Hyderabad: The International Clinical Trials’ Day is celebrated around the world every year on May 20.
Clinical Trials Day is celebrated around the world in May to recognize the day that James Lind started what is often considered the first randomized clinical trial aboard a ship on May 20, 1747.
The day is also dedicated to patients, particularly those who have participated in clinical trials and because of whom there is access to better and newer medicines.
Groundbreaking scientific advances are possible only because of the participation of volunteers, both healthy and those diagnosed with an illness, in clinical trials. It is patients who are the real heroes as, without their contribution to understanding how humans react to different medicines, we will not be able to see the advancements in healthcare.
What is Clinical trial?
Before a new medicine is approved for use in a wider population, it must undergo extensive testing and be approved by relevant regulatory agencies.
Clinical trials are carefully designed and monitored research studies to test investigational study drugs, devices or procedure to find out if they are safe and effective before they can be approved for marketing and for general public use.
The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings, and are required for regulatory authority approval of new therapies.
At present, Clinical Trials' day has much significance as the world is going through a crisis. The whole world is coming together to combat the COVID-19 pandemic and respond to this global outbreak.
Many people voluntarily offered themself for human trial of COVID-19 vaccine world-wide. We know that every day millions of people in the world are getting infected by the COVID-19, which has claimed thousands of lives.
In this hour of crisis, where scientists need specimens for human trial to develop a vaccine against coronavirus, there are people who are coming forward for the experiment. Sometimes they even sacrifice their lives so that the lives of others can be saved.
"Solidarity” is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners.
It provides simplified procedures to enable even overloaded hospitals to participate, with no paperwork required. More than 80 countries are working together to find an effective therapeutics as soon as possible through the trial. Therefore, Solidarity trial will reduce the time taken by 80%.
A new public health tool dubbed World Without COVID was also launched with the aim of connecting patients to coronavirus clinical trials across the country.
India has recently been recognized as an attractive country for clinical trials. But the country's journey in the clinical research field has a long history. India has a rich heritage of traditional medicine – Ayurveda. The classic ayurvedic texts contain detailed observations on diseases and in-depth guidance on remedies. It is likely that these descriptions are based on direct observations made by the ancient Ayurveda experts. However, there is no recorded documentation in the ancient texts of any clinical experiments. Hence, one has to fall back on current history of medical research in India.
The major historic milestones of the Indian Council of Medical Research reflect, in many ways, the growth and development of medical research in the country over the last nine decades.
Clinical studies are an important part of drug development globally. The number of registered clinical trials has increased significantly in recent years. As of October 2019, there were about 318,901 thousand clinical studies registered globally.
The number of clinical studies has increased significantly since there were just 2,119 registered in 2000. In general, clinical trials have grown more complex in recent years and remain vital for the research and development of new drugs and products.
There is a gradual revival in the number of clinical trials being done in India. From an all-time low of 17 clinical trials approved by the Drug Controller General of India (DCGI) in 2013, the number has slowly increased to 97 in 2017, a more than 400% jump in five years.
Here are the Regulatory Bodies In World-
USA: FDA, Dept of Health and Human Services
CANADA: Health Canada
UK : Medicines and Healthcare products regulatory agency (MHRA)
EU : European Medicines Agency (EMEA)
JAPAN : Pharmaceutical and Medical Devices agencies (PMDA)
INDIA: The Central Drugs Standard Control Organisation (CDSCO) and The Drugs Controller General (India)(DCGI).
