New Delhi: As the global community commemorates another International Clinical Trials Day on May 20th, the clinical research fraternity in India opines that regulatory challenges, misconceptions about clinical trials and lack of awareness amongst the general public are the most important factors holding back the progress of clinical research in India. The survey, which was conducted by pharmaceutical company Sanofi amongst attendees of the Annual Conference organised by the Indian Society for Clinical Research (ISCR) earlier this year, further identified the following as critical requirements:
Improve the image of clinical research in the country by working closely with health authorities, organising patient awareness programs, strengthening collaborations with the media and introducing clinical research as a subject in pharmacy and medical college
Enhance the quality of trials conducted in India by strengthening the regulatory framework; increasing awareness among stakeholders including patients; accrediting investigators, sites and ethics committees; and increasing frequency of regulatory inspections.
Many of these areas will be the focus as ISCR commemorates International Clinical Trials Day through various activities that will be held in the week of May 16th. Workshops and seminars with multi-stakeholders, panel discussion and deliberations with the regulators, training sessions and webinars are just some of the activities being conducted by ISCR Councils across the country, In addition, member organisations are hosting their own commemorative activities across locations which will include the screening of a public education film and a patient guide on clinical trials.
Each year, May 20th is celebrated as International Clinical Trials Day to mark the day the world’s first controlled clinical trial was conducted. This year, ISCR has decided to continue its focus on the theme of Patients First, to acknowledge patients who participate in clinical trials and contribute to finding new cures for so many diseases and to reiterate the clinical research fraternity’s commitment to patients who wait in hope of better treatment and cure.
Suneela Thatte, President, ISCR says, “International Clinical Trials Day gives us an opportunity every year to highlight the invaluable role clinical research plays in helping millions of patients the world over get access to new and novel medical treatments and to thank those who have participated in clinical trials and helped in the discovery of life saving medicines and therapies. All stakeholders need to work together to rebuild confidence and trust amongst the global community in doing clinical research in India now that we have a more conducive regulatory environment in India for the conduct of clinical research.”
ISCR believes that while the value of clinical research in India is being appreciated more, its full potential has yet to be realized. India has 17 percent of the global population and 20 percent of the global disease burden yet India’s share of all clinical studies being done in the world is less than 1.4 percent. Given that many of the regulatory challenges of the last two years have now been addressed through new amendments and orders, there is a need to rebuild the confidence of global and local stakeholders in order to strengthen clinical research in India.
This year, ISCR reached out to create a wider sphere of engagement for patients to mark International Clinical Trials Day. The Society held a logo design contest for patients and asked them to send in entries that represented clinical research and its value to patients. The winner was Meryl Mammen, a 26-year old patient of Pompe Disease, a rare genetic disorder. The logo she has created will be used in all communication material for this year’s International Clinical Trials Day.