Emerging Markets Clinical Trials: BRIC Countries (PH143)

BRIC Clinical Trials Report Sample

The following excerpt is taken from Chapter 3, "India." The first half of the chapter explores India's clinical development environment, including demographics, economics, politics and healthcare system.

Private Healthcare

The private sector is large and less regulated, yet only 0.2% of Indians have private insurance (Table 3.4). In general, it provides better healthcare for those who can afford to pay. Many foreigners take advantage of the private sectors, and medical tourism is a growing market in India. By 2012, medical tourism is forecast to have revenues of almost $2.5 billion. However, Indians who utilize private healthcare options often incur high levels of debt from medical costs.

Nonprofit Healthcare

The private nonprofit sector has a variety of health services. These services are covered by voluntary organizations (of which there are over 700), charitable institutions, missions, and charitable trusts. Healthcare in rural markets is growing. Run by the government, the National Rural Health Mission (2005-2012) takes a holistic approach to healthcare and strives to provide measures to offer quality healthcare in rural communities. It aims to increase GDP health expenditure while providing quality healthcare and does so by establishing programs and clinics to promote good healthcare practices, raise awareness on nutrition and sanitation, and track diseases.

The NRHM has worked with experts in a range of topics to provide resources for communities to increase their healthcare. For example, NRHM hired Accredited Social Health Activists to help pregnant women deliver and immunize their children, while also promoting continued best practices, and it formed Village Health and Sanitation Committees in communities to help implement village-wide healthcare practices.

The following is an excerpt from Chapter 3, section 2, "Clinical Development Strategy." The section includes executives' best practices based on their experiences conducting trials in India.

Opt For a CRO Willing to Contradict a Sponsor

Too often, eagerness overrides competency in negotiations with CROs - on the part of both the CRO and the sponsor - hindering overall trial success. The sponsor may insist on completely unrealistic timelines or protocols that no CRO could meet, and CROs often exaggerate their abilities in an effort to close the contract. When this scenario happens, the CRO wins the contract, but the trial falters. In India, where it is culturally incorrect to say "no," this communication disconnect occurs frequently, to the detriment of the clinical trial industry. In these circumstances, both companies are to blame. Sponsors, however, must take the first step in re-establishing honest communication, as their development pipelines are ultimately at stake.

Companies should look for CROs that are willing to tell them when they are mistaken. An interviewee gave an example from her experience in Type 2 diabetes drug trials:

"In the United States, one entry criterion for diabetes is usually some level of obesity, which is defined as a BMI upwards of 30. But India's diabetics genetically are lean. They don't look like Western diabetics, who tend to be overweight. The sponsor was getting blown out of the water because the BMI entry criterion was too high, and they were either having to constantly waive it, which looked bad on the audit report, or they were rejecting otherwise perfectly good patients because they were too thin. And so, they had to learn that while in India, one of the qualifications for diabetes is you could have a BMI of 21 and still be diabetic."

In situations such as these, the CRO needs to step in and provide insight based on its experience in the disease state and geography. As the clinical knowledge experts, this is their responsibility.

In the same trial, the interviewee ran into another protocol issue, in which the sponsor needed to find specific drug-naive patients. She was forced to return to the sponsor and say, "Look, if everybody is treated with this drug in India, and you can't use those patients to support your claim, then don't be going to India. Find another country. Maybe Russia has a different protocol for early treatment in Type 2 diabetics. Maybe you want to go there instead."

If a CRO cannot bluntly provide this insight, then it should not be trusted with managing a sponsor's trial. Ideally, sponsors would always conduct the necessary market research before contracting a CRO. But this is rarely the case, placing the burden of responsibility on the CRO.