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Clinical Trial Stats
Trial Overview
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. (Source: CenterWatch)
One out of every four volunteers drops out of a study after they have begun participation. (Source: CenterWatch)
In the 1960s it took 8.1 years to develop a new drug-in the 1990s it took researchers 15.3 years, or nearly double the time. (Association of Clinical Research Professionals)
From 2001 to 2004 the number of people who stated that they had the opportunity to participate in a clinical research study increased by almost 50% from 13% to 19% (Harris Interactive, May 2004)
Although 61% of new cases of cancer occur among the elderly, recent studies indicate that the elderly comprise only 35% of participants in cancer clinical trials. (Journal of Clinical Oncology, 2003)
One in 8 physicians (13%) currently serve as a clinical investigator (Harris Interactive, May 2004)
In 2001, there were 402 different drugs in cancer trials, according to a survey on new medicines in development for cancer, published by the Pharmaceutical Research and Manufacturers of America (PhRMA)
Eighty-seven percent of physicians are not involved in clinical trials - 38% attribute lack of opportunity as the main reason for not serving as a Principal or Sub Investigator in a clinical trial and 32 % feel that the time commitment is too much (Harris Interactive, May 2004)
Treatment & Cures of Diseases
There are currently 122 new medicines in development to treat heart disease and stroke, two of the top three causes of death in the United States. (Source: Pharmaceutical Research and Manufacturers of America)
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. (Source: National Cancer Institute)
The five year survival rates for cancer patients has increased to 64% from 59% just ten years ago. (National Cancer Institute and Centers for Disease Control and Prevention.
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)
