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| Clinical Research Environment |
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Globalization Trends
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Over the last decade, we have witnessed a significant growth in clinical research activities outside of the traditional countries - US and Western Europe. This growth reflects a trend towards globalization of research and is a result of two major drivers
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Pressures on R & D Productivity - faced by pharmaceutical companies, this is reflected in widening of the gap between R & D investments and average NCE approvals per year with resultant cost pressures on development of new drugs.
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Regulatory Standardization - ICH and initiatives for regulatory harmonization have acted as major triggers for globalization of clinical development by defining norms for global acceptance of data.
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These changes in clinical research environment are driving the growing internationalization of research activities in emerging countries like Latin America, Eastern Europe and Asia.
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Status of Clinical Research in India
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Most of the research conducted in India was for registering the new drugs in India through 100-patient registration studies or BE/BA studies for generics. International clinical development in India is a relatively new discipline being less than a decade old. With a number of intrinsic strengths (English as a medium of communication, therapeutic diversity, computing infrastructure, low costs of medical care etc), Phase II-IV global clinical trials in India are witnessing a rapid growth. Increasing number of sponsors, CROs, SMOs and investigator sites are participating in clinical development. The government in turn is playing its part by defining the ground rules. Release of India GCP guidelines by the DCGI and guidelines on biomedical ethics by ICMR are steps in this direction. The realization of clinical research potential by the government is clearly indicated by exemption of import duties on clinical supplies in 2003 budget. The stage is being set for rapid evolution of clinical research industry.
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Critical Success Factors
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There are three critical success factors for the growth of clinical research industry in India. These are Purpose, People and Processes. These have been elaborated as follows -
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Purpose-A clear vision and mission with definition of a business plan for clinical research in India would be essential. A clear articulation of the way forward by the government or the professional association would provide the much needed direction for efforts for growth of clinical research.
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Processes-Clinical research is knowledge intensive and it is important there should be systems for generating, recording and handling knowledge. As research involves human beings, systems for human subject protection (regulations, ethics and consent) must be given considerable attention.
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People-A clinical research endeavor is by people, on people and for people. It is important that these stakeholders are aware and are well equipped to perform their role in clinical research. This is the key CSF and will be discussed in detail
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Stakeholders in Clinical Research
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People are key stakeholders holders in clinical research. The stakeholders are in a unique position as they influence research as well as are beneficiaries of research. The product of clinical research (new information about drugs) is meant for the benefit of people. The way the research is conducted also needs to withstand the tests of public assurance in research enterprise. This can be achieved if we have a conducive research environment.
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Conductive environment is a composite of various elements. It can be described in terms of roles and readiness of various stakeholders. It consists of Sponsors (defining and monitoring of specific research conduct), Institutes (with research infrastructure), Investigators (with training and experience), Patients (availability and informed), Ethics committees (constituted and operating per defined norms) and Regulatory authorities (defining policies and monitoring research conduct).
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Clinical Research Environment
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In the early nineties, research environment was in its infancy. We were faced with institutes with poor research infrastructure, investigators with negligible clinical research experience, poor documentation practices, patients blindly trusting their physicians, non-existent or non-conforming ethics committees and weak regulatory environment. Over the last decade or so, we have seen a number of developments to address several of the above issues.
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With an increasing number of sponsors and CROs conducting research in India and with the realization of its value by the hospital administrators, we have seen a meteoric rise in the research infrastructure at clinical research sites. It is now not difficult to locate sites with good research facilities such as a well-equipped local laboratory and communication infrastructure when planning new studies. In fact, some hospitals have realized potential for growth in this area and have centralized clinical research activities in the hospital. This allows implementation of uniform policies and a single front to deal with sponsors.
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In parallel, more and more investigators are participating in clinical studies. We estimate that more than 500 investigators in different therapeutic areas across the country have been trained and are experienced in GCP compliant clinical research. Initiatives such as the Academy for Clinical Excellence offer one stop facilities for training in clinical research. The availability of a sizable population of trained and certified professionals is not a distant reality any more.
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Availability of patients in different therapeutic areas and a consequent compression of development time is an established advantage of doing studies in India. Patient awareness about clinical research is also gradually increasing.
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Considerable improvements are noticeable on all fronts related to ethics committees. These include - constitution and operations of the committee as well as training of ethics committee members, we still are a long way from the ideal ethical oversight framework. Initiatives such as Forum for Ethics Review Committees in India (FERCI) are a step in the right direction.
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Perhaps the most important developments are noticed in regulatory framework. Publication of CDSCO GCP guidelines that will be applicable to all clinical research conducted in India, norms on biomedical ethics, exemption of import duty on research supplies are three key milestones in this area.
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Unfinished Agenda
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While we have taken significant strides towards developing a strong clinical research culture in the country, there are clearly many areas that will need more efforts. Apart from the two broad areas, viz., a vision for clinical research in India; and developing systems for the conduct of clinical research, a number environmental efforts are needed.
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Clinical research is now increasingly recognized as a career option among those already working in the industry. However, the trend has not, as yet, gained momentum in academia. More effort from health care administrators is needed to bridge this gap.
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The functioning of ethics committee is another area that requires focused attention of administrators. Merely establishing a compliant framework is not sufficient. Opportunities should be created for training of members of ethics committees so that they may perform their roles optimally.
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Ongoing efforts towards training of investigators and coordinator must continue. Basic training facilities need further expansion. More advanced training modules need to become available so that individuals with sufficient basic experience can enhance and update their skills.
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A Clinical research services is a rapidly growing area. While the advantages of having the local resources that can fulfill demand are obvious, we need to put in more efforts to define systems and training needs for this sector.
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Overall, clinical research capacity building efforts need a systematic approach. A professional association can facilitate this by offering the necessary framework. Efforts in this direction will help India realize her true potential in clinical research and development.
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