In the last few months, clinical research organisations (CROs) have witnessed some positive steps being taken by regulators such as introducing draft amendments to some of the contentious guidelines, taking into cognisance stakeholder concerns. Suneela Thatte, President, Indian Society for Clinical Research, in an email interaction with Nandita Vijay, hopes these amendments incorporating stakeholder feedback will be introduced soon so that there is a more conducive environment created for clinical research in India. Excerpts:
Do you see signs of ‘back-to-business’ phase in the Indian clinical trials industry?
The last year and a half has been a challenging one for clinical research in India. Uncertainty and unpredictability in the regulatory environment have considerably slowed down the conduct of clinical research in the country. Considering that India has 16 per cent of the world’s population and 20 per cent of the global disease burden, the country’s responsibility towards the health of its citizens is critical in creating an enabling environment for clinical research and drug innovation. In the recent past, we have seen more receptivity by the regulatory authorities to concerns that have been raised by various stakeholders on some of the more challenging guidelines and orders and are hopeful they will be addressed.
However, winning back the confidence of stakeholders, beyond just sponsors of research, in doing clinical research in India will be a challenging and uphill task. Given some of the sensationalism and misinformed reporting of clinical research, there is a need to get the trust of investigators in conducting clinical research and of the general public in participating in human studies. It will take several months before we see clinical research back in India on track. One of the focus areas of the new government is on public health education. We need to foster an environment where patients and investigators participating in clinical research do not do so in fear of its consequences. Public health education on the value of clinical research and the responsibilities of patients is much-needed to address the misinformation and negative perceptions that exist about the clinical research process.
Global trends have highlighted the positive correlation between growth of the clinical research industry and biopharma innovation. A slowdown in the growth of the clinical research industry is detrimental to the culture of biopharma innovation that the Government of India is trying to encourage and could represent a lost opportunity for our researchers. There are several biopharma companies, not-for- profit organizations and academic institutions in India interested in undertaking research for diseases that affect our population. We need to encourage such innovation and not deter the scientific and medical community from continuing in the quest to find safer and effective treatment.
The argument for clinical research has to be a rational one, based on the principles of science and guided by local and international guidelines that are in place for the conduct of human studies. We cannot allow emotions to drive policies particularly in a discipline like clinical research which is so critical to the advancement of healthcare.
Are you of the view that India will regain the lost glory in human studies and return to the phase of action in 2010-2012?
For us the key consideration is the need to ensure that Indian clinical research is reflective of and proportionate to the healthcare needs. With a sixth of the world’s population and the highest diseases burden in the world, less than two per cent of global research is done in India. It is only through clinical research that we have found and will be able to find newer medicines and reduce mortality rates. Our concern is therefore not about whether we can regain lost glory but whether enough research is being done in India to address our triple disease burden which includes communicable and non-communicable diseases resulting from infection and lifestyle respectively. Titles like the ‘diabetes capital of the world’ is just one indication of how underserved our population is, and how much we need to do, to ensure more effective and cost efficient treatments are made available.
How far we are able to restore the faith of MNCs in conducting human studies here ?
Clinical research in India is not just restricted to multinational companies. Indian and multinational biopharma, not-for- profit organizations and academic institutions are all equally involved. The current regulatory environment has created a crisis of confidence across all these groups. Several Indian companies have publicly stated their decision to move their clinical research to the overseas. We need to restore confidence amongst all stakeholders in doing clinical research in India so that we do not lose out in the quest to discover and develop new medicines.
The Union Government has made some efforts to regulate this sector. Are you convinced about this and what are your suggestions to generate the momentum in clinical trials?
ISCR is fully supportive for a transparent framework, one which ensures the practice of the highest standards of ethics and quality and where patient rights and safety are protected. We are therefore encouraged by the steps undertaken by the regulatory authorities to put in place a tighter regulatory framework to clinical research in India.
However, some initiatives like the compensation guidelines, mandatory audio- visual recording of informed consent for all clinical trial patients which disregards socio-cultural and religious sensitivities and restricting the number of studies that an investigator can undertake to an arbitrary number, had knee jerk reactions owing to environmental pressures. This is because these are seen not to provide adequate guidance and go against the basic principles of research and patient interest.
We need a more collaborative approach in the development of policies and guidelines that have a stakeholder feedback mechanism; more capacity and infrastructure at the regulatory end; consistency and stability in the regulatory office; openness and transparency besides quicker responsiveness on issues addressed. All this must be guided by a policy framework that places clinical research at the forefront of a health agenda for India.
What is your view on the subject of compensation as now CROs are apprehensive on the clarity of the norms?
ISCR is not against compensation for injury caused during and due to participation in clinical trial. We are supportive of the need for a transparent compensation policy that provide clarity and leaves no room for ambiguity. This is because compensation has been a contentious issue in the past. The amendments introduced in January, 2013, (Rule 122 DAB and a new Appendix-XII in Schedule Y) had a wide reaching impact on the conduct of clinical research because of certain clauses that were against the tenets of research. However, with the regulators recently introducing draft amendments to Rule 122 DAB and announcing a formula to calculate compensation for Serious Adverse Event (SAEs), on both of which it has invited stakeholder feedback. We are hopeful that our concerns will be addressed and we will soon have in place a compensation framework that accepts stakeholder feedback and safeguards patients, while ensuring that clinical research can progress in our country.
It is important to ensure that participants in a clinical trial are not coerced or induced into participating in a trial with the promise of large compensation. Indian GCP (good clinical practice) guidelines are clear in stating that ‘Subjects should be reimbursed for expenses incurred, in connection with their participation in research. They may also receive free medical services. However, payments should not be so large or the medical services so extensive as to induce prospective subjects to consent to participate in research against their better judgment. All payments, reimbursement and medical services to be provided to research subjects should be approved by the Institutional Ethics Committee (IEC).’
Coming to clinical trial education, it took a hit from 2008 and now we have training centres promising the earth and charging a hefty fee. From an ISCR standpoint, what can be done to convince the growing number of science and medicine graduates who wish to opt for this?
Given the slowdown in clinical research, it is going to be challenging in the short term for life sciences graduates to find careers in core clinical work. Having said that, there are several clinical research organizations that have diversified into a wider portfolio of services within the broader framework of clinical research like data management, Pharmacovigilance, analytics etc which offer exciting career opportunities. Students should explore and pursue these opportunities which are also patient-focused and at the cutting edge of emerging areas in clinical research.
How would you describe the current clinical trials scene in India?
The clinical research industry in India is best described as an uncertain and unpredictable regulatory environment driven by extraneous pressures which has led to a crisis of confidence amongst clinical research stakeholders.
The impact of all this is twofold: One is that patients are impacted the most. For many, participation in a clinical trial can provide early access to new therapies including for debilitating and life-threatening conditions. For patients who have run out of other options, clinical trials are often the only option for hope of a cure or better quality of life. Second is a need to create a sound clinical research eco system that encourages local innovation.
What are the visible emerging trends?
With clinical research almost at a standstill, there are no indicative trends in India except that sponsors, including multinational and Indian organisations, academic institutions and not-for- profit organisations are moving studies abroad.
However, many companies that are impacted are diversifying their portfolio of services as a de-risking strategy and identifying new opportunities in allied services like Pharmacovigilance, data management, etc.
What is your view on the creation of a committee to check and clear human studies for oncology and cardiology?
This development has to be seen in the light of the July 3, 2014 order on Procedure for Review of Application of Clinical Trials and New Drugs where regulators have said that NDACs (New Drug Advisory Committees) who evaluate new applications will be renamed as Subject Expert Committees (SECs) and reconstituted with a pool of experts.
We believe that more such SECs will follow. While the concept is good, in practice there have been bottlenecks in the approval process which are a major deterrent and one of the major causes for sponsors moving clinical research to countries where there is more predictability in the approval timelines. What we need is a more streamlined and rational process for the approval of new drug applications, which will only happen if the functioning of SECs is bound by working procedures based on principles of research.
How does ISCR view the future of the clinical trials industry in India?
As we have said earlier, ISCR is fully supportive for a transparent framework. In many ways, developments in the last few years on the regulatory front have been a major step forward in ensuring better governance in the conduct of clinical research in India. However, what we need is more clarity on some of the regulations, guidance on their implementation and a rational, scientific framework within which they are introduced.
In the last few months, there have been positive steps forward by regulators in introducing draft amendments to some of the contentious guidelines, while taking into cognisance stakeholder concerns. We hope these amendments incorporating stakeholder feedback will be introduced at soon so that there is a more conducive environment created for clinical research in India.
Most organisations and institutions are adopting a wait and watch approach at the moment which covers concerns on compensation in particular, more predictable approvals and a closure of the Supreme Court PIL( public interest litigation) which will go a long way in reassuring stakeholders to do clinical research in India. Our greater concern is about the impact on patients who will face the real impact of the current environment in the next year or two as newer and more efficient drugs will not be accessible to them.