Quality with a supersized Q

Naz Haji, SVP and Managing Director, QuintilesIMS India, elaborates on the need to improve awareness amongst the Indian public about the role and relevance of clinical research and their rights and responsibilities as patients

Between 2012 and 2015, clinical research in India was at its nadir. Hit by regulations and guidelines, clinical research in the country had reached its lowest point and was virtually at a standstill. Global sponsors pulled clinical research out of India, while Indian sponsors chose to place their trials in neighbouring countries which offered a more predictable and secure regulatory environment. The most impacted in all of this were patients for many of whom participation in a clinical trial was their only access to a life-saving opportunity. Delayed or halted clinical trials also meant more that patients who were waiting in hope of new and more effective treatment would either have no access or delayed access to the latest treatment.

Fortunately, if anything, events of the past brought clinical research stakeholders in India together on a collaborative platform to deliberate over what needed to be done to restore normalcy in the clinical research regulatory environment. Meetings were held, arguments put forth and discussed and, slowly but surely, not only were new regulations introduced but corrections were made in existing regulations and guidelines to ensure that we had a strong regulatory environment in place which was patient-centric and focussed on safety and ethics. While there are still areas that need to be addressed, we are now at a stage where clinical trials are starting to come back to India. It may not be at the same pace as what was anticipated but then restoring trust and confidence is a slow process and will take time, notwithstanding the fact that in a clinical trial, decisions are not made overnight.

As the clinical research ecosystem in the country emerges from its dark shadows to take on the challenges of a new regulatory environment, there is renewed interest amongst global stakeholders in India. There is one area above all that we need to focus on and it is quality, with a supersized Q. While data from global clinical research inspections validates the high quality of clinical research being done in India (source: ISCR), any findings around data integrity or quality could cause serious reputation damage and set the industry back several years. It is imperative therefore for all stakeholders to be conscious, more than ever before, of the need to ensure that quality is paramount in all that we do, even if it means giving in more than a 100 per cent.

Dr W Edwards Deming, the father of the quality revolution, talked of quality being everyone’s responsibility and the need for everybody in the company to work towards accomplishing this transformation. In our business, we need to extend the ‘company’ to include the entire spectrum of clinical research stakeholders. Quality is the responsibility of each and every one of us and we need to work together to ensure that we are seen as a country that is committed to and delivers clinical research of exceptional quality.

We owe this to our patients. With the second largest global population and the world’s highest disease burden, India faces a ‘triple burden’ caused by communicable diseases, non-communicable diseases and socio-behavioral illnesses. We struggle with diseases that are close to being eradicated in other regions – such as cholera, tuberculosis, and measles – and at the same time must contend with rising rates of cancer, diabetes, cardiovascular ailments and other typically Western illnesses as a result of increasing incomes, changing lifestyles and an ageing population. Yet less than 1.4 per cent of global clinical trials are carried out in India.

We also owe it to our sponsors. Given the billions of dollars it costs to bring a new drug to market, any quality oversight will not just add additional time and cost to the drug development process, but it could jeopardise the future of a promising molecule. We have to ensure that the conduct of clinical research and the data we submit from India does not give any sponsor or regulatory authority cause for concern. It is a responsibility that we constantly remind ourselves of within our organisation, which is why quality is a continuous focus and commitment.

Over and above, the need for an enhanced quality culture, there are other areas that we need to address. There is a need to improve awareness amongst the Indian public about the role and relevance of clinical research and their rights and responsibilities as patients. Additional investment in capacity building and infrastructure will contribute to better governance and management of clinical research, helping to further advance patient safety and protection. This will further build trust and confidence among worldwide stakeholders. We also need to encourage more research and development among domestic biopharma companies, and teaching and academic institutions.

It is heartening to see Indian regulators committed to build an increasingly balanced and scientific framework for clinical research. A major milestone was the pledge in 2015 from India’s Drug Controller General, Dr GN Singh, that his objectives included “streamlining regulatory procedures without compromising patient safety.” This was further confirmed by Singh’s statement in a business publication in July 2016 which stated, “I can tell you with certainty that India is ready to do extremely good work in clinical trials now. We have created a platform through which India will become a preferred destination for clinical trials. In the next eight to 10 years, our contribution to the global clinical trial industry should be at least 10 per cent.”

For biopharma companies seeking a cost-effective location with ready access to patients, expertise and experienced site leadership, India may well be a land of opportunity for bringing new therapies to patients. But for this to happen, we need to ensure that we build a strong culture of quality and that quality is recognised as an intrinsic part of our clinical research offering. This requires commitment and effort for as William A Foster said, “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives.”