In the U.S., protracted contract negotiations between sponsors or contract research organizations (CROs) and investigator sites are the norm. They set trials back an average of three months.
In India, investigator sites come with their own set of problems, but contracting delays are not among them, says Dan McDonald, vice president of business development at Excel Life Sciences, a Chicago-based trial management organization that works exclusively in India (like a contract research organization, but without the monitoring). The average time spent contracting with sites: three to five weeks.
Says McDonald: “In the U.S., experienced sites have become a business, with a business development person, a CFO, and an accountant that can weigh in on: Does this study work for us? In India, the process is not nearly as complicated or aggressive."
Sites and their inner workings in India remain simpler. Yes, there is competition experienced investigators in India, but it's not as intense as it is in mature markets. Only a handful of the most experienced sites in India are juggling multiple trial offers.
Indian investigators' reasons for participating are different. “It's not just the money,” says McDonald. “They are motivated by the prestige that comes with working on a global clinical trial, the opportunity to be published and attend international symposia, as well as getting access to cutting-edge medicines and techniques. It's valuable to them professionally. You see less of this in a more mature market.”
Costs in India remain low. Alan Morgan, chief operating officer of Icon Clinical Research, shared some numbers. For a recent Icon global trial, which he felt was representative of prices across the industry, investigator fees per patient averaged $5,300 in the U.S; $3,400 in the UK; $2,400 in Brazil; $2,200 in China; $2,000 in Russia; and $1,300 in India.
Problem is, there aren't yet enough experienced investigators in India. "There's a significant pool of very experienced and qualified clinicians, many of whom are internationally recognized and Western trained, English-speaking, computer-savvy,” McDonald says. “They have the foundation for being good investigators. There is a growing pool of global clinical investigators that's getting bigger by the day, but it is still relatively small.”
How small? No official numbers exist. Excel's numbers are probably the most accurate available. The company works with sponsors to find appropriate sites for studies; it uses a 150-data-point questionnaire to determine a doctor's suitability. Some of the criteria are patient pool; years in practice; board certifications, etc. Once a doctor makes it through the screening process, Excel visits his or her office.
366 Per 1.17B
Of the 2,700 doctors who have been screened and scrutinized, McDonald says, about 1,100 were deemed ready and able to work as investigators on global clinical trials. Of that 1,100, McDonald estimates that about one-third are very experienced with global trials (more than 10 trials completed), another third have a little experience (five trials or less), and one-third have none. That means there are approximately 366 very experienced investigators in a county of 1.17 billion people.
Who are they? The clinical pioneers in India were firms like DiagnoSearch Life Sciences (formerly iGate), Quintiles, Pfizer and Lilly. They set the agenda. “Essentially, the companies that were early to India were interested in the therapeutic areas of diabetes, oncology, infectious diseases and the neuro-sciences,” explains Vasu Ginde, co-founder, president and managing director of 12-year-old CRO DiagnoSearch, which conducts trials exclusively in India. “Today, you see the fruits of these efforts. Those are the areas where you have the experienced investigators and the investments in investigator infrastructure.”
As in the states, there are few training programs or courses for doctors who want to become investigators on clinical trials. CROs must provide training on regulatory compliance and other topics, says Kohkan Shamsi, CEO of U.S. operations for the Bangalore-based CRO Manipal Acunova. The company instituted a clinical trials course in a local university to help with the process. But Shamsi says it's one of very few.
“The doctors are doing what they do best: their clinical practice,” he says. “But clinical practice is not always pharmaceutical practice. It becomes our responsibility to teach them what it is to run a pharmaceutical practice.”
100 vs. 30
And the doctors, seeing the industry grow all around them, are hungry to get involved. Ginde says large numbers of doctors approach his company asking to be trained as investigators, so DiagnoSearch puts on three-day workshops. “It's not just on GCP guidelines, but we go through practical things: how data should be collected, the process of documentation. Lots of practical aspects,” says Ginde. “The doctors are asking for it.”
So far, many of the investigator sites in India have tended to be in large, multi-specialty institutions where the doctors are generally internationally trained and the patients are those who can't afford private health insurance. The patient load is colossal; doctors in such settings see about 100 patients a day, compared to the approximate 30 a day in the U.S. As a result, physicians need plenty of help from co-investigators, assistants and, if warranted, a study coordinator. The doctor must handle informed consent and administration of the treatment. Helpers can do the rest. In large hospitals, it's a mad rush.
But the nature of investigator sites in India is changing. Private hospitals and clinics are becoming more prominent. “There's a full spectrum there,” says McDonald. “You have ultramodern private institutions on par with anything [in the U.S.], then I've seen mid-range facilities that have a dated look, then lower-quality settings that aren't as nice.”
Where a trial is set depends on what's being tested. Take conjunctivitis. It's rampant during the monsoon months among the rural poor. So the best setting for a conjunctivitis trial would be rural government hospitals. But for sponsors seeking cancer patients on third-line treatment, more upscale settings would be more appropriate places to look.
People invested in the industry are trying to build up investigator sites as quickly as possible. When a sponsor approaches DiagnoSearch about conducting a trial in India, Ginde reports, the company may initially request ten very experienced sites and a start-up time of four months. After Ginde tells them those two requests are mutually exclusive&mndash;that the most experienced sites are busy and can't get a trial up and running in four months—a more realistic alternative may be for six experienced sites and four inexperienced ones. The upside for the sponsor: the four inexperienced ones are able to be more nimble, faster. The upside for the industry: Newly minted (and badly needed) investigators get trained and enter the field.
“These new investigators require more oversight and hand holding, but the intent is to scale up,” says Ginde. “Capacity is being built. That's the way many of us have invested in new sites.”
—by Suz Redfearnd9A2t49mkex