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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.