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Clinical Trials

"Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available. Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women. In the United States, an independent committee of physicians, statisticians and members of the community must approve and monitor the protocol. They make sure that the risks are small and are worth the potential benefits." Source: National Institutes of Health

Clinical trials are an essential part of the evaluation of new drugs and treatments. Each clinical trial (clinical research study) evaluates a new scientific question as researchers work to find better ways to prevent, screen for, diagnose, or treat a disease. Through clinical trials new drugs and treatments are evaluated and tested to be certain that they are safe and effective. Unfortunately, not enough people know or understand the need for clinical trials and the need for more participants. Here are some facts:

  • Currently there are approximately 50,000 clinical trials taking place in the United States, 80% are delayed at least one month because of unfulfilled enrollment. (CenterWatch)
  • Less than 5% of cancer patients participate in clinical trials. If 10% participated, studies could be completed in one year, instead of the three-five years that studies currently require. (National Cancer Institute)
  • A survey in May 2008, released by the Society for Women's Health Research, indicates that 94% of Americans have never been informed of eligible medical research studies by their doctors. (Research America)
  • New medicines generated 40% of the gain in life expectancy over the past 25 years. (National Vital Statistics Reports; U.S. Bureau of the Census)
  • 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 trials; down from 12% in 1995. This situation is of great concern because the information we get from clinical trials is of greater value when trial participants more closely represent our population. (First Clinical Research)
  • A 2002 study by the Robert Wood Johnson Foundation found that African Americans and Latinos are far less likely than whites to participate in HIV research trials, although these groups account for nearly half of HIV/AIDS patients. (Getz, The Gift of Participation)
  • 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. (Healthday News: June, 2004)
  • More than 70% of those who have participated in clinical studies in the past are likely to do so again. (Research America)
  • For all childhood cancers combined, 5 year relative survival has improved markedly over the past 30 years from less than 50% before the 1970s to nearly 80% today due to new and improved treatments. (American Cancer Society. Cancer Facts and Figures 2007)

The Center for Information and Study on Clinical Research Participation (CISCRP), was established to "educate, inform, and empower patients, the public, medical and research professionals, the media and policymakers, about clinical research participation and what it means to be an active participant in the process." CISCRP, a non-profit organization, is not involved in recruiting patients for clinical trials nor is it involved in conducting clinical trials.

The following resources will help you become more informed. You can:

 


Page updated: 14 January 2009
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