Clinical Trials

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June 2011 India has become the hub for clinical trials with its huge population along with the availability of state-ofthe-art medical infrastructure and trained medical personnel. There is enough scope for research to be conducted here both in private and government hospitals. An insight into the clinical research conducted in India. Dr Asma Mohd Yousuf

Clinical research is an indispensible part of the drug discovery & development process. Today, due to the current lifestyle changes, there has been a dramatic surge in incidence of new age diseases across the globe. Also, with the development of new diagnostic methods, now early detection of a disease is possible. Due to these factors, biopharma companies in collaboration with various hospitals and medical institutions are making huge investments in new drugs, aimed at ameliorating various diseases. In such a scenario, clinical trials are of greater significance than they were a century ago. And India is making a major contribution in this sector. For the past few years, India has been looked upon as a major centre for clinical research as it has a diverse patient pool as well as qualified people, including doctors and clinical research professionals to conduct clinical trials. Also, India has the largest pool of patients suffering from cancer, diabetes and other maladies. Added to this, there is a significant cost advantage as well. These factors make India an ideal destination for conducting clinical research.

Dipanjan Chakraborty

Giving insights into the status of clinical research in India, Dipanjan Chakraborty, Head – Clinical Research Services, BioQuest Solutions Pvt Ltd, Bengaluru, informs, “According to projections from McKinsey & Company, the Indian clinical research industry was positioned to attract $1.5 billion of revenue from US and European sponsors by 2010. However, the recent statistics suggest that the Indian clinical research industry is currently valued at approximately `8,000 crore ending fiscal 2010-2011, and is making rapid strides in the global arena. The industry was valued at `1,200 crore in 2006, and had subsequently grown to `6,500 crore in 2009-10. Indeed, India is emerging as one of the most important cogs in this wheel.”

Dr Abhijit Bopardikar

Today, multinational companies are establishing their R&D facilities in India. Justifying this, Dr Abhijit Bopardikar, Director and Pathologist, Ree Laboratories Pvt Ltd, Mumbai, says, “This is because of three main reasons. First, the research in India is more advanced than ever before to take up this challenge, second is the fact that pricing can be adequately curtailed coupled with relative ease of acquiring funding, and third, the legal systems, legislations and regulatory authorities are currently quite proactive in promoting and encouraging undertaking such trials.”
Preclinical and clinical studies in India Preclinical trials are necessary before the company decides to undertake clinical trials. This is because clinical trial is an expensive proposition and needs to be initiated judiciously and scrupulously only if it has a potential to achieve desired results. Preclinical trials help achieve this before full fledged launching of clinical trials. Discussing the status of preclinical trials in India, Chakraborty says, “This is an area where there is enormous scope, but we have not realised the full potential. In the drug discovery pipeline, there is still no alternative to bypass animal testing. For vital parameters like cardiovascular functions, renal functions,

hepatic functions, neurological responses, etc, we still have to depend on existing animal models. Although not many companies or institutes provide such services, things are looking a little better of late.” He continues, “There is enormous market potential, but regulations have to be str eamlined. Animal experimentation norms have to be relooked. Good Laboratory Practice (GLP) compliant set ups for animal research is a must, and we are lacking in this respect. Thankfully, we do have Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA) guidelines in place now, and the cost advantage of clinical research is set to be extrapolated to the preclinical arena as well.”

Dr Rasika G Bhat

After successful preclinical trials and the approval of Investigational New Drug Application (INDA), clinical trials are conducted on human subjects in four phases. Dr Rasika G Bhat, Medical Geneticist and Lecturer – Medical Genetics, Institute of Nursing Education; J J Hospital; and Bombay Hospital College of Nursing, Mumbai, informs, “The current regulations do not approve phase I trials for molecules discovered outside India, except when the drug being tested is of relevance to the health problems in India or if it is a repeat phase I study. Phase II and phase III trials can be conducted in parallel with the trials in the rest of the world as long as data from earlier phases is submitted with the application. And the phase IV involves post marketing surveillance of the drug in the market. However, the US Food and Drug Administration (FDA) does not approve data from trials in which more than 20 per cent of subjects are from developing countries.” Private vs government hospitals

Dr Rajiv Chandel

In India, clinical trials are conducted in both private as well as government hospitals. Dr Rajiv Chandel, Business Development/Analyst, Hinduja Hospital, Mumbai, explains, “Clinical trials that are conducted in private and government hospitals are no different except may be the class of patients included. These institutions have local Ethical Committee/Institutional Review Board (EC/IRB), which supervise the clinical trials and ensure proper conduct. Studies are also conducted in private small establishment which depend upon non institutional IRBs.” An Institutional Ethics Committee (IEC) or IRB is an essential component of clinical research set up. It is the committee designated to approve, monitor and review clinical trials. The aim for setting up this committee is to protect the rights and welfare of the research subjects. An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It also reviews all study-related materials before and during the trial. It ensures that clinical trial participants are exposed to minimal risks in relation to any benefits that might result from the research. However, IEC/IRB should operate in accordance with national and/or local regulations as well as with International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines. “Institutional Ethics Committees are attached to almost every medical institution. Government and private hospitals are formed in line with requirements of the GCP guidelines. As our country is by and large a multilingual society it is mandatory to ensure informed consent and patient information leaflets translated into regional languages,” informs Dr R Bhat. She continues to explain, “In general, the privately owned and run hospitals are better equipped as compared to government hospitals. However, it is the government hospital, which receives the bulk of the patient population. Sponsors should aim for careful balance of private, semi-private and government institutes while choosing sites in India.”

Discussing the ethical environment in Indian hospitals, Chakraborty says, “The compliances are often stricter in a government hospital setting. However, private hospitals are now making a conscious effort to bring in absolute transparency. But recruitment rates are better in government hospitals due to socioeconomic factors. On the other hand, standards of care and turnaround time are advantages of conducting trials at private hospitals.” Further, elaborating on the clinical research facility at Hinduja Hospital, Dr Chandel says, “The hospital has a separate research department with proper EC/IRB, conducts workshops to train principal investigators, and research fellows in GCP, research methodology, and writing skills. It takes special efforts to inculcate research discipline among its post-graduate students.” He adds, “Clinical trials at Hinduja include almost all medical specialties and basic sciences, such as neurology, chest medicine, gastroenterology, endocrinology, oncology, rheumatology, ENT, paediatrics, critical care, orthopaedics, haematology, microbiology, biochemistry, nuclear medicine and infectious disease. However, the most common trials sponsored by multinationals are in oncology, diabetes, chest medicine, nephrology and neurology. Unfortunately, infectious diseases are neglected by multinationals.” CTRI: A key factor Clinical trials could go a long way in defining the role of a therapeutic use of drug that can benefit millions of patients worldwide. However, to ensure transparency of the data collected during research process, Clinical Trial Registry (CTRI) has been formed. This puts studies in the public domain. The aim of CTRI is to bring in greater precision into the process of clinical trials in India, and to help stakeholders conform to international and Indian principles and ethics while conducting a clinical study. Providing further details on the CTRI, Dr Bopardikar says, “CTRI is the authority that registers the clinical trial. It further supervises all the phases, recommends changes and alterations if any and finally decides whether the trial can be approved or rejected.”

Dr Ganapathi M Bhat

Elaborating further, Dr Ganapathi M Bhat, Consultant Medical Oncologist & Stem Cell Transplant Physician, Jaslok Hospital and Research Centre, Mumbai, says, “With fears that India had bec ome an easy target location for illegal trials, the DCGI made it mandatory in June 2009 for all trials to get registered under CTRI before a single subject was recruited for the study. India is currently hosting 1,400 clinical trials. CTRI is an online, primary register of the World Health Organization‟s International Clinical Trials Registry Platform (WHO ICTRP). It is open to the prospective registration of clinical trials of any intervention conducted in India involving human participants in addition to being voluntary and free of charge for registration as well as data search.” Weighing the pros and cons Although steps are taken to promote clinical research in India, one must keep a tab on the approach. A critical evaluation of the benefits and risks of clinical research has to be conducted in the backdrop of the socioeconomic scenario in India. There is a difference in the socioeconomic environment in India, compared to the developed countries. “According to health economists, only 15 per cent of the country‟s healthcare expenditure comes from the government. About 4 per cent is from social insurance, and about 1 per cent from private insurance parties. The remaining 80 per cent is borne by individuals using private services, without insurance coverage. Therefore, the need of enrolling oneself to a clinical trial is not just for a better medical prospect, but sometimes due to desperation to receive treatment free of cost. However, this factor should not be exploited,” informs Chakraborty. He further adds, “We must ensure that we do not let our own citizens be used as „guinea pigs‟ for unethical and unscientific research. There are enough regulations in place, but a culture of strict adherence to them is what we, as Indians, need to imbibe. At any cost, patient safety and rights are of foremost importance. Safeguarding the interests of our population is paramount. The responsibilty lies on everyone, not just on clinical research professionals. Indian government, media, social activists, researchers, medical professionals and citizens at large will have to take up the onus on themselves.” Taking the discussion further, Dr G Bhat says, “As most of the trials are sponsored by foreign companies, it is very important that while designing a trial the vast cultural, economic, social and educational differences that exist between different countries is considered. It is just unrealistic for the pharma company to adopt the western model of a trial without ethnicity considerations into the complex situation that exists here.” He further adds, “The success and ethical grounding of the trial also significantly depend on the assumed responsibility of the clinical investigator. Indian investigators have demonstrated their compliance by virtue of participation in more than 60 global trials; a majority of those trials were FDA or

European registration trials, requiring strict compliance with GCP and regulatory guidelines. The data have been accepted by foreign regulatory authorities and published in international scientific journals of repute.” There is an increased need for inspection and audits of trials in India, and greater emphasis on compliances is required, which will only come with raised awareness. There should be indegenous R&D to stimulate Indian patient centric drug discovery and development. Moreover, awareness should be instilled in the education system in the country to imbibe the culture of conducting scientific and ethical clinical research. Agrees Dr G Bhat, “Participation in global trials also encourages resear ch directed towards domestic disease conditions. Scientific misconduct needs to be tackled and not ignored.” What’s next? With increasing number of trials carried out in India, the future of clinical research in India appears bright. Successful completion of the current clinical trials will not just provide the common man with plenty of treatment options for various ailments, but will also reduce the cost of prevalent drugs for those disorders substantially. “With positive clinical trial outcomes, the economy will thrive as every successful molecule will have buyers willing to pay millions of dollars in India and overseas,” admits Dr Bopardikar.

Vamsi Maddipatla

As per Vamsi Maddipatla, Director, International Drug Discovery and Clinical Research (IDDCR), Hyderabad, “India‟s economy is growing rapidly, thereby creating a large middle class that is able to afford medicines. Its epidemiological profile is also changing along with increasing ageing population. Therefore, the demand is likely to increase for drugs for cardiovascular problems, disorders of the central nervous system and other chronic diseases such as diabetes, which is increasing at an alarming rate.

According to PricewaterhouseCoopers, the total market is expected to rise to a value of approximately $50 billion by 2020.” With major research like the stem cell trials and studies for AIDS and tropical diseases underway, there is a huge scope for potential therapies for various disorders to be developed in India in the near future. However, clinical trials should always be conducted in accordance with the ethical principles and governing laws of the country. As mentioned in the ICH GCP principles, the rights, safety, and well-being of the trial subjects are the most important considerations, and their well-being should prevail over interests of science and society. It is only then that one can reap benefits from the advances in medical research.

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