What Everyone Needs to Know About Clinical Trials

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  • More than 20 million people in the U.S. – and 50 million worldwide – are enrolled in clinical trials, an increase of 300 percent in one decade.
  • It costs more than $6,000 to have one participant go through a clinical trial from recruitment to completion.
  • The U.S. government requires that any American company or person conducting a clinical trial overseas must meet only the ethical and legal standards of the country where the drug is being tested, not US standards.
  • Clinical trials are a $24-billion-a-year industry.
  • There are more than 1,000 private companies—Clinical Research Organizations—conducting the majority of clinical trials in the U.S., operating with less regulation than colleges and universities conducting clinical trials.
  • The pharmaceutical industry has seen the largest, steadiest annual growth of any industry in the United States since the 1940s.
  • The pharmaceutical and clinical research organization industries are so large in one part of Pennsylvania that the region is known as “pharm” country.
  • The 1954 clinical trials testing the polio vaccine was the largest and most successful in history, involving 1.8 million American children. Mostly forgotten is that 220 children became infected with polio and ten of them died after receiving a bad batch of the vaccine from one supplier.
  • Clinical trials are always experimental and should not be seen or presented as offering treatment, although researchers commonly foster that misconception in order to recruit subjects.
  • The U.S. Department of Health and Human Services says the FDA inspects less than one percent of all clinical trials. Out of the 350,000 trials sites the FDA had registered from 2000 to 2005, they inspected fewer than 3,000.
  • Sponsors of clinical trial can pick and choose which trial results they release. Out of 74 clinical trials for 12 antidepressants between 1987 and 1994, 94% of the drug trials that yielded positive results were published compared to only 14% percent of the unfavorable results.