June 16, 2005 -- U.S. Drug Clinical Trial Starts Surge to New Record in 2004-New PAREXEL Report New clinical trial starts for drugs spiked 39% in the United States during 2004, according to an analysis in PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2005/2006. The analysis found that industry submitted 542 commercial INDs in support of new drug trials in calendar year 2004, up from 391 in 2003.
As measured by commercial IND submissions, U.S. clinical trial starts had been in a slow but steady decline since the late 1990s. But the 542 commercial IND submissions in 2004 not only set a new record, they soared past the previous record of 441 in 1998 by 23% as well, according to the analysis.
FDA reporting practices for 2003 and 2004 have made tracking clinical research starts and continuing activity difficult. In both years, CDER has included filings for both drugs and therapeutic biological products (over which CDER assumed responsibility in October 2003) in reporting a single figure for commercial IND submissions. In 2004, CDER received an additional 79 commercial INDs for therapeutic biological products.
[Editor’s note: The FDA often revises the counts of IND submissions in the years following the original count. For most years, the agency revises the submissions downward slightly. The agency, however, revised its original count of commercial IND submissions in 1998 substantially, from an original count of 498 to the current count of 441.]
The sudden surge in new U.S.-based clinical trial starts comes amidst increasing talk of major companies shifting more trials overseas, particularly to Eastern Europe, India, and China, in an effort to control research costs.
Number of Industry-Sponsored Commercial IND Submissions, 1990-2004
Commercial INDs
1990 = 382
1991 = 369
1992 = 370
1993 = 384
1994 = 341
1995 = 340
1996 = 389
1997 = 396
1998 = 441
1999 = 425
2000 = 410
2001 = 409
2002 = 417
2003 = 391
2004 = 542
Not surprisingly given the overall rise in clinical research starts, industry-sponsored IND submissions rose in several therapeutic areas last year. Submissions for anti-infectives, reproduction/urological, medical imaging/radiopharmaceutical, and dermatological/dental drugs more than doubled in 2004, while metabolism/endocrine and special pathogens saw gains in excess of 80%. Only submissions for cardio-renal drugs saw a downturn in new commercial research starts in 2004 (down 16%).
Overall Clinical Trial Activity Up 6.1% in 2004
As measured by active commercial INDs, which are INDs under which pharma companies are thought to be actively researching new drugs, industry’s U.S.-based drug clinical research activities rose 6.1% in 2004 to perhaps a new record. At year-end 2004, there were 4,227 active commercial INDs for drug products at CDER, compared to 3,984 at year-end 2003.
The numbers of active commercial INDs for drug products have been on a slow, but steady, rise over the past several years. Although active INDs have risen throughout the 1990s and 2000s, the 4,227 commercial INDs active at year-end 2004 represented just a 30.3% increase over the 3,243 active as of year-end 1993.
In 2004, there was also a 7.1% increase in the number of active commercial INDs for therapeutic biological products at CDER. At year-end 2004, CDER had 600 active commercial INDs for such products.
The full analysis on U.S. clinical research activity is available in PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2005/2006 ($395, www.barnettinternational.com or 800-856-2556, x2176).