With a very large number of drugs, worth more than $50 billion in annual revenues, coming off patent in the next few years, many western pharma companies are now increasingly relinquishing business activities that are not considered core, such as clinical research, and are moving towards contract research..
Since in the western countries, clinical research is characterized by extremely high costs and long gestation periods and the same work can be performed in developing countries at a fraction of the cost and much faster, many global pharma companies are increasingly turning their attention to Asia to benefit from low R&D costs in the region and also to gain access to Asia's drug markets.
Clinical trials have thus gone ‘global,’ because CROs find it easier to conduct them in underdeveloped countries, as this is cheaper or has less ethical encumbrances or legal risks. Naïve patient populations, English speaking doctors, low costs and other advantages offered by developing countries have opened up new avenues for the clinical trials market.
Hence there is lot of scope for clinical research activities for the South Asian nations if they make use of the upcoming opportunities in this field. But how far they are prepared to make use of the opportunities is a debatable question.
India
The future of clinical research in India continues to be hazy. While on the one hand there are predictions that India will be the next hotspot for clinical trials, on the other , industry forums speak of ongoing challenges and stagnant growth for a variety of reasons, such as regulatory delays in approval, escalating costs, inconsistent quality, ethical irregularities etc. While several CROs have started operations in India basing their future on the rosy predictions, it is equally true that existing players are struggling to grow or even sustain their current business.
Since registration of clinical trials in Clinical Trial Registry of India (CTRI) was made mandatory from mid-2009 onwards, close to 1800 trials have been registered in this database. Of these, about 69 per cent are sponsored by the pharmaceutical industry (both multinational and Indian companies), the rest being funded by grants from various government and not-for-profit institutions (e.g. DBT, CSIR, AIIMS, ICMR, Ministry of Defence, WHO, NIH etc).
Indian CROs can now look forward for more opportunities to conduct clinical studies within the generic space. For drugs that are not absorbed in the GI tract, plasma concentrations are not useful to determine delivery of the drug to the site of activity, and hence bioequivalence of the generic product to the innovator cannot be established by BA/BE studies. In such cases, one needs to demonstrate therapeutic equivalence with clinical or pharmaco-dynamic studies.
Assocham had predicted that India would garner about 15 per cent of the global clinical trials opportunity. However, out of over 1,00,000 human trials being conducted in 178 countries, less than 2,000 (two per cent) are being done in India compared to over 9,000 (nine per cent) in China.
Some of the advantages that India offers as a clinical trial destination are : availability of diverse patient population across major therapeutic segments such as oncology, metabolics, neurology etc; high degree of compliance to international guidelines such as the ICH GCP and the regulations laid down by the US FDA; availability of well qualified, English speaking research professionals including physicians; lower costs compared to the west; increasing prevalence of illnesses common to both developed and developing countries; availability of good infrastructure and changes in Patent Laws since January 2005.
Bangladesh
According to an article in The Pharma World, leading health Journal in Bangladesh, notwithstanding its potential, clinical research is still underdeveloped in Bangladesh. There is a lack of capacity for bioequivalence studies, no analytical capacity (samples have to be shipped to foreign countries such as Singapore for any analytical treatment) and limited bio-banking and documentation of clinical specimens. There is no CRO activity in the country. This cripples the ability of the health and pharmaceutical industry to move forward, severely stunts the professional growth of health care personnel and limits their ability to become competitive for funding in the global arena.
Fortunately, with appropriate input from global scientists and consultants, Bangladesh appears very well placed to fill this void and develop world-class clinical research capacity. There is a significant foundation for such clinical research capacity in the health care sector in Bangladesh. Hospitals in the country have the advantage of access to a large population base presenting a range of clinical conditions. These hospitals have talented physicians who are fluent in English and eager to take advantage of opportunities to expand their expertise and scope of activities into state-of-the-art health care research.
Moreover Bangladesh has a significant generic pharma industry, currently marketing its products mainly in the domestic market and in non-regulated international markets. Building Contract Clinical Research capacity in Bangladesh will serve the local pharmaceutical companies and allow Bangladesh to take its deserved position in the rapidly-growing global clinical research products and services market.
Bangladesh can be the next frontier in the global CRO industry. Based on GDP and the volume of the pharma industry compared to other Asian economies such as India and China, Bangladesh could potentially capture five per cent of the Asian CRO market by 2020. The country is well poised to launch a CRO for multiple reasons that involve both its own fledgling pharma industry as well as the increasing demands in the global market, the article says.
The development of a globally-competitive CRO will have an impact beyond the domestic pharma industry. It will attract foreign companies, seeking high quality research at more affordable prices. It will also have a multiplier effect on other areas of the economy that transcend the pharma industry, and contribute to the transition from low-wage labour-intensive activities into higher-wage knowledge-based industries. Building capacity for upscale knowledge industries, including biotechnology and health science, historically has had a remarkable impact on wealth building and human development in the West and is expected to have a similar positive impact in emerging economies.
Global Health Expansion (GHE) LLC is a Washington DC-based company that is currently partnering with Bangladeshi entities to develop a world class CRO in Bangladesh. The goal of GHE is to team international know-how in regulatory issues, clinical pharmacology and contract clinical research with the current capacity in Bangladesh in clinical research and drug manufacturing. This could be done by building synergies between academia and industry in order to develop the capacity (human and physical) for a true knowledge-based industry in Bangladesh. Driving such efforts through an international partnership will create unique opportunities for all partners, the article points out.
Pakistan
The clinical research industry is still in its infancy in Pakistan despite having a large pool of patients, a large number of English-speaking physicians, low value of rupee, a network of high volume medical centres and a good know how of this business as many physicians have conducted clinical trials in other countries
The country is the sixth most populous country in the world and being a developing country, the patients’ population in Pakistan is also very large.
Industry experts are of the view that unless the government encourages research culture and streamlines public-sector universities, the country would continue to lose opportunities in this important arena.
Some experts believe that the local private sector is not motivated to conduct research. This is in contrast to China and India, which have emerged as the top destinations for researchers in the global pharmaceutical industry.
If Pakistan is interested in attracting more clinical trials to the country, it must take bold steps in these areas, publicize them and inspire the confidence of international sponsors in the measures taken. The speed of current healthcare and regulatory reforms will be crucial in this respect, they point out.
Sri Lanka
Sri Lanka is an emerging market for clinical trial business with some contract research organizations already operational in the country. Although Sri Lanka is getting involved more and more in clinical research, it significantly lacks professionals formally trained in conducting trials. The need for clinical research training in Sri Lanka for medical and life science graduates has been stressed upon by various research papers published by Sri Lankan authors.
In the recent past, the government has been working on promoting the conduct of global clinical trials in Sri Lanka. In 2010, Treasury Secretary Dr P.B. Jayasundara, addressing the corporate sector revealed that it hoped to create a clinical trials “industry” to earn US $ 1 billion annually. Only global clinical trials ‘imported’ to Sri Lanka, not locally initiated ones, could possibly achieve this.
The clinical trials group of the Human Genetics Unit was set up to undertake industry sponsored clinical trials in Sri Lanka with the collaboration of clinicians in various institutions communing under the Ministry of Health of Sri Lanka.
The availability of large numbers of patients and well trained clinicians, a good system of ethics review and an efficient regulatory process implemented through the Drug Regulatory Authority of the Ministry of Health make it possible to run clinical trials in Sri Lanka according to ICH-GCP guidelines.
Need to plug loopholes
For the future progress of clinical trials in these countries , the regulatory set up needs to be tightened up. It is essential to make trial regulation less complicated and more readily adaptable to risk, and for having guidelines that are globally applicable and adaptable to all types of trial. Such guidelines would be as easily applied to pragmatic trials of existing treatments or disease management questions as they would be for trials of new drugs and vaccines.
Since developing countries have needs and abilities distinct from those of more developed countries, these countries should be allowed to work with sufficient leeway to address issues specific to these regions.
Bringing the clinical trials enterprise of developing countries back into the hands of local populations could have widespread benefits, feel some of the experts
Pre-trial community engagement, ongoing dialogue and post-trial information sharing are important to build and foster community trust for clinical research. Researchers in the developing world should come from the same or similar community and relative standard of living in which the research is being done. This would not only mean they have a sense of belonging to that community and the country, but the country and the community also would own and take pride in their researchers, they feel.
If the loopholes are plugged and existing laws are stringently implemented to ensure that clinical trials are conducted with utmost transparency and diligence , the prospects for clinical trials would be quite high in these nations, they opine.