Before a new compound can begin clinical trials and ultimately reach the market in the US, it first needs to be approved as an IND by the FDA. Phase III data from US trials is also required.

Because the US is the major market goal for the majority of new drug products, firms have typically submitted an IND application as early as possible in the compound's development, before it enters first-in-man studies, and continued the clinical programme from here.

However, it is also possible to obtain an IND using preclinical, Phase I and II data obtained from accredited sites from outside the US, and then begin US-based studies at a much later stage in development, and it appears that this is a route that more and more companies are now choosing.

While the total number of investigational new drug (IND) applications being submitted to the FDA has actually seen its second-highest jump in the last few years (by 8.2 per cent in 2006, compared to 4.3 per cent the previous year), the agency has anecdotally witnessed a simultaneous jump in the number of INDs being based upon data gathered from early-phase research conducted outside the US.

In an internal manual of policies and procedures (MaPP) released by the FDA's Center for Drug Evavluation and Research (CDER) earlier this year, titled "Good Review Practice: Consultative Review of Drugs Regulated Within OND," the agency stated that it has been observing:

"…a trend for INDs to be opened with studies of increasing complexity, such as late Phase II or III clinical trials that are intended to be part of an NDA or BLA submission, or Phase II trials that will affect the design of subsequent pivotal trial protocols, after completion of early phase clinical trials in non-US sites."

No definite figures or explanation could be obtained for the apparent trend, because "That particular quote relates to an overall consensus from the review divisions on the trend they are noting in IND submissions and not based on collections of any particular hard data," an FDA representative told Ootsourcing-Pharma.com.

However, the agency did say that "outside organisations such as CMR International do note a growing trend in global research and development especially in Southeast Asia (including India) and Latin America, moving away from US, EU and Japan due to costs and the desire to create a global 24/7 drug development program."

Indeed, early-phase research is growing at a prohibitive rate in the US. According to figures released by Goldman Sachs in 2006, Phase I R&D spend in the US was $5.2bn (€3.8bn) in 2005, rising to $5.8bn in 2006, and is projected to grow to $8.9bn in 2010.

Non-US sites in low-cost destinations have been hailed as being able to offer cost savings of up to 50 per cent.