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2010: Indian clinical research odyssey

Thursday, February 26, 2004 20:00 IST
Dr Arun Bhatt & Dr Umakanta Sahoo

Over last decade, there is an increasing focus on India's capabilities for quality clinical research. The pace of change in quality of trials has been slow. The approach of key stakeholders - sponsors, regulatory agency, ethics committee and investigators - to the challenges has been reactive and cautious. As the number of trials placed in India was small and global attention to India was limited, this unhurried style of facing the key challenges was tolerable. However, India is now emerging as a compelling new destination for global pharma companies and the scenario is likely to change dramatically. As we move towards a country with patent regime, India will be a favoured country for placing clinical trials. This phase will bring new challenges in Indian clinical scene.

From Acceptance to Attraction 1995-2004

India's journey into global GCP quality trials started in last decade, when several multinational pharma companies and contract research organizations (CRO) set up their global clinical trials in India. These early pioneers faced the regulatory and ethics environment, which was unfriendly for quality clinical trials. Besides, there was a dearth of experienced investigators and clinical research professionals. However, with patience and persistence, they brought about a change in the quality of research professionals, brought awareness of GCP compliance and made efforts to improve ethical aspects.

This ultimately led to significant changes in the clinical research arena. The introduction of Ethical Guidelines for Biomedical Research in Human Beings and Indian GCP guidelines provided a boost to the efforts of the sponsors. The next major step has been revision of Schedule Y. When the revised Schedule Y comes into force, it will enhance India's image as a clinical research destination.

In the early 90s, we faced the question: Are Indian clinical trials acceptable globally? With the above changes over the last decade, acceptance is no longer an issue. The country, as in other technical areas, has moved from acceptance to attraction!

From Attraction to Acceleration 2005-2010

The clinical trial activities of last decade have converted clinical trials from a registration activity to status of an industry. According to CenterWatch, estimated size of Indian clinical trials market in 2002 (industry spending on CRO services and investigator grants) was US $30 to $35 million. The estimated number of ICH-GCP clinical studies was 40-50 and the number of GCP trained investigators was 200-250. Assuming 100 patients per study or 20 patients per investigator, this translates into 4000-5000 patients. At present, most studies are carried out in 20-25 major public hospitals in capital cities.

The size of the industry is very small by global standards. In US, for example, the number of GCP trials is 60000 and the number of GCP trained investigator is over 40000. According to CenterWatch 2.8 million US subjects completed initial screening in 1999, of which 5 per cent (140000) completed the trial and 2005 projections for screening are19.8 million subjects! However, because of global pressures on industry to recruit patients faster and make the trials economic, large numbers of clinical trials are likely to be placed in countries like India. This is expected to explode the Indian clinical trials market over next 5 years.

CenterWatch has predicted that by 2010, the industry will spend around US$ 250 - $300 million on clinical trials in India. McKinsey estimates much higher figure of US$ 1-1.5 billion. The compound annual growth rates (2002 to 2010) of Indian clinical trials range from 30-50 per cent! This rapid acceleration of market will create huge challenges for medical manpower and healthcare infrastructure.

Challenges Ahead

To achieve anticipatedgrowth by 2010, the challenge will be to:
- Organize large number of subjects
- Develop large number of trained investigators / site staff
- Create adequate supportive medi-cal and general infrastructure
- Prepare large number of industry clinical research professionals

Challenges of Quantity

Assuming average cost of US$ 5000 per patient, in 2010, we will need to reach an annual enrolment of 50000-60000 patients at conservative estimates of US$ 250-300 million and 2,00,000-3,00,000 at the ambitious estimates of US$ 1-1.5 billion.

With the current annual recruitment rates of 20 patients per site, the country will require 2500-3000 investigators at conservative estimates and 10,000-15,000 investigators at ambitious targets. If 5 investigators were active in handling different therapeutic areas at any hospital, the corresponding number of medical institutions needed would be 500-600 or 2000-3000! This has to be matched by an increase in number of industry clinical research professionals - monitors, medical advisors, project managers and auditors - from the current 120-150 to 6000-9000 trained professionals.

Challenges of Quality

The above numbers spell a huge effort in building quality health infrastructure across the country. At present only about 20-25 institutions in major metro towns are actively involved in GCP trials. We will need to include even small town and city hospitals to increase this number 30-100 fold! This means improving the basic medical facilities, improving telecommunication, establishing IT infrastructure, setting up GCP compliant ethics committees, providing air links, assuring adequate electricity, and organizing special courier / logistic services.

The institutions will also need investigators trained in research methodology and GCP, and well-informed ethics committees. As future trials are likely to be e-clinical trials, the investigator teams will have to be IT savvy! Above all the institutional management has to be progressive and pragmatic to support the research activities.

The sponsors and CROs will face a daunting task of recruiting and retaining large number clinical research staff. Our current experience of recruitment shows that only about 5% of over 800 applicants for the position of clinical research associates had adequate functional knowledge of clinical research and GCP. These professionals will have to be trained in technical areas - clinical research, GCP, ethics, regulatory system, IT.

Besides, they will require other soft skills - leadership, teamwork, communication skills, diplomacy and conflict management, decision making, crisis management, project planning and personnel, financial and time management.

All the above improvements will be effective only if there are adequate number of subjects available for clinical trials. At present, most Indian patients taking part in clinical trials are from low socio-economic class and are not well educated. To include large number of patients, both public and private hospitals will have to be included as investigator sites. However, this will not happen unless the government, medical community and industry make efforts to create awareness amongst the patients and society about need for clinical research and to generate confidence in the human protection measures for research subjects. The press and media will also have to play a vital and a constructive role in reinforcing these efforts!

Potential Approach

The current efforts at training are fragmented. The training focus of sponsors and CROs is on the investigators involved in their trials and their own monitors and other professionals. With the result, a small number of the trained investigators are retrained and large numbers of untrained physicians remain unexposed to research training!

Non-profit set ups like Academy for Clinical Excellence provide a good alternative training option. However, it would be difficult to expect some sponsors or CROs or academic institutions to meet the challenge of creating huge trained workforce of investigators and clinical research professionals.

The present model of training is based on occasional 1-2 day workshops planned by CROs and academia. There is some effort in providing comprehensive training by Academy for Clinical Excellence through long term diploma courses lasting over 1 year. These courses typically run over weekends and are handled predominantly by part-time industry / CRO / academia faculty. These courses have, so far, attracted professionals working in industry / CRO. The other critical population - potential medical investigators - is largely uncovered either because of 1) lack of interest of medical professionals in clinical research or 2) difficulty of devoting time. Besides, the location of the course in one city limits its reach to professionals working in other cities. These efforts, though laudable, are unlikely to meet the huge and growing demand for trained investigators and professional.

New Model

We need to develop a new model along the lines of training provided for industry sales persons. We have experience of conducting successfully a 1-day basic GCP training module for 50 participants. Based on this experience, we feel that such a module can be expanded to a 5-day (50 hours) orientation course covering core knowledge of clinical research and relevant management skills. A team of 10 full time trainers, with expertise in diverse disciplines, can manage such a course for 50 participants. Such a course, if run every week, will cover over 2500 professionals in one year. By preparing 5 such teams located in different cities, we can train over 10000 professionals in just one year! Of course, the faculty should be full time, drawn from senior retired professionals from industry / academia, many of whom are willing to devote their time to such activities. Besides, there are professionals in industry / CRO, who are keen to have a full time career in training. ollowing the orientation course, subsequent training can be on the job, supplemented by web based course, refresher and advanced workshops.

The enormous challenge of large number of quality professionals - medical and clinical research - can only be met by cooperative and collaborative efforts between industry, academia and government. Besides the man power efforts, the training activity will need financial support. In US the industry spends over $ 300 million on training. The funding of these efforts has to come from all stake holders, with majority share coming from the major beneficiary - pharma industry.

If we want "India shining" in clinical research, the mantra for next 5 years must be - "India mining" for subjects, "India training" the trainers and research professionals!

-- The authors, Dr Arun Bhatt is President, ClinInvent Research Pvt Ltd; while Dr Umakanta Sahoo is Project Manager with the same company