An Overviewof Oncology Clinical Trials - Clinipace · B, et al. Participation of racial/ethnic...
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NATIONAL CANCER INSTITUTE (NCI) ESTIMATES 5, 6 THE NEED COST OF ONCOLOGY CLINICAL TRIALS THE HIGH STAKES OF ONCOLOGY CLINICAL TRIALS cost per patient averages $ 75,000 PHASE III ONCOLOGY STUDIES $ 120,000 EARLY PHASE TRIALS OVER 500,000 AMERICANS DIE EACH YEAR OF CANCER An Overview of Oncology Clinical Trials the number of any other therapeutic area NUMBER OF ONCOLOGY DRUGS IN CLINICAL DEVELOPMENT is more than 2 X ONCOLOGY DRUGS HAVE THE WORST APPROVAL RATES SOURCES: 1 http://www.cancer.org/acs/groups/content/@nho/documents/document/acspc-024113.pdf 5 NCI Cancer Bulletin. Legislative Update: Most States Fall Short of Requirements for Insurance Coverage of Cancer Clinical Trials. http://www.cancer.gov/ncicancerbulletin/011012/page7 6 Bond MC, Pritchard S. Understanding clinical trials in childhood cancer. Paediatr Child Health. 2006;11(3):148-150. 8 Sateren WB, Trimble EL, Abrams J, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. Journal of Clinical Oncology. 2002. 20(8):2109-17. 9 Research!America. America Speaks: Poll Data Summary. http://www.researchamerica.org/uploads/AmericaSpeaksVolume9FINAL.pdf. 10 Getz K. Clinical Trial Complexity. http://www.iom.edu/~/media/Files/Activity%20Files/Quality/VSRT/LST%20Workshop/Presentations/Getz. pdf. 11 Lewis JH, Kilgore ML, Goldman DP, Trimble EL, Kaplan R, Montello MJ, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003;21(7):1383-1389. 12 Evelyn B, Toigo T, Banks D, Pohl D, Gray K, Robins B, et al. Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995-1999. J Natl Med Assoc. 2001;93(Suppl 12):18S-24S. 13 Du W, Gadgeel SM, Simon MS. Predictors of enrollment in lung cancer clinical trials. Cancer. 2006;106(2)420-425. 14 Newburger PE, Elfenbein DS, Boxer LA. Adolescents with cancer: access to clinical trials and age-appropriate care. Curr Opin Pediatr. 2002;14(1):1-4. 15 Haynes MA and Smedley BD, eds. The Unequal Burden of Cancer: An assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved. 1999, National Academy Press, Washington, DC. 16 Sateren WB, Trimble EL, Abrams J, Brawley O, Breen N, Ford L, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol. 2002;20(8):2109-2117. 17 Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52(12):1143-1156. LOW LITERACY OR LANGUAGE DIFFERENCES PHYSICIAN LACK OF AWARENESS COMPLEX AND BURDENSOME PROTOCOLS 10 2012 analysis indicated that typical clinical trial protocol included 13 ENDPOINTS 167 PROCEDURES 35 INCLUSION AND EXCLUSION CRITERIA + + + Study patients were required to make 11 over an average of 175 VISITS DAYS LOGISTICAL CHALLENGES BARRIERS TO PARTICIPATION AND ENROLLMENT Participating in clinical research is of great value Said they would likely participate in a clinical research study NEGATIVE PERCEPTIONS ABOUT CLINICAL RESEARCH IN 2007 SURVEY, AMERICANS RESPONDED 71 % 57 % BUT ONLY COST OR LACK OF INSURANCE STUDY OF NCI CANCER-TREATMENT FOUND that uninsured patients represented only 5 . 4 % of all trial participants 8 WHO ARE UNDERREPRESENTED? 11-17 10 % of 15-to-19 year-old cancer patients enter into clinical trials, while 60% under age 15 take part LOW INCOME RURAL Low socio-economic status has a negative impact on clinical research participation Suburban geographic areas had the highest overall accrual rate OTHERS Others who are underrepresented include those with special health needs (disabled, chronic illness, comorbidities) and the uninsured NCI trials demonstrated that women were less likely than men to be enrolled in colorectal and lung cancer trials WOMEN ETHNIC Collectively racial/ethnic groups represented less than 10% of participants in trial testing cancer drugs in 1995-1999 ADOLESCENTS 2/3 of cancer patients are age 65+; account for less than of trial enrollees ELDERLY 1/3 3 % 50 % ADULT CLINICAL TRIAL PARTICIPATION RATE CHILD CLINICAL TRIAL PARTICIPATION RATE CANCER IS THE 2 ND MOST COMMON CAUSE OF DEATH IN THE UNITED STATES AND AFFLICTS EVERY AGE GROUP 1 $ 9 ...
Transcript of An Overviewof Oncology Clinical Trials - Clinipace · B, et al. Participation of racial/ethnic...
NATIONAL CANCER INSTITUTE (NCI) ESTIMATES 5, 6
THE NEED
COST OF ONCOLOGY CLINICAL TRIALS
THE HIGH STAKES OF ONCOLOGY CLINICAL TRIALS
cost per patient averages
$75,000PHASE III ONCOLOGY STUDIES
$120,000EARLY PHASE TRIALS
OVER 500,000 AMERICANS DIE EACH YEAR OF CANCER
An Overview of Oncology Clinical Trials
the number of any other therapeutic areaNUMBER OF ONCOLOGY DRUGS IN CLINICAL DEVELOPMENT is more than 2X
ONCOLOGY DRUGS HAVE THE WORST APPROVAL RATES
SOURCES:1http://www.cancer.org/acs/groups/content/@nho/documents/document/acspc-024113.pdf 5NCI Cancer Bulletin. Legislative Update: Most States Fall Short of Requirements for Insurance Coverage of Cancer Clinical Trials. http://www.cancer.gov/ncicancerbulletin/011012/page7 6Bond MC, Pritchard S. Understanding clinical trials in childhood cancer. Paediatr Child Health. 2006;11(3):148-150. 8Sateren WB, Trimble EL, Abrams J, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. Journal of Clinical Oncology. 2002. 20(8):2109-17. 9Research!America. America Speaks: Poll Data Summary. http://www.researchamerica.org/uploads/AmericaSpeaksVolume9FINAL.pdf. 10Getz K. Clinical Trial Complexity. http://www.iom.edu/~/media/Files/Activity%20Files/Quality/VSRT/LST%20Workshop/Presentations/Getz.pdf.11Lewis JH, Kilgore ML, Goldman DP, Trimble EL, Kaplan R, Montello MJ, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003;21(7):1383-1389. 12Evelyn B, Toigo T, Banks D, Pohl D, Gray K, Robins B, et al. Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995-1999. J Natl Med Assoc. 2001;93(Suppl 12):18S-24S. 13Du W, Gadgeel SM, Simon MS. Predictors of enrollment in lung cancer clinical trials. Cancer. 2006;106(2)420-425. 14Newburger PE, Elfenbein DS, Boxer LA. Adolescents with cancer: access to clinical trials and age-appropriate care. Curr Opin Pediatr. 2002;14(1):1-4. 15Haynes MA and Smedley BD, eds. The Unequal Burden of Cancer: An assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved. 1999, National Academy Press, Washington, DC. 16Sateren WB, Trimble EL, Abrams J, Brawley O, Breen N, Ford L, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol. 2002;20(8):2109-2117. 17Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52(12):1143-1156.
LOW LITERACY OR LANGUAGE DIFFERENCES
PHYSICIAN LACK OF AWARENESS
COMPLEX AND BURDENSOME PROTOCOLS 10
2012 analysis indicated that typicalclinical trial protocol included
13 ENDPOINTS
167 PROCEDURES
35 INCLUSION
AND EXCLUSION CRITERIA
+ + +
Study patients were required to make
11 over an average of 175
VISITS DAYS
LOGISTICAL CHALLENGES
BARRIERS TO PARTICIPATION AND ENROLLMENT
Participating in clinicalresearch is of great value
Said they would likely participate in a clinical research study
NEGATIVE PERCEPTIONS ABOUT CLINICAL RESEARCH
IN 2007 SURVEY, AMERICANS RESPONDED
71%
57 %
BUT ONLY
COST OR LACK OF INSURANCE
STUDY OF NCI CANCER-TREATMENT FOUNDthat uninsured patients representedonly
5. 4% of all trial participants 8
WHO ARE UNDERREPRESENTED?11-17
10 % of 15-to-19 year-old cancer patients enter into clinical trials, while 60% under age 15 take part
LOW INCOME
RURAL
Low socio-economic status has a negative impact on clinical research participation
Suburban geographic areas had the highest overall accrual rate
OTHERS Others who are underrepresented include those with special health needs (disabled, chronic illness, comorbidities) and the uninsured
NCI trials demonstrated that women were less likely than men to be enrolled in colorectaland lung cancer trials
WOMEN
ETHNIC Collectively racial/ethnic groups representedless than 10% of participants in trial testing cancer drugs in 1995-1999
ADOLESCENTS
2/3 of cancer patients are age 65+; account for less than of trial enrollees
ELDERLY
1/3
3% 50 %ADULT CLINICAL TRIAL PARTICIPATION RATE
CHILD CLINICAL TRIAL PARTICIPATION RATE
CANCER IS THE 2ND MOST COMMON CAUSE OF DEATH IN THEUNITED STATES AND AFFLICTS EVERY AGE GROUP
1
$
9
...
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