Dr Chirag Trivedi, President, Indian Society for Clinical Research (ISCR),emphasises on the importance of clinical trials in drug development and recommends measures to create an ecosystem conducive for good quality, ethical clinical research in India
The last few years have been a transformative one for clinical research in India. Important regulatory changes have led to a more supportive environment for conducting research. Many of the challenges in regulations and guidelines have been addressed. Overall, there has been a positive shift in people’s attitudes and perceptions about clinical trials but, given the huge disease burden India carries, a lot more remains to be done.
In the larger context of India’s unique healthcare requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, we need clinical research to develop new and effective medicines and vaccines to tackle our mammoth disease burden and unmet medical needs. India has 17 per cent of the world’s population and 20 per cent of the global disease burden and yet, less than 1.4 per cent of global trials take place in India. Hence, it is imperative for us to introduce new drugs in the country to address the unmet medical needs of our patients. And since clinical research is the cornerstone of the drug development process, while we need to have rules which protect the rights, safety and well-being of the patients that participate in research, at the same time we need to ensure that the ease of doing business is a reality for conducting good quality, ethical clinical research in India.
Several positive measures have been introduced by clinical research regulators in the last few years to facilitate the discovery of new treatments for Indian patients. Today, clinical research regulations in India are more balanced and the pendulum that had earlier swung to an extreme is gradually moving towards the centre. The application and approval process flows are more well-defined, making the process for clinical trial applicants easier. Timelines for providing approvals have also been defined by the regulators, which has made the environment for research a lot more stable and predictable compared to the period of uncertainty we saw between 2013-2015. Steps such as online submission of clinical trials, making minutes of Subject Expert Committee and Technical Committee meetings available online, etc. have led to increased transparency. The regulators have been very forthcoming in soliciting and implementing feedback received from various stakeholders about the steps that need to be introduced to create a more balanced and scientific framework for conducting quality clinical research in India. While we have made significant progress, there are certain areas that still need to be addressed for India to realise its true research potential. For instance, the functioning of the Subject Expert Committee (SEC) needs to be made uniform and the protocols should be reviewed in a standardised manner. This will help remove the subjectivity in the review process and will serve as a guide to SEC members as well as sponsors on how a study protocol will be evaluated.
While the approval timeline has significantly improved as compared to 2013, there is scope to improve it further. The current approval timeline of six months provided by the regulators still does not provide India the competitive edge it needs when it comes to global drug development. Bringing it down even further to three months will really benefit our country and there are ways to achieve this without compromising on patient safety. Not all trials should be required to pass through the three-tiered approval process comprising of a review by the SEC, Technical Committee, and the Apex Committee. There needs to be well-defined criteria for identifying the types of clinical trials that need to be approved by all the three committees in addition to a review by the CDSCO, and defining the types of clinical trials that will require fewer levels of review and approvals. Additionally, the committee meetings should be conducted regularly at pre-defined frequent intervals to expedite the reviews.
There is a need for better clarity on the accreditation process of Ethics Committees that is intended to take effect from January 1, 2018. Timelines and roles need to be defined for the various steps in the accreditation process in terms of what exactly will be done, how it will be done, when it will be done and by whom it will be done. Absence of clarity and well-defined timelines could lead to confusion and errors in implementation. For implementing the accreditation process, an incubation period of at least three years ideally should be provided so that the entire machinery is geared up for operation at the end of the three years. Even at its peak, India was conducting less than two per cent of all global clinical trials. For a country the size of India with a huge burden of unmet medical needs this definitely needs to increase by several folds. The regulators will need to continue addressing the areas of concerns and, at the same time, let the outside world know how processes have been made easier in India to facilitate clinical research. This will augur well with our government’s theme of Make in India. While clinical research in India has not reached its ultimate desirable state, we are headed in the right direction for facilitating drug development in India to meet the unmet medical needs of our patients. India has excellent scientific talent, as well as the necessary infrastructure to conduct good quality clinical research in adherence with national and international regulations and guidelines to keep patients safe while discovering newer treatments. We all need to work together to make this a reality.