Info & Opinion
May 26, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
If you're flying into Bangalore, India you can expect to emerge into a modern airport. But don't expect a road that will get you from the airport to town. The government got the airport built, but not the road. Not yet.
And therein lies one of the problems that plagues clinical research in India: As various industries arrive (technology, financial services, research), the government struggles to create enough airports, roads and office parks—not to mention a reliable power grid. Some of it is there. Some isn't. But businesses come anyway, and make the best of it, and wait. And the scientific community is no exception.
“From an infrastructure standpoint, it's just not there yet,” says Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development, and a long-time watcher of the CRO space.
Many say it's just a matter of adapting, for now. Take power. India has an electricity problem. The country has about four times as many people as the U.S. but consumes just 588 billion kwh compared to USA’s 3.7 trillion kwh, according to the CIA World Factbook.
To properly support the population—and all the recent growth—India would need 24 times more electricity than it has today. That would take a costly expansion of its power grid. Until that happens, India remains a place of frequent and random power outages, some as long as 12 hours. And things worsen in the summer when usage is higher.
Got delicate samples in the fridge? Better have generators and back-up generators, says Ferzaan Engineer, CEO of Quintiles India. “We spend more on the back up than you'd spend in a country that doesn't have power issues. Some [labs and investigator sites] have two back up systems.”
And hospitals (where India's trials are conducted) can be startling to behold. “You usually see very large hospitals, in some cases of a scale we find hard to understand in the U.S.,” says Simon Britton, vice president of Asia Pacific for PPD, and formerly of Glaxo in India. He recalls visiting a psychiatric hospital with well over 1,000 beds.
What's more, most of the hospitals are traditional multi-specialty facilities in urban centers, drawing in large numbers of patients from the surrounding rural area. “A patient might travel from quite some distance,” Britton says. “They go to the hospital as their primary provider. They sit outside and wait for hours, and they might only get to spend a few minutes with the doctor.”
Investigators are well trained, eager to get involved in research, but are often overburdened. Even so, urban facilities remain the most popular for trials: they have more doctors trained in Western settings and have worked in other countries. “The expertise is there, but the money to treat in a typical western fashion isn't,” says Britton.
This may be changing, though, as more of the health care in India is starting to take place in newer, private hospitals. Other very modern hospitals are now being built to draw medical tourists to India. “It'll be interesting to see how these hospitals might motivate the government to improve the infrastructure,” says Britton.
Improving hospitals, good delivery services for samples, and decent airports are all ingredients of a very workable infrastructure for trials, says Kohkan Shamsi, CEO for India-based CRO Manipal Acunova's operations in the U.S. The roads, though? Still a problem. "Roads are not good," says Shamsi. "Most of the places, it takes long time to get anywhere; traffic is a mess."
Also of concern: staffing. Recent research by the Indian Government’s Planning Commission found that the country needs between 30,000 and 50,000 research personnel, including trial investigators, auditors, staff qualified to serve on ethics committees and drug safety monitoring boards. This is no surprise to CROs, which see the shortages in their own ranks.
Britton notes that in India, special time, effort and money must be taken to be certain staff are happy and stay put. Well-qualified employees will often get poached by other CROs, especially new firms coming into the market. Alan Morgan, chief operating officer of Icon Clinical Research says: “There's so much growth and development, new entrants come into the market and try to steal staff from companies like ourselves. It's cheaper than training someone.”
And oftentimes poaching isn't hard. Morgan says the Indian workforce tends to be far more willing to relocate for a job for just a small promotion. “The marketplace is very dynamic,” he says. “There's a real career hunger there.”
Attrition rate for employees is around 30 percent, he says, unless the staff is contented and well compensated. Some firms even benchmark salaries and pay their employees 20 percent above that just to retain them. Naturally, such practices can reduce some of the cost savings that lead the industry to India in the first place.
All in all, however, the picture is still brightening. Medium-sized cities (called Tier 2 cities) that had no airports or good roads a few years back now do. And smaller cities (called Tier 3) have formed recently, too, in response to the influx of companies. Flights in and out of these areas and in and out of India? Manipal Acunova's Shamsi estimates that the number of flights has increased 100-fold over the last decade. All of this has allowed the research industry to spread, and for companies conducting trials to reach more potential patients.
So the perception of India as a difficult environment for research may be outdated. “The old preconception is that conducting trials in India is quite a challenge,” says Morgan. “Maybe those folks who haven't got longevity of experience operating here may see it as being a complicated place. But I don't think there are many downsides to doing business there if you have a good understanding of the infrastructure and know what you're doing.”
—by Suz Redfearn