India needs to be more proactive in conducting clinical research and assume a leadership role globally as the country accounts for 20 per cent of the world's disease burden and 17 per cent of the world's population, yet less than 1.4 per cent of global clinical trials are done in India.

Ahead of its 10th Annual Conference, the Indian Society for Clinical Research (ISCR) drew these points with particular reference to the recent changes in the regulatory environment and its impact in the last two years on the healthcare industry.

“Against the background of recent changes in the clinical research regulatory environment, there is an increasing need to do more clinical research in India to meet our emerging health concerns such as antibiotic resistant pathogens, H1N1, dengue, entrenched diseases such as HIV, malaria, tuberculosis especially drug resistant TB and equally, rare diseases such as Gaucher Disease, Pompe Disease,” said Dr Sanish Davis, organising committee co-chair, ISCR Conference.

“It is against this background that we are holding our 10th Annual Conference on the theme Patients First and Research for Patients. Over two days, stakeholders will deliberate and discuss what the future holds for clinical research in the country with a focus on patients,” he added. The event is being held in Mumbai on February 10th & 11th.  

Speaking at the curtain-raiser, Suneela Thatte, president of ISCR said, “Our Conference assumes greater significance in its 10th year given all the recent regulatory changes. The strengthening of the regulatory-ethical-operational framework for conducting clinical research in India has led to an ongoing process of multi-stakeholder consultation which we hope will continue. This is also a time for us to renew and refocus our efforts on learning, partnering and collaborating with each other to further strengthen the agenda for ethical clinical research in India.”

Suneela Thatte also summarised the recent changes in the regulatory environment and the significance of these changes for clinical research stakeholders in the country.

Dr. Sneha Limaye, head – clinical trials division, national coordinator – Respiratory Research Network of India provided an investigator’s perspective on clinical research in India. “As an investigator, we see firsthand the true benefit and value that clinical research derives for patients. Nothing can be more fulfilling than seeing a patient’s despair turn to optimism because of the promise and hope a new drug offers.

“Undertaking research not just benefits patients, but enriches our experience and knowledge which in turn leads to better and more informed clinical practice. We have been challenged over the last few years by an unpredictable regulatory environment but fortunately many of these challenges have now been addressed. We hope, for the sake of our patients, that there will be increased confidence amongst global stakeholders in doing clinical research in India,” she added

The two-day line-up of ISCR’s 10th conference includes panel discussions and speaker sessions focusing on the relevance and contemporariness from the perspective of clinical operations, investigator-initiated research, accreditation, ethics, training, regulatory, pharmacovigilance, medical writing, data management, statistics and career development in clinical research.

The conference will be attended by reputed national and international speakers from across the clinical research stakeholder spectrum. Leading up to the annual conference, four pre-conference workshops have been scheduled for clinical researchers and students on February 9th. These workshops will focus on data transparency, clinical research coordinator training, research methodology, and drug safety surveillance.

“We want to empower patients to raise their voice for clinical research and we hope our Annual Conference will help strengthen and give voice to patient advocacy groups in the country,” said Thatte.

ISCR is an association of clinical research professionals that aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics.