Clinical trials play a significant role, in the development breakthroughs and new approaches in medicine. These trials are keys to the advancement of medical sciences. Clinical trials look at new ways to detect, prevent or treat diseases. The treatments might be in the realm of formulation of new drugs or combination of drugs, new surgical procedures or devices, or more effective ways to use existing treatments. The goal of clinical tests is to determine if a new molecule or its application in treatment of people works and is safe. Clinical trials are essential a sine qua non in the development of new treatments. Whether a person should participate in such clinical trials depends on a person’s understanding of the risks and benefits for him/her and for the society as a whole. The theme for this year’s celebration of International Clinical Trials Day which falls on May 20th every year is “Data Centric Clinical Research’.
The world’s first clinical trial is recorded in “The Book of Daniel” in the Bible. This experiment resembling a clinical trial was not conducted by a medical practitioner, but by king Nebuchadnezzar. During his rule in Babylon, Nebuchadnezzar ordered his people to eat only meat and wine, and diet. He believed this would keep them in sound physical condition. But several young men of royal blood, who preferred to eat vegetables, objected. The king allowed these rebels to follow a diet of legumes and water – but only for 10 days. When Nebuchadnezzar’s experiment ended, the vegetarians appeared better nourished than the meat eaters, so the king permitted the legume lovers to continue their diet. This probably was one of the first times in the evolution of the human species that an open, uncontrolled and wilful human experiment guided a decision on public health.
Naval Surgeon James Lind famously conducted the first controlled clinical trial in order to find a remedy for a group of sailors suffering from Scurvy. He divided the sailors into 6 pairs. He gave each a different dietary supplement such as cider, vinegar, sea water, sulphuric acid, oranges and lemons. Within a week, the sailors who received the oranges and lemons were able to recover. This resulted in a clear evidence that citrus is a crucial part of any sailors diet. In India clinical pharmacologist, academician, and champion for the rational use of drugs Ranjit Roy Chaudhury, is often referred to as the ‘Father of Clinical Trials’ in India. He headed the first National committee for formulating the policy and guidelines on drugs and clinical trials in India.
Clinical trials are the core of medical research and involve people (health volunteers or patients) that test the safety and efficacy of a new treatment. If clinical trials are to be successful, it is critical that more people get involved. We need to spread the word about participating in clinical trials. There are two types of trials or studies – interventional and observational. There can be many challenges associated with starting clinical trials e.g. ensuring diversity, patient retention. In the case of rare diseases, finding enough people to participate in clinical trials can also be a big challenge. The most popular clinical trials presently are in the area of cancers, mental health, endocrinology, cardiovascular nervous system and digestive diseases.
Clinical trials are empirical and best suited to compare different approaches to preventing and treating illnesses and health problems. Health professionals and patients need the proven/verified evidence from trials to know which treatments work the best. Without trials there is a risk that people could be given treatments which have no edge or advantage, resulting in wasting resources and might even be downright harmful. Many treatments that are now in common use in health care were once rigorously tested through clinical tests. Clinical trials are a window to also look at the aspects of care of the patients: such as improving the quality of life for people with chronic illness. Modern medical advances have helped millions of people live longer, and rich assured healthier lives. We owe these, improvements to decades of billions of investment in medical research.
Before a pharmaceutical company starts clinical trials on a drug or a molecule, they are mandated to conduct extensive pre-clinical studies. Pre-clinical studies involve ‘in vitro’ (i.e. test tube or laboratory) studies and trials on animal population. Everyone cannot participate in a clinical trial. Eligibility for a candidate is based on your age, gender, overall health, type and stage of disease, treatment history, and other critical conditions. Clinical trials and studies do come with some possible risks. Before giving your consent to take part in a clinical trial, a candidate must find out the exact arrangements that have been made for the trial as well as the compensation that will be paid in the event of a lapse. In view of the increasing incidences of both communicable and non-communicable diseases - and especially after the devastating effects that the COVID-19 had on public health worldwide, the emphasis on clinical research assumes greater importance. Well designed, clinical trials benefit the participants, the investigators, the sponsors and the community. In Goa, VerGo Pharma research is a leading research organisation situated in Verna providing innovative drug development solutions to global pharmaceutical industry.
Clinical trials are a systematic investigation done on human subjects to evaluate the safety and efficacy of a new drug or molecule. People are invited to take part in a study in which they receive the new interventions to evaluate the effects of health outcomes. The more people take part, the faster we can find better treatments and ways to prevent the spread and cure of diseases. The process of clinical trials can take a minimum of 15 years to complete. Considering the large and diverse patient pool and a highly skilled workforce, India offers a conducive environment for efficient and cost effective clinical trials. India is becoming a favoured global destination for conducting clinical trials. China and Russia have also been performing clinical trials on a large scale. The Drug Controller General of India grants approval for clinical trial and is the final authority which specifically oversees clinical trials. The Drugs Controller is a part of the Central Drugs Standard Control Organisation.
(The writer a social scientist and practicing criminal lawyer)