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PEER REVIEWED

C L I N I C A L
Umakanta Sahoo, PhD, MBA | Dipti Sawant, PhD, MBA, CCRA

The Clinical Research Profession

R E S E A R C H
in India
I ndia is emerging as a global hub for clinical research. According to projections
from McKinsey & Company, the Indian clinical research industry could

C A R E E R S
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
By 2008,up to 30% of global 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
clinical trials will take place 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
outside the U.S.and western clinical trial data when launching a product globally. Registration of new drugs
for marketing in India requires submission of data generated on Indian
Europe,and India has patients. A 100-patient, noncomparative, open-label study on patients treated
for the primary indication is sufficient. For drugs that treat rare conditions, a
emerged as a favorable lower sample size is usually negotiable.2
With increased outsourcing from the U.S. and Europe to India, global phar-
destination for these trials. maceutical companies and Indian entrepreneurs have set up contract research
organizations (CROs) in India. They are attracting highly competent profes-
sionals, 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 begin-
ning, 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 India’s 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 statisti-
cal 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-

PEER REVIEWED ❘ 51
metrics business, creating abundant ing the Food and Drug Administration’s Europe, and to reduce time to market.
opportunities in the knowledge-based guidances for GCPs and more than An entry-level clinical researcher earning
service sector. Figure 1 depicts the swift 40,000 GCP-trained investigators, but the just one-tenth as much as a more experi-
evolution of these different roles. number of investigators is decreasing enced colleague from his or her Indian
even as the number of trials increases. employer could still be hired by a U.S. or
Recruitment is a major stumbling block European sponsor at a 20–25% savings
Supply and Demand Gaps
in the drug development process, and for the sponsor versus the counterpart
According to a 2001 CenterWatch sur- increasing staff costs mean that more and abroad.4 However, this difference is
vey,5 the U.S. has slightly more than more studies will be outsourced to India. growing narrower with time. In addi-
200,000 clinical research professionals Sponsors are looking at India to lever- tion, many sponsors accept only trained
(Figure 2). There are 60,000 trials follow- age the high cost of trials in the U.S. and and experienced personnel, which may
force CROs into the costly position of
Figure 1. Evolution of Clinical Research in India 1995–2015 delaying assignment of their newest
researchers to certain types of projects
2015 for six months to a year.
Clinical Trial Insurance
Outsourcing Sponsors are looking at India
Protocol
2010
Database Designing to leverage the high cost of
Biometrics
BD
trials in the U.S.and Europe,
2005 QA
EDC
and to reduce time to market.
Medical Writing
If India’s clinical trial business grows
Regulatory
2000 to 10% of the scope seen in the U.S. by
Data Management
2015, then the industry will need ap-
Data Entry proximately 50,000 recruits.6 India has a
Clinical Monitoring huge pool of scientific, pharmaceutical,
1995
and medical talent, but the supply of
trained professionals in India is approxi-
mately one-tenth of its demand (Figure
Source: Chiltern International Private Limited,Mumbai.
3). Unless research training institutes are
established, this huge gap between the
Figure 2. People Involved in Trials in the U.S.
demand and supply of trained personnel
cannot be bridged.
Most global pharmaceutical com-
Other Site Staff 35,000 panies conducting multicenter studies in
India have small clinical research depart-
ments handling regulatory and market-
ing support, local pharmacovigilance
Investigator 50,000 reporting, conduct of local registration,
and postmarketing surveillance studies.
This team coordinates with its global
project management or outsourcing
CRO Staff 44,000 partners to mentor, maintain timelines,
ensure checks and balances for regulatory
compliance, and collect quality data. The
outsourcing decisions for these global
Sponsor Staff 78,000
studies are mostly made in the U.S. and
Europe; however, as India becomes a
0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 90,000 major hub and contributes further to
subject recruitment in clinical studies,
Source: CenterWatch 2001 Survey. Indians will play a much larger role in the

52 ❘ MONITOR SEPTEMBER 2007


Figure 3. Demand-Supply Gap 2010 in India with strong inclinations toward the con-
duct of ethical clinical research. Hence,
this industry looks for experienced prin-
cipal investigators who have set up and
4,000
Other Site Staff conducted global clinical trials and have
400 competent study staff at their sites. Ten
Demand years ago, it was very difficult to find a
Supply
principal investigator who had worked
2,000 on GCP trials. Recently, however, CROs
Investigator and global pharmaceutical companies
300
have started working with clinicians and
physicians in different therapeutic fields
in an effort to familiarize these invest-
6,000 igators with GCP and International Con-
CRO Staff
1,000 ference on Harmonization (ICH) E6
Guidelines.9
The growing clinical research sector
has propelled the emergence of many
1,000
Sponsor Staff ancillary career opportunities in central
200 laboratories, investigational product
manufacture, packaging, warehousing,
0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 distribution, and refrigeration service
providers. Other critical support services
Source: Chiltern International India Estimates.
that translate to business opportunities
in India involve translating and printing
clinical trial materials, providing cogni-
outsourcing process. Career prospects intricacies of installing, implementing, tive testing, validating rating scales and
with CROs and site management organi- and training users (investigators and quality-of-life questionnaires in local
zations (SMOs) in India are quite attrac- monitors) to use it effectively.8 languages, storing trial materials on a
tive, considering the number of clinical This industry is heavily dependent on long-term basis, forming centralized
trials currently under way in India in another set of resources: investigators ethics committees, managing accredita-
diverse therapeutic areas (Figure 4).
India has also created a niche for itself Figure 4. Clinical Trials Done in India
in the bioanalytical and bioequivalence
business, through cost effectiveness and Dermatology Haematology
the ready availability of healthy trial
Respiratory
subjects. There are more than 15 rep-
utable centers for such studies in India, Paediatrics
specializing in short-term trials that Infection
Ophthalmology
generate quick revenue. These centers
Orthopaedic
need CRAs, physicians, phlebotomists,
nurses, quality assurance auditors, prin- Gastroenterology
cipal investigators, pathologists, bio-
chemists, laboratory technicians, and Endocrinology
biostatisticians.7
Many sponsors have started using
Indian centers of excellence to save time
and money on their biometrics needs. Cardiology
This has created a huge number of jobs
in data entry, data management, pro-
gramming, coding, statistical analysis,
and medical writing, as well as opportu- Oncology
nities in database and statistical analysis Psychiatry
system training. The growing trend for
EDC will attract more skilled profession-
als who understand the software and the Source: Clinical Trial Registry,www.clinicaltrials.gov,accessed in January 2007.

PEER REVIEWED ❘ 53
tion and validation agencies, and offer- professionals to acquire higher positions Training and Courses
ing insurance for clinical trial partici- and pay packages. Offered in India
pants. Although many operators in the Thus, the clinical research industry is
Clinical research training is another
public and private domain can provide facing a challenge of huge attrition. The
for these needs at a basic level, service important issue, given the gap between
Financial Express says the attrition rate
providers who fully understand the need supply and demand for trained profes-
has grown three times in the last two
for confidentiality, security, and docu- sionals in India. To foster expertise in
years, and is even higher than in the
mentation in the clinical trial business clinical research, organizations have
Indian IT sector. 11 Attrition is higher
may be difficult to identify in India at started training their employees in ICH
in CRA and project manager positions,
this time. and GCP guidelines and company pol-
as these two professions have changed
Meanwhile, experienced investigators icies, then exposing them to hands-on
over a decade. And with mushrooming
have started demanding per patient costs training in their respective departments:
growth of CROs, there is high demand
equivalent to their counterparts in west- clinical operations, data management,
for experienced heads of operations,
ern countries, but on average, these costs regulatory, or medical affairs. Most of
which leads to the poaching of successful
are estimated at just one-half of western the global players started their clinical
professionals at senior management or
costs. The unit costs for tests and proce- research work in India with on-the-
CEO level. Global players attempt to
dures are also less in India. job training programs for their few staff
attract experienced talent by offering
and implemented a “train the trainer”
competitive salaries and providing ex-
model to further localize their training
Professional Hazards posure to global work in process and
programs.
systems. By contrast, domestic players at-
Monitors, who comprise 70–80% of tract experienced professionals from
India’s clinical research professionals, CROs and global pharmaceutical com-
face more hazards than their counter- panies with even higher salaries and
To foster expertise in clinical
parts in western countries. The nature of prestigious designations. Attrition causes
their job demands extensive traveling in instability; hence, organizations in India research,organizations have
the extremes of summer, winter, and the and abroad are seeking innovative ways
rainy season. Sites are geographically dis- to reduce the attrition rate through bet- started training their
tant, and the fastest mode of transport ter salaries, training, learning opportuni-
is by air. Travel time may be more than ties, attention to employees’ personal employees in ICH and GCP
10 hours for a single visit. In order to needs, and enhancement of employees’
make site visits cost effective to sponsors, global exposure.
many monitors visit two or three sites in guidelines and company
a week. They spend more time at sites, as
Home-Based Model policies,then exposing them
patient recruitment is three to five times
higher than at an average western site In India, most professionals prefer office-
and, invariably, CROs prefer 100% based, permanent jobs, and few CROs to hands-on training in their
source data verification.10 It is equally and pharmaceutical companies have
challenging for the monitors to properly provided a home-based model for their
meet with investigators who are busy monitors that would place CRAs in
respective departments.
with patient care and hospital research locales from which they could oversee
priorities that compete with the trials for regional study sites, allowing them to Until recently, there were no struc-
their attention. save travel time and lead balanced pro- tured, formal training courses focusing
There are multiple job opportunities fessional careers. only on clinical research. The training
available for monitors in the current Under ideal conditions, the CROs and efforts by the CROs and big pharmaceu-
scenario. A professional with a few years sponsors could also save travel time and tical companies have shaped the profes-
of experience can quickly be absorbed costs; however, India still has many sion. Looking at the growth prospects in
by CROs, SMOs, data management infrastructural bottlenecks to this con- this industry, many local universities and
firms, and even IT companies with life cept. For instance, it is very expensive to global training institutes have started
science and clinical specializations. This get advanced internet connectivity for an full-time, short-term diploma courses
has led to salary hikes and upgraded individual operating from home. So, for (classroom based and/or online) in clin-
positions. Strong skill sets and careful now, providing all the facilities necessary ical research management.12 However,
attention to the complexities of han- for monitors to operate from home is the real challenge for the industry is to
dling trials have taken a back seat to the more costly than operating from the create quality resources through proper
lure of money, driving clinical research office. training and exposure.

54 ❘ MONITOR SEPTEMBER 2007


The Future Outlook 2005, 14-15 Nov, 2005; Federation House, Clinical Trials, www.actmagazine.com, Feb
FICCI, New Delhi, India. 2006.
Acceptance of the clinical research pro- 2. Sahoo U. 2005. Look East for the future devel- 11. http://in.rediff.com/money/2007/jan/19guest.
fession by young talents is growing fast. opment of new drugs and speedy clinical trials. htm.
Pharmaceutical Journal 275, 26 November 12. Sahoo U. 2005. Indian CRO industry: the tal-
More universities and institutions can be
2005, www.pjonline.com. ent pool. Global Outsourcing Review.
expected to introduce full-time courses 3. Montagne M. 1996. The role of clinical re-
for students to help supply the industry’s search in the drug development process. In
needs on a continuous basis. As has been Bleidt B and Montagne M, eds. Clinical Re-
Umakanta Sahoo, PhD, MBA, is managing direc-
seen with IT professionals, this resource search in Pharmaceutical Development. New
tor of Chiltern International Pvt Ltd in Mumbai,
York: Marcel Dekker.
pool will be a source of pride for India 4. Sahoo U. 2005. Careers in clinical research—
India. He has more than 15 years of experience in
that is recognized globally for its sin- clinical operations, project management, regula-
India. The Monitor 19(4): 37-42.
tory affairs, and data management functions in a
cerity, scientific knowledge, and skills. 5. Clinical Research Jobs in the New Economy.
variety of pharmaceutical companies and CROs.
Although there are often differences 2001. A Special CenterWatch Report. Center-
Among his many honors, he was awarded a
Watch 8(9): September 2001.
between the clinical research profession- diploma in management and marketing with a spe-
6. Bhatt A, Sahoo U. 2004. 2010: Indian clinical
als of India and western countries in research odyssey. Pharmabiz, February, 26,
cial emphasis on the biopharmaceutical industry
terms of their levels of direct experience 2004. by the Kriger Research Institute in Canada. He can
be reached at umakanta.sahoo@chiltern.com.
in trials and their understanding of the 7. Takoo M, Mirashi M, Sahoo U. 2006. Bioavail-
complexities of the drug development ability and bioequivalence trials: a promising
business opportunity in India. The Monitor Dipti Sawant, PhD, MBA, CCRA, is an ACRP-
process, India is rapidly improving upon 20(3): 43-6. certified clinical research associate working with
this situation as it seeks to one day 8. Sahoo U. 2005. Data capture shifts paradigm, Chiltern International Pvt Ltd as a senior clinical
emerge as a global leader in the CRO EDC vendors eyeing India. Chronicle Pharma- team leader. She obtained her postgraduate degree
industry. biz Asia, July 2005. in biochemistry and her PhD in applied biology
9. Sawant D. 2006. Human resource—a growing from Seth GSMC and KEM Hospital, Mumbai. She
need. Chronicle Pharmabiz, India Calling. A also holds an MBA in personnel management from
Pharmabiz Special Exclusive to CphI, p55, Sep New Port University. She has five years of experi-
References
28, 2006. ence in the clinical research industry and has
1. White Paper on Global Clinical Trials in India: 10. Sahoo U, Sanghavi V, Kermani F 2006. Subject worked in various therapeutic areas. She can be
Prospects and Challenges. BioBusiness Summit recruitment: an Indian perspective. Applied reached at dipti.sawant@chiltern.com.

PEER REVIEWED ❘ 55