Extension of geographical boundaries for clinical research offers the opportunities to crunch timelines at a lower cost. The selection of strategic locations for clinical research in case of global trials is becoming important as it is based on the long term planning of the company. The language, patient pool, availability of reliable investigators and institutions, easy and fast recruitment possibilities and the regulatory framework are the prime considerations of the companies while choosing various locations worldwide, for global clinical research.
According to a latest report based on a survey by Ernst & Young India-'An analytical survey on the clinical trial activities of multinational pharmaceutical companies in India', by 2008, about 30 per cent of the global clinical trial activities will take place outside the US and Western Europe due to high demand for study subjects and well trained clinical research professionals. India, China, Eastern Europe and Latin America are the key markets earmarked for rapid growth in clinical research. India is estimated to capture about 10 per cent of the global clinical research market within the next five years.
Several MNC pharma companies have been conducting their clinical development activities in India for the last 5-10 years. They have been scaling up their investments aggressively by setting up dedicated clinical research teams to initiate and monitor pivotal clinical studies. Apart from local registration trials, MNC pharma companies are also contributing patients from India for multi-centric global trials of drugs for FDA and EMEA submissions.
Off-shoring clinical development to India has become a strategic imperative for most global pharmaceutical companies. Competition for talent, new technologies and easier market access have accelerated the process of R&D globalisation, with countries such as India and China hosting significant volumes of R&D activity for multinationals.
E & Y India has conducted a nationwide survey of senior executives of the MNC pharma companies in India to analyse their clinical research activity in the country.
Of the total 29 companies surveyed, 17 are conducting clinical trails in India. About 24 per cent of the respondents from companies conducting trials in India said that they are carrying out BE / BA studies, 53 per cent of them are conducting phase II trials, 88 per cent of them are conducting phase III trials, 18 per cent are carrying out biometric studies and 24 per cent are conducting other studies.
Various therapeutic segments where MNC pharma have already initiated clinical trials are oncology, anti-infectives, psychiatry, cardiology, neurology, gastroenterology, ophthalmology and dermatology, the largest segment being oncology.
Several driving forces have positioned India as an emerging hub for collaborative clinical trial activities which include the number of potential clinical trial subjects, cost savings, disease profile of the country, and intent to support future domestic marketing.
Several business risks having significant bearing on the strategic decision to undertake trials in India such as IPR and patient data protection, documentation and record keeping, regulator non-compliance, human subject protection / institutional ethics, import and export requirements, third party contract non-compliance etc.
MNCs are following certain strategies to face these risks by conducting medical affairs training, appointing internal process auditors, creating a specialised in-house department and investing in information technologies security.
Out of the 17 companies not conducting clinical trials in India, three companies are planning to conduct clinical trials in India in future, in the coming three years.
The report concludes that the global harmonisation of the regulatory framework and recent amendments to the Patent Act and the regulatory approval for conducting concurrent phase II and phase III trials reinforce the government's commitment to create a favourable environment for conducting clinical research in India.