1. Clinical research: Less than 1.4 pct of global trials take place in India

Clinical research: Less than 1.4 pct of global trials take place in India

Clinical research is the systematic investigation of better ways to diagnose, treat, prevent, and understand diseases.

Published: May 25, 2017 5:23 AM
The biggest deterrent to a patient’s participation is lack of public awareness about the rights of trial participants and about the ethical and legal systems and monitoring mechanisms set by the government. (Representational Image: Reuters)

Clinical research is the systematic investigation of better ways to diagnose, treat, prevent, and understand diseases. Each year, May 20, is celebrated as International Clinical Trials Day to mark the day when the world’s first controlled clinical trial was conducted in 1747 by James Lind, a Scottish physician. Since patients are vital to the entire drug development process, International Clinical Trials Day is an opportune time for us to acknowledge the invaluable role patients have played in the discovery of new drugs and treatment, thus positively affecting the lives of millions suffering from various diseases across the globe.

Despite several positive reasons to participate in a trial, patient participation in clinical studies in India is low and enrolling patients in studies is a challenge. The biggest deterrent to a patient’s participation is lack of public awareness about the rights of trial participants and about the ethical and legal systems and monitoring mechanisms set by the government.

Patient retention and recruitment is key to ensuring the success of a clinical study. And retaining a patient throughout the life cycle of a clinical study is vital from a scientific and an economic point of view. 6,969 clinical trials have been registered in the Clinical Trials Registry India (CTRI) since its inception. But studies have revealed that less than 10% of clinical trials are completed on time and poor patient recruitment and retention is one of the main reasons for the delay.

An estimated 20% of principal investigators (PIs) are unable to enrol a single patient and 30% of Pis, who are able to enrol patients, fail to retain them. This is ironic considering India’s population is one of the largest and most diverse in the world.

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The reason for this paradox varies for the two categories of patients—the research naive patient population comprising of patients who do not know what research is and have never participated in a trial and the research sensitised patient population comprising of patients who have in some form been informed about trials or have participated in a trial before.

It can take the investigators a long time explaining the research naive population of patients what clinical research is, what it entails, how it is different than standard medical treatment, their rights, and how it can be beneficial to them. Lack of knowledge and awareness of clinical research in the Indian population is the biggest obstacle in recruiting patients for studies. Another factor is the perception of clinical trials being a risky affair, often driven by misrepresentation and use of the insulting term ‘guinea pigs’ for patients. The long duration of time commitment required for a study can be another inhibiting factor, especially for patients with jobs.

Patients who have participated in a trial before might be hesitant to participate in another trial if the new drug or procedure involves risks beyond the common symptoms of headaches, gastrointestinal symptoms or nominal discomfort. Complex protocols demanding long time commitments, invasive procedures, frequent blood withdrawals, paranoia associated with the audio video consent procedure, and the medicine or drug not being available in India after the study are other common reasons for the research sensitised patient population not participating in a trial.

There is a need to raise public awareness and clear misconceptions about clinical research and in this regard the media can play an important role in representing an accurate scenario of the clinical research environment in the country. Public and social media campaigns can be an effective medium to reach out to the masses and educate them. In the larger context of India’s unique healthcare requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, we need clinical research to develop new and effective medicines and vaccines to tackle our mammoth disease burden and unmet medical needs. India has 17% of the world’s population and 20% of the global disease burden and yet, less than 1.4% of global trials take place in India. If we have to find better and more cost-effective cures for these diseases in a population that is multi-racial and heterogeneous, it is necessary to conduct clinical research in India.

-By Sneha Limaye

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