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

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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