Clinical trials are the basis for determining the safety and efficiency of pharmaceuticals, biologics, and medical devices. They are a field of science which is subject to strict rules specified in the legal acts pertaining to the industry so as to protect the subjects by means of appropriate procedures for organizing, monitoring, and controlling each trial.

Pharmaceutical companies are increasingly shifting clinical trials to emerging markets - as much as 40% of all drug trials in 2005, up from about 10% in 1999 (FORTUNE Magazine). Trials continue to shift to poorer countries in search of more patients, lower costs, and faster recruitment. Further, many of these countries have centralized health systems; meaning that hundreds of patients with similar symptoms are found in the same place. And, the subjects often have not built up resistance to new drugs from years of antibiotic treatments.

The shift from the U.S. and the UK to poorer countries is largely being driven by economics – in other words, faster time-to-market equals lower costs. In 2005, FORTUNE named Russia as the frontier, but noted that as it gains experience and improves its research standards, costs will inevitably go up. Drug companies are already well established in Poland and the Czech Republic and are looking farther east (i.e. India and China) for new testing locations.

Why Clinical Trials Are Moving East
According to an August 2006 “Global Regulatory Update” (Mahadev Murthy, Ph.D., MBA) in the leading life sciences publication, Regulatory Affairs Focus (RA Focus) Magazine, a main factor in this decision to head East is that India and China have joined the World Trade Organization (WTO), which has invigorated both countries’ economies. As a result, clinical trials conducted in these countries are no longer confined to evaluating new medicines for their own markets. India and China have opened up new opportunities for U.S. and Western European firms to expand their pharmaceutical and biotechnology product markets substantially. In 2006, the global clinical trials sector was estimated to be about $10 billion.

Murthy’s report in RA Focus states that India presents a good option for outsourcing several drug development process components, including clinical trials, due to factors such as:

• excellent and expanding hospital and clinical facilities


• a huge patient population base


• therapeutic diversity


• data processing infrastructure for bioinformatics


• well-trained, English-speaking physicians and support personnel


• dominant generic drug makers


• a relaxed regulatory environment

Can India Handle Complex Clinical Trials?
It is a well-known fact that the world is looking at India as a clinical trial destination of choice. The number of clinical trials conducted in India has increased over the last two to three years, but it still comprises a small fraction of total trials. This growth is expected to continue as more and more firms begin to outsource their clinical studies to India, either as part of their global recruitment strategy or for specific products. However, is India capable of handling large, complex clinical trials?

Dr. Nermeen Varawalla, Vice President Corporate Development of PRA International, claims there are several important issues that India must pay immediate attention to in order to handle large clinical trial projects effectively and to sustain a steady growth in the clinical trials market. These include:

• Gap Analysis in Clinical Trials: There is a large influx of clinical trials from across the globe heading towards India. Major pharmaceutical companies and global Contract Research Organizations (CROs) are expanding staff and business activity in India. In this situation, it is mandatory for India to tackle issues to sustain in the industry keep other competing countries at edge.



• Infrastructure: Creating large-scale exclusive clinical trial facilities in India are a must. There is a need for hospitals to create special beds for clinical trials. Research institutions and pharmaceutical companies should establish clinical trial centers that do not overlap with the existing R&D facilities.



• Manpower: There is an acute manpower attrition in India. Qualified and experienced clinical trial investigators are the need of the hour. Experienced investigators who can take decisions in adverse situations have to be strengthened.



• Data Management: Effective data collection, storage and maintenance need to be strategically adapted in India. Electronic data storage and analysis need could help streamline some cumbersome process and would also save significant time.



• Regulatory Compliance and Ethical Issues: “India needs to implement a robust GCP-compliant ethical framework and environment,” said. Although, the Indian Government has revised the ethical guidelines for clinical trials in 2007, CROs must practice and follow the guidelines diligently.

On the flipside, according to Murthy, India’s healthcare infrastructure and clinical trial capabilities have improved significantly in recent years. In fact, many prominent U.S.- and Western Europe-based Contract Research Organizations (CROs) that are experienced in conducting and monitoring clinical trials are involved at various levels, including data management, and have offices in India.

Surmised Dr. Sten Olsson, Chief WHO Program Officer and Head of External Affairs, at the “Conference on Clinical Research and Development in India” (April 2007) on whether India can (and should) handle the surge of global clinical trials: “It is pertinent for Indian companies and research institutes to meet the large demands put on them in clinical trials in an effective way. India has a great potential for serving the world and this is the right time for it to gear up and strengthen its regulatory requirements and manpower.”

SOURCES:
Regulatory Affairs Focus Magazine
BioSpectrum Magazine – Asia Edition