The number of commercial Investigational New Drug (IND) applications to start industry-sponsored clinical trials in the US rose by 11.6% to a record high of 662 in 2007, according to new data from contract research organisation Parexel International.

The 593 commercial IND applications filed by the biopharmaceutical industry in 2006 was a previous record. IND submissions have been steadily increasing from 542 in 2004, representing a cumulative increase of 22.1% over the three-year period, noted Mark Mathieu, director of publications at Parexel and editor of the CRO’s Bio/Pharmaceutical R&D Statistical Sourcebook, 2008/09.

As Mathieu pointed out, the year-on-year trend for commercial IND submissions has been less consistent for therapeutic biological products than for drugs. Perhaps surprisingly, given the growing presence of biologicals in pharmaceutical company pipelines, the 83 commercial INDs filed for these products in 2007 was a 27.2% decline on the 114 submitted in 2006. That figure, however, represented a jump of 67% over the number of biologicals submissions in 2005.

Oncology continued to be a focal point for new drug development efforts, accounting for the highest proportion – nearly 15% – of any therapeutic area in the total number of US clinical trials initiated during 2007. The volume of clinical trial starts for oncology drugs rose by 13% last year.

Trial starts involving neurology compounds grew sharply by 45% in 2007 compared with 8% in 2006, making up nearly 11% of last year’s total. Also accounting for 11% of all new commercial clinical trials were metabolism and endocrinology compounds, although the volume of these starts fell by 6% against 2006.

Overall, US clinical research activity sponsored by the biopharmaceutical industry was slightly down last year. Parexel’s analysis includes the number of active commercial INDs at the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER).

This assessment showed that, by the end of 2007, a total of 5,417 active commercial INDs were being managed by CDER, compared with 5,445 at the close of 2006. That followed steady growth in the volume of active commercial INDs over recent years, Mathieu observed.