Indian professionals, global standards
Dr John Hooper Chief Executive Officer The Institute of Clinical Research Global, UK & Chief Executive Officer
Institute of Clinical Research Professionals (India)
India is widely seen as the most exciting country in the clinical research world. Its potential to deliver large numbers of patients into global clinical trials relatively rapidly, combined with physicians’ fluency in English (the global language of clinical research) and a positive attitude towards the global marketplace have put India at the top of many global study managers’ lists for consideration. However, India is at risk of being a victim of its own success, as demand outstrips the number of skilled professionals required to manage and conduct these clinical trials. Many activities are already in place to meet this challenge, but time and resources will be needed if India is to fulfil its potential.
Growth of Indian clinical research
Although clinical research has been conducted in India since the early 1990s, it was in 2005, with the amendments to intellectual property law and to Schedule Y, that global clinical trials really started to take off in India. At that time, around two percent of studies (worth around $75million) were conducted in India. This has projected by various commentators to increase to nearly 5 percent global market share by 2010 (worth up to $1.5 billion, according to McKinsey).
Opinions are divided over what impact the current global economic turbulence will have on the international balance of clinical research sites. For companies who primarily use Indian research sites as a way to reduce costs, the impact of this driver is likely to decrease as western salaries and supplier costs fall while those in India continue to gradually converge with western norms (as is also being seen in other developing regions for clinical research, such as Eastern Europe and Latin America). However, the key advantage of Indian sites is their potential to provide large numbers of patients quickly. This is relatively unaffected by the changing economic climate, and is ultimately more important for study sponsors. The additional revenue gained from getting a successful medicine to market earlier would generally outweigh relatively small fluctuations in the cost.
In short, the future for India in the global clinical research market is bright, if it can continue to deliver the results to match its potential.
The core standards underpinning clinical research are global in scope. The ICH guidelines (of which, E6 on ‘Good Clinical Research’ is most relevant here) form the basis of the regulation of clinical research in most countries, including the “Good Clinical Practices for Clinical Research in India” guideline. Similarly, the Declaration of Helsinki sets out principles of research ethics acknowledged by physicians around the world (and, again, is cited in the Indian GCP guideline).
Further, the quality, internal validity and usability of data from a global clinical trial depends on the use of global Standard Operating Procedures (SOPs) for the conduct of the trial. These can vary slightly from company to company, but they apply globally and, as the data from the studies need to meet global standards, even SOPs from different companies are broadly consistent.
Mid-way between regulations and company SOPs are Professional Standards for specific clinical research roles and activities. These guidelines are also global in scope, being agreed across the profession as a whole. They detail how to carry out key tasks while complying with regulations and acknowledged best practice. More practical than regulations, but less prescriptive than SOPs, they are arguably the best starting point for people entering the industry to benchmark how they should be carrying out their duties on a clinical study. In summary, while subtle variations exist between countries and between organisations, the standards to which clinical research professionals should comply are broadly the same around the globe.
As acknowledged above, the key hurdle facing India is developing its capacity quickly enough to meet the rapidly increasing demand, in terms of skilled and experienced professionals as well as its infrastructure and regulatory framework. While India has many well-qualified and experienced physicians, clinical research is rarely a standard part of doctors’ training. Even those fortunate to have some academic research experience earlier in their careers might be unprepared for the rigour of conducting a commercially-sponsored clinical trial to the standard currently required by the FDA, EMEA and other regulatory bodies.
Once a study is in progress, it is the responsibility of the study sponsor to ensure that investigators, sub-investigators and other site personnel are “appropriately trained” for the roles they are expected to perform. However, it is generally the case that a site that cannot demonstrate that its staff meets this requirement will not be selected to take part in the study, so it is vital that sites take the initiative in ensuring that their clinical research teams are trained to the global standards described above.
Not just physicians
While it is vital for the physicians working as investigators at clinical research sites to be educated (and preferably experienced) in the global standards and processes required to conduct high quality clinical research, this alone is not enough. As many tasks, particularly related to data collection, drug accountability and administration, are delegated to sub-investigators and other site personnel (eg, research nurses) it is also important that these individuals receive appropriate training to carry out these tasks. As different site personnel are required to carry out different tasks, a “one size fits all” attitude towards education is not sufficient.
Traditional methods of informing investigators and site personnel of how to carry out their responsibilities, such as investigator meetings and site set-up/monitoring visits, are adequate for covering study-specific topics and perhaps providing a ‘refresher’ on broader topics. However, this is predicated on an existing understanding of the principles behind high quality clinical research, and should certainly not be relied upon as the sole source of education for anyone involved in clinical research.
Not just site personnel
There is also a need for a similar increase in the number of personnel working in sponsor companies, CROs and other more specialised support services. These professionals are needed to manage study administration and logistics, monitor sites, handle data queries and manage the study from an operational viewpoint. Again, this group of professionals must also be appropriately trained for their activities within the study team, with a subtly different set of requirements to meet regulatory, professional and company-specific standards.
It is important to note that physicians, nurses and other site personnel are already in place, and mainly require only training to apply their existing skills to a clinical research context. However, these industry roles often need to be created ab initio, providing a great opportunity for life science graduates but a more complex task for companies, who need to identify potential candidates and make selections based on attitudes and transferable skills before training them for a career in clinical research. This is an area of intense interest to ambitious young graduates, but care must be taken not to understate the complex and demanding nature of working in clinical research, nor to overstate the potential for financial benefits and rapid career progression.
For India to continue its expansion into the global clinical trials market, there must be a rapid increase in the number of research-active physicians, research nurses and industry personnel alike. Each of these different groups of professionals require subtly different training to be able to perform in compliance with global standards.
What’s being done
The issues described above have been broadly understood throughout the Indian clinical research community, and by the group of world-leading companies looking to include Indian sites in their research programmes. Many initiatives are in place, at governmental, professional and commercial levels, attempting to manage the situation successfully. The Institute of Clinical Research Global is working at the forefront of many of these areas, both directly through its Indian organisation, Institute of Clinical Research Professionals (India), from its office in Hyderabad, and in collaboration with partners throughout the Indian clinical research community.
Training and eLearning
Training is vital in building capacity to conduct high quality clinical research. Training should encompass global guidelines and professional standards, while (of course) detailing compliance with national regulations, structures and practices. To ensure that a training course meets these requirements, it should be delivered by a well-respected training provider or by experienced training professionals with broad knowledge of both Indian legal requirements and global standards. If a local training provider is used, then it is advisable that the training course be accredited against ICH GCP and/or the appropriate professional standards to demonstrate that it is of the required quality.
The Institute of Clinical Research Global has delivered many clinical research courses to Indian professionals at its headquarters and provides open courses and in-company courses in India using experienced trainers. It also works to support educational bodies teaching clinical research in India. The Institute of Clinical Research Global has also accredited training courses being delivered by other Indian training providers.
If face-to-face training is logistically difficult, it is also possible to gain detailed education on a specific topic, or a basic grounding in the principles of clinical research, online via an elearning package. Again, a number of providers exist, and the scope and quality of different courses varies. Elearning packages should take account of global standards and guidelines, but ideally also be tailored to national requirements and/or specific roles.
Examinations and certification
While certificates of attendance at training courses are generally acceptable as evidence of training, a far more robust and transferrable measure of knowledge about clinical research is the passing of examinations. The Institute of Clinical Research Global offers three levels of examination that are relevant to Indian professionals. The Part 1: Certificate examination may be taken once the theory and basic principles of clinical research have been acquired, while the Part 2: Diploma tests the application of these principles and should be taken after 6-12 months of practical experience has been acquired. The Global GCP Certification examination is designed to test the professional’s broad overview of the essential aspects of clinical research, not just guidelines and regulations, making it an ideal way to demonstrate knowledge of internationally accepted regulations and core concepts. This examination is made up of three sections, comprising a compulsory section on ICH GCP, a global variations section testing knowledge and understanding of regional regulation (eg, Schedule Y), and a functional variations section on issues relating to site personnel, Clinical Research Associates (CRAs)/Monitors, Clinical Trial Administrators (CTAs) or Project Managers.
India is the most exciting emerging region in clinical research. It has the potential to play a central role in the next stage of the development of the global profession. However, in order to achieve this, it is vital that the number of clinical research professionals in India increases to meet the growing demand, and that those professionals are trained to meet global as well as national standards. Many organisations offer training, examinations and certification, but it is essential that the path you choose to take in developing your personnel takes account of the global framework underpinning modern clinical research.