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C L I N I C A L

Umakanta Sahoo, PhD, MBA | Dipti Sawant, PhD, MBA, CCRA

The Clinical Research Profession in India I

By 2008,up to 30% of global clinical trials will take place outside the U.S.and western Europe,and India has emerged as a favorable destination for these trials.

R E S E A R C H

ndia is emerging as a global hub for clinical research. According to projections from McKinsey & Company, the Indian clinical research industry could attract US $1.5 billion of revenue from U.S. and European sponsors by 2010, creating a demand for more than 10,000 investigators trained in good clinical practice (GCP) and supported by nearly 50,000 clinical research professionals.1 Analysts project that by 2008, up to 30% of global clinical trials will take place outside the U.S. and western Europe, and India has emerged as a favorable destination for these trials. Most regulatory authorities accept India-specific clinical trial data when launching a product globally. Registration of new drugs for marketing in India requires submission of data generated on Indian patients. A 100-patient, noncomparative, open-label study on patients treated for the primary indication is sufcient. For drugs that treat rare conditions, a lower sample size is usually negotiable.2 With increased outsourcing from the U.S. and Europe to India, global pharmaceutical companies and Indian entrepreneurs have set up contract research organizations (CROs) in India. They are attracting highly competent professionals, both in the clinical research profession and the knowledge process outsourcing sector.3 Evolution of the Clinical Research Profession in India Contract clinical research is a new phenomenon in India. A decade ago, the industry focused only on monitoring clinical operations. Most pharmaceutical companies and the evolving CROs performed only clinical operations. Hence, career opportunities came only to clinical research associates (CRAs) and project managers who could monitor and handle clinical studies. In the beginning, pharmacists had an edge over other clinical research professionals, but slowly the science graduates and medical and alternate medical professionals entered the industry as CRAs and project managers.4 Since then, there has been a growing number of players on Indias stage. Global and domestic CROs provide a spectrum of services at different stages of drug development: project management, clinical trial monitoring, medical affairs, regulatory assistance, quality assurance, data management, and statistical analysis. Medical writing, business development, training and consultancy, database programming, medical coding, electronic data capture (EDC), and support services industries have also emerged. The information technology (IT) and IT-enabled services sectors, already familiar with India, have brought large-scale data management and statistical analysis outsourcing business to the country. Software companies with huge capital bases are entering the bio-

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metrics business, creating abundant opportunities in the knowledge-based service sector. Figure 1 depicts the swift evolution of these different roles. Supply and Demand Gaps According to a 2001 CenterWatch survey,5 the U.S. has slightly more than 200,000 clinical research professionals (Figure 2). There are 60,000 trials follow-

ing the Food and Drug Administrations guidances for GCPs and more than 40,000 GCP-trained investigators, but the number of investigators is decreasing even as the number of trials increases. Recruitment is a major stumbling block in the drug development process, and increasing staff costs mean that more and more studies will be outsourced to India. Sponsors are looking at India to leverage the high cost of trials in the U.S. and

Figure 1. Evolution of Clinical Research in India 19952015

2015 Clinical Trial Insurance Outsourcing 2010 Protocol Database Designing Biometrics BD 2005 QA EDC Medical Writing Regulatory 2000 Data Management Data Entry Clinical Monitoring 1995 Source: Chiltern International Private Limited,Mumbai.

Europe, and to reduce time to market. An entry-level clinical researcher earning just one-tenth as much as a more experienced colleague from his or her Indian employer could still be hired by a U.S. or European sponsor at a 2025% savings for the sponsor versus the counterpart abroad.4 However, this difference is growing narrower with time. In addition, many sponsors accept only trained and experienced personnel, which may force CROs into the costly position of delaying assignment of their newest researchers to certain types of projects for six months to a year.

Sponsors are looking at India to leverage the high cost of trials in the U.S.and Europe, and to reduce time to market.
If Indias clinical trial business grows to 10% of the scope seen in the U.S. by 2015, then the industry will need approximately 50,000 recruits.6 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 (Figure 3). 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 multicenter studies in India have small clinical research departments handling regulatory and marketing support, local pharmacovigilance reporting, conduct of local registration, and postmarketing 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

Figure 2. People Involved in Trials in the U.S.

Other Site Staff

35,000

Investigator

50,000

CRO Staff

44,000

Sponsor Staff

78,000

0 Source: CenterWatch 2001 Survey.

10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 90,000

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Figure 3. Demand-Supply Gap 2010 in India

4,000 Other Site Staff 400 Demand Supply 2,000 Investigator 300

6,000 CRO Staff 1,000

1,000 Sponsor Staff 200 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000

Source: Chiltern International India Estimates.

outsourcing process. Career prospects with CROs and site management organizations (SMOs) in India are quite attractive, considering the number of clinical trials currently under way in India in diverse therapeutic areas (Figure 4). India has also created a niche for itself in the bioanalytical and bioequivalence business, through cost effectiveness and the ready availability of healthy trial subjects. There are more than 15 reputable 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.7 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.8 This industry is heavily dependent on another set of resources: investigators
Figure 4. Clinical Trials Done in India
Dermatology Respiratory Paediatrics Ophthalmology Orthopaedic Gastroenterology Endocrinology

with strong inclinations 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 elds in an effort to familiarize these investigators with GCP and International Conference on Harmonization (ICH) E6 Guidelines.9 The growing clinical research sector has propelled the emergence of many ancillary career opportunities in central laboratories, investigational product manufacture, packaging, warehousing, distribution, and refrigeration service providers. Other critical support services that translate to business opportunities in India involve translating and printing clinical trial materials, providing cognitive testing, validating rating scales and quality-of-life questionnaires in local languages, storing trial materials on a long-term basis, forming centralized ethics committees, managing accredita-

Haematology

Infection

Cardiology

Oncology Psychiatry

Source: Clinical Trial Registry,www.clinicaltrials.gov,accessed in January 2007.

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tion and validation agencies, and offering insurance for clinical trial participants. Although many operators in the public and private domain can provide for these needs at a basic level, service providers who fully understand the need for confidentiality, security, and documentation in the clinical trial business may be difficult to identify in India at this time. Meanwhile, experienced investigators have started demanding per patient costs equivalent to their counterparts in western countries, but on average, these costs are estimated at just one-half of western costs. The unit costs for tests and procedures are also less in India. Professional Hazards Monitors, who comprise 7080% of Indias clinical research professionals, face more hazards than their counterparts in western countries. The nature of their job demands extensive traveling in the extremes of summer, winter, and the rainy season. Sites are geographically distant, and the fastest mode of transport is by air. Travel time may be more than 10 hours for a single visit. In order to make site visits cost effective to sponsors, many monitors visit two or three sites in a week. They spend more time at sites, as patient recruitment is three to ve times higher than at an average western site and, invariably, CROs prefer 100% source data verification.10 It is equally challenging for the monitors to properly meet with investigators who are busy with patient care and hospital research priorities that compete with the trials for their attention. 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, SMOs, 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. 11 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 experienced heads of operations, which leads to the poaching of successful professionals at senior management or CEO level. 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. Home-Based Model In India, most professionals prefer ofcebased, permanent jobs, and few CROs and pharmaceutical companies have provided a home-based model for their monitors that would place CRAs in locales from which they could oversee regional study sites, allowing them to save travel time and lead balanced professional careers. Under ideal conditions, the CROs and sponsors could also save travel time and costs; however, India still has many infrastructural bottlenecks to this concept. For instance, it is very expensive to get advanced internet connectivity for an individual operating from home. So, for now, providing all the facilities necessary for monitors to operate from home is more costly than operating from the ofce.

Training and Courses Offered in India Clinical research training is another important issue, given the gap between supply and demand for trained professionals in India. To foster expertise in clinical research, organizations have started training their employees in ICH and GCP guidelines and company policies, then exposing them to hands-on training in their respective departments: clinical operations, data management, regulatory, or medical affairs. Most of the global players started their clinical research work in India with on-thejob training programs for their few staff and implemented a train the trainer model to further localize their training programs.

To foster expertise in clinical research,organizations have started training their employees in ICH and GCP guidelines and company policies,then exposing them to hands-on training in their respective departments.
Until recently, there were no structured, formal training courses focusing only on clinical research. The training efforts by the CROs and big pharmaceutical companies have shaped the profession. Looking at the growth prospects in this industry, many local universities and global training institutes have started full-time, short-term diploma courses (classroom based and/or online) in clinical research management.12 However, the real challenge for the industry is to create quality resources through proper training and exposure.

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The Future Outlook Acceptance of the clinical research profession by young talents is growing fast. More universities and institutions can be expected to introduce full-time courses for students to help supply the industrys needs on a continuous basis. As has been seen with IT professionals, this resource pool will be a 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. References
1. White Paper on Global Clinical Trials in India: Prospects and Challenges. BioBusiness Summit 10. 2.

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2005, 14-15 Nov, 2005; Federation House, FICCI, New Delhi, India. Sahoo U. 2005. Look East for the future development of new drugs and speedy clinical trials. Pharmaceutical Journal 275, 26 November 2005, www.pjonline.com. Montagne M. 1996. The role of clinical research in the drug development process. In Bleidt B and Montagne M, eds. Clinical Research in Pharmaceutical Development. New York: Marcel Dekker. Sahoo U. 2005. Careers in clinical research India. The Monitor 19(4): 37-42. Clinical Research Jobs in the New Economy. 2001. A Special CenterWatch Report. CenterWatch 8(9): September 2001. Bhatt A, Sahoo U. 2004. 2010: Indian clinical research odyssey. Pharmabiz, February, 26, 2004. Takoo M, Mirashi M, Sahoo U. 2006. Bioavailability and bioequivalence trials: a promising business opportunity in India. The Monitor 20(3): 43-6. Sahoo U. 2005. Data capture shifts paradigm, EDC vendors eyeing India. Chronicle Pharmabiz Asia, July 2005. Sawant D. 2006. Human resourcea growing need. Chronicle Pharmabiz, India Calling. A Pharmabiz Special Exclusive to CphI, p55, Sep 28, 2006. Sahoo U, Sanghavi V, Kermani F 2006. Subject recruitment: an Indian perspective. Applied

Clinical Trials, www.actmagazine.com, Feb 2006. 11. http://in.rediff.com/money/2007/jan/19guest. htm. 12. Sahoo U. 2005. Indian CRO industry: the talent pool. Global Outsourcing Review.

Umakanta Sahoo, PhD, MBA, is managing director of Chiltern International Pvt Ltd in Mumbai, India. He has more than 15 years of experience in clinical operations, project management, regulatory affairs, and data management functions in a variety of pharmaceutical companies and CROs. Among his many honors, he was awarded a diploma in management and marketing with a special emphasis on the biopharmaceutical industry by the Kriger Research Institute in Canada. He can be reached at umakanta.sahoo@chiltern.com. Dipti Sawant, PhD, MBA, CCRA, is an ACRPcertified clinical research associate working with Chiltern International Pvt Ltd as a senior clinical team leader. She obtained her postgraduate degree in biochemistry and her PhD in applied biology from Seth GSMC and KEM Hospital, Mumbai. She also holds an MBA in personnel management from New Port University. She has five years of experience in the clinical research industry and has worked in various therapeutic areas. She can be reached at dipti.sawant@chiltern.com.

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