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Clinical Trial Facts & Figures - CISCPR

A Very comprehensive collection of information about clinical trials and participation. Thanks to Taltell on the Yahoo board for finding this

http://www.ciscrp.org/professional/facts_pat.html


Public Attitudes and Perceptions -- Charts
General Information About Clinical Trials
-The Drug Development Process
-Cost of Research/Investment and the Economic Impact
-Physician Involvement
General Patient Recruitment Information
Global Data About Clinical Trials
Information About Participation and Clinical Trials by Ethnicity, Age and Gender
Information About Participation and Clinical Trials by Disease


Public Attitudes and Perceptions:

1. In a survey conducted by CISCRP on 1000 people in 2008,
17% say that they generally believe clinical research studies and trials are very safe
51% said that they believed them to be somewhat safe
11% said they did not believe them to be very safe
7% said they did not believe them to be safe at all
14% said they did not have any knowledge on the topic. (www.ciscrp.org)

2. In a 2006 survey conducted by CISCRP a thousand people were asked to choose which form of medical participation makes the greatest contribution to mankind, among the options were: giving blood, volunteering in a clinical trial, raising money for a charity by running a race and donating an organ, participating in a clinical trial finished last with nine percent of the votes. (www.ciscrp.org)

3. According to CenterWatch, 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 they have little to no knowledge about the clinical research enterprise and the participation process. (www.ciscrp.org)

4. More than half of respondents to a 2005 CISCRP survey on clinical trial registry users would have greater trust in clinical research information if the results were made available on a public website registry. (www.ciscrp.org)

5. In March of 2008, 57% of Americans say health-related research has helped them or someone close to them, but 90% purchased prescription drugs for themselves or family last year. (Research!America, 2008)

6. Seventy five percent of Americans think it is very important that the United States is a global leader in medical research. (Research!America, 2007)

7. Sixty nine percent of Americans are more likely to support a presidential candidate in favor of federal spending on medical, health and scientific research and 25 % say there are less likely to vote in that favor. (Research!America, 2007)

8. Seventy nine percent of Americans believe that it is very important that new medicines and health services are made available as soon as the FDA can adequately test their safety. (Research!America, Charlton Poll 2007)

9. Seventy one percent of Americans believe the information and research achieved through clinical trials is of great value. (Research!America, Charlton Poll 2007)

10. Fifty seven percent of Americans say they would be likely to participate in clinical research and 40% say they would not. (Research!America, Charlton Poll, 2007)

11. Recent polls show that positive public opinions persist in regards to the importance of clinical research. Out of 450 US households surveyed, the results showed that 63% believe that clinical trials contribute to the advancement of medicine and health care. (LJS Healthcare, 2007)

12. A 2007 Harris Interactive poll found that among 1,726 US adults, 27% of the public distrusts- 'somewhat' or 'very strongly'- the Food and Drug Administration. That same poll found that 31% of Americans believe that the FDA is effective at ensuring safety, down from 56% who did so in 2004. Nearly half of those polled said that they distrusted Capital Hill officials who govern regulatory oversight and drug development processes. (Harris Interactive, 2007)

13. Forty two percent of Americans distrust the pharmaceutical and biotechnology companies and 39% gave poor ratings to pharmaceutical and biotechnology companies for failing to serve companies in 2007. This percentage is significantly higher than the 19% who rated pharmaceutical and biotechnology companies poorly in 1997. (Harris Interactive, 2007)

14. In January of 2008, 44% of Americans said they viewed pharmaceutical and biotechnology companies unfavorably, 27% said that they do not trust them to provide reliable information about drug side effects and safety, and 45% said they do not trust the research sponsors to inform the public quickly when safety concerns about a drug are discovered. (Kaiser Foundation, 2008)

15. One in four respondents to a 2007 survey believed that their doctors would expose them to unnecessary risk in clinical trials. (Braunstein, Medicine, 2008)

16. A 2006 CISCRP survey conducted among 900 US adults found that the public's perception regarding why people choose to participate in clinical trials is because they are 'very sick without any other options' or they are 'looking to make money'. Sadly, also in this study, 34% of Americans said that they 'Do Not Admire' people who volunteer for clinical trials. (www.cicsrp.org)

17. A recent study showed that less than five percent of Americans know where to find information about relevant clinical trials. (Getz, Philadelphia Survey)

18. More than 70% of those who have participated in clinical trials] are likely to do so again. (Sun, "Sometimes Bumpy Road". 2008)


General Information About Clinical Trials:

The Drug Development Process:

1. The delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial. When calculated, this is an annual cumulative loss of 26 years, on average, for each company. (Beasely, "Recruiting". 2006)

2. Over the past five years the number of potential new drugs in development for 4,600 indications, has increased from 2,000 to 2,700. (PhRMA, 2008)

3. Between June 2007 and April 2008, 50 new medicines have been approved by the FDA in the United States. However, new drug applications and supplemental new drug applications for more than 200 drugs are still awaiting approval. (www.pharmalive.com)

4. It takes approximately 10 years of study in test tubes and laboratory mice to reach the point where a treatment may be tested for its safety and effectiveness in humans. (Getz, Informed Consent, 29)

5. 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. (Silverman, Star-Ledger, 2004)

6. Approximately one in 50 drugs that enter pre-clinical testing prove safe enough and effective enough to be tested in people. (Getz, The Gift of Participation, 59)

7. One in five drugs that enter clinical trials will prove safe and effective enough to receive FDA approval. Some of these drugs end up being most effective for patients with different diseases than those that they were originally created to treat. (Getz, The Gift of Participation, 60)

8. In 2006, 119 new remedies got the FDA's stamp of approval, including 29 "priority" drugs with a potential for significant advances over preexisting treatments. (Getz, The Gift of Participation, 60)

9. 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. (Getz, The Gift of Participation)

10. According to the FDA, approximately 70% of new medical treatments pass Phase I testing stage. (Ken Getz, Informed Consent, 34)

11. 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. (Getz, The Gift of Participation, 26)

12. 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. (Getz, The Gift of Participation, 26)

13. Therapies that have reached phase III have already passed toxicity testing and have proved to be at least somewhat effective. However, 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. (Getz, The Gift of Participation, 27)

14. 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, The Gift of Participation, 28)

15. About 80% of drugs that enter Phase III will successfully complete this stage. (Ken Getz, Informed Consent, 36)

16. Currently more than 530 drugs - new chemical entities, new formulations, and new indications - are in Phase III trials in the United States and, new indications, and new formulations are in Phase II/III trials. (www.pharmalive.com)

17. More than 1,000 new chemical entities, new indications, and new formulations are being investigated in Phase II trials in the United States. (www.pharmalive.com)

18. There are more than 130 new chemical entities, new indications, and new formulations comprising Phase I/II trials in the United States and more than 840 new chemical entities, new indications, and new formulations are in Phase I trials in the United States. (www.pharmalive.com)

19. According to a recent report in Cutting Edge Information, clinical trials last 42% longer than expected in Phase I, 31% longer in Phase II, and 30% beyond planned deadlines in Phase III - all because of recruitment delays. (Beasely, "Recruiting". 2008)

20. Each day a drug is delayed from market, sponsors lose up to $8 million. (Beasely, "Recruiting". 2008)

21. In 2007 there were 174,000 adverse effects reported to the FDA by consumers and 121,000 reported to the FDA by physicians. (www.fda.gov)

22. New medicines generated 40% of the gain in life expectancy over the past 25 years. (U.S. Census, National Vital Statistics)

23. Fifty thousand to 60,000 of these trials are industry sponsored, while the remaining are government sponsored. (Institute of Medicine)

24. Six percent of clinical trials are completed on time, and 72% of trials run over schedule by more than one month. (www.fda.gov)

25. Eighty percent of total trials are delayed at least one month because of unfulfilled enrollment. (Lamberti, "State of Clinical Trials Industry", 292)

26. The average number of patients per new drug application (NDA) is declining; a typical NDA had data from 2,186 patients in 2007, less than half the level observed ten years ago (5,582). Changing clinical study design strategies and investigator difficulty recruiting and retaining study volunteers are contributing factors to this decline.


Cost of Research/Investment and the Economic Impact:

1. The average cost of clinical trials has risen to nearly 60% of total development costs, compared to just over 30% in the 1980s. (www.pfizer.com)

2. The cost of pediatric trials increased nearly eight fold from 2000 to 2006.
(www.pfizer.com)

3. Currently about six cents of each health dollar spent in the United States is spent on medical health and research; when Americans were polled in regards to this figure:
-55% said they would like to see it increased to at least seven cents or more
-14% believe five to six cents should be adequate
-4% voted for zero to four cents
-27% percent said they did not know (Research!America, Charlton Poll, 2007)

4. Fifty seven percent of Americans said that they were willing to pay one dollar more per week in taxes, if they were sure that this money would be spent on additional medical research. (Research!America, Charlton Poll, 2007)

5. The United States' pharmaceutical and biotechnology research companies put forth a record $58.8 billion in the year 2007 towards the research and development of new life changing medicines and vaccines. This is an increase of nearly $3 billion since 2006. (PhRMA, 2008)

6. Over the past seven years, America's pharmaceutical research companies have consistently invested 18% of their sales in research and development projects. (PhRMA, 2008)

7. As of 2007, due much in part to the rigid regulations of the FDA, the average cost for moving a new drug from the test tube to the market ranges from $500 to $800 million. (www.emedonline.com)

8. The average American spends around $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, Charlton Poll, 2007)


Physician Involvement:

1. Sixty percent of physicians surveyed by CenterWatch in 2006 said that they have referred patients to clinical trials. Those that had not referred patients into trials, explain that their number one hindrance to participation was the lack of information available about the treatments. (CenterWatch 2006)

2. The most common types of clinical trials that the doctors refer their patients to are cardiology, oncology and psychology. (MacDonald, "The Psychology", CenterWatch 2006)

3. The Top Five Reasons Doctors Don't Refer Patients Into Clinical Trials:
-31% Lack of information on treatments and new investigational drugs
-15% Trials are not appropriate for my particular practice
-13% Not enough time to learn about a particular trial
-10% Lack of access to information
-7% Fear of losing a patient (MacDonald, "The Psychology", CenterWatch 2006)

4. A crucial aspect of the clinical trial process is finding an appropriate trial for each patient. Within the past few years, several useful online resources were made available to healthcare professionals to help better direct their patients towards making an education decision regarding clinical trials. Some examples of available resources: www.patientnavigation.com, The American Cancer Society (ACS), NCI and AstraZeneca all offer patient navigation programs and 60 ACS navigation programs are in place, with plans for another 50 to begin over the next five years. ("Bringing Cures". 2007)

5. Industry data suggests that fewer than four percent of all U.S. physicians participate in clinical trials. (www.futurepharmaus.com)

6. 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)

7. 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)

8. A new survey in May 2008, released by the Society for Women's Health Research indicates 94% of Americans have never been informed by their doctors of medical research studies in which they might participate. (Sun, "Sometimes Bumpy Road". 2008)

9. Seven percent of Americans say that their doctors have ever suggested that they participate in a clinical study. (Getz, Public Confidence)


General Patient Recruitment Information:

1. Less than 1/3 of people who come in for a screening end up completing a clinical trial. Some participants never pass the eligibility criteria. Others drop out...or get too busy. You have the right to quit a trial at any time, for any reason-or no reason at all. (Getz, The Gift of Participation, 40)

2. Out of all of the research sites in the United States, less than a 1/3 contain 70% of the valuable subjects. Therefore 70% of the research sites under-perform, and somewhere between 15%-20% never even enroll a single patient. (Pierre, "Recruitment and Retention". 2006)

3. Fifty percent of clinical research sites enroll one or no patients in their studies. (Pierre, "Recruitment and Retention". 2006)

4. In an analysis of 25,855 study volunteers in the United States 73.2% of participants completed Overall clinical trials (Phases I-IV), 75.4% completed Phase I clinical trials, 69.7% completed Phase II/III clinical trials and 93.8% completed Phase IV clinical trials. (CenterWatch, 2003)

5. Recent studies show that enrollment rates have dropped from 75% in 2000 to 59% in 2006 and retention rates have fallen from 69% to 48% during same period. (Getz, "Public Confidence")

6. Surveys have shown a trend toward poor volunteer retention in studies, because overall one out of every four stick with a study until its completion. Most participants dropout during phases II and III. (CenterWatch, 2005)

Global Data About Clinical Trials:

1. 26,145 unique investigators conducted FDA-regulated clinical trials world wide in 2007. (Getz, Zuckerman and Rochon, 'Landscape changes highlight growing challenges for clinical research sponsors' 2009)

2. Since 1990, the number of unique PIs has been growing 8.7% annually though year-to-year growth since 2001 has been far slower at 2.1%. (Getz, Zuckerman and Rochon, 'Landscape changes highlight growing challenges for clinical research sponsors' 2009)

3. The number of active investigators in the US has declined 3.5% annually since 2001 whereas active investigators outside the US has increased 13.5% each year during that same period. Annual growth in non-US based investigators is decelerating due to a number of factors including diminishing economic advantages and global regulatory constraints. (Getz, Zuckerman and Rochon, 'Landscape changes highlight growing challenges for clinical research sponsors' 2009)

4. Latin America, Eastern Europe and Asia have seen rapid growth in FDA-regulated clinical trials primarily for confirmatory, later stage studies. Steady growth in emerging regions is due to many factors including lower relative study conduct costs; harmonization of good clinical practice guidelines; well-positioned contract research organizations; and the availability of well trained professionals and treatment-naive patients. (Getz, Zuckerman and Rochon, 'Landscape changes highlight growing challenges for clinical research sponsors' 2009)

5.- 8.5% of active FDA-regulated investigators are based in Central and Eastern Europe, making it the largest non-Western region; the proportion of investigators based in Asia is now comparable to that from Latin America at 5.5% each. (Getz, Zuckerman and Rochon, 'Landscape changes highlight growing challenges for clinical research sponsors' 2009)


Information About Participation and Clinical Trials by Ethnicity, Age and Gender:

Volunteer Demographics:

1. In 2006, of the total number of people completing clinical trials, 775,000 people participated in government funded clinical trials, 880,000 participated in industry funded clinical trials (phases I-III) and 750,000 people participated in industry funded clinical trials (phase IV). (www.ciscrp.org)

2. About 2% of the United States population gets involved with clinical research trials each year. Among people who suffer from severe, chronic illnesses, only 6% participate. As a result, an increasing number of clinical trials are delayed because too few people...even knew they had the opportunity to get involved. (Getz, The Gift of Participation, 42)

3. Studies have shown that while 44% of people find out about studies through the media, 14% gain the information from their physicians. (Humphrey, Public Awareness)

4. An overwhelming majority of people (77%), say that they would consider getting involved in an appropriate clinical research study if asked; however, 10% of those eligible to participate in clinical trials do so in the United States. (www.ciscrp.org)

Minority
a. The involvement of minority physicians has been shown to have a positive impact on minorities 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. (Getz, The Gift of Participation, 71)

b. Unexplained cancer-related health disparities remain among population subgroups. For example, Blacks and people with low socioeconomic status have the highest rates of both new cancers and cancer deaths. (http://progress.cancer.gov)

c. In a study conducted nationwide on 3,000 women who are HIV positive and 1,000 women who were at high risk for contracting the disease, 80% of these women were of a minority subgroup. (www.womenshealth.gov)

d. Certain minority populations are more likely to suffer from specific diseases, such as diabetes and hypertension, and respond to medications differently. In response, the government has made minority inclusion mandatory for trials that it sponsors. (Getz, The Gift of Participation, 68)

e. A survey conducted on 717 US adults in 2007 found high levels of public distrust in clinical research staff. The break down showed that this level of distrust was significantly higher in minority adults, as 73% said they were 'very likely' or 'likely' to be treated as guinea pigs without their consent, whereas 49% of whites responded this way. (Braunstein, "Race Medical Researcher". 2008)

Women
a. Many diseases disproportionately affect women; among them: breast cancer, Alzheimer's disease, rheumatoid arthritis, multiple sclerosis, osteoporosis, diabetes and depression. And there are a multitude of unanswered questions. (Getz, The Gift of Participation, 67)

b. A Federal Law passed in 1993 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)

c. 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)

d. Researchers are finding that men and women are different in ways that go far beyond their reproductive systems, hormones and bone structures. Diseases may evoke different symptoms in men and women, run a different paced course through the body and finally men and women may respond differently to the same treatment. Therefore, it is very important that both sexes are represented in trials and the FDA ensures it. (www.fda.gov)

e. The National Institute of Health offered a $50,000 grant in 2006 to be put towards research regarding women and gender differences in drug usage, abuse, prevention and treatment. (www.grants.gov)

f. Cardiovascular disease is the leading killer in the United States of both men and women, but it is still considered a man's disease. The discrepancy lies in the fact that women exhibit much different symptoms and the onset of these symptoms on average occurs 10 years later in life. Seventy percent of the cardiovascular clinical trials over the past 100 years have included women, without sex difference analysis. The FDA is currently pushing to increase the enrollment of women in these trials and to cater specifically to gender differences. (www.medicaldevicestoday.com)

g. Females are underrepresented in clinical trials. Nine percent of the female respondents in a survey of 2,000 American adults released concerning Sex Differences in Health Awareness Day had ever participated in medical research, and 93% said their doctor had never mentioned the opportunity to them. In addition, 25% of these 2,000 people were unaware that healthy individuals can participate in clinical trials. (Coles, "Doctors Lack Female Participants". 2008)

Seniors
a. While seniors make up two-thirds of patients with breast, colorectal, prostate, or lung cancer, they represent one third of clinical trial participants. (www.ciscrp.org)

b. More than 700 of the approximately 1,000 drugs now being evaluated in clinical trials are aimed at treating diseases or conditions associated with aging. (Baker, "Assessing the Risks". 2008)

c. A recent study, which reviewed the Medline database for randomized controlled trials, revealed that patients were excluded due to age in 72.1% of all trials, (60.1% in pediatric populations and 38.5% in elderly patients). (Fowler, "Eligibility Criteria". 2007)

d. 63% of people in the general population age 65 or older had cancer, only 25% of patients in that age group were represented in clinical trials. (Hutchins, New England Journal of Medicine, 1999)

Pediatric
e. In 2006, the FDA disclosed that there were 465 proposed pediatric study requests, 317 actual written requests and 118 exclusively granted. (www.fda.gov)

f. Including vaccines, the pediatric drug market reaches close to $20 billion worldwide. (Lamberti, State of the Clinical Trials Industry, 88)

g. An estimated 20-30% of drugs approved by the FDA are labeled for pediatric use. (FDA, From Test to Patient, 2006)
According to a chart generated by PhRMA in 2005, the majority of drugs in clinical trials for children are intended to treat cancer. (Getz, The Gift of Participation, 209)

h. For all childhood cancers combined, the five 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, 2007)

Information About Participation and Clinical Trials by Disease:

Cancer:
a. Finding a cure to cancer would be worth about $47 trillion to the U.S. Economy alone. (Wu, "Cure for Cancer". 2006)

b. Nearly nine million Americans have survived cancer and today in the United States, there about 400 new cancer therapies in preclinical and clinical development. (Colaizzi, "Most Cancer Patients". 2006)

c. While the majority of cancer clinical trial participants are highly satisfied with their experience, as few as one in ten cancer survivors report ever being made aware of trial opportunities during treatment, according to Cancer Clinical Trials Awareness and Attitudes in Cancer Survivors, a survey conducted by the Coalition of Cancer Cooperative Groups and Northwestern University. (Colaizzi, "Most Cancer Patients". 2006)

d. Less than five percent of cancer patients participate in clinical trials. If ten percent participated, studies could be completed in one year, instead of the three-five years that studies currently require. (National Cancer Institute)

e. Government agencies, such as the National Cancer Institute (NCI) and other parts of the National Institutes of Health (NIH), the Department of Defense, and the Department of Veterans Affairs, sponsor and conduct clinical trials. In addition, organizations or individuals, such as physicians, medical institutions, foundations, volunteer groups, and pharmaceutical companies, also sponsor clinical trials. NCI sponsors a large number of clinical trials and has a number of programs designed to make clinical trials widely available in the United States. (National Cancer Institute)

f. When informed about a clinical trial by their doctor, 40% of cancer patients either enrolled or tried to enroll. Of those people who met eligibility requirements and participated, 96% said they "were treated with dignity and respect" during the trial, and 91%, said they would recommend participation to a family member or friend with cancer. (Mundell, "Clinical Trials". 2006)

g. Clinical trial participants are credited with helping to develop treatments that now save the lives of 70% to 80% of the victims of childhood leukemia. (Reader's Digest) 8. In the past three decades, the cure rate for childhood cancer has improved from less than 10% to 75%, thanks to the medical advances made by clinical research. (www.CureSearch.org)

h. In June 2008, the United States House of Representatives passed the "Caroline Pryce Walker Conquer Childhood Cancer Act", which promises significantly increased federal investment into childhood cancer research. (www.CureSearch.org)

i. Overall four out of five children diagnosed with some form of pediatric cancer can be successfully treated. (www.ccrf.org)
Ninety seven percent of respondents who participated in cancer clinical trials reported they were treated with dignity and respect and received excellent or good quality care, while 76% of trial participants said they would recommend clinical trial participation to someone with cancer. (Taylor, "Misconceptions". 2001)

j. From 1996 through 2002, 75, 215 patients were enrolled in National Cancer Institute-sponsored cooperative group nonsurgical treatment trials for breast, lung, colorectal, or prostate cancers. Approximately 3.1% of trial participants were Hispanic, 85.6% were white, 9.2% were black, 1.9% were Asian/Pacific Islanders, and 0.3% were American Indians/Alaskan Natives. In addition, although cancer incidence was evenly divided among the 3 participating age groups (30-64, 65-74, 75 years), the representation of trial participants was heavily skewed toward the youngest age group (68.0% of trial participants were 30-64 years old).

Heart Disease:
a. 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)

b. On average, it takes five years to develop, from IND filing to NDA submission, cardiovascular therapies. (CenterWatch)
Trial volunteers are credited with helping to develop the treatments that have cut the male death rate from coronary heart disease by 50%. (Reader's Digest)


If you have suggestions for more facts and figures to add to this page, please contact [e-mail] or 617-725-2750.