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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
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