Clinical Research in India has undergone several changes in the last few years. Strengthening of the regulatory-ethical-operations framework for conduct of clinical research and clinical trials in India has led to an ongoing process of regulatory streamlining and changes in the conduct of clinical research at sites. Clinical research is essential not only for developing medicines for emerging health concerns such as antibiotic resistant pathogens, H1N1, dengue and for entrenched diseases such as HIV, malaria, tuberculosis (especially drug resistant TB), diabetes, hypertension, cancer, heart failure etc. but also for finding safer and better medicines for Rare Diseases such as Gaucher disease, Pompe disease etc.
India, with its large patient population, and limited resources has significant unmet health needs. We need to make newer and better treatment options available locally and to the patients globally. For this, India must proactively participate in conducting clinical research (“Research for India”) and assume the leadership role globally (“Made for the World”). As we are operating in a recently strengthened and improved regulatory and operational environment, we have a significant task ahead of us – strengthening the Hospital sites, investigators/academia and our ethics committees, and empowering the patient who is the center of the clinical research undertaken. All of this is in keeping with ISCR’s theme and focus since of its inception – “Patients First”! It is also a time of renewal and refocussing for Academic clinical researchers and research focused Pharmaceutical Industry on learning, partnering and collaborating with all the stakeholders in Clinical Research in India and the world to strengthen ethical conduct of clinical research.
The theme for the 11th Annual Conference is “Collaborative Clinical Research for better Patient outcomes.” The objective is to discuss and evolve strategies to get all stake holders to collaborate more and conduct high quality clinical research for better patient outcomes. The topics planned to be covered include those of relevance for academic and investigator initiated research, accreditation, ethics, training, regulatory for clinical research conduct in all settings for all stakeholders.