March 2010

Today, corporate hospitals also recognise the utility of research

PROF. (DR.) UPENDRA KAUL
utive Director Department of Cardiology Dean Department of Academics & Research
Fortis Escorts Heart Institute & Research Centre

dIgitalhealth

In a recent initiative, Fortis Healthcare announcedits plan to focus on its academics and researchprogramme with the objective of fostering andfacilitating academics and clinical researchenterprise across Fortis network of hospitals. Startingwith cardiology, the company has appointed FortisEscorts Heart Institute as the Site ManagementOrganisation (SMO) to provide services for clinicaltrials in Cardiology that will be conducted across theFortis hospitals under the exceptional leadershipof Dr. Upendra Kaul.

In an exclusive interview with eHEALTH, Dr.Upendra Kaul, Padamshree and recipient of Dr. BCRoy Award, and utive Director Department ofCardiology & Dean Department of Academics Research Fortis Escorts Heart Institute & ResearchCentre, provided insight into the major activities ofFortis Healthcare in this domain and an overview ofthe global clinical research market.

There has been a recent surgein clinical research activities inIndia. Please tell us about Fortis Healthcares recent foray intoacademics and research and its planfor future activities.

dIgitalhealth

I have dedicated several years ofmy life in teaching and researchactivities at the All India Instituteof Medical Sciences, Delhi. AfterAIIMS, I worked with Batra Hospital,between 1997 and 2005, where alsoI was mainly involved in scienceand research activities. Post BatraHospital, I joined Fortis Escorts HeartInstitute & Research Centre.

After joining EHIRC, I realised thatcorporate hospitals also recognisethe utility of research. Good healthdelivery is not possible unless youhave good evidence-based medicinebeing practiced in the hospital alongwith some teaching programmesbeing offered. A good hospitalshould have teaching programmesand research activities carried out bypeople, who have an experience inthis field and who can further trainothers.

Research not only means focuseson development of new molecules,but also involves improvement ofpatient care, thereby ensuring theprovision of best quality care.I believe, the best way to achievethis is to identify new productsbeing developed as a result ofR&D activities and to uate andcompare them with the existingproducts in a scientific way. In thisway, the judgment is done by a thirdparty and not the researcher himself,whose decision may be biased. Thisrequires an independent group ofpeople, who can carry out theseresearch activities.

In terms of academics, what coursesare you offering and/or planningto offer?

To provide doctors with a regularcertificate or prestigious degree, acollege should be involved in formalteaching activities. Private hospitals,which are not universities, can offercourses accredited by the NationalBoard of Examinations (NBE).

Further, the hospital must ensurethat a good teaching curriculum,which is academics oriented andprovides all information and facilitiesfor education in the form of teachingourses, classes, libraries, faculty,discussions with the students, etc., isin place.

Our courses recognised by the NBEinclude courses in cardiology andfellowships in paediatric cardiology,cardiac surgery, critical medicineand electro-physiology. We havealso built our own programmes byorganising fellowships that are notattached with the NBE.

We also have a department ofclinical research, however researchprojects are not easy to get andperform as they involve a lot of legalintervention.

These include going to theethics committee or permission forrecruiting patients, who need to bewell informed about the study. Duringthe study, the coordinators have tokeep coordinating with the patientson various activities. We alreadyhave ten coordinators to handlethese patients. Certain projects aremulti-centric and require a largepatient population so that statisticscan be applied to them. Such projectsalso need constant examination toensure the authenticity of the fi guresbeing recorded. External observersare also required for these projects,who can keep a check on variousprotocols being followed properly.Such projects come from the DCGI.

All Fortis Hospitals have acommon external ethics committee.We have an institutional review boardthat has a chairman who is not fromthe hospital. There is also a memberfrom the teaching community. Thebasic idea is not only to uate thescientifi c content of the study, butalso the ethical part of it. The teams job is to see whether the hospital hasadequate resources and manpowerto carry out the project. Also, beforethe project is targeted, it has to beapproved by an independent ethicscommittee, otherwise one can notget FDA sponsored projects. Thefederal government is very strict andensures that there is not even an iotaof error in the research. The ICMRand ethics committee must alsofollow the ICMR guidelines.

The awareness level of patients inIndia is low.Do you see this as achallenge in terms of convincingpatients to be a part of a clinicalresearch activity?

Yes, this is a challenge becauseawareness level is low and despiteof all methods being used for takingconsent, it is very diffi cult to recruitpatients. Patients have to sign aconsent form that has differentangles to it. Although there is a setof patients who agree to be a partof the research without giving itmuch thought, there are others whoare just not ready to participate init. The investigator, also, should beconvinced that the drug being usedin the research should not harm thepatient.

On the other hand, the patientmust be compliant and so that hecan revisit the hospital as and whenrequired. Compliance should at leastbe 90 percent, otherwise the researchactivity will not bear accurateresults. Being a large population,theoretically, we feel that we canget larger number of patients ascompared to European countriesand this is the reason why the Westis looking at India and China forclinical research activities. However,the processes have now becomemore complex owing to the policieslaid by the ICMR and the DCGI. If theinstitutions do not comply to theseguidelines and policies, they will beblacklisted.

How do you plan to take this initiativeforward? Do you also have plans fortie-ups with other institutes?

We have research projects, which arebeing sponsored and taken care of byvarious pharmaceutical companiesWe follow our own protocols, throughwhich we uate indigenous drugs.If the product matches our level ofexpectation, then we should proudlyuse it instead of going for its moreexpensive foreign counterparts andalso export it to other countries.

What will be the long-term benefi ts ofthis initiative for Fortis Healthcare aswell as the healthcare community?

Such initiatives provide goodopportunities to the hospital. If theresearch project is internationallyacknowledged and its results areaccepted by the internationalauthorities, then it turns outbenefi cial for the drug manufacturer,as well. Further, by doing theseprojects facility centres get stateof-the-art drugs and equipment tosupport research activities. Also,global research projects are fundedso the facility carrying out theresearch does not need to spend anymoney on it; even the patients forthat matter are funded.

Please provide an overview of theclinical research market in India andits growth potential. How does FortisHealthcare plan to tap this growingmarket?

The scope of growth of clinicalreserach market is immense.Clinincal Research plays as animportant driving factor in ensuringthat the new drugs entering themarket are safe and effi cacious.

The figures of the year 2007suggest that approximately 1.2 lakhsclinical trials were carried out in thatyear and around 10 million patientsparticipated globally in these trials.In 2010, approximately 12 millionpatients are expected to participatein clinical research activities andout of these 2 million patients willbe from India. Considering thatapproximately 4000 drugs aredeveloped every year, the scope forthese researches is huge.

Utilizing the size and strengthof its network hospitals, Fortis willconduct all phases of clinical trials.Fortis will leverage the strength ofits network, cutting edge diagnosticfacilities, talent and pool of patientpopulation to provide end-to-endsolution for multicenter trials.

Considering that Fortis hasstandardized its Research protocols,the idea is to introduce newinformation, observational researchconcepts, and technical skills bybringing the latest state-of-the artdiagnostic and treatment advancesto physicians both within FortisGroup of Hospitals and the largerhealthcare community.

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