In the past two years, clinical trials in India have come increasingly under public scrutiny. As a result, clinical research organisations (CROs), companies that conduct clinical trials for drug makers, are somewhat under pressure.
However, leading CROs in the country, such as Quintiles, are riding on the hope that they will be able to redeem the opportunities in the sector once the regulatory system is set right. As that happens, the threat to this area, where India till recently had a lead over China, shall be overcome, and things will be back to normal.
US-based Quintiles made its India foray in the late 1990s by conducting clinical trials. Today, 75 per cent of its revenue from the country comes from non-clinical services. Data-led business contributes to 60 per cent of the top line. Its largest data centre is in Bangalore.
No country other than the US has as much to offer as India: Data services, pharma vigilance and safety, cardiac (reading ECGs sent online and sending back reports online) services, clinical research (the original offering) and laboratory services. “We do a significant part of our own back office and technology work in India. This is a very strategic location,” says Anil Raghavan, managing director, Quintiles India.
Managing data lies at the heart of clinical trials. During clinical trials, a new drug gets regulatory approvals after its administration to humans under strict supervision. This is to see the efficacy, as well as the side effects, of the drug. Before the advent of the digital era, clinical research associates used to travel to trial sites to manage compliance, look at documentation and verify data. It is on the basis of the data in patient dossiers that the regulator takes a decision.
Today, a lot of what happens at a research site, hospital or clinic, can be done remotely, because data is recorded electronically and can be accessed from anywhere. So, even though clinical operations remain country-specific, a study on data can be done remotely. Once a trial is complete, the data is ‘cleaned up’, ‘locked up’ and transferred to bio-statisticians, who generate tables and graphs. Medical writers, using these inputs, write a clinical study report, which goes to the regulator. Today, clinical data management is in step with clinical operations.
Quintiles began ramping up its data business from 2004, and took a strategic decision to grow data services in India. “There has been a phenomenal growth in all the data services out of India in the past five years,” says Sanjay Patel, head of clinical data management. Roughly 40 per cent of all of Quintiles’s data management staff is in India, who manage data of global studies. “We are a global data-digesting facility.” The business expects to keep growing at the current annual pace of 30 per cent.
In keeping with the rise of data management, the way CROs get business is changing. Earlier, they grew by winning businesses study after study. Over the past decade, even as outsourcing has matured, a more strategic approach to drug development has evolved. Drug makers have grown, but so have their challenges, such as the expiry of blockbuster patents, leaving only a short pipeline of new drugs. This has put a high premium on speed, like bringing a selected molecule to the market much faster. Simultaneously, regulators have raised the bar on reliability and risk.
With sponsors needing to smooth processes, evolve strategies, throw away legacy tools and adopt new technology, CROs have come up with the idea of getting into “strategic relationships with sponsors, offering portfolio-level support in all their studies to give them analytical support and enable them to take decisions,” says Sudha Kanago, vice-president, biometrics, Asia-Pacific. Sponsors are helped with the right data bases and the right tools to ensure the data is of the highest integrity. This involves looking at the entire portfolio, tools and processes of sponsors. “We drive standardisation, automation, re-usable tools, libraries, better ways of functioning, and better analytical view of data by working across portfolios,” she adds.
This allows sponsors to concentrate on their core competence of betting on the right molecule, so once the regulatory approval comes, they can take it to market. A lot of what comes in between -- systems and process to test molecules for safety and efficacy -- can be outsourced and Quintiles’s new play (a bit over two years old) is to help companies strategically in this. As many as 1,000 of Quintiles’ 2,250 staff in India come under this operation, making it a large part of the India business. The delivery to Asian, US and European centres is made from India. This service is growing at about 30 per cent, and there is great optimism on its future.
Of all the services offered out of India, those in the cardiac sphere are headquartered here. Starting 2001, ECGs from trial sites round the world — 82 countries and 20 therapeutic areas — are being sent to India in digital form to core labs in Mumbai and Bangalore. Reports from specialists are transmitted back in 24 hours. The importance of cardiac monitoring in trials has grown rapidly since the US Food and Drug Administration issued guidelines in 2005 for molecules to have to clear cardiac safety. This is also needed for approval of new dosages and indications for drugs already approved. “The business has seen double digit growth in the past two-three years, and this should continue for the next five,” says Niraj Vyas, director, lab operations, cardiac safety services.
This operation also gives consulting services to drug start-ups to navigate the regulatory map and undertake protocol review. There is a research team for cardiac safety, which has published 17 papers in international peer-reviewed journals and 48 in other publications. “In 2001, many asked if a core lab in India could deliver cardiac-safety data. We are now considered a thought leader in cardiac safety in clinical studies. It has been an exciting journey in building a reputation,” adds Vyas.
The first of a two-part series on clinical research
Exploring digital frontiers
ECGs getting examined in India and reports going back in less than 24 hours have thrown up other possibilities. This model can be replicated in other therapeutic areas. An image of a tumour in oncology can come to India digitally and doctors can comment on it. So, the cardiac therapeutic area can transform into a multi-model bio-imaging business. Imaging is becoming a key part of clinical delivery. The infrastructure for this is being built and the process may not start in a year or two, but that is the direction in which things are moving.
Remote monitoring of signals can also be enabled by a cell phone, which is able to automatically send out signals on a person’s cardio-vascular condition.
This can give an early warning of a person about to get a heart attack or a stroke. An hour gained this way prove beneficial.
While these are futuristic, what has already arrived is medicines getting approved with real-world data conditions.
The Canadian regulator has approved a drug on condition that an ECG is taken before and after its administration. So, a patient has to spend six hours in a clinical setting before he can leave the hospital after a verification by an external cardiologist.
This highlights the role of transmitting ECGs to specialists, and getting their opinion promptly.
