A new frontier for clinical trials

With highly developed IT and data collection capabilities and no language barrier, India is fast becoming an attractive destination for clinical trials carried out by North American companies.

Companies need to increase productivity, decrease costs and shorten the time to market for new drugs. The costs of the clinical trials needed to gain regulatory approval represents roughly two-thirds of the typical billion-dollar cost of developing a single new clinical entity (NCE). There is a critical need to conduct clinical trials that provide lower cost and faster recruitment without compromising the quality of the research.

India provides a number of significant advantages for the outsourcing of clinical trials because it offers a large patient population, low per-patient trial cost, and a highly qualified professional medical community, plus global quality hospitals and clinical research facilities.

Why India?
Until recently, there were few clinical trials conducted in India by Western pharmaceutical and biotech companies, primarily because of regulatory hurdles. Recognizing the significant advantages that India offers to multinational companies and the potential and benefits of conducting clinical trials in India, the Indian government made major changes to these regulations in 1999, with the Amendments to Schedule Y of the Drugs and Cosmetics Act.

These changes formalized the definition and conduct of clinical trials; specified the responsibilities of the sponsor, the investigators, and the ethics committees; and developed guidelines and procedures for importing drugs. They also instituted required compliance with good clinical practice; specified the requirements for informed consent; and defined the structure, content and format of clinical study reports. In addition, the Indian government provided increased protection for intellectual property.

India offers major advantages for conducting clinical trials, including a Western disease distribution, high patient numbers and patients who are generally ‘therapy naive,’ along with many tertiary care and specialty hospitals, and a large number of highly qualified and Western-trained medical specialists.

The cost per patient for trials in India is approximately 40-60 percent of the cost in Western nations. More importantly, patient recruitment can be greatly accelerated, and this provides a major advantage in terms of shortening the time to market for a new drug.

Based on all these advantages, the number of clinical trials in India is expected to grow exponentially over the next 5 to ten years. It has been estimated that in 2005 only one percent of global clinical trials were conducted in India; this percentage is projected to grow to 15 percent of global trials by 2011.

Rapid growth is projected – by the year 2011 over 300,000 patients will be enrolled in clinical trials in India, with 1500 to 2000 good clinical practice (GCP) studies being conducted in India per year, requiring 10,000 to 15,000 GCP-trained investigators, and supported by 50,000 clinical research professionals.

Increased demand
India has substantial capacity to meet the rapidly growing demand for clinical trials. The country has 300 universities, more than 750 graduate and postgraduate programs and about 50 million college graduates. There are over 700,000 medical professionals and over 600 International Conference on Harmonisation (ICH)/GCP compliant sites.

The Indian government and industry have taken a number of major steps to strengthen the infrastructure for conducting clinical trials. New GCP standards have been established, a number of comprehensive training programs have been developed, and many new graduate and undergraduate programs have been initiated. English is the main language used in higher education, business and medicine.

These measures have led to the creation of a large pool of specialist clinical investigators who are GCP-trained and compliant, and who have participated in numerous international clinical trials and are supported by trained clinical research professionals. The government has also streamlined the process for regulatory review of clinical trials to facilitate protocol approvals. Clinical trials are regulated by the Drugs Controller General of India (DCGI), who is now responsible for assuring that all clinical trials are ICH/GCP compliant.

The DCGI approval process categorizes clinical trials into two types. If the study protocol has already been approved by the regulatory authorities in one or more developed countries, the study is classified as a Type A trial and can be approved using a fast-track process within two to six weeks after the required documentation has been submitted. All other studies are classified as Type B. For these, the approval process is generally eight to 12 weeks.

The institutional review board approval process can be conducted in parallel with the DCGI review and, if import licenses are needed, the applications for these can also proceed in parallel. These provisions facilitate the process of getting the study protocols in place and initiating the trials, leading to the initiation of trials in a much shorter time than in many other countries.

With all these advantages, why isn’t the number of clinical trails in India much larger than it is today? In the past, several constraints have limited the number of clinical trials conducted in India. Communication was an issue because of cultural differences between Western countries and India, and the large time difference created further difficulties in communication and monitoring of work. There were also some significant differences between Western and Indian business and operational practices.

Indian researchers needed to clearly understand the needs of Western sponsors and Western sponsors needed to overcome their perception that India was a non-traditional ‘developing’ nation – the ‘land of the generics,’ with limited capacity and uncertain quality of work. Western sponsors were also concerned about intellectual property protection.

These issues are not unique to clinical trails. Similar issues have been successfully addressed in fields such as IT and business process outsourcing (BPO), in which India is now a leading provider of services to Western clients. With recent actions by the government, the regulator and CROs, these problems are being overcome, and we expect India to experience a very rapid growth in the number of clinical trials.

Exciting opportunities
How can companies take advantage of these benefits? Sponsors or CROs who want to conduct clinical trials in India should align themselves with partners who are well versed in the following areas:

• The ability to efficiently navigate the process of filing for regulatory approval to perform the study in India, including applicable translations of informed consent forms and facilitation of all required import/export.
• A thorough understanding of the evolving regulatory environment in India, as well as the FDA, the European Medicines Agency (EMEA) and other global markets.
• Deep experience in the business culture of India, and how differences between India and the West can be overcome to assure consistency and quality.
• The ability to build relationships with the top medical institutions and thought leaders across India to assure that quality sites with experienced GCP investigators are involved in the trial.
• Excellent medical governance at all levels of the organization to assure accurate and timely reporting of findings to regulatory authorities.

In addition, potential partners should have access to a US-based office that is fully staffed and well-versed in Indian systems and regulations, and that can provide effective client service and rapid response to client needs, providing the sponsor with the benefit of having minute-to-minute control and awareness of the ongoing study.

About Edward J. Brennan
Edward J. Brennan, Jr., is President and CEO of IndiPharm LLC, which provides Western pharmaceutical and biotechnology companies with a range of global quality clinical research organization services, including identification of experienced sites and GCP-trained investigators, regulatory and IRB/ethics committee submissions, clinical protocol preparation, and medical monitoring/safety reporting.

IndiPharm projections based on information from The Boston Consulting Group and Business Communications Co.