The ISCR has chosen the theme of "Patients First" for this year's International Clinical Trials Day that will be observed on May 20. A series of workshops and seminars would be held to highlight and celebrate the very important role that patients play in clinical trials and how their safety and welfare are a top priority for all clinical research stakeholders.

As per Ms Suneela Thatte, president, ISCR, "On the International Clinical Trials Day, we acknowledge the selfless contribution of clinical trial patients in inventing new drugs and treatments. We would also like to dedicate this very important day to patients who are still waiting for new breakthroughs in medical science for a better quality of life. At less than 1.5%, the share of India in global clinical trials is very low, despite the country accounting for 17% of the world's population and 20% of the global disease burden. We will be organizing several workshops and seminars on May 20 to deliberate upon the current environment for clinical trials in India and how clinical research stakeholders can collaborate to ensure an enabling environment for clinical research in the country."

Suneela Thatte added: "Over the last few months, several steps have been taken by Indian regulators to bring clinical research in India back on track. We now need to restore confidence among all the stakeholders that robust and streamlined guidelines and systems are in place in the country for conducting clinical research. Thousands of patients are desperately waiting for new therapies and drugs to enter the market, and we, as clinical research professionals, have an enormous responsibility to fulfill this need. We are fully committed to working with everyone across the clinical research spectrum to create an enabling environment which encourages scientific and ethical clinical research so that patients can have better and quicker access to new treatments."

New Launches on May 20 by ISCR

To create an enabling environment for clinical research by raising awareness about its role and relevance, ISCR has launched a nationwide advocacy program called NavChetana. On May 20, ISCR will be relaunching its publication called "Clinical Trials - A Guide for Participants" under the NavChetana banner. The Guide empowers patients by providing a better understanding of clinical trials so that they can make a responsible and informed decision to participate. It guides patients on questions to ask investigators before making a decision to participate in clinical trials.

ISCR will also be launching an educational film on the occasion, showcasing clinical research testimonials and experiences. In addition, it will be distributing its Code of Conduct for Clinical Research in India. This 12-point, patient-centric code, applicable to all ISCR members, reinforces their commitment to ethical, scientific and regulatory compliance while engaging in any clinical research activity.

Said Suneela Thatte: "As a professional organization representing clinical research professionals, ISCR fully supports a more robust and regulated clinical research environment to ensure highest standards of ethics and quality and protect patient rights. We seek media support in acknowledging the role of clinical trial patients who are unsung heroes and highlighting the experience and struggles of today's patients, particularly those suffering from unmet medical needs. We need to build an environment that fosters clinical research, drug discovery and innovation through public education and awareness."

International Clinical Trials Day is celebrated on May 20 each year. On this day in 1747, Dr James Lind, a Scottish physician, conducted the world's first controlled clinical trial aboard a ship on sailors suffering from scurvy. The patients were given the same general diet, but supplemented with additional items such as cider, elixir vitriol, vinegar, seawater, nutmeg and (crucially) oranges and lemons. In just six days, those sailors taking citrus fruits became fit for duty. In this manner, Dr Lind discovered the fact that citrus fruits (Vitamin C) in the diet could prevent scurvy. He is now regarded as the father of clinical trials. And like those sailors 268 years ago, several hundreds of thousands of healthy volunteers and patients have since then contributed to the development of new treatments and drugs by participating in clinical trials.