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Research in India: Tomorrow and Beyond

Viraj Rajadhyaksha discusses the challenges and opportunities for the progression of clinical trials in India

2010 marked the 15th anniversary of the first global clinical trial in India. While both public and private organisations had been involved in drug research activity before this time, it was only in 1995 that the first ever global clinical trial was conducted. In the same year, Pfizer and Eli Lilly started their clinical research operations in India. Over the last 15 years, India has not only emerged as a major destination for conducting clinical trials, but also as a driver of several other associated activities such as data management, statistics, medical writing and pharmacovigilance.

Clinical trials are highly regulated activities and over the last decade regulators in the western world have become more stringent with their requirements, taking standards of science as well as ethics to a new level. Getting approval for a product, whether drug or biologic, has become more difficult than ever before. Intense competition and longer approval times during development have led to a situation where getting adequate return on R&D investment is an increasing challenge. This has meant that newer regions such as India have become attractive destinations for clinical trials.

THE FIRST PHASE

In India, the first phase of clinical trials (1995 to 2000) was marked by limited activity in specific therapeutic areas in selected institutions. The universal acceptance of ICH Good Clinical Practice (GCP) guidelines helped India to participate in clinical trials. This phase involved organised collaboration between sponsors, ethics committees and institutions starting clinical programmes in different areas. In spite of this, the span of clinical trials remained only within particular regions, used by the same group of organisations, which were largely multinational ethical pharmaceutical CROs and one or two Indian CROs. The hallmark of this phase was in the culmination of the Indian GCP guidelines (launched in 2001) – a unique example of the collaboration between regulators, academics and the industry.

THE SECOND PHASE

The second phase spans the last decade up to 2009, which saw the expansion of clinical trials across different regions in India with movement into second-line cities, towns and even beyond. This phase was also marked by the arrival of nearly all the big multinational pharmaceutical organisations, most leading biotechnology companies, many global CROs, as well as the set-up of several Indian CROs. To address the challenge of the adequately trained manpower shortage, several training programmes in clinical trials, data management and pharmacovigilance were initiated both by private players as well as some university departments. Some of these, such as the Academy for Clinical Excellence in Mumbai, were products of a collaboration between industry and academia. The setting up of an independent ethics committee, first in Mumbai, and then in other cities, was also instrumental in clinical trials being conducted in non-institutional, small clinic settings.

To remove existing regulatory challenges and streamline drug development, regulators worked towards significant modifications in existing regulations governing clinical trials, resulting in amended Schedule Y in 2005. This modification removed existing barriers and helped towards harmonise clinical trials with international standards. Another step was the signing of TRIPS, which resulted in product patents being granted. Innovative pharmaceutical companies saw this as creating a level playing field, offering a more favourable environment for further R&D investment. The ethics environment was also strengthened by the development and release of ethics guidelines in biomedical research in 2006 by the Indian Council of Medical Research which, along with the Indian GCP and Schedule Y, forms the basis for conduct of clinical trials in India. To bring all stakeholders on a common platform and strengthen clinical research in India, the Indian Society for Clinical Research was set up to serve as a cross-functional single voice for all stakeholders. The Society’s objectives include capacity building of sites, ethics committees, offering organised dialogue with regulators, and training of professionals, media and patients on clinical trials. While the economic recession of 2008 did have an adverse impact on the placement of clinical trials, the impact has been seen to be temporary with a significant increase in the number of programmes in the last six to eight months. Mandatory clinical trial registration for all clinical trials requiring regulatory approval was one of the hallmarks of 2009.

THE THIRD PHASE

As we enter the third phase in 2010, a combination of organised expansion and sustained maturation appears likely. In terms of expansion, the number of ongoing clinical trials in India at the present count is 416; specific therapeutic areas are shown in Figure 1. The CTRI has 1,009 trials registered in total (2). The trial density (ratio of clinical trial sites to the overall population) has been shown to be much lower (0.7) than countries such as Korea (9.5) and Russia (7.7) (3). Hence, there is a real opportunity for conducting more clinical work than ever before. This requires a specific programme for capacity building in second and third-tier towns, and even beyond. The number of investigators will have to be expanded exponentially. While, on the one hand, the supply of monitors, data managers and pharmacovigilance professionals has been good, the training of ethics committee members, and the paucity of adequately trained study co-ordinators, co-investigators and investigators, has emerged as a major challenge. Academic universities and the industry will have to come together to address this by including clinical research in the medical and pharmacy curriculum, while also providing more incentives for professionals to work as co-ordinators and co-investigators, online training and certification programmes. We need to develop more specialised programmes targeted towards co-ordinators and coinvestigators who end up conducting several significant activities in a clinical trial. Such a programme can operate on two levels: the first would be to expose them to basic research methodology, ethics, regulations and so on, which will focus on knowledge domain. Following this, we can have a second programme concentrating on more specialised functions in clinical trials including informed consent, pharmacovigilance, investigational drug management, quality assurance, communication with ethics committees and sponsors. Table 1 shows existing challenges and proposed opportunities to address these questions.

Table 1: Challenges and opportunities for future expansion   
Challenges Opportunities
Huge patient load resulting in less time for research Creation of central clinical research secretariats to harmonise and streamline conduct of trials
Clinical trials restricted to specific towns and hospitals Expansion in terms of capacity building by training programmes, development of nodal centres for referrals
Finite number of investigators with GCP study experience Conducting GCP programmes in second- and third-tier cities with medical associations 

Secondly, the industry will have to look at diseases of national importance – infectious and tropical diseases, specific cancers such as oral, cervical and chronic conditions such as low HDL-cholesterol are just a few examples. For this, we will have to conduct structured epidemiological programmes, provide encouragement and incentives for big pharmaceutical and India-based multinational pharmaceutical businesses to develop medicines for these conditions, and invoke the help of academic institutions in the development of these programmes. This will assist in the development of sites, expose them to international methods of research and, at the same time, address the unmet medical needs of the local community. For this, the industry may need to form collaborations, whether in the form of industry to industry, industry to biotech, industry to academic or industry to government agencies.

Sustained Maturation
Looking at all stakeholders, there is a need to develop a strong network of ethics committees to share best practices, harmonise processes and develop accreditation guidelines for ethics committees in addition to CRO/pharmaceutical clinical departments (as has already been proposed). This would also help in addressing countryspecific issues such as indemnity and clinical trial insurance. The way in which clinical trials are conducted in hospitals must be more structured, which would include setting up central research secretariats, a network of sites attached to a nodal centre, demarcation of clinical and support staff using information technology in patient records, ethics processes and pharmacovigilance. This would help to improve the efficiency levels of clinical trial processes at a national as well as site level. In the expansion phase, the main focus can be on expertise building, while in the maturation phase the main focus can be on efficiency. Needless to say, both the phases will have to be harmonised to achieve optimum outcomes.

CONCLUSION

Quality, speed and cost are the three drivers of clinical trials. In recent years, regulatory inspections from the FDA/EMA have shown that there is an increasing acceptance of Indian data in several pivotal submissions. The speed of conducting a programme, especially patient recruitment, is much faster in India, leading to faster completion of the programme and effective cost savings. As the clinical trials scene in India matures, there is a strong need for all stakeholders to come together to make sure that science, ethics and operational excellence are the top priorities. What India can deliver is excellent quality of work at a much faster speed, but to maintain this momentum, we will have to look beyond tomorrow.

References

  1. www.clinicaltrials.gov, accessed on 20 April 2010
  2. www.ctri.in, accessed on 20 April 2010
  3. Thiers FA, Sinskey AJ and Berndt ER, Trends in the globalisation of clinical trials, Nat Rev Drug Disc 7 pp:13-14, 2008

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Viraj Rajadhyaksha works in India as a pharmaceutical physician and has experience in conducting Phase II, III and IV global, regional and local clinical trials. He completed his MD from Seth GS Medical College and KEM Hospital, University of Mumbai, working as co-investigator in studies on acute coronary syndrome and hyperlipidaemia, during which time he received the Gufic Award for Best Original Research. Currently enrolled on the MSc Pharmaceutical Medicine programme at the University of Surrey, UK, he is an affiliate member of the Faculty of Pharmaceutical Medicine, UK. He is a regular faculty member for courses at major institutes and universities in India, is section editor for Perspectives in Clinical Research, and is a reviewer at the Indian Journal of Ophthalmology.
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