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Clinical Research Profesionals in India

Clinical Research Profesionals in India

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The Clinical Research Professionin India
PEER REVIEWED
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ndia is emerging as a global hub for clinical research.According to projectionsfrom McKinsey & Company,the Indian clinical research industry couldattract US $1.5 billion ofrevenue from U.S.and European sponsors by 2010,creating a demand for more than 10,000 investigators trained in good clinicalpractice (GCP) and supported by nearly 50,000 clinical research professionals.
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Analysts project that by 2008,up to 30% ofglobal clinical trials will takeplace outside the U.S.and western Europe,and India has emerged as a favorabledestination for these trials.Most regulatory authorities accept India-specificclinical trial data when launching a product globally.Registration ofnew drugsfor marketing in India requires submission ofdata generated on Indianpatients.A 100-patient,noncomparative,open-label study on patients treatedfor the primary indication is sufficient.For drugs that treat rare conditions,alower sample size is usually negotiable.
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With increased outsourcing from the U.S.and Europe to India,global phar-maceutical companies and Indian entrepreneurs have set up contract researchorganizations (CROs) in India.They are attracting highly competent profes-sionals,both in the clinical research profession and the knowledge processoutsourcing sector.
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Evolution of the Clinical Research Profession in India
Contract clinical research is a new phenomenon in India.A decade ago,theindustry focused only on monitoring clinical operations.Most pharmaceuticalcompanies and the evolving CROs performed only clinical operations.Hence,career opportunities came only to clinical research associates (CRAs) andproject managers who could monitor and handle clinical studies.In the begin-ning,pharmacists had an edge over other clinical research professionals,butslowly the science graduates and medical and alternate medical professionalsentered the industry as CRAs and project managers.
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Since then,there has been a growing number ofplayers on India’s stage.Global and domestic CROs provide a spectrum ofservices at different stages of drug development:project management,clinical trial monitoring,medicalaffairs,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),andsupport services industries have also emerged.The information technology (IT) and IT-enabled services sectors,already familiar with India,have broughtlarge-scale data management and statistical analysis outsourcing business to thecountry.Software companies with huge capital bases are entering the bio-
PEER REVIEWED
Umakanta Sahoo,PhD,MBA | Dipti Sawant,PhD,MBA,CCRA
 C  L  I  I   C  A  L   R  E   S  E  A  R   C    C  A  R  E  E  R   S  
By 2008,up to 30% of globalclinical trials will take placeoutside the U.S.and westernEurope,and India hasemerged as a favorabledestination for these trials.
 
metrics business,creating abundantopportunities in the knowledge-basedservice sector.Figure 1depicts the swiftevolution ofthese different roles.
Supply and Demand Gaps
According to a 2001 CenterWatch sur-vey,
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the U.S.has slightly more than200,000 clinical research professionals(Figure 2).There are 60,000 trials follow-ing the Food and Drug Administration’sguidances for GCPs and more than40,000 GCP-trained investigators,but thenumber ofinvestigators is decreasingeven as the number oftrials increases.Recruitment is a major stumbling blockin the drug development process,andincreasing staffcosts mean that more andmore studies will be outsourced to India.Sponsors are looking at India to lever-age the high cost oftrials in the U.S.andEurope,and to reduce time to market.An entry-level clinical researcher earning just one-tenth as much as a more experi-enced colleague from his or her Indianemployer could still be hired by a U.S.orEuropean sponsor at a 20–25% savingsfor the sponsor versus the counterpartabroad.
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However,this difference isgrowing narrower with time.In addi-tion,many sponsors accept only trainedand experienced personnel,which may force CROs into the costly position of delaying assignment oftheir newestresearchers to certain types ofprojectsfor six months to a year.
Sponsors are looking at Indiato leverage the high cost of trials in the U.S.and Europe,and to reduce time to market.
IfIndia’s clinical trial business growsto 10% ofthe scope seen in the U.S.by 2015,then the industry will need ap-proximately 50,000 recruits.
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India has ahuge pool ofscientific,pharmaceutical,and medical talent,but the supply of trained professionals in India is approxi-mately one-tenth ofits demand (Figure3).Unless research training institutes areestablished,this huge gap between thedemand and supply oftrained personnelcannot be bridged.Most global pharmaceutical com-panies conducting multicenter studies inIndia have small clinical research depart-ments handling regulatory and market-ing support,local pharmacovigilancereporting,conduct oflocal registration,and postmarketing surveillance studies.This team coordinates with its globalproject management or outsourcingpartners to mentor,maintain timelines,ensure checks and balances for regulatory compliance,and collect quality data.Theoutsourcing decisions for these globalstudies are mostly made in the U.S.andEurope;however,as India becomes amajor hub and contributes further tosubject recruitment in clinical studies,Indians will play a much larger role in the
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MONITORSEPTEMBER 2007Figure 1.Evolution of Clinical Research in India 1995–2015
 Source:
Chiltern International Private Limited,Mumbai.
20052000199520102015Clinical Trial InsuranceOutsourcingProtocolDatabase DesigningBiometricsBDQAEDCMedical WritingRegulatoryData ManagementData EntryClinical Monitoring
Figure 2.People Involved in Trials in the U.S.
 Source:
CenterWatch 2001 Survey.
78,00044,00050,00035,00090,00080,00070,00060,00050,00040,00030,00020,00010,0000 Sponsor Staff CRO Staff InvestigatorOther Site Staff 
 
outsourcing process.Career prospectswith CROs and site management organi-zations (SMOs) in India are quite attrac-tive,considering the number ofclinicaltrials currently under way in India indiverse therapeutic areas (Figure 4).India has also created a niche for itself in the bioanalytical and bioequivalencebusiness,through cost effectiveness andthe ready availability ofhealthy trialsubjects.There are more than 15 rep-utable centers for such studies in India,specializing in short-term trials thatgenerate quick revenue.These centersneed CRAs,physicians,phlebotomists,nurses,quality assurance auditors,prin-cipal investigators,pathologists,bio-chemists,laboratory technicians,andbiostatisticians.
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Many sponsors have started usingIndian centers ofexcellence to save timeand money on their biometrics needs.This has created a huge number ofjobsin data entry,data management,pro-gramming,coding,statistical analysis,and medical writing,as well as opportu-nities in database and statistical analysissystem training.The growing trend forEDC will attract more skilled profession-als who understand the software and theintricacies ofinstalling,implementing,and training users (investigators andmonitors) to use it effectively.
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This industry is heavily dependent onanother set ofresources:investigatorswith strong inclinations toward the con-duct ofethical clinical research.Hence,this industry looks for experienced prin-cipal investigators who have set up andconducted global clinical trials and havecompetent study staffat their sites.Ten years ago,it was very difficult to find aprincipal investigator who had workedon GCP trials.Recently,however,CROsand global pharmaceutical companieshave started working with clinicians andphysicians in different therapeutic fieldsin an effort to familiarize these invest-igators with GCP and International Con-ference on Harmonization (ICH) E6Guidelines.
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The growing clinical research sectorhas propelled the emergence ofmany ancillary career opportunities in centrallaboratories,investigational productmanufacture,packaging,warehousing,distribution,and refrigeration serviceproviders.Other critical support servicesthat translate to business opportunitiesin India involve translating and printingclinical trial materials,providing cogni-tive testing,validating rating scales andquality-of-life questionnaires in locallanguages,storing trial materials on along-term basis,forming centralizedethics committees,managing accredita-
PEER REVIEWED
53
Figure 3.Demand-Supply Gap 2010 in India
 Source:
Chiltern International India Estimates.
7,0006,0005,0004,0003,0002,0001,0000 Sponsor Staff CRO Staff InvestigatorOther Site Staff 2001,0003004001,0006,0002,0004,000DemandSupply
Figure 4.Clinical Trials Done in India
 Source:
Clinical Trial Registry,www.clinicaltrials.gov,accessed in January 2007.
InfectionOncologyPsychiatryCardiologyEndocrinologyGastroenterologyOrthopaedicOphthalmologyPaediatricsRespiratoryDermatologyHaematology

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