| Paula Brown Stafford |
May 20 may be an unexceptional date to most, but to those of us within the clinical research community, it marks International Clinical Trials Day – a commemoration of the day that James Lind began his famous clinical trials into the causes of scurvy in 1747. More importantly, it provides a focal point to raise awareness of the significance of research to healthcare, which contributes to a better understanding of patient needs around the word.
International Clinical Trials Day seems like an appropriate time to consider just how far we have come in regard to clinical research. Lind’s experiments in 1747 consisted of just 12 men, grouped into pairs and given a variety of dietary supplements from cider to oranges and lemons. The trial only lasted six days before Lind saw notable improvement in the fruit-eating group, providing him evidence of a clear link between citrus fruits and scurvy.
These days, I am happy to say that we bring much more sophistication to clinical trials, thanks to the innovation of our forbearers. Edward Jenner’s development of the first ever vaccine for smallpox in 1796 represented a huge breakthrough, but it wasn’t until 1946 that British epidemiologist Sir Austin Bradford Hill pioneered the randomised clinical trial, eliminating bias and introducing us to the power of statistical reasoning in clinical research.
And now, we are at the precipice of the next big leap forward — the era of data-driven, intelligent drug development. Innovative processes, like risk-based monitoring, and the powerful data analytics of today’s technology, are currently converging to transform the clinical trial on an unprecedented scale. Today’s Clinical Trialists have the unique opportunity to become information managers, combining their skills with data to create insights that can improve drug development globally. We are truly on the threshold, about to step into a new, knowledge-driven world.
The positive impact of this transformation will benefit clinical research worldwide, including in India, which represents a key component of our global solution at Quintiles. We invested in this region early on back in 1997, and our collaborations there have now successfully evolved, first from local trials to global trials, and then from functional resourcing to full-service. From a clinical research standpoint, the region remains particularly attractive due to the availability of large pools of potential patients and motivated investigators for clinical trials.
India is integral to our global workforce with greater than 2,500 Quintiles resources based locally there today. This heavy resource investment reflects not only our confidence that the region will flourish as an essential hub for clinical trials, but also the fact that the therapeutic spread in India mirrors many other countries, which helps us serve patients on both a global and local scale. For example, diabetes is one of the most common lifestyle diseases in India, and it also leads the US in cost of care; therefore, by leveraging our local expertise in conjunction with our global footprint, Quintiles is uniquely positioned to make a significant impact in this disease area in the coming years — but only if we are able to research biopharma products related to diabetes within and outside of India.
India has been a significant contributor to clinical research and the development of new medicines for patients worldwide. In recent months, however, the current regulatory climate in India has been challenging and could prove to be a barrier to including patients from this country in global research efforts. Although we have performed several pivotal regulatory trials with large international companies in India, the regulatory milieu could preclude a lot of the region’s potential growth. Whereas in other Asia Pacific countries the time to obtain protocol approval is generally decreasing, in India it appears to be on the rise. In addition, some of the rules in the country’s new compensation guidelines go against the basic principles of research. If we cannot resolve these challenges quickly, it will be very difficult for India to compete with other Asia Pacific countries as we enter this new era of clinical research.
In James Lind’s day, the conduct of clinical trials was much simpler. Now, the current drug development landscape is a complex balancing act of several key factors. Of course, cost and speed to market are essential elements of effective clinical research, but ensuring impeccable conduct and quality are always at the heart of our work; in these areas, we will not compromise. The good news is that we now have more tools to address each of these challenges than ever before. Intelligent trial design and novel data integration technology are allowing us to coordinate our research on a global scale with unprecedented efficiency, quality and transparency. With gene sequencing and new biomarkers, we are transforming clinical research into a more targeted effort via personalised medicine. India has an important part to play in this new era if we can use these tools to address its current challenges.
As we celebrate International Clinical Trials Day, let us remember why India and the rest of the world should all be proud to be part of clinical drug research. The clinical trial has contributed to nearly all of the life-saving medicines that we know today. It has led to drugs that make organ transplants possible, make diabetes a manageable condition, and added nearly 20 years of life expectancy to AIDS patients. Clinical trials are a necessity to the advancement and launch of new products to treat the diseases that plague our young and old in both India and the rest of the world. India holds 16 per cent of the world’s population and the highest disease burden in the world, creating a compelling case for clinical research in this country. We have come a long way, and I have no doubt if India can work together with the global clinical community to address its current regulatory challenges, this region will continue to play a pivotal role in the great medical invention known as clinical research.