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10 1Facts about

Published July 2005

1. More than 2.3 million people participate Volunteer Participation 1-15


in approximately 80,000 total clinical Public Perception 16-23
trials every year throughout the US. Clinical Research Process 24-38
(CenterWatch) Cost of Research 39-49
2. 50,000—60,000 of these trials are Adverse Events 50-55
industry sponsored, while the Physician Involvement 57-59
remaining are government sponsored. Minorities 60-65
(Institute of Medicine)
Women 66-71
3. In the past 20 years, the average
Elderly 72-76
number of patients per trial increased
Pediatric 76-78
from 1,700 to more than 4,000.
(PharmaExec.com) Cancer 79-91
4. In order to meet expected demand, the Heart Disease 92-95
number of respondents to clinical study HIV/AIDS 96-98
promotions will have to increase Lung Disease 99-101
sevenfold, from 2.8 million in 1999 to 9. In 2003, 22% of studies were
19.8 million in 2005. (Applied Clinical completed with a one month delay,
Trials)
while a whopping 72% of studies saw
5. From 2001 to 2004 the number of a delay of over one month.
people who stated that they had the (CenterWatch)
opportunity to participate in a clinical 10. Surveys have shown a trend toward
research study increased by almost poor volunteer retention in studies, as
50% from 13% to 19% (Harris Interactive, overall only one out of every four
May 2004)
(73.2%) of volunteers stick with a
6. The average number of participants study until its completion. Most drop-
needed for a new drug trial jumped outs occur during phases II and III.
from 2270 participants in the 1980s to (CenterWatch, 2003)
3,700 participants in the 1990s. (Food & 11. From 1997 to 2003, the percentage of
Drug Administration)
studies completed on time decreased
7. Studies have shown that while 44% of from 18% to 6%. (CenterWatch)
people find out about studies through
12. Only 30% of clinical trial participants
the media, only 14% gain the
report that they first learned about a
information from their physicians. (Harris
Interactive) clinical trial from their primary/specialty
health care provider – most
8. 80% of total trials are delayed at least
information comes from media or the
one month because of unfulfilled
internet. (Institute of Medicine)
enrollment. (CenterWatch)
13. One study showed that 10% of volunteers
did not look at the informed consent
before signing it; 18% signed without
input from their personal physician, nurse,
family member, or trusted; and 70%
reported that, at the outset of the informed
consent process, they did not know what
questions to ask. (Applied Clinical Trials)
14. Most adult cancer patients who
participate in clinical trials say that a 20. Only 12% of survey respondents stated
physician had a great deal of influence on that they have spoken with their doctor or
their decision to participate. (Harris healthcare provider about clinical
Interactive) research. (CISCRP/ODC Survey, 2004)
15. Even though most people do not rely on 21. From 1996 to 2002, the percentage of
their physicians for information, 78% of the public who distrusted information
the public say the physician is their most received from clinical research
trusted source of information. (CenterWatch) professionals increased from 28% to
75%. (Research America / Harris Interactive)
22. Two-thirds (66%) of Americans think that
clinical research studies are safe for
16. In a recent poll, 94% of people recognize those who participate. (CISCRP/ODC Survey)
the importance of participating in clinical 23. More than half of respondents would
research in order to assist in the have greater trust in clinical research
advancement of medical science. Yet information if the results were made
75% of the general public state that they available on a public website registry.
have little to no knowledge about the (CISCRP/OCD Survey)

clinical research enterprise and the


participation process. (CenterWatch)
17. Despite distrust, from 1995 to 2003 the
24. It takes approximately 10 years of study
percentage of people who believed that
in test tubes and laboratory mice to reach
clinical research was important in
the point where a treatment might be
advancing science increased from 83% to
tested for its safety and effectiveness in
94%. (Carlton Research and Harris Interactive)
humans. (Ken Getz, Informed Consent)
18. The major factors people look at when
25. A clinical trial is sometimes called a
considering participation in clinical trials
clinical research study or a research
includes “If it would benefit me or
protocol, but a clinical trial primarily
someone else” (58%). “If I knew all about
refers to the location where a study
the risks” was second (48%); “If the risk
protocol is being tested. In other words, a
was minimal or if the reward outweighs
single protocol involves multiple locations
the risk” was third (35.3%); “For a cure”
across a variety of cities, states and even
was fourth (35.2%); and “If my doctor
countries where clinical trials are
recommended it” was fifth (34.5%) (Harris
Interactive) conducted. (Star-Ledger Staff)
19. An overwhelming majority of people 26. Approximately one in 50 drugs that enter
(77%), say that they would consider pre-clinical testing prove safe enough
getting involved in an appropriate clinical and effective enough to be tested in
research study if asked; however, only people. (Ken Getz, Informed Consent)
10% of those eligible to participate in 27. In the 1960s, it took 8.1 years to develop
clinical trials do so in the United States. a new drug; in the 1990s it took
(Harris Interactive) researchers 15.3 years, or nearly double
the time. (Association of Clinical
Research Professionals)
28. Only one in five drugs that enter clinical
36. The FDA review period usually lasts
trials will prove safe and effective
about one year for most New Drug
enough to receive FDA approval. And
Applications (NDAs). The FDA also
some of these drugs end up being
has an expedited review process for
most effective for patients with different
priority drugs—usually lasting under six
diseases than those that they were
months. Priority drugs are those that
originally created to treat. (Ken Getz,
Informed Consent)
represent a notable treatment benefit
for critical and severe illnesses.
29. More than 120 new remedies get the
Approximately
FDA’s stamp of approval every year,
60% of all NDAs
including a handful of “breakthrough”
are approved by
drugs that provide the first effective
the FDA. (Ken Getz,
treatment ever for a variety of medical Informed Consent)
conditions. (Ken Getz, Informed Consent)
37. About 80% of
30. Even relatively small improvements drugs that enter
to existing drugs, which represent over phase III will
40% of new drugs approved by the successfully
FDA each year, provide important complete this
health benefits to patients. (Ken Getz, stage. (Ken Getz,
Informed Consent) Informed Consent)
31. According to the FDA, approximately 38. While the pharma-
70% of new medical treatments pass ceutical industry
Phase I testing stage. (Ken Getz, has increased research and
Informed Consent)
development spending over the past 20
32. Only about one-third of drugs that years, to a record $30.5 billion in 2001,
enter clinical testing ever successfully the number of new drugs has not
complete phase II and progress to increased in proportion. (Applied Clinical
larger-scale phase III studies. This Trials)
stage provides hard, statistical facts
about a drug. (Ken Getz, Informed Consent)
33. For every, 10,000 molecules screened,
an average of 250 enter pre-clinical 39. Drug companies have been increasing
testing, 10 make it through to clinical their R&D spending by about 6% a
trials, and only one is approved by the year since 1995. The Center for
regulator. (Economist, June 18, 2005) Medicines Research International
34. Phase III clinical trials involve project that will total $55 billion at the
extensive testing to assess safety, end of 2005. (Economist, June 18, 2005)
efficacy and dosage levels in a large 40. The average HIV drug cost $479m to
group of patients facing a specific bring to market. (Economist, June 18, 2005)
illness. The study drug is tested on as 41. The average cost to bring a rheumatoid
many as several thousand people over arthritis drug to market is $936 million.
a period of two to five years. (Ken Getz, (Economist, June 2005)
Informed Consent) 42. The average American spends almost
35. Therapies that have reached phase III $5,000 a year on health care. Less
have already passed toxicity testing than $20 of that amount is invested in
and have proved to be at least research to prevent, treat and cure
somewhat effective. But subjects in diseases and disabilities. (Research
phase III trials still usually have no America)
better than a 50% chance of getting the 43. In all, it may take as much as 20 years
investigational treatment versus a to bring a single new drug treatment
placebo or standard therapy. (Ken Getz, from its initial discovery through to the
Informed Consent) market. (PhRMA)
44. The projected 2005 spending for R&D 54. On average, one out of every 30 study
by phase: preclinical $12b, phase I subjects per NDA will have a serious
$4.7B, Phase II $16.2b, Phase IIIb/IV adverse event. (Food & Drug Administration)
$8.7b. (CenterWatch; Goldman Sachs) 55. Each year, 800 Serious Adverse Events
45. According to a Yale University Study, (SAEs) are typically reported to the FDA
in 1980 32% of biomedical research for newly approved drugs (Food & Drug
and development in the US was Administration)
funded by industry. By 2000, the figure 56. In reports from industry to the FDA, one
had soared to 62%. (Business Week, June out of 10,000 study subjects has died
2004) as a result of study drug effects while
46. R&D funding by therapeutic area: participating in clinical research studies.
Cancer and Endocrine 24%, Central This compares to 1 in 3,000 people who
Nervous 23%, GI/GU 15%, Infectious die from an accidental injury each year,
Disease 12%, Cardiovascular 12%, and 1 out of every 6,000 people who die
Other 10%, Nutrients 5%, Respiratory from a motor vehicle accident annually.
4%, Biologicals 3%. (CenterWatch (Food & Drug Administration)
Estimates 2004; BCC, 2003)
47. Trials funded by companies tend to be
four times more likely to have results
favorable to them than those funded
by other sources. (Guardian Unlimited: 57. One in eight physicians (13%) curently
Foregone Conclusions)
serve as a clinical investigator. (Harris
48. In 2002, the National Institutes of Interactive, May 2004)
Health (NIH) and pharmaceutical and
biotechnology companies spent more 58. 87% of physicians are not involved in
than $50 billion on research and clinical trials - 38% attribute lack of
development, from the discovery opportunity as the main reason for not
phase to FDA approval, on thousands serving as a Principal or Sub
of potential medical treatments. (Ken Investigator in a clinical trial and 32%
Getz, Informed Consent) feel that the time commitment is too
much (Harris Interactive, May 2004)
49. The money spent on clinical trials is
used to pay for the research 59. Federal agencies, who along with drug
professionals managing the projects, companies rely on community doctors
for equipment and facilities and study for about 80% of patients participating
grants to research centers conducting in studies. (WebMD Medical News)
the projects. In 2002, more than $4
billion—of the original $10 billion in
2002—will be paid as grants to
investigators within these research
centers. (Ken Getz, Informed Consent)
60. African-American, Hispanic and Asian
50. The pharmaceutical industry currently trial participants represent over 1/3 of
spends well in excess of U.S. $30 our population, yet in 1999 only 6%
billion a year in worldwide drug safety, African-Americans, 1% Asians and 1%
financing a boost in the number of Hispanics, for a total of 8%, participated
drug safety reviewers from 109 to 134. in trial; down from 12% in 1995. This
(The Boston Globe, 2005)
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. (First Clinical Research)
51. An average of 3.6 deaths attributed to 61. The involvement of minority physicians
study drug effects are reported to the has been shown to have a positive
FDA each year. (Food & Drug impact on minority involvement in
Administration) clinical trials. At this time, only about 7%
52. One adverse event per study subject of all physicians in the United States
per New Drug Application (NDA) is belong to a minority group and a very
typically reported to the FDA. (Food & small percentage are actively involved
Drug Administration) in clinical research. Several medical
societies and associations are now
53. Each year, 17,200 adverse events looking for ways to encourage minority
(AEs) are reported to the FDA for new physician involvement in clinical trials.
drugs. (Food & Drug Administration) (Ken Getz, Informed Consent)
62. In 1996,African-American patients 69. The close of the previous decade saw 8
represented 11% of all cancer trial out of the 10 prescription drugs withdrawn
participants, by 2002 that number declined from the U.S. market because they
to 7.9 percent. Hispanics, who make up caused statistically greater health risks for
9.1% of the U.S. population, made up only women than men. (Science, June 10, 2005)
3% of participants in clinical trials in 2002, 70. Between 2000 and 2003, the U.S.
down from 3.7% in 1996. (Healthday News, National Institutes of Health awarded an
June 2004)
average of 3% of its grants per year for
63. Certain minority populations are more the research on sex differences. (Science,
likely to suffer from specific diseases, such June 10, 2005)
as diabetes and hypertension. Also, 71. Men are more likely than women to enroll
minorities often respond to medications in colorectal cancer trials and lung cancer
differently. In response, the government trials. (JAMA)
has made minority inclusion mandatory
for trials that it sponsors. (Ken Getz,
Informed Consent)
64. According to some studies, three quarters
of Latinos get their information about 72. Approximately to 20% of all participants in
drugs from pharmacists, not doctors. drug trials are over the age of 65. (AARP
Usually, pharmacists are not included in Bulletin Online: June 2003)
the wide net that companies use to recruit 73. While the elderly make up two-thirds of
patients into trials. (Forbes.com) patients with either breast, colorectal,
65. The National Institutes of Health (NIH) first prostate, or lung cancer, they represented
published guidelines in 1987 for including only one-third of clinical trial participants.
(Healthday News)
more minorities in government-funded
clinical studies, but these guidelines do 74. More than 700 of the 1,000 or so drugs
not apply to industry-funded research. now being evaluated in clinical trials are
(First Clinical Research) aimed at treating diseases or conditions
associated with aging, according to the
Pharmaceutical Research and
Manufacturers of America. (AARP)
66. A 1993 Federal Law requires that the 75. There is a strong relationship between
women be included in every clinical trial age and enrollment fraction, with trial
involving a disease that affects them and participation for people 30 to 64 years of
that the NIH make sure studies are age representing 3.0% of incident cancer
designed to collect and analyze data on patients in that age group, in comparison
gender differences. (www.healthywomen.org) to 1.3% of 65-74 year olds and 0.5% of
patients 75 years and older. This inverse
67. Many diseases disproportionately affect relationship between age and trial
women; among them: breast cancer, enrollment fraction was consistent across
Alzheimer’s disease, rheumatoid arthritis, racial and ethnic groups. (JAMA)
multiple sclerosis, osteoporosis, diabetes
and depression. (Ken Getz, Informed Consent)
68. From 1977 to 1993, the FDA forbade early-
stage testing of most medications on
women of childbearing potential for fear of
causing birth defects. Now, women are
recruited for trials even if they are of
childbearing age, but are informed of any
potential risks of untested medication on
fertility- and pregnancy- related issues.
(www.healthywomen.org)
83. Only 3% of adult cancer patients sign up
for trials even though 20% typically meet
eligibility requirements, according to a
1999 study by the American Society of
76. Only five of the 80 drugs most
Clinical Oncology. (WebMD Medical News)
frequently used in newborns and infants
are labeled for pediatric use. 84. Although 61% of new cases of cancer
(CenterWatch) occur among the elderly, recent studies
77. An estimated 20-30% of drugs indicate that the elderly comprise only
approved by the FDA are labeled for 35% of participants in cancer clinical
pediatric use. (Food and Drug Administration) trials. (Journal of Clinical Oncology, 2003)
78. Including vaccines, the pediatric drug 85. Today, over 60% of pediatric patients
market reaches close to $20 billion with cancer are enrolled in clinical trials.
(Bristol-Myers-Squibb)
worldwide. (CenterWatch)
86. Clinical trial participants are credited with
helping to develop treatments that now
save the lives of 70 to 80 percent of the
victims of childhood leukemia. (Reader’s
79. Finding a cure to cancer would be worth Digest)
about $47 trillion to the U.S. economy 87. The five year survival rate for cancer
alone. (University of Chicago study) patients has increased to 64% from 59%
80. Nearly 9 million Americans have just ten years ago. (National Cancer Institute
and Centers for Disease Control and Prevention)
survived cancer. Today in the US there
are close to 400 new cancer therapies 88. In the past three decades, the cure rate
in pre-clinical and clinical development. for childhood cancer has improved from
(Coalition of National Cancer Cooperative less than 10% to 75%, thanks to medical
Groups, Inc.) advances made by clinical research.
81. Approximately 1.3 million people will be (CureSearch)
diagnosed with cancer in the US this 89. Although only 12% of the eligible
year; about 50,000 (less than five population participates in overall
percent) will enroll in cancer clinical industry-funded clinical research, 54% of
trials. Because of this limited eligible pediatric leukemia patients
enrollment, it will take about 14 years to participate in cooperative studies. (NIH
bring cancer research out of the lab and and IOM)
into the lives of cancer patients. (Coalition 90. According to a survey of nearly 6000
of National Cancer Cooperative Groups, Inc.) cancer patients conducted in Spring
82. Less than 5 percent of cancer patients 2000, Eighty four percent of respondents
participate in clinical trials. If 10 percent said they were unaware that participation
participated, studies could be in a clinical trial was a treatment option;
completed in one year, instead of the however the majority of these individuals
three-five years that studies currently said they would have been receptive to
require. (National Cancer Institute) the idea of a clinical trial if they knew it
was an option. (Harris Interactive)
91. According to the same survey, Ninety
seven percent of respondents who
participated in clinical trials reported they
were treated with dignity and respect and
received excellent or good quality care,
while seventy six percent of trial
participants said they would recommend
clinical trial participation to someone with
cancer. (Harris Interactive)
98. Although only 12% of the eligible
population participates in overall
92. Trials volunteers are credited with industry-funded clinical research, a
helping to develop the treatments that whopping 41% of eligible AIDS patients
have cut the male death rate from participate in cooperative studies. (NIH
and IOM)
coronary heart disease by 50 percent.
(Reader’s Digest)
93. Death rates from the nation’s number
one killer, heart disease, have been cut
by more than 60% in the past 50 years. 99. Thanks to ongoing clinical trials, the
(Research America) American Lung Association anticipates
94. On average, it takes 5 years to develop, important asthma treatment
from IND filing to NDA submission, breakthroughs in the next five years.
(Reader's Digest)
Cardiovascular therapies. (CenterWatch)
100. In 2004, four percent of the total funding
95. Health economists estimate that the
spent on research and development
thousands of lives saved by preventing
was spent on respiratory therapies.
and treating heart disease and stroke (CenterWatch)
from 1970 to 1998 were worth $1.1
101. Over the last 80 years, the Nationwide
trillion each year. (Research America)
American Lung Association has granted
millions of dollars to scientific studies
that have formed the basis for new
96. It is estimated that 14% of adults treatments and helped further our
receiving care for HIV infection understanding of lung disease and
participated in a medication trial or ways to prevent it. Since 1985, the
study; 24% had received experimental association has invested more than $58
medications; and 8% had tried and million in lung disease research,
failed to obtain experimental treatments. funding more than 2,000 scientists.
(Breathe Easy Magazine, 2004)
(New England Journal of Medicine)
97. Of the drugs granted “Fast Track” status
by the FDA, 10% were for HIV/AIDS
drugs. (CenterWatch)

This publication was compiled by The Center for Information and Study on Research Participation
(CISCRP), an independent nonprofit group dedicated to educating and informing the public,
patients, the media, and policy makers about clinical research participation.

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