Drug Companies are Outsourcing Drug Trials – WP

Drug Companies are Outsourcing Drug Trials – WP

Wed, 4 May 2005

The Washington Post reports that a study by Tufts has found a drop in the number of pharmaceutical company sponsored drug trials. Fewer new drug applications are being submitted to the FDA, and there has been a drop “largely caused by the cancellation of trials entering their final phase.” That means the drugs were likely not safe. As one FDA official acknowledged, lack of efficacy has not prevented a drug from gaining FDA approval for marketing – even a miniscule “effect” greater than placebo is sufficient.

“The number of American sites where clinical trials were underway declined from about 51,000 in 2001 to 48,000 in 2003. During that same period, the number of FDA-approved investigational drug studies in all phases of research rose from about 3,900 to 4,500 — but with less research being done at U.S. sites.”

At the same time, “the number of principal investigators leading clinical trials declined by 11 percent in the United States. The number of investigators working on FDA-approved trials abroad increased by 8 percent — suggesting that the outsourcing of drug research is beginning to accelerate.”

Outsourcing human experiments is something to be concerned about – inasmuch as neither the ethical standards for the protection of human subjects, nor the scientific standards that ensure the integrity of the trials may be comparable to the requirements in the US. There is at the very least a loss of quality control when research is outsourced.

Contact: Vera Hassner Sharav
212-595-8974

washingtonpost.com
Clinical Trials of Drugs Fewer, Study Says
Report Also Notes Decline in Number of Principal Investigators in U.S.
By Marc Kaufman
Washington Post Staff Writer
Wednesday, May 4, 2005; A02

The drug industry is conducting significantly fewer clinical trials of potential new medicines now than it did in 2001, and the number of principal investigators leading those efforts in the United States has declined even more steeply, according to a study by an academic think tank on drug industry issues.

Using information collected by the Food and Drug Administration, researchers with the Tufts Center for the Study of Drug Development found that, after a major expansion during the 1990s, the number of drug industry-sponsored clinical trials leveled off in 2000 and began to drop after 2002. Study author Kenneth A. Getz said that the drop was largely caused by the cancellation of trials entering their final phase.

During that same period, the number of principal investigators leading clinical trials declined by 11 percent in the United States. The number of investigators working on FDA-approved trials abroad increased by 8 percent — suggesting that the outsourcing of drug research is beginning to accelerate.

“The big message here is that the decline in principal investigators is not solely a function of the short-term decline in clinical projects,” Getz said. “If we continue to see this in the longer term, it could diminish our ability to innovate.”

The Tufts study is believed to be the first to look at overall trends among FDA-regulated principal investigators and their work. The declines it found parallel the well-reported drop in innovative new drug applications being submitted to the FDA and reaching market.

The study also looked at the economics of clinical trials, which are becoming less lucrative for doctors and researchers. Reflecting that decline, more clinical trials are being conducted at cheaper sites abroad, and in southern states rather than in more expensive northern states. Between 1994 and 2004, the proportion of principal investigators working in the South grew by nearly 20 percent, to more than 40 percent of the nation’s total. During the same time, the proportion active in the Northeast declined from 23 to 19 percent of the total.

The study found that the number of female principal investigators is small and getting smaller. Although 28 percent of all board-certified physicians were women in 2003, only 12 percent of clinical-trial investigators were women, a lower percentage than in 1992.

The principal investigators studied are board-certified physicians hired by drug companies to conduct clinical trials that test the safety and efficacy of medications in development. Getz and his colleagues examined the forms each investigator must submit to the FDA describing his or her work. He found that the number of U.S. principal investigators peaked at 25,000 in 2001 and dropped below 21,000 by 2003.

The number of American sites where clinical trials were underway declined from about 51,000 in 2001 to 48,000 in 2003. During that same period, the number of FDA-approved investigational drug studies in all phases of research rose from about 3,900 to 4,500 — but with less research being done at U.S. sites.

Getz said his work and conversations with drug industry officials indicate that new clinical trials are increasingly being done abroad. He said that although ongoing clinical trials in the United States are generally not being moved overseas, the lower costs abroad — and the often greater professional and public interest — are leading many companies to set up new trials in Eastern Europe, South America and India.

Reflecting this trend, Tadataka Yamada, GlaxoSmithKline’s chairman of research and development, said yesterday that 29 percent of the company’s clinical trials are now done abroad, and that he expects that figure to jump to 50 percent in two years.

© 2005 The Washington Post Company

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