PROF. (DR.) UPENDRA KAUL
Executive Director Department of Cardiology &Â Dean â Department of Academics & Research
Fortis Escorts Heart Institute & Research Centre
In a recent initiative, Fortis Healthcare announcedÂ its plan to focus on its academics and researchÂ programme with the objective of fostering andÂ facilitating academics and clinical researchÂ enterprise across Fortis network of hospitals. StartingÂ with cardiology, the company has appointed FortisÂ Escorts Heart Institute as the Site ManagementÂ Organisation (SMO) to provide services for clinicalÂ trials in Cardiology that will be conducted across theÂ Fortis hospitals under the exceptional leadershipÂ of Dr. Upendra Kaul.
In an exclusive interview with eHEALTH, Dr.Â Upendra Kaul, Padamshree and recipient of Dr. BCÂ Roy Award, and Executive Director Department ofÂ Cardiology & Dean â Department of Academics &Â Research Fortis Escorts Heart Institute & ResearchÂ Centre, provided insight into the major activities ofÂ Fortis Healthcare in this domain and an overview ofÂ the global clinical research market.
There has been a recent surgeÂ in clinical research activities inÂ India. Please tell us about FortisÂ Healthcareâs recent foray intoÂ academics and research and its planÂ for future activities.
I have dedicated several years ofÂ my life in teaching and researchÂ activities at the All India InstituteÂ of Medical Sciences, Delhi. AfterÂ AIIMS, I worked with Batra Hospital,Â between 1997 and 2005, where alsoÂ I was mainly involved in scienceÂ and research activities. Post BatraÂ Hospital, I joined Fortis Escorts HeartÂ Institute & Research Centre.
After joining EHIRC, I realised thatÂ corporate hospitals also recogniseÂ the utility of research. Good healthÂ delivery is not possible unless youÂ have good evidence-based medicineÂ being practiced in the hospital alongÂ with some teaching programmesÂ being offered. A good hospitalÂ should have teaching programmesÂ and research activities carried out byÂ people, who have an experience inÂ this field and who can further trainÂ others.
Research not only means focusesÂ on development of new molecules,Â but also involves improvement ofÂ patient care, thereby ensuring theÂ provision of best quality care.Â I believe, the best way to achieveÂ this is to identify new productsÂ being developed as a result ofÂ R&D activities and to evaluate andÂ compare them with the existingÂ products in a scientific way. In thisÂ way, the judgment is done by a thirdÂ party and not the researcher himself,Â whose decision may be biased. ThisÂ requires an independent group ofÂ people, who can carry out theseÂ research activities.
In terms of academics, what coursesÂ are you offering and/or planningÂ to offer?
To provide doctors with a regularÂ certificate or prestigious degree, aÂ college should be involved in formalÂ teaching activities. Private hospitals,Â which are not universities, can offerÂ courses accredited by the NationalÂ Board of Examinations (NBE).
Further, the hospital must ensureÂ that a good teaching curriculum,Â which is academics oriented andÂ provides all information and facilitiesÂ for education in the form of teachingÂ ourses, classes, libraries, faculty,Â discussions with the students, etc., isÂ in place.
Our courses recognised by the NBEÂ include courses in cardiology andÂ fellowships in paediatric cardiology,Â cardiac surgery, critical medicineÂ and electro-physiology. We haveÂ also built our own programmes byÂ organising fellowships that are notÂ attached with the NBE.
We also have a department ofÂ clinical research, however researchÂ projects are not easy to get andÂ perform as they involve a lot of legalÂ intervention.
These include going to theÂ ethics committee or permission forÂ recruiting patients, who need to beÂ well informed about the study. DuringÂ the study, the coordinators have toÂ keep coordinating with the patientsÂ on various activities. We alreadyÂ have ten coordinators to handleÂ these patients. Certain projects areÂ multi-centric and require a largeÂ patient population so that statisticsÂ can be applied to them. Such projectsÂ also need constant examination toÂ ensure the authenticity of the fi guresÂ being recorded. External observersÂ are also required for these projects,Â who can keep a check on variousÂ protocols being followed properly.Â Such projects come from the DCGI.
Â All Fortis Hospitals have aÂ common external ethics committee.Â We have an institutional review boardÂ that has a chairman who is not fromÂ the hospital. There is also a memberÂ from the teaching community. TheÂ basic idea is not only to evaluate theÂ scientifi c content of the study, butÂ also the ethical part of it. The teamâsÂ job is to see whether the hospital hasÂ adequate resources and manpowerÂ to carry out the project. Also, beforeÂ the project is targeted, it has to beÂ approved by an independent ethicsÂ committee, otherwise one can notÂ get FDA sponsored projects. TheÂ federal government is very strict andÂ ensures that there is not even an iotaÂ of error in the research. The ICMRÂ and ethics committee must alsoÂ follow the ICMR guidelines.
The awareness level of patients inÂ India is low.Do you see this as aÂ challenge in terms of convincingÂ patients to be a part of a clinicalÂ research activity?
Yes, this is a challenge becauseÂ awareness level is low and despiteÂ of all methods being used for takingÂ consent, it is very diffi cult to recruitÂ patients. Patients have to sign aÂ consent form that has differentÂ angles to it. Although there is a setÂ of patients who agree to be a partÂ of the research without giving itÂ much thought, there are others whoÂ are just not ready to participate inÂ it. The investigator, also, should beÂ convinced that the drug being usedÂ in the research should not harm theÂ patient.
On the other hand, the patientÂ must be compliant and so that heÂ can revisit the hospital as and whenÂ required. Compliance should at leastÂ be 90 percent, otherwise the researchÂ activity will not bear accurateÂ results. Being a large population,Â theoretically, we feel that we canÂ get larger number of patients asÂ compared to European countriesÂ and this is the reason why the WestÂ is looking at India and China forÂ clinical research activities. However,Â the processes have now becomeÂ more complex owing to the policiesÂ laid by the ICMR and the DCGI. If theÂ institutions do not comply to theseÂ guidelines and policies, they will beÂ blacklisted.
How do you plan to take this initiativeÂ forward? Do you also have plans forÂ tie-ups with other institutes?
We have research projects, which areÂ being sponsored and taken care of byÂ various pharmaceutical companiesÂ We follow our own protocols, throughÂ which we evaluate indigenous drugs.Â If the product matches our level ofÂ expectation, then we should proudlyÂ use it instead of going for its moreÂ expensive foreign counterparts andÂ also export it to other countries.
What will be the long-term benefi ts ofÂ this initiative for Fortis Healthcare asÂ well as the healthcare community?
Such initiatives provide goodÂ opportunities to the hospital. If theÂ research project is internationallyÂ acknowledged and its results areÂ accepted by the internationalÂ authorities, then it turns outÂ benefi cial for the drug manufacturer,Â as well. Further, by doing theseÂ projects facility centres get stateof-Â the-art drugs and equipment toÂ support research activities. Also,Â global research projects are fundedÂ so the facility carrying out theÂ research does not need to spend anyÂ money on it; even the patients forÂ that matter are funded.
Please provide an overview of theÂ clinical research market in India andÂ its growth potential. How does FortisÂ Healthcare plan to tap this growingÂ market?
The scope of growth of clinicalÂ reserach market is immense.Â Clinincal Research plays as anÂ important driving factor in ensuringÂ that the new drugs entering theÂ market are safe and effi cacious.
The figures of the year 2007Â suggest that approximately 1.2 lakhsÂ clinical trials were carried out in thatÂ year and around 10 million patientsÂ participated globally in these trials.Â In 2010, approximately 12 millionÂ patients are expected to participateÂ in clinical research activities andÂ out of these 2 million patients willÂ be from India. Considering thatÂ approximately 4000 drugs areÂ developed every year, the scope forÂ these researches is huge.
Utilizing the size and strengthÂ of its network hospitals, Fortis willÂ conduct all phases of clinical trials.Â Fortis will leverage the strength ofÂ its network, cutting edge diagnosticÂ facilities, talent and pool of patientÂ population to provide end-to-endÂ solution for multicenter trials.
Considering that Fortis hasstandardized its Research protocols,Â the idea is to introduce newÂ information, observational researchÂ concepts, and technical skills byÂ bringing the latest state-of-the artÂ diagnostic and treatment advancesÂ to physicians both within FortisÂ Group of Hospitals and the largerÂ healthcare community.