A policy promoting clinical research and innovation needs to be supported by action at various levels opines Suneela Thatte, President, Indian Society for Clinical Research (ISCR)
In recent times, there have been encouraging reports in India around new discoveries and more effective treatment for unmet medical needs made possible through clinical research done in the country. Even as we celebrated the success of clinical trials for the first indigenous vaccine for rotavirus, the renowned Tata Memorial Hospital announced at a symposium in Goa that clinical research had contributed to mortality rates for breast cancer dropping significantly in the last 20 years in particular. Yet elsewhere the irony wasn’t lost when media reports mentioned that the quest for a vaccine for dengue had been stymied in India due to a challenging regulatory environment for clinical research or when the father of a child suffering from Pompe disease spoke of his desperation to find a trial in India his daughter could participate in. The reality is that, under current conditions, sponsors are turning away from doing clinical research in India. In a few years from now, we will see the real impact of the current environment when several new medicines and potentially superior therapies will be out of reach of Indians simply because no clinical research was conducted in the country. In 2005, when the decision was taken to remove the phase lag for clinical trials in India, the rationale was so as to ensure that India would not lag behind in access to new medicines. Today, the clinical research environment in the country is unfortunately far away from that vision for research and innovation.
One does not need to overemphasize the importance of clinical research in the drug development process which is long, expensive and complex. It takes an average of 10-15 years for a new medicine to be developed for human use. It is only through clinical research that one can determine the safety and effectiveness of a new drug or treatment or an existing one being used in a new way. The genetic makeup and profiles of people has a significant role to play in how their bodies respond to therapeutic intervention which is why a multi-ethnic, multi-racial population like India needs clinical research. Besides, India has a sixth of the global population and a fifth of the global disease burden. The Government of India working group on Disease Burden (communicable and non-communicable diseases) for the formulation of the Twelfth Five Year Plan (2012-2017) referred to the triple burden of disease that India has:
- Communicable diseases like TB, leprosy, vector borne diseases, water-borne diseases, zoonotic diseases and vaccine preventable diseases
- Emerging non-communicable lifestyle diseases like cancer, cardiovascular diseases
- Emerging infectious diseases like Ebola virus, SARS, H1N1.
All these factors make a compelling proposition for sponsors to conduct clinical research in India and yet in the last two years most have chosen not to. The factors that triggered this development are all too familiar now. In January, 2013, through a gazette notification that took the clinical research fraternity by surprise, CDSCO brought into effect new compensation guidelines that had a far reaching impact on the conduct clinical of clinical research in India. Ill thought through and prompted by misguided activism and judicial developments, these guidelines were the beginning of a series of landslide developments in the regulatory environment that were compounded by unpredictable approval timelines and a spate of unannounced site inspections by teams who were ill equipped and had little or no GCP training.
Today, almost two years later, not much has changed in the regulatory environment. Although there have been attempts by regulators to review several of the challenging regulations through a multi-stakeholder collaborative approach and a commitment that change will come sooner than later, the key issues that stakeholders across the clinical research spectrum continue to face are:
- Irrational and unbalanced compensation guidelines
- Unpredictable review and approval process
- Myopic operational orders such as mandatory across the board audio visual recording of informed consent, limiting the number of trials an investigator can conduct at a given point in time and limiting the distribution of clinical trial sites.
So where does India go from here? Assuming that the regulators recognise that there is an urgent need to fix the roadblocks that today challenge clinical research and are committed to introducing guidelines based on ethics and the principles of science (as has been stated at recent public events), there is still a lot that needs to be done. A policy framework for clinical research has to be an integral part of the Government’s health agenda for the country for it is only through clinical research that we will be able to find newer and more effective treatment to treat our growing and unique burden of diseases.
A policy promoting clinical research and innovation needs to be supported by action at various levels:
- Rational regulations: Regulations and guidelines developed through a multi stakeholder consultative approach that are based on science and highlight a commitment to patient safety, ethics and confidentiality in line with per globally accepted practices There are situations unique to India like literacy, socio economic considerations and social cultural norms which must also be taken into cognizance in the development of guidelines so that no one is denied the right to participate in research because of these challenges as with audio visual recording of informed consent for instance.
- Capacity building: We need more trained resources within CDSCO to ensure the smooth roll out and governance of clinical research in the country. Guidelines will remain guidelines with good intent unless there is operational guidance and trained staff to ensure their implementation.
- Accreditation: To address the concerns that have been raised about the conduct of clinical research in India, we should have an objective system to accredit investigators, sites and ethics committees. The accreditation should be provided by an independent third party and reviewed at periodic intervals.
- Infrastructure development: If we want to grow clinical research in the country and ensure a healthy balance of research across geographies, the Government needs to invest in better infrastructure particularly at government run hospitals and institutions. It is unfortunate that many patients do not have the option of participating in clinical research in many areas of our country because sites are ill equipped and investigators not trained in clinical research.
- Public education and awareness: Misreporting and sensationalism of clinical research in India has created fear and suspicion amongst the public at large. A key requirement is public education and awareness not just about clinical research in general but also about the rights and responsibilities of those who participate in a clinical trial. We need to create an environment where patients have the confidence and trust that their participation in a trial is to their benefit.
- Transparency and Openness: We are in a situation where there is a crisis of confidence. Greater transparency and openness by the regulators will go a long way in restoring trust amongst various stakeholders.
There was much hope held out for patients in our country when clinical research began to grow in India in the 1990s and indeed in the last few years we have seen several life saving drugs being introduced. We are all patients and beneficiaries of better and more effective medication made possible through clinical research. It is likely that there will be a downward trajectory in new medicines introduced in India over the next few years but regulatory will and intent through speedy action can change this…as well as a demand from stakeholders across the clinical research spectrum for the right to better healthcare and treatment.