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International Clinical Trials Day is a day to create awareness about the value of clinical trials, but also a day to share with patients and society at large that we are committed to addressing our burden of disease and to find cures that will help patients lead a better quality of life. Nowhere does the burden of disease hit one more than in India, a country with the world’s highest disease burden and many unmet medical needs. My work as a Senior Clinical Research Associate (CRA) is a constant reminder of the important role I play in the drug development chain and how much more research needs to be done in the country.

Pritesh

I remember working on an oncology trial and visiting sites which exposed me to the suffering of cancer patients. The satisfaction that I derived when I saw the molecule come to market was indescribable. I was filled with gratitude to know that a drug that I worked on would help improve the quality of life of many cancer patients.

It has been seven years since I have been working as a CRA. I always wanted to be a part of the healthcare industry because it is such a noble profession to be in. Where I am positioned today gives me a great insight into how a molecule develops in a clinical trial and the various stages of clinical research. But my work is challenging.

The regulatory environment in India is complex which means that there is a lot of documentation to be maintained, training to be done and stakeholders to be managed. I am the critical reviewer, the third eye that has to ensure protocols are maintained, feedback given to investigators and sponsors as required, guidelines are followed and all this, while ensuring what we do is with 100% attention to quality and ethics.

My days are tough and time management is critical. There is a lot that goes into a site visit, including interactions with internal and external stakeholders and balancing the multiple issues one comes across at various sites at any given point in time. One cannot afford to procrastinate as everything is bound by timelines. One cannot upset the rhythm of what happens at a site but at the same time one has to ensure that one’s work is done and that investigators understand the rigour of a clinical trial in comparison to clinical practice. There is a tough calmness with which we have to approach our work. We have to be on our toes at all times. 

Currently I am working on a study that involves 7000+ patients across sites in India. Large studies such as this can be exhilarating and also challenging.

But what drives me is a passion for what I do. Around me I don’t just see patients suffering from diseases that have no cure. I also see patients who are not even aware about the diseases they suffer from. This is what drives me to do more. I want to be able to contribute to a better, healthier society. That is why I believe we need more awareness to be created about the good that comes out of clinical trials. I remember the first trial I worked on as a CRA which was a psoriasis trial. On my routine monitoring visits, I saw condition that patients waiting in the outpatient department for their doctor appointments were in – the lesions, the itching and the discomfort. During my discussions with the Investigator, I was told of a patient in the trial who had been suffering from uncontrolled psoriasis for five years but had now found immense relief from the investigational drug and her quality of life had improved significantly. This was a visit that left a deep impression on me about how clinical trials contribute to drug development and better patient outcomes.

I am witness to this day in and day out when I visit sites and I hope there will come a day when everyone recognizes that no medicine we take today would have been possible without a trial and without a patient who participated in it.

 

Written by Pritesh Narvekar, Senior Clinical Research Associate, QuintilesIMS India