Public Perception

• The major reasons cited by patients for participating in clinical trials include “If it would benefit me or someone else” (58%). “If I knew all about the risks” was second (48%); “If the risk was minimal or if the reward outweighs the risk” was third (35.3%); For a cure” was fourth (35.2%); and “If my doctor recommended it” was fifth (34.5%) (Source: Harris Interactive)
• An overwhelming majority of people (77%), say that they would consider getting involved in an appropriate clinical research study if asked; only 10% of those eligible to participate in clinical trials do so in the United States. (Source: Harris Interactive)
• Very few patients are even aware that they are eligible to participate. And surprisingly, only 30% of participants report that they first learned about a clinical trial from their primary/specialty health care provider. (Source: Institute of Medicine)
• In a recent poll, 94% of people recognize the importance of participating in clinical research in order to assist in the advancement of medical science. Yet 75% of the general public state that they have little to no knowledge about the clinical research enterprise and the participation process. (Source: CenterWatch)
• More than half the public (55%) thinks pharmaceutical companies do enough to test and monitor the safety of their drugs, and the same share (55%) trust pharmaceutical companies at least somewhat to quickly notify the public about safety concerns. Majorities also think that pharmaceutical companies act in an ethical way when testing their products on people (62%) and on animals (56 %). (Source: USA Today, Kaiser Family Foundation, Harvard School of Public Health)
• About half of Americans say that pharmaceutical companies have too little or the right amount of influence on which drugs are approved by the U.S. Food and Drug Administration, compared with about four in 10 who say these companies have too much influence. A slim majority (52%) also says the government moves too slowly when reviewing and approving new drugs. (Source: USA Today, Kaiser Family Foundation, Harvard School of Public Health)
  

Adverse Events

• Each year, 17,200 adverse events (AEs) and 800 serious adverse event
  (SAEs) are typically reported to the FDA for newly approved drugs (Source: Food & Drug Administration)
• Each year, an average of 3.6 deaths attributed to study drug effects are reported to the FDA. (Source: Food & Drug Administration)
• One adverse event per study subject per New Drug Application (NDA) is typically reported to the FDA. (Source: Food & Drug Administration)
• On average, one out of every 30 study subjects per NDA will have a serious adverse event. (Source: Food & Drug Administration)
• In reports from industry to the FDA, one out of 10,000 study subjects have died as a result of study drug effects while participating in clinical research studies. This compares to 1 in 3,000 people who die from an accidental injury each year, and 1 out of every 6,000 people who die from a motor vehicle accident annually. (Source: Food & Drug Administration)

Minority Populations

• African-American, Hispanic and Asian trial participants represent over 1/3 of our population, yet in 1999 only 6% African-Americans, 1% Asians and 1% Hispanics, for a total of 8%, participated in trial; down from 12% in 1995. This situation is on great concern because the information we get from clinical trials is of greater value when trial participants more closely represent our population. (Source: First Clinical Research)
• The National Institutes of Health (NIH) first published guidelines in 1987 for including more minorities in government-funded clinical studies, but these guidelines do not apply to industry-funded research. (First Clinical Research)
• In 1996, black patients represented 11% of all cancer trial participants, by 2002 that number declined to 7.9 percent. Hispanics -- who make up 9.1% of the U.S. population -- made up 3% of participants in clinical trials in 2002, down from 3.7% in 1996. (Source: Healthday News: June, 2004)
• Approximately to 20% of all participants in drug trials are over the age of 65. (Source: AARP Bulletin Online: June, 2003)
  

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Costs Related to Research and Development:

• According to a Yale University study, in 1980, 32% of biomedical research and development in the U.S. was funded by industry. By 2000, the figure had soared to 62%. (Source: Business Week: June, 2004)

   

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