India: A Future Clinical Hub
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India: A Future Clinical Trial Hub
Analysis of Indian and Global conditions, susceptible for emerging India as a Clinical Trial Hub
Kaustubh Aparajit, Samveg Sethi, Nitesh Kumar and Sachin Chavare,
Shailesh J Mehta School of Management, IIT Bombay
1. Concept Definition
1.1 Clinical Trails
Clinical Trials are studies performed with human subjects in order to test the performance of a new drug, new approaches to surgery or procedures to improve the diagnosis of disease and quality of life of the patient.
The National Institute of Health (NIH) in USA defines a Clinical Trial as a prospective biomedical or behavioural research study of human subjects that is designed to answer specific questions about biomedical or behavioural interventions. Clinical Trials consist of a researcher or researchers, also known as investigators who directly observe a study subject or subjects, and/or who collect data to answer a scientific or medical question about the safety or potential benefit of an intervention such as a medication, device, teaching concept, training method, or behavioural change.
Clinical Trials are conducted in following cases:
1. New drug
2. New uses of existing drugs
3. Medical devices
4. New drug delivery system
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5. Toxicity studies
1.2 Phases of Clinical Trial
A Clinical Trial is conducted in four different phases which are described in the table below: Phase Objective No. of Subjects Duration Phase I To determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way 50-100 Few weeks Phase II To test the longer term safety and efficacy of the drug 100-300 9 months-2 yrs Phase III Thorough inspection of effectiveness, benefits, range of adverse effects 1000-5000 1-2 yrs Phase IV Post Marketing: Long term information gathering >1000 >2 yrs
Table 1.1: Phases of a Clinical Trial
India: A Future Clinical Hub
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2. Trend of Clinical Trial Business and Global Hubs
In 2012 North America reported to have conducted the highest number of Clinical Trials worldwide. In the same year number Clinical Trials conducted in western European countries was greater than that of rest of the world put together.
The whole of the Asian region is one of the most rapidly growing markets for global Clinical Trials. India, China, Taiwan, Korea, and Singapore are leading drug and device development in this region while giving a stiff competition to each other. Emerging markets now contribute to ~36% of global patient enrolment as compared to ~20% in 2001.The main reason for Asia to have immense potential as a Clinical Trial market is its large, diverse patient population with illnesses that are prevalent in most countries. This helps drug companies complete the Clinical Trials on time and saves millions of dollars.
The major players (Contract Research Organizations) and Pharmaceutical companies in the clinical research business include Quintiles, ICON, PPD, Parexel, Kendle, Eli Lilly, Pfizer, Biocon etc. The 20 largest U.S.-based drug makers conduct a third of their phase III Clinical Trials abroad.
Fig 2.1: Number of Clinical Trials conducted in major countries in 2012
3. Regulatory Aspects: Opportunities and Challenges
Clinical Trials are now regulated by the Drugs Controller General of India (DCGI), who is responsible for assuring that all Clinical Trials comply with the requirements of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, as well as Good Clinical Practices. The DCGI approval process categorizes Clinical Trials into two types. If the study protocol has already been approved by a cognizant regulatory authority in one or more developed countries (such as the U.S., Canada, U.K., Switzerland, Germany, Australia, Japan, and South Africa), 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 8 to 12 weeks. The Institutional Review Board (IRB) 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 study protocols in place and quickly initiating the trials.
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India: A Future Clinical Hub
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3.1 Opportunities
Fiscal and other incentives have been churned out to the clinical research industry over the past few years:
1. No import duty on Clinical Trial supplies
2. Exemption from registration requirements for Clinical Trial supplies
3. Export of Clinical Trial-related human blood specimens allowed based on the earlier practice of seeking DCGI-NOC-Approval from the Director General Foreign Trade being no longer required
4. Exemption from service tax on new drug testing
MNCs already present are further consolidating their presence in India while new entrants are expanding their toehold. MNCs are increasingly restructuring their operations with global parents increasing their equity stakes in their Indian affiliates. In India, the central government, via the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare, largely works on developing standards and regulatory measures for drugs, diagnostics and devices; laying down regulatory measures by amending acts and rules; and regulating the market authorisation of new drugs – all in an effort to standardize clinical research in India and bring safer drugs to the market. With the number of Clinical Trials being conducted in India increasing rapidly, the regulatory bodies are recognizing the need to frame guidelines and regulatory approval processes in line with international standards.
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Scientific Feasibility: Strong availability of study subjects across major therapeutic segments Favourable Regulatory Environment: that allows the conduct of global trials, duty-free imports of drugs intended for use in trials, bioequivalence studies for export of data, etc; Cost Competitiveness: India offers a significant cost advantage as compared to developed and emerging economies, 40- 60% lower than in developed countries and around 10- 20% lower than emerging economies
3.2 Challenges For registering new drugs for marketing in India, submission of data generated on Indian patients is essential. For this purpose, a 100-patient non-comparative open-label study on patients treated for the primary indication is sufficient. For drugs that treat rare conditions, a lower sample size is usually adequate. In conducting research, informed consent is the most basic and complex principle of clinical research ethics. An ethically valid informed consent has four key components: disclosure, understanding, voluntariness, and competence. In that case, the usual question that arises is whether the concept of informed consent extends to research involving the critically ill, because in many cases, critically ill patients are incompetent or unable to make a sound decision. Sometimes, the family members may not know the patient’s wishes, or may not be legally authorized to give consent for the patient’s involvement in research. All such issues create challenges for researchers in paediatrics, psychiatry, emergency and critical care medicine. A major threat India faces in this area is its low literacy levels, which has always kept regulators skeptical about the possibility of the volunteers being not adequately informed about the risks they are undertaking. However, compliance to International Conference on Harmonization-Good Clinical Practice or ICH-GCP norms, trained investigators, a growing population of experienced monitors and exposure to international protocols seem to provide some relief to such issues.
India: A Future Clinical Hub
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4. Current Global/Local Situation Benefits for India
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4.1 Local Situation benefits
India is increasingly being recognised as a hub for global clinical research with over 100 domestic and multinational companies conducting trials. India offers following benefits that are directing research-driven pharmaceutical and biotechnology companies to conduct clinical research in India.
1) Large and diverse patient pool: With a booming Indian population, there is an availability of a large pool of treatment naïve patients providing for a multiethnic and multiracial base.
2) Spectrum of diseases: The country has witnessed the presence of varied diseases that are not prevalent in the West. These include diseases such as multi drug resistant pneumonia, hepatitis B, diabetes and some forms of cancer.
3) Recruitment of subjects: Subject willingness is critical for the compliance to undergo the full process. In India, with a large section of the population unable to afford their own treatments, subjects opt for these trials as they are assured on quality treatment and healthcare, which would have not been available otherwise. Hence the subject return rates are amongst the highest in the world in India.
4) Availability of medical graduates: Pharma giants are also magnetized by India due to the fact that the country offers nearly 700,000 speciality hospital beds, 221 medical colleges and skilled English-speaking medical personnel.
5) Regulatory compliance and standards: Based on the USFDA, any drug before it is released in the market must first be tested on a global population.
6) Highly developed IT industry: IT plays a major role in Clinical Data Management for pharma giants and CROs. Known for outsourcing, Indian software companies have CDM department and experts to provide solutions.
4.2 Global Situation benefits
The US$ 64 billion global clinical research industry is witnessing a transition since life-science companies are turning toward emerging markets like India, to pursue clinical research.
1) Cost of Clinical Trial: Clinical Trials in western countries are very expensive. US and Germany are the countries where most Clinical Trials are carried out. It is estimated that in US cost of development of a drug are $700-950 million. A similar Clinical Trial in India can be done at 40-60% cost reduction of the whopping cost.
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2) Time of Clinical Trial: In western countries, time required for development of a drug is 9-10 years. This is owing to large recruitment time of subjects.
3) Economy: While all sectors are leveraging India’s benefits with economy through outsourcing, the drug companies too are tapping the potential with the country as they can save up to 30 to 50% overall on the cost of conducting the trials here in India.
4) English speaking experts/patients: India has a strategic advantage over other emerging markets like China and Brazil in Clinical Trials as English is the medium of transaction in higher education, business and medicine.
5. Future of Indian Clinical Trial Market
5.1 The Way Forward
Based on these advantages and those listed above, the number of Clinical Trials in India is expected to grow exponentially over the next five to ten years. It has been estimated that in 2005 only 1% of global Clinical Trials were conducted in India. This percentage is projected to grow to 15% of global trials by 2011.
India: A Future Clinical Hub
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The charts below illustrate the effects of such rapid growth, projecting that by the year 2013 over 300,000 patients will be enrolled in Clinical Trials in India. McKinsey projects that within five years, more than 3000 GCP studies will be conducted in India per year, requiring 10,000 to 15,000 GCP-trained investigators, and supported by 50,000 clinical research professionals.
Graph 5.1: Number of Global Trials and % in India
Graph 5.2 Number of Clinical Trials and Spend in India
5.2 How well prepared India is today
India has substantial capacity to meet the rapidly growing demand for Clinical Trials. India has 221 medical universities, over 750 graduate and post-graduate programs, and about 50 million college graduates. There are over 700,000 medical professionals. Government and Private Universities have started special diploma and degree courses in subjects like Clinical data management, pharmaco vigilance and clinical research. More and more qualified graduates are expected to be available to meet the demand of experts in this ever growing domain.
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The government is the most important contributor in developing a conducive environment for growth of medical technology industry in India. At the same time, the industry members need to work hand-in-hand with the government to encourage innovation. Indian Government and industry have cooperatively 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. Organizations like The Clinical Trials Registry- India (CTRI)-2009, Indian Association for Statistics in Clinical Trials (IASCT) 2007, Indian Society for Clinical Research do activities like publishing journals, white papers, case studies and conducting seminars on regular basis.
5.3 Threats
There are some hurdles along with the glorious opportunities that India offers. These need to be duly addressed :
1. Time zone difference between western countries and India creates difficulties in communication and monitoring
2. Competition from other emerging markets
3. Difference in business culture between western countries and India
4. There have been some concerns over ICH-GCP norms
5. The implementation of the CTRI remains dependent on wider awareness of the issues
6. There is still no mandatory compensatory payment/penalty against a defaulting company
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6. Case Study
Clinical Trial of the drug Patupilone Patupilone (epothilone B, EPO906) is an investigational agent in development for the treatment of cancer. A Phase I, Dose-Finding Study of Single Agent EPO906 (Epothilone B) administered once every three weeks to adult patients with advanced solid tumours. Process involves recording of all AEs(Adverse events) and SAEs(Serious adverse events), hematology, blood chemistry and urinalysis determinations; vital signs (heart rate, blood pressure [supine, sitting, and standing], body temperature), weight, physical examinations (including an abbreviated neurologic assessment), and electrocardiograms.
Table 6.1: Results of case study Clinical Trial of the drug Patupilone
References
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC314535/
http://www.indipharm.com/pdf/The_India_Opportunity.pdf
http://legalservicesindia.com/article/article/clinical-trial-regulation-in-india-678-1.html
http://www.biocon.com/docs/Biocon_AnnualReport_2012.pdf
Acknowledgements :
Dr. Kajal Sachdev : Clinical Research Institute, Mumbai
Ms Sugandh Kohli : Clinical Data Manager, Cognizant
