huge number of jobs in data entry, data management, programming, coding, statistical analysis, and medical writing, as well as opportunities in database and statistical analysis system training. The growing trend for EDC will attract more skilled professionals who understand the software and the intricacies of installing, implementing, and training users (investigators and monitors) to use it effectively. This industry is heavily dependent on another set of resources: investigators with strong inclination toward the conduct of ethical clinical research. Hence, this industry looks for experienced principal investigators who have set up and conducted global clinical trials and have competent study staff at their sites. Ten years ago, it was very difficult to find a principal investigator who had worked on GCP trials. Recently, however, CROs and global pharmaceutical companies have started working with clinicians and physicians in different therapeutic fields in an effort to familiarize these investigators with GCP and International Conference on Harmonization (ICH) E6 Guidelines. There are multiple job opportunities available for monitors in the current scenario. A professional with a few years of experience can quickly be absorbed by CROs, Data management firms, and even IT companies with life science and clinical specializations. This has led to salary hikes and upgraded positions. Strong skill sets and careful attention to the complexities of handling trials have taken a back seat to the lure of money, driving clinical research professionals to acquire higher positions and pay packages. Thus, the clinical research industry is facing a challenge of huge attrition. The Financial Express says the attrition rate has grown three times in the last two years, and is even higher than in the Indian IT sector. Attrition is higher in CRA and project manager positions, as these two professions have changed over a decade. And with mushrooming growth of CROs, there is high demand for trained Clinical Research Professionals and also Heads of operations, which leads to the poaching of trained professionals at all levels. Salaries in CRO industry are on par with IT industry ranging from Rs. 15000 to more than Rs. 50,000 per month to start with. Clinical Research - Career pathways: Global players attempt to attract experienced talent by offering competitive salaries and providing exposure to global work in process and systems. By contrast, domestic players attract experienced professionals from CROs and global pharmaceutical companies with even higher salaries and prestigious designations. Attrition causes instability; hence, organizations in India and abroad are seeking innovative ways to reduce the attrition rate through better salaries, training, learning opportunities, attention to employees' personal needs, and enhancement of employees' global exposure.
Pharmaceutical industry all over the world has gained an unmatched momentum, making Clinical Research one of the lucrative careers in recent times. Since the niche pharmaceutical products from various pharmaceutical industries have touched down in terms of its time span, the new avenues and new drugs are the order of the day. Clinical Research involves studies world over; the effect as well as the safety of drugs needs to be studied considering the variation in the race, genetic makeup, cultures, food habits, environmental and climatic variations. For e.g the drug which could be safe in African race may not be safe for the Asian origin. Apparently, to gain an approval for new drugs, it has to undergo Clinical Research in multiple centres and multiple countries. In addition, the data generated needs to establish reasonable correlation in safety and efficacy from place to place. The coordination, compliance and the data management requires huge manpower.
There could not be a better time for clinical research. The global market is estimated to be worth over USD 52 billion. There are more than 2,50,000 positions vacant with attractive salaries. Moreover, with a dramatic increase in the number of trials being conducted worldwide; the demand for clinical research professionals is ready to reach an all-time high.
Clinical Research - Advantage India -
India is a multicultural, multi-linguistic, highly populated country with tropical climate. It is a diverse and therapy-naïve population with vast genetic diversity ready to undergo clinical trials. Moreover, India is home to vast reserve of knowledge and resource base and is strategically located in the arena of global clinical research and trials. India's potential as a favorite outsourcing destination has led many global Pharma companies to set up clinical research businesses here. India has emerged as the favorable destination and new global hub for Clinical Research business for a decade and has been tremendously growing for past 2 to 3 years. Contract Clinical Research relatively is a new business and profession in India but according to projections by McKinsey & Company, the Indian Clinical Research Industry could attract US $1.5 billion of revenue from the worldwide Pharmaceutical & CRO Industry creating job opportunities for more than 10,000 Principal Investigators and nearly 50,000 Clinical Research Professionals, who are trained in Clinical Research including ICH-GCP/ FDA guidelines If India's clinical trial business grows to 10% of the scope seen in the U.S. by 2010 according to McKinsey's projections, then the industry will need approximately 50,000 recruits. India has a huge pool of scientific, pharmaceutical, and medical talent, but the supply of trained professionals in India is approximately one-tenth of its demand. Unless research training institutes are established, this huge gap between the demand and supply of trained personnel cannot be bridged. Most global pharmaceutical companies conducting multi-center studies in India have big and small Clinical Research Departments handling regulatory and marketing support, local Pharmaco-vigilance reporting, conduct of local registration, and post-marketing surveillance studies. This team coordinates with its global project management or outsourcing partners to mentor, maintain timelines, ensure checks and balances for regulatory compliance, and collect quality data. The outsourcing decisions for these global studies are mostly made in the U.S. and Europe; however, as India becomes a major hub and contributes further to subject recruitment in clinical studies, Indians will play a much larger role in the outsourcing process. Clinical research is the key discovery of the latest diagnostic methods and to develop modern drug for treating of diseases. Working for the "blockbuster drug" most of pharmaceutical companies invest several hundred million dollars every year; it takes approximately $450-$800 million to bring a drug from a lab to the shelf of pharmacist. Its start from the identification of the lead molecule to the last phase of clinical trial of a single drug would take about 9years on an average, most of the companies would like to reduce this time for profit maximization. According to estimate by PHARMA and ING Barings LLC, outsourced clinical phase I-IV market in 1998 was about US $4.4 billion and is projected to grow to US $7.8 billion in 2002. Around 80,000 clinical trials are being conducted globally each year. Researcher indicates that conducting clinical trials in India would approximately cost less than one-third of the cost which they spend in conducting a clinicaltrials in western countries. Traditionally, Indian pharma companies have been known for its success in generic drug marketing. Now the huge cost of new drug development in western countries is giving a break through opportunity for drug discovery services outsourcing to India, which created the heat in the Indian entrepreneurs and technocrafts.
Developing countries like India are devising tailor -made strategies for catering the needs of the industries. However, India has been a major pit stop for the western pharma industries as the sheer numbers of India's talent force make a compelling case for outsourcing R&D to India. India has some 22 million graduates, including 6million science graduates, 1.2 million with engineering degrees and 600,000 doctors, according to data compiled by The Economic Times Intelligence Group. And by scenes the population is growing rapidly 1 billion plus, with crude birth rate of 26/ 1000 population and increasing life expectancy to 62years, more than 20,000 hospitals, and increasing rate of literates.
Not only these factors have attracted the western pharma industry but the most important factors are:
- Overall less costs for conducting the clinical trials (cost effectiveness)
- Wide spectrum of diseases, with low per capita drug expenditure
- Large and fast growing private hospitals and healthcare industries
- With increase stringent regulatory scrutiny/ norms, and government commitment to provide Intellectual Property Protection from Jan2005.
- Hospitals attached to medical institutions: 164 plus other major corporate hospitals and specialized institutions
- High caliber, dedicated scientists and clinical research professionals known to have the best brains in information technology
- Increased enthusiasm to participate in global multicentre clinical trials and cutting-edge technology
- English being the first language of education and communication
- • Rapidly increasing awareness of Good Clinical Practice(GCP) English being the first language of education and communication
- Rapidly increasing awareness of Good Clinical Practice(GCP)
India has become a signatory to TRIPS; consequently, a new patent law has come into picture which is effective from January 2005(Schedule Y) and also for medical devices effective from March 2006. India has well-defined guidelines for carrying out various phases of clinical trials. These guidelines are in line with the global guidelines on clinical research (ICHGCP).
The various guidelines that govern the conduct of clinical trails in India include: Schedule Y of Drugs and Cosmetics Act, 1940 Ethical Guidelines for Biomedical research on Human subjects, 2000 also known as ICMR code. Good clinical practices, 2001 Looking of these various factors experts in clinical research have varying view on opportunities in India, and no doubt India being the hub for the clinical trails, saying so India has everything it needs to cater the global Pharma market. But the trick is in doing it. Well having said that me being in the family of clinical research, whenever someone gets rapid relief from a severe migraine, severe dental pain, undergoes cardiac bypass surgery without blood transfusion or find helps for a number other problems, I get a warm feeling by knowing I have played an important role in doing so. Advantage India Key factors contributing to India's emergence as a hub for clinical research: • Multi-cultural and multi-linguistic - pool of diverse data under a single umbrella • Local cost of clinical studies – 50 to 70% of costs in the US/EU • Fast recruitment, accelerated approvals and good communication skills • Gigantic pool of dissimilar diseases • English speaking investigators • Regulatory facilitation of parallel phase studies The Future Outlook: Indian CROs v/s Outsourced Projects from Europe & USA: Acceptance of the clinical research profession by young life sciences, Pharma & medical graduates is growing fast. More universities and institutions can be expected to introduce full-time courses for students to help supply the industry's needs on a continuous basis. As has been seen with IT professionals, this resource pool is also becoming source of pride for India that is recognized globally for its sincerity, scientific knowledge, and skills. Although there are often differences between the clinical research professionals of India and western countries in terms of their levels of direct experience in trials and their understanding of the complexities of the drug development process, India is rapidly improving upon this situation as it seeks to one day emerge as a global leader in the CRO industry. Unlike software/ IT industry, which are completely dependent on American and European clients, Clinical Research Industry is not completely dependent. India has major giant pharma companies who themselves have their own CRO establishments. Opportunities, Growth & Career Prospects: Career prospects with CROs and site management organizations (SMOs) in India are quite attractive, considering the number of clinical trials currently underway in India in diverse therapeutic areas. There are more than 360 big and small CROs in Mumbai, Delhi, Gurgaon, Noida, Hyderabad and Bangalore. India has also created a niche for itself in the Bioanalytical and Bio-equivalence business, through cost effectiveness and the ready availability of healthy trial subjects. There are more than 20 big reputed centers for such studies in India, specializing in short-term trials that generate quick revenue. These centers need CRAs, physicians, phlebotomists, nurses, quality assurance auditors, principal investigators, pathologists, biochemists, laboratory technicians, and biostatisticians. Many sponsors have started using Indian centers of excellence to save time and money on their biometrics needs. This has created a huge number of jobs in data entry, data management, programming, coding, statistical analysis, and medical writing, as well as opportunities in database and statistical analysis system training. The growing trend for EDC will attract more skilled professionals who understand the software and the intricacies of installing, implementing, and training users (investigators and monitors) to use it effectively. This industry is heavily dependent on another set of resources: investigators with strong inclination toward the conduct of ethical clinical research. Hence, this industry looks for experienced principal investigators who have set up and conducted global clinical trials and have competent study staff at their sites. Ten years ago, it was very difficult to find a principal investigator who had worked on GCP trials. Recently, however, CROs and global pharmaceutical companies have started working with clinicians and physicians in different therapeutic fields in an effort to familiarize these investigators with GCP and International Conference on Harmonization (ICH) E6 Guidelines. There are multiple job opportunities available for monitors in the current scenario. A professional with a few years of experience can quickly be absorbed by CROs, Data management firms, and even IT companies with life science and clinical specializations. This has led to salary hikes and upgraded positions. Strong skill sets and careful attention to the complexities of handling trials have taken a back seat to the lure of money, driving clinical research professionals to acquire higher positions and pay packages. Thus, the clinical research industry is facing a challenge of huge attrition. The Financial Express says the attrition rate has grown three times in the last two years, and is even higher than in the Indian IT sector. Attrition is higher in CRA and project manager positions, as these two professions have changed over a decade. And with mushrooming growth of CROs, there is high demand for trained Clinical Research Professionals and also Heads of operations, which leads to the poaching of trained professionals at all levels. Salaries in CRO industry are on par with IT industry ranging from Rs. 15000 to more than Rs. 50,000 per month to start with. Clinical Research - Career pathways: Global players attempt to attract experienced talent by offering competitive salaries and providing exposure to global work in process and systems. By contrast, domestic players attract experienced professionals from CROs and global pharmaceutical companies with even higher salaries and prestigious designations. Attrition causes instability; hence, organizations in India and abroad are seeking innovative ways to reduce the attrition rate through better salaries, training, learning opportunities, attention to employees' personal needs, and enhancement of employees' global exposure.
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