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Research Made The Difference ISCR Theme for International Clinical Trials Day
On 20 May each year, International Clinical Trials Day is celebrated across the world to commemorate the day that James Lind, considered the originator of clinical trials, started his famous trial to treat scurvy. Lind carried out his experiment to study the efficacy of citrus fruits in preventing scurvy in 1747 while serving on board HMS Salisbury. All his scurvy patients were given the same general diet which was supplemented with various additional items that included cider, elixir vitriol, vinegar, seawater, nutmeg and oranges and lemons. In just six days, patients taking citrus fruits were fit for duty and Lind was able to establish the link between citrus fruits in the diet and the prevention of scurvy. Clinical trials have progressed considerably since Linds experiment. In 1863, placebos were first used in a clinical trial and in 1923, the concept of randomisation was introduced. The first trial using appropriately randomised treatment and control groups was carried out in 1948 by the Medical Research Council, and involved the use of streptomycin to treat pulmonary tuberculosis. This trial also featured blind assessment (where neither the researchers nor the patients knew which treatment group each patient was in at the time of the study) enabling unbiased analysis of the results (ref: http://genome.wellcome.ac.uk/doc_WTD020948.html). Over the years, clinical trials have made a significant contribution to the progress of healthcare. International Clinical Trials Day provides an opportunity to raise awareness about the importance of research to health care and highlight the need for various stakeholders to work together in partnership for advancement of research and improved health. The Indian Society for Clinical Research (ISCR) would like to commemorate the International Clinical Trials Day with the theme Research Made The Difference to highlight the positive difference that Clinical Research has made to a cross-section of stakeholders, most importantly patients who have benefitted from newer and better medicines. We seek your support on this day to highlight the value and contribution of clinical research to our country which has been significant, as captured in the summary below:

Indian Society for Clinical Research

5, Patel Estate, Jogeshwari (West), Mumbai 400 102. Tel: 022- 6570 6167 / 6693 2028 Email: info@iscr.org, Website: www.iscr.org

A large number of Indian patients have benefitted from new therapies for serious conditions such as cancer, heart disease and infections, debilitating neurological diseases and the new epidemic of diabetes. Indian physicians have received training in scientific and ethical aspects of clinical research. The number of investigators has increased significantly in India while the research infrastructure has also improved to a great extent. Clinical research has become an attractive new discipline and has created job opportunities. Today, we have a large and growing number of trained clinical research professionals research physicians, regulatory and ethics experts, study managers, monitors, quality assurance and pharmacovigilance experts, data managers, biostatisticians, medical writers, etc. Management of clinical trial data has supported growth of the Indian IT/KPO sector Positive spin-offs in allied disciplines have lead to expansion of special labs devoted to clinical trials and development of the clinical trial packaging & distribution industry.

We would like to reiterate that ISCR is committed to the need for a more robust and regulated environment in India for the conduct of clinical research, one which ensures the practice of the highest standards of ethics and quality and where patients rights and safety are protected. We also recognise the need to educate the larger public about the role and relevance of clinical research in our country and have appealed to the media to support us in communicating this message, while also highlighting the rights and responsibilities of patients. In the larger context of Indias requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, clinical research is needed to develop new and effective medicines and vaccines to tackle our mammoth disease burden and unmet medical needs. India has 16% of the worlds population and 20% of the global disease burden but less than 2% of global trials happen here. ISCR is planning a few activities to commemorate International Clinical Trials Day. We request all clinical research professionals to support us in this initiative by hosting events at their workplaces to bring attention to the difference that clinical research has made in our country. About ISCR
ISCR (www.iscr.org) brings together professionals engaged in clinical research activities in India and provides a forum for exchange of information and learning. ISCR aims to build awareness of clinical research as a specialty and facilitate its growth in the country, while helping to evolve the highest standards of quality and ethics. ISCRs mission is to influence the future of clinical research in India by: Intensifying efforts to encourage the adoption of highest standards of science and ethics; Shaping regulations and policy through a process of constructive dialogue; Creating a network for training and information exchange; Representing interests of all stakeholders. ISCR drives its initiatives through Six Councils namely - Ethics, Regulatory, Investigator, Training, Clinical Data Management, Biostatistics & Medical Writing and Media Councils.

Indian Society for Clinical Research

5, Patel Estate, Jogeshwari (West), Mumbai 400 102. Tel: 022- 6570 6167 / 6693 2028 Email: info@iscr.org, Website: www.iscr.org