India – Most Economical Destination for Conducting Global Clinical Trials

[Liberal_in_LA]

http://www.emailwire.com/release/18678-India-Most-Economical-Destination-for-Conducting-Global-Clinical-Trials.html

India – Most Economical Destination for Conducting Global Clinical Trials
As per a new research report by RNCOS, with strong savings on staff, utilities, land and time, India represents the most cost-effective destination for conducting global clinical trials.

(EMAILWIRE.COM, January 07, 2009 ) New Delhi, India - Developing a new drug is getting costlier, with our research, “Booming Clinical Trials Market in India”, estimating the cost of developing a new drug at nearly US$ 1200 in 2008, with nearly half of the cost being spent on clinical trials (phase-I to phase-IV). As a result, all major drug companies and CROs are outsourcing their clinical trials to offshore destinations to curb their surging costs.

According to our analysis, India is one of the most economical destinations for conducting global clinical trials. Companies can save a substantial amount in India on both staff and utilities. For instance, the salary of a clinical research associate is only 13% of that in the US and 17% and 19% as that in the UK and Germany respectively. Similarly, the cost of a biostatistician in India is only 15%, 18% and 17% as that in the US, UK and Germany respectively. Companies also save substantially on utilities and land while setting up their operations in India.

http://www.bio-itworld.com/newsitems/2008/jan/22-clinical-trials-india/

ndia Becoming Favored Destination for Clinical Trials

By Deborah Borfitz
Jan. 22, 2008 | As a place to conduct clinical trials, India has become strategic to the growth of biopharmaceutical companies and large clinical research organizations (CROs) contending for patients on a global scale.

All the major industry players are doing trials here with the help of in-country partners, and some of them have established an on-the-ground research presence. “India’s participation is reducing time to complete trials and helping bring drugs to market sooner,” says Ferzaan Engineer, CEO for Quintiles India. “India is also a large and growing market for pharmaceuticals.”

Companies conducting trials here include GSK, Pfizer, Novartis, Eli Lilly, Roche, and Eisai, as well as international CROs Quintiles, Covance, PPD, Parexel, Icon, Omnicare, and Clintec. A number of Indian CROs, such as SIRO and iGate, have also been growing in stature, according to Utkarsh Palnitkar, a leader in the policy and investment advisory services of Ernst & Young Private Limited in Hyderabad. “The quantum of outsourcing to India has also seen a steady increase year on year.”

[SoCalDem]

1. And poor people who die from side-effects, are just dropped from the rolls

and no one knows...

Drug testing in 3rd world countries is a "given".. Brown lives are not as "valuable", and can be used for testing..:(

[Tartiflette]

3. Actually it's more complex than that

The European and American health authorities will rarely (if ever) accept trials conducted only in the 3rd world, as the demographics are not comparable to the western countries, and there are other complicating factors that might mean results are not directly translatable. Hence, while the cost of such research is cheap, there is not necessarily any benefit to be gained from doing so, at least for large scale, confirmatory (Phase III) trials. Typically, these would be conducted across a range of countries, and with the agreement of the health authorities to which the eventual application for a new drug authorization will be submitted. However, in earlier phase trials this might hold true, and once demographic influences can be determined to be of little relevance (such as post-submission trials, for example) then of course, this might also affect choice of location for conducting a clinical trial.

[Lasher]

2. Great idea for companies seeking approval by India.

US drug approval should be based on trials conducted in the US.

[Tartiflette]

4. It almost always is

Approval in the US is almost always based on one or more large scale clinical trials having been conducted in the States (often there is one large scale trial in the US and one in the RoW) Rarely, however, there might be dispensation for trials conducted in Europe alone, although the larger Black population (I say this to avoid African American, as that term only applies to American, of course!) in the US tends to lead to slightly different demographics, and hence FDA dispensation like this is unusual.