Indian regulator must work to bring clinical research in India back on track. End of last year and early this year, several steps have been taken to this effect. However, there is a need to restore confidence among all stakeholders that robust and streamlined guidelines and systems are in place in the country for conducting clinical research, views Indian Society for Clinical Research.
An aging population, an increase of chronic diseases, and a growing demand for biologic are some of the factors driving the clinical research in India, according to BCC Research.
Thousands of patients are desperately waiting for new therapies and drugs to enter the market and clinical research professionals have an enormous responsibility to fulfill this need. We are fully committed to working with everyone across the clinical research spectrum to create an enabling environment which encourages scientific and ethical clinical research so that patients can have better and quicker access to new treatments. The clinical research fraternity is not against regulation but there is a need to ensure that there is a strong regulatory framework rooted in the principles of science and research with quality, ethics, patient safety and confidentiality as its guiding principles. Given that India has the highest disease burden in the world, it seems only logical that the country should have a clinical research agenda of her own. On the contrary, in spite of being home to 17% of the population of the world and having a fifth of the world’s disease burden, our contribution to global drug trials is less than 1.5%, stated Suneela Thatte, president, Indian Society for Clinical Research.
“There are many patients in India who are being denied the right to fair and equitable treatment to clinical trials and newer and more effective medicines that clinical research makes possible. It is ironical that while on one side we have success stories such as an indigenously developed and tested rotavirus vaccine which is now part of the national immunization schedule, on the other hand we have lost innovation opportunities due to the challenges we have had in the recent past.
This is a compelling enough reason for us to ensure that over and beyond the regulatory developments, all of us work collectively towards rebuilding confidence and trust in doing clinical research in India so that our patients have access to news and better treatment, she added.
“Clinical research has not got the right perspective in the Indian context which has actually deprived our country from some very imperative and relevant research being ignored,” said Samir Sethi, president, Indian Rett Syndrome Foundation.
“While we have the requisite expertise, infrastructure and need in the country, however, certain factors have not permitted clinical research to grow as it should have. We hope that as the regulatory environment improves, a new dimension would unfold between the regulators and the patients, pushing clinical research not only by researchers and scientists in the country, but also as a preferred destination from overseas sponsors. Our children have a right to live with dignity and in an environment where there are investments being made in clinical research that could help them lead a better quality of life. We seek the support of the media in highlighting the cause of rare diseases in India and the challenges of patients living with illnesses for which there is no known cure, said Sethi.
According to Prof Y K Gupta, professor and head, department of pharmacology, AIIMS & executive council member, ISCR clinical research is essential not only for developing medicines for emerging health concerns such as XDR TB, antibiotic resistant pathogens, H1N1, Ebola virus, etc. but also for finding safer and better medicines for entrenched diseases such as HIV, malaria, diabetes, hypertension etc.
India, with its large patient population, unmet health needs, and limited resources, needs to make newer and better treatment options available to its population in a quick, economical and dependable manner. For this, India must take a proactive part in clinical research and assume leadership role globally,” said Prof Gupta.
“Events of the past have eroded the confidence of various stakeholders in conducting clinical research in India. The science of clinical research will be negatively impacted if we do not stabilize the environment for clinical research in the country soon enough. We have an obligation to ensure that patients have access to the best and most advanced treatment, made possible through clinical research, to alleviate their suffering,” said Dr Shamsher Dwivedee, head and director, department of neurology, Fortis Memorial Research Institute, Gurgaon.
“For many patients, participation in a clinical trial can make a difference between life and death. Patients cannot wait and it is important for us to remember this. We need an environment that encourages and fosters clinical research so that patients can benefit,” said Vivek Tomar husband of a patient suffering from lung cancer.
To create an enabling environment for clinical research by raising awareness about its role and relevance, ISCR has launched a nationwide advocacy programme called NavChetana which operates through three tracks: Education Track which collaboration with educational institutions to sensitise students on clinical research; Professional Alliance Track which involves outreach with professional bodies, associations, NGOs, etc and Media Track which aims to generate mass awareness about clinical research, stated Thatte.
Therefore we fully support a more robust and regulated clinical research environment to ensure highest standards of ethics and quality and protect patient rights. “There is a need to acknowledge the role of clinical trial patients and highlight their experiences and struggles, particularly those suffering from unmet medical needs. We need to build an environment that fosters clinical research, drug discovery and innovation through public education and awareness,” said the ISCR president.
In recent years, contract research particularly clinical studies benefits in saving costs and eliminating the issues to conduct human studies. “Outsourcing has become a viable business strategy that is enabling pharmaceutical firms to transfer non-core activities to external partners in order to restructure their distribution networks, leverage resources, spread out risk, focus on issues imperative to achieve competitive advantage and assures future growth,” noted Shalini Dewan, analyst, BCC Research.