Works Cited

Clinical Trials: Considerations for Women and Ethnic Minorities

Course #91403 - $20 • 5 Hours/Credits

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1. Powe NR, Gary TL. Clinical trials. In: Beech BM, Goodman M (eds). Race and Research: Perspectives on Minority Participation in Health Studies. Washington, DC: American Public Health Association; 2004: 61-78.

2. Gullo K. New survey shows public perception of opportunity to participate in clinical trials has decreased slightly from last year. Harris Interact Healthcare News. 2005;5:1-14.

3. National Institutes of Health. NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. Available at https://grants.nih.gov/grants/guide/notice-files/not94-100.html. Last accessed July 5, 2019.

4. Rodríguez MD, Rodríguez J, Davis M. Recruitment of first-generation Latinos in a rural community: the essential nature of personal contact. Fam Process. 2006;45(1):87-100.

5. Clinicaltrials.gov. Learn About Clinical Trials. Available at https://www.clinicaltrials.gov/ct2/about-studies/learn. Last accessed July 5, 2019.

6. National Cancer Institute. What Are Clinical Trials? Available at https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials. Last accessed July 5, 2019.

7. UCSF Helen Diller Family Comprehensive Cancer Center. What Are Clinical Trials All About? Available http://cancer.ucsf.edu/clinical-trials/what-are-clinical-trials-all-about. Last accessed July 5, 2019.

8. Posavac EJ, Carey RG. Program Evaluation: Methods and Case Studies. 8th ed. New York, NY: Routledge; 2016.

9. Benowitz S. Clinical trial transparency: registries, databases raise questions, stir debate. J Natl Cancer Inst. 2005;97(22):1640-1641.

10. Wadman M. Verdict on clinical trial registries? Good, but must do better. Nat Rev Drug Discov. 2006;5(3):175-176.

11. Bhatt A. Evolution of clinical research: a history before and beyond James Lind. Prespect Clin Res. 2010;1(1):6-10.

12. Meldrum ML. A brief history of the randomized controlled trial: from oranges and lemons to the gold standard. Hematol Oncol Clin North Am. 2000;14(4):745-760.

13. Lilly Pharmaceuticals. The History of Clinical Trials. Available at http://ictd2015.lillycoi.com. Last accessed July 5, 2019.

14. Collier R. Legumes, lemons and streptomycin: a short history of the clinical trial. CMAJ. 2009;180(1):23-24.

15. Sood A, Prasad K, Chhatwani L, et al. Patients' attitudes and preferences about participation and recruitment strategies in clinical trials. Mayo Clin Proc. 2009;84(3):243-247.

16. Shuster E. Fifty years later: the significance of the Nuremberg Code. N Engl J Med. 1997;337(20):1436-1440.

17. Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003;21(5):830-835.

18. Madsen SM, Holm S, Riis P. Attitudes towards clinical research among cancer trial participants and non-participants: an interview study using a grounded theory approach. J Med Ethics. 2007;33(4):234-240.

19. Almeida L, Azevedo B, Nunes T, Vaz-da-Silva M, Soares-da-Silva P. Why healthy subjects volunteer for phase I studies and how they perceive their participation. Eur J Clin Pharmacol. 2007;63(11):1085-1094.

20. Jenkins V, Farewell D, Batt L, et al. The attitudes of 1066 patients with cancer towards participation in randomised clinical trials. Br J Cancer. 2010;103(12):1801-1807.

21. Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P. Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med. 2002;251(2):156-168.

22. Truong TH, Weeks JC, Cook EF, Joffe S. Altruism among participants in cancer clinical trials. Clin Trials. 2011;8(5):616-623.

23. Trauth JM, Musa D, Siminoff L, Jewell IK, Ricci E. Public attitudes regarding willingness to participate in medical research studies.J Health Soc Policy. 2000;12(2):23-43.

24. Goldman DP, Berry SH, McCabe MS, et al. Incremental treatment costs in National Cancer Institute-sponsored clinical trials. JAMA. 2003;289(22):2970-2977.

25. Gifford AL, Cunningham WE, Heslin KC, et al. Participation in research and access to experimental treatments by HIV-infected patients. N Engl J Med. 2002;346(18):1373-1382.

26. Greenberger PE, Knab S. News from the Society for Women's Health Research: subgroup analysis of clinical trials: detecting sex differences. J Womens Health Gend Based Med. 2002;11(1):7-9.

27. Vidaver RM, Lafleur B, Tong C, Bradshaw R, Marts SA. Women subjects in NIH-funded clinical research literature: lack of progress in both representation and analysis by sex. J Womens Health Gend Based Med. 2000;9(5):495-504.

28. Ramasubbu K, Gurm H, Litaker D. Gender bias in clinical trials: do double standards still apply? J Womens Health Gend Based Med. 2001;10(8):757-764.

29. Geller SE, Adams MG, Carnes M. Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials.J Womens Health. 2006;15(10):1123-1131.

30. Blauwet LA, Hayes SN, McManus D, Redberg RF, Walsh MN. Low rate of sex-specific result reporting in cardiovascular trials. Mayo Clin Proc. 2007;82(2):166-170.

31. Geller SE, Koch A, Pellettieri B, Carnes M. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress? J Womens Health (Larchmt). 2011;20(3):315-320.

32. Wendler D, Kington R, Madans J, Van Wye G, Christ-Schmidt H. Minority participation in health research: facts and fiction.PLoS Med. 2006;3(2):153-154.

33. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291(22):2720-2726.

34. Stone VE, Mauch MY, Steger K, Janas SF, Craven DE. Race, gender, drug use, and participation in AIDs clinical trials: lessons from a municipal hospital cohort. J Gen Intern Med. 1997;12(3):150-157.

35. Stark N, Paskett E, Bell R, et al. Increasing participation of minorities in cancer clinical trials: summary of the "Moving Beyond the Barriers" Conference in North Carolina. J Natl Med Assoc. 2002;94(1):31-39.

36. Mak WW, Law RW, Alvidrez J, Pérez-Stable EJ. Gender and ethnic diversity in NIMH-funded clinical trials: review of a decade of published research. Adm Policy Ment Health. 2007;34(6):497-503.

37. Larson EL, Cohn EG, Meyer DD, Boden-Albala B. Consent administrator training to reduce disparities in research participation.J Nurs Scholarsh. 2009;41(1):95-103.

38. U.S. Census Bureau. Age and Sex Composition: 2010. Available at https://www.census.gov/prod/cen2010/briefs/c2010br-03.pdf. Last accessed July 5, 2019.

39. U.S. Census Bureau. U.S. Census Bureau Projections Show a Slower Growing, Older, More Diverse Nation a Half Century from Now. Available at https://www.census.gov/newsroom/releases/archives/population/cb12-243.html. Last accessed July 5, 2019.

40. Giacomini M, Baylis F. Excluding women from medical research: reasons and rejoinders. Clinical Researcher. 2003;3(10):12-15.

41. Secundy MG. Ethical issues in research. In: Adams DL (ed). Health Issues for Women of Color: A Cultural Diversity Perspective. Thousand Oaks, CA: Sage Publications; 1995: 228-238.

42. Hussain-Gambles M. Ethnic minority under-representation in clinical trials: whose responsibility is it anyway? J Health Organ Manag. 2003;17(2):138-143.

43. Garber M, Arnold R. Promoting the participation of minorities in research. Am J Bioeth. 2006;6(3):W14-W20.

44. Glanz K, Croyle RT, Chollette VY, Pinn VW. Cancer-related health disparities in women. Am J Public Health. 2003;93(2):292-298.

45. Melloni C, Berger JS, Wang TY, et al. Representation of women in randomized clinical trials of cardiovascular disease prevention. Circ Cardiovasc Qual Outcomes. 2010;3(2):135-142.

46. Society for Women's Health Research. Barriers to Women's Participation in Clinical Trials and SWHR Proposed Solutions. Available at https://swhr.org/barriers-to-womens-partipication-in-clinical-trials-and-swhr-proposed-solutions. Last accessed July 5, 2019.

47. Lyerly AD, Little MO, Faden R. The second wave: toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2008;1(2):5-22.

48. U.S. Department of Health and Human Services Office of Minority Health. Profile: Black/African Americans. Available at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=61. Last accessed July 5, 2019.

49. U.S. Department of Health and Human Services Office of Minority Health. Profile: American Indian/Alaska Native. Available at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=62. Last accessed July 5, 2019.

50. U.S. Department of Health and Human Services Office of Minority Health. Profile: Hispanic/Latino Americans. Available at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=64. Last accessed July 5, 2019.

51. Vaidya V, Partha G, Karmakar M. Gender differences in utilization of preventive care services in the United States. J Womens Health (Larchmt). 2012;21(2):140-145.

52. Mason SE. Offering African Americans opportunities to participate in clinical trials research: how social workers can help. Health Soc Work. 2005;30(4):296-304.

53. Peppercorn JM, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet. 2004;363:263-270.

54. Meinert CL. Redesign of trial under different enrollment mixes. Stat Med. 1999;18(3):241-251.

55. Kenny SC. "I can do the child no good:" Dr. Sims and the enslaved infants of Montgomery, Alabama. Social History of Medicine. 2007;20(2):223-241.

56. Wall LL. The medical ethics of Dr. J. Marion Sims: a fresh look at the historical record. J Med Ethics. 2006;32(6):346-350.

57. Marks L. Human guinea pigs? The history of the early oral contraceptive clinical trials. History and Technology. 1999;15(4):263-288.

58. Gejman PV, Weilbaecher A. History of the eugenic movement. Isr J Psychiatry Relat Sci. 2002;39(4):217-231.

59. Killien M, Bigby JA, Champion V, et al. Involving minority and underrepresented women in clinical trials: the National Centers of Excellence in Women's Health. J Womens Health Gend Based Med. 2000;9(10):1061-1070.

60. Weinstein M. A public culture for guinea pigs: U.S. human research subjects after the Tuskegee Study. Sci Cult. 2001;10(2):195-223.

61. Stevens PE, Pletsch PK. Informed consent and the history of inclusion of women in clinical trials. Health Care Women Int. 2002;23(8):809-819.

62. Van Dyke EM, Gerbert DA, Herman LM, et al. Paradigm shifts in the approach to women's health care. JAAPA. 2006;19(10): 50, 52-53, 55.

63. Kahn J. Genes, race, and population: avoiding a collision of categories. Am J Public Health. 2006;96(11):1965-1970.

64. Wells AA, Zebrack B. Psychosocial barriers contributing to the under-representation of racial/ethnic minorities in cancer clinical trials. Soc Work Health Care. 2008;46(2):1-14.

65. Ding EL, Powe NR, Manson JE, Sherber NS, Braunstein JB. Sex differences in perceived risks, distrust, and willingness to participate in clinical trials: a randomized study of cardiovascular prevention trials. Arch Intern Med. 2007;167(9):905-912.

66. Woods MN, Harris KJ, Mayo MS, Catley D, Scheibmeir M, Ahluwalia JS. Participation of African Americans in a smoking cessation trial: a quantitative and qualitative study. J Natl Med Assoc. 2002;94(7):609-618.

67. Lin JS, Finlay A, Tu A, Gany FM. Understanding immigrant Chinese Americans' participation in cancer screening and clinical trials. J Community Health. 2005;30(6):451-466.

68. Samsudeen BS, Douglas A, Bhopal RS. Challenges in recruiting South Asians into prevention trials: health professional and community recruiters' perceptions on the PODOSA trial. Public Health. 2011;125(4):201-209.

69. Russell SL, Katz RV, Kressin NR, et al. Beliefs of women's risk as research subjects: a four-city study examining differences by sex and by race/ethnicity. J Womens Health. 2009;18(2):235-243.

70. Hamilton LA, Aliyu MH, Lyons PD, et al. African-American community attitudes and perceptions toward schizophrenia and medical research: an exploratory study. J Natl Med Assoc. 2006;98(1):18-27.

71. Flaskerud JH, Nyamathi AM. Attaining gender and ethnic diversity in health intervention resesearch: cultural responsiveness versus resource provision. ANS Adv Nurs Sci. 2000;22(4):1-15.

72. Hochhauser M. Informed consent and patient's rights documents: a right, a rite, or a rewrite? Ethics Behav. 1999;9(1):1-20.

73. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358(9295):1772-1777.

74. Durant RW, Legedza AT, Marcantonio ER, Freeman MB, Landon BE. Different types of distrust in clinical research among whites and African Americans. J Natl Med Assoc. 2011;103(2):123-130.

75. Bates BR, Harris TM. The Tuskegee study of untreated syphilis and public perceptions of biomedical research: a focus group study.J Natl Med Assoc. 2004;96(8):1051-1064.

76. Mays VM, Coles CN, Cochran SD. Is there a legacy of the U.S. Public Health Syphilis Study at Tuskegee in HIV/AIDS-related beliefs among heterosexual African-Americans and Latinos? Ethics Behav. 2012;22(6):461-471.

77. Gilley BJ, Keesee M. Linking "white oppression" and HIV/AIDS in American Indian etiology: conspiracy beliefs among MSMs and their peers. Am Indian Alsk Native Ment Health Res. 2007;14(1):44-62.

78. Bogart LM, Thorburn S. Are HIV/AIDS conspiracy beliefs a barrier to HIV prevention among African Americans? J Acquir Immune Defic Syndr. 2005;38(2):213-218.

79. Moutsiakis DL, Chin NP. Why Blacks do not take part in HIV vaccine trials. J Natl Med Assoc. 2007;99(3):254-257.

80. Knerr S, Wayman D, Bonham VL. Inclusion of racial and ethnic minorities in genetic research: advance the spirit by changing the rules? J Law Med Ethics. 2011;39(3):502-512.

81. Fisher JA, Kalbaugh CA. Challenging assumptions about minority participation in US clinical research. Am J Public Health. 2011;101(12):2217-2222.

82. Johnson VA, Edwards KA, Sherman SL, et al. Decisions to participate in fragile X and other genomics-related research: Native American and African. J Cult Divers. 2009;16(3):127-135.

83. Saldov M, Kakai H, McLaughlin L, Thomas A. Cultural barriers in oncology: issues in obtaining medical informed consent from Japanese-American elders in Hawaii. J Cross Cult Gerontol. 1998;13(3):265-279.

84. Rooney LK, Bhopal R, Halani L, et al. Promoting recruitment of minority ethnic groups into research: qualitative study exploring the views of South Asian people with asthma. J Public Health (Oxf). 2011;33(4):604-615.

85. Hsiung YY, Ferrans CE. Recognizing Chinese Americans' cultural needs in making end-of-life treatment decisions. J Hosp Palliat Nurs. 2007;9(3):132-140.

86. Palafox NA, Buenconsejo-Lum L, Riklon S, Waitzfelder B. Improving health outcomes in diverse populations: competency in cross-cultural research with indigenous Pacific Islander populations. Ethn Health. 2002;7(4):279-285.

87. Gwadz MV, Leonard NR, Nakagawa A, et al. Gender differences in attitudes toward AIDS clinical trials among urban HIV- infected individuals from racial and ethnic minority backgrounds. AIDS Care. 2006;18(7):786-794.

88. Han H, Kang J, Kim KB, Ryu JP, Kim MT. Barriers to and strategies for recruiting Korean Americans for community-partnered health promotion research. J Immigr Minor Health. 2007;9(2):137-146.

89. Stoddart ML, Jarvis B, Blake B, Fabsitz RR, Howard BV, Lee ET, Welty TK. Recruitment of American Indians in epidemiologic research: the strong heart study. Am Indian Alsk Native Ment Health Res. 2000;9(3):20-37.

90. Schmidt CW. Indi-gene-ous conflict. Environ Health Perspect. 2001;109(5):A216-A219.

91. Brown R, Bylund CL, Siminoff LA, Slovin SF. Seeking informed consent to phase I cancer clinical trials: identifying oncologists' communication strategies. Psychooncology. 2011;20(4):361-368.

92. Zaller N, Nelson KE, Ness P, Wen G, Bai X, Shan H. Knowledge, attitude and practice survey regarding blood donation in a Northwestern Chinese city. Transfus Med. 2005;15(4):277-286.

93. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: U.S. Government Printing Office; 1979. Available at https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html. Last accessed July 5, 2019.

94. Helmreich RJ, Hundley V, Norman A, Ighedosa J, Chow E. Research in pregnant women: the challenges of informed consent.Nurs Womens Health. 2007;11(6):576-585.

95. Meddings F, Haith-Cooper M. Culture and communication in ethically appropriate care. Nurs Ethics. 2008;15(1):52-61.

96. Hanssen I. An intercultural nursing perspective on autonomy. Nurs Ethics. 2004;11(1):28-41.

97. Mehlman MJ, Berg JW. Human subjects protections in biomedical enhancement research: assessing risk and human benefit and obtaining informed consent. J Law Med Ethics. 2008;36(3):546-549.

98. Schonfeld TL, Amoura NJ, Stoner JA, Gordon BG. Women and contraception in research: a pilot study. J Womens Health. 2009;18(4):507-512.

99. Resnik DB. Randomized controlled trials in environmental health research: ethical issues. J Environ Health. 2008;70(6):28-30.

100. Maxwell AE, Bastani R, Vida P, Warda US. Strategies to recruit and retain older Filipino-American immigrants for a cancer screening study. J Community Health. 2005;30(3):167-179.

101. Larson EL, Ferng YH, Wong-McLoughlin J, Wang S. Retention and protocol adherence of Hispanic volunteers in a longitudinal trial. Am J Health Behav. 2009;33(4):435-444.

102. Ramos-Gomez F, Chung LH, Gonzalez Beristain R, et al. Recruiting and retaining pregnant women from a community health center at the US-Mexico border for the Mothers and Youth Access clinical trial. Clin Trials. 2008;5(4):336-346.

103. Olsen SJ, Malvern KT, May BJ, Jenkins IL, Griffin CA. Partnership with an African American sorority to enhance participation in cancer genetics research. Community Genet. 2008;11(4):201-207.

104. James RD, Yu JH, Henrikson NB, Bowen DJ, Fullerton SM. Strategies and stakeholders: minority recruitment in cancer genetics research. Community Genet. 2008;11(4):241-249.

105. Zhu K, Hunter S, Bernard LJ, Payne-Wilks K, Roland CL, Levine RS. Recruiting elderly African-American women in cancer prevention and control studies: a multifaceted approach and its effectiveness. J Natl Med Assoc. 2000;92(4):169-175.

106. Ejiogu N, Norbeck JH, Mason MA, Cromwell BC, Zonderman AB, Evans MK. Recruitment and retention strategies for minority or poor clinical research participants: lessons from the Healthy Aging in Neighborhoods of Diversity across the Life Span study. Gerontologist. 2011;51 Suppl 1:S33-S45.

107. King WD, Defreitas D, Smith K, et al. Attitudes and perceptions of AIDS clinical trials group site coordinators on HIV clinical trial recruitment and retention: a descriptive study. AIDS Patient Care STDs. 2007;21(8):551-563.

108. Yick AG, Berthold SM. Conducting research on violence in Asian American communities: methodological issues. Violence Vict. 2005;20(6):661-677.

109. Bhopal R. Race and ethnicity: responsible use from epidemiological and public health perspectives. J Law Med Ethics. 2006;34(3):500-507.

110. Roberts DE. Legal constraints on the use of race in biomedical research: toward a social justice framework. J Law Med Ethics. 2006;34(3):526-534.

111. Wood SF. Tracking inclusion of women in clinical trials. J Womens Health. 2010;18(3):301-302.

112. Green L. Explaining the role of the nurse in clinical trials. Nurs Stand. 2011;25(22):35-39.

113. Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med. 2010;153(3):158-166.

114. Collier R. Clinical trial registries becoming a reality, but long-term effects remain uncertain. CMAJ. 2009;180(10):1007-1008.

115. Bhatt A. Evolution of clinical research: a history before and beyond James Lind. Perspect Clin Res. 2010;1(1):6-10.

116. Cimons M. CDC Says It Erred in Measles Study. Available at https://www.latimes.com/archives/la-xpm-1996-06-17-mn-15871-story.html. Last accessed July 5, 2019.

117. McCarthy CR. Historical background of clinical trials involving women and minorities. Acad Med. 1994;69(9):695-698.

118. Joshi V, Kulkarni AA. Public awareness of clinical trials: a qualitative pilot study in Pune. Perspect Clin Res. 2012;3(4):125-132.

119. Foulkes MA. After inclusion, information and inference: reporting on clinical trials results after 15 years of monitoring inclusion of women. J Womens Health. 2011;20(6):829-836.

120. Geller SE, Koch A, Pellettieri B, Carnes M. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress? J Womens Health. 2011;20(3):315-320.

121. Kaneshiro B, Geling O, Gellert K, Millar L. The challenges of collecting data on race and ethnicity in a diverse, multiethnic state. Hawaii Med J. 2011;70(8):168-171.

122. ClinicalTrials.gov. Trends, Charts, and Maps. Available at https://clinicaltrials.gov/ct2/resources/trends. Last accessed July 5, 2019.

123. Blauwet LA. Sex and race/ethnicity reporting in clinical trials: a necessity, not an option. J Womens Health. 2011;20(3):313-314.

124. Berlin JA, Ellenberg SS. Commentary: inclusion of women in clinical trials. BMC Med. 2009;7:56.

125. Rivera-Goba MV, Dominguez DC, Stoll P, et al. Exploring decision-making of HIV-infected Hispanics and African Americans participating in clinical trials. J Assoc Nurses AIDS Care. 2011;22(4):295-306.

126. Azétsop J, Rennie S. Principlism, medical individualism, and health promotion in resource-poor countries: can autonomy based bioethics promote social justice and population health? Philos Ethics Humanit Med. 2010;5:1.

127. Kass NE, Chaisson L, Taylor HA, Lohse J. Length and complexity of U.S. and international HIV consent forms from federal HIV Network Trials. J Gen Intern Med. 2011;26(11):1324-1328.

128. Green BL, Li L, Morris JF, et al. Detailed knowledge of the Tuskegee Syphilis Study: who knows what? A framework for health promotion strategies. Health Educ Behav. 2011;38(6):629-636.

129. Ross MW, Essien EJ, Torres I. Conspiracy beliefs about the origins of HIV/AIDS in four racial/ethnic groups. J Acquir Immune Defic Syndr. 2006;41(3):342-344.

130. Symonds RP, Lord K, Mitchell AJ, Raghavan D. Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines. Br J Cancer. 2012;107(7):1017-1021.

131. Bishop FL, Adams AEM, Kaptchuk TJ, Lewith GT. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trials participants are told about placebos. PLoS One. 2012;7(6):1-7.

132. Germino BB, Mishel MH, Alexander GR, et al. Engaging African American breast cancer survivors in an intervention trial: culture, responsiveness and community. J Cancer Surviv. 2011;5(1):82-91.

133. Las Nueces D, Hacker K, DiGirolamo A, Hicks LS. A systematic review of community-based participatory research to enhance clinical trials in racial and ethnic minority groups. Health Serv Res. 2012;47(3 Part 2):1363-1386.

134. Falcon R, Bridge DA, Currier J, et al. Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the gender, race, and clinical experience study. J Womens Health. 2011;20(7):1043-1050.

135. Okuyemi K, Cox L, Nollen N, et al. Baseline characteristics and recruitment strategies in a randomized clinical trial of African-American light smokers. Am J Health Promot. 2007;21:183-191.

136. Sadler GR, Gonzalez J, Mumman M, et al. Adapting a program to inform African American and Hispanic American women about cancer clinical trials. J Cancer Educ. 2010;25(2):142-145.

137. Nicholson L, Schwirian PM, Klein EG, et al. Recruitment and retention strategies in longitudinal clinical studies with low-income populations. Contemp Clin Trials. 2012;32(3):353-362.

138. Phillips AK, Fischer BA, Baxter RJ, et al. Recruiting Latina families in a study of infant iron deficiency: a description of barriers, study adjustments and review of the literature. WMJ. 2011;110(1):26-31.

139. The Center for Information and Study on Clinical Research Participation. Charts and Statistics: Useful Information about Clinical Research Before Participating in a Trial. Available at http://0393122.netsolhost.com/education-center/charts-and-statistics/before-participation. Last accessed July 5, 2019.

140. Sharma NS. Patient centric approach for clinical trials: current trend and new opportunities. Perspect Clin Res. 2015;6(3):134-138.

141. World Medical Association. WMA Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Available at https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects. Last accessed July 5, 2019.

142. Mazure CM, Jones DP. Twenty years and still counting: including women as participants and studying sex and gender in biomedical research. BMC Women's Health. 2015;15:1-16.

143. Wechsler J. Clamor grows to expand trial participation of women and minorities. Appl Clin Trials. 2014;23(8/9):10.

144. Ramers-Verhoeven CW, Perrone F, Oliver K. Exploratory research into cancer patients' attitudes to clinical trials. E Cancer Medical Science. 2014;8:413-446.

145. Bloch F, Charasz N. Attitudes of older adults to their participation in clinical trials: a pilot study. Drugs Aging. 2014;31(5):373-377.

146. Kwiatkowski K, Coe K, Bailar JC, Swanson GM. Inclusion of minorities and women in cancer clinical trials, a decade later: have we improved? Cancer. 2013;119(16):2956-2963.

147. Chen MS Jr, Lara PN, Dang JH, Paterniti DA, Kelly K. Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual. Renewing the case for enhancing minority participation in cancer clinical trials. Cancer. 2014;120(Suppl 7):1091-1096.

148. UC Davis Health System. Minority Clinical Trials Participation and Analysis Still Lag 20 Years After Federal Mandate. Available at https://health.ucdavis.edu/publish/news/newsroom/8305. Last accessed July 5, 2019.

149. Ruiz-Casares M. Research ethics in global mental health: advancing culturally responsive mental health research. Transcult Psychiatry. 2014;51(6):790-805.

150. Rush University Medical Center. How Gender Affects Health: When It Comes to Health, Women and Men Aren't Equal. Available at https://www.rush.edu/health-wellness/discover-health/how-gender-affects-health. Last accessed July 5, 2019.

151. Salganicoff A, Ranjii U, Beamesderfer A, Kurani N. Women and Health Care in the Early Years of the ACA: Key Findings from the 2013 Kaiser Women's Health Survey. Available at https://www.kff.org/womens-health-policy/report/women-and-health-care-in-the-early-years-of-the-aca-key-findings-from-the-2013-kaiser-womens-health-survey. Last accessed July 5, 2019.

152. Manne S, Kashy D, Albrecht T, et al. Attitudinal barriers to participation in oncology clinical trials: factor analysis and correlates of barriers. Eur J Cancer Care. 2015;24(1):28-38.

153. Livaudais-Toman J, Burke NJ, Napoles A, Kaplan CP. Health literate organizations: are clinical trial sites equipped to recruit minority and limited health literacy patients? J Health Dispar Res Pract. 2014;7(4):1-13.

154. Ford ME, Siminoff LA, Pickelsimer E, Mainous AG. Unequal burden of disease, unequal participation in clinical trials: solutions from African American and Latino community members. Health Soc Work. 2013;38(1):29-38.

155. Sprague D, Russo J, LaVallie DL, Buchwald D. Barriers to cancer clinical trial participation among American Indian and Alaska Native tribal college students. J Rural Health. 2013;29(1):55-60.

156. Heller C, Balls-Berry JE, Nery JD, et al. Strategies addressing barriers to clinical trial enrollment of underrepresented populations: a systematic review. Contemp Clin Trials. 2014;39(2):169-182.

157. Eggly S, Barton E, Winckles A, et al. A disparity of words: racial differences in oncologist-patient communication about clinical trials. Health Expect. 2015;18(5):1316-1326.

158. Frew PM, Omer SB, Parker K, et al. Delivering a "dose of hope:" a faith-based program to increase older African Americans' participation in clinical trials. JMIR Res Protoc. 2015;4(2):e64.

159. Ma GX, Seals B, Tan Y, et al. Increasing Asian American participation in clinical trials by addressing community concerns.Clin Trials. 2014;11(3):328-335.

160. Anderson A, Borfitz D, Getz K. Global public attitudes about clinical research and patient experiences with clinical trials. JAMA Netw Open. 2018;1(6):e182969.

161. Vitale C, Fini M, Spoletini I, Lainscak M, Seferovic P, Rosano GM. Under-representation of elderly and women in clinical trials. Int J Cardiol. 2017;232:216-221.

162. Nellhaus EM, Davies TH. Evolution of clinical trials throughout history. Marshall Journal of Medicine. 2017;3(1):9.

163. Bothwell LE, Podolsky SH. History of clinical trials: the emergence of the randomized, controlled trial. N Engl J Med. 2016;375(6):501-504.

164. ClinicalTrials.gov. History, Policies, and Laws. Available at https://clinicaltrials.gov/ct2/about-site/history. Last accessed July 5, 2019.

165. Burchard EG, Oh SS, Foreman MG, Celedon JC. Moving toward true inclusion of racial/ethnic minorities in federally funded studies. Am J Respir Crit Care Med. 2015;191(5):514-521.

166. Fisher JA, McManus L, Wood MM, et al. Healthy volunteers' perceptions of the benefits of their participation in phase I clinical trials. J Empir Res Hum Res Ethics. 2018;13(5):494-510.

167. Igwe E, Woodburn J, Davolos J, et al. Patient perceptions and willingness to participate in clinical trials. Gynecol Oncol. 2016;142(3):520-524.

168. Cartmell KB, Bonilha HS, Matson T, et al. Patient participation in cancer clinical trials: a pilot test of lay navigation. Contemp Clin Trials Commun. 2016;3:86e93.

169. Willison DJ, Richards DP, Orth A, Harris H, Marlin S. Survey of awareness and perceptions of Canadians on the benefits and risks of clinical trials. Ther Innov Regul Sci. 2018; [Epub ahead of print].

170. Research!America. Public Perceptions of Clinical Trials. Available at https://www.researchamerica.org/sites/default/files/July2017ClinicalResearchSurveyPressReleaseDeck_0.pdf. Last accessed July 5, 2019.

171. Hoff C. Taking on Gender Bias in Clinical Trials. Available at https://www.nwhn.org/taking-on-gender-bias-in-clinical-trials. Last accessed July 5, 2019.

172. Duma N, Aguilera JV, Paludo J, et al. Representation of minorities and women in oncology clinical trials: review of the past 14 years. J Oncol Pract. 2018;14(1):e1-e10.

173. Geller SE, Koch AR, Roesch P, Filut A, Hallgren E, Carnes M. The more things change, the more they stay the same: a study to evaluate compliance with inclusion and assessment of women and minorities in randomized controlled trials. Acad Med. 2018;93(4):630-635.

174. Michaels TI, Purdon J, Collins A, Williams MT. Inclusion of people of color in psychedelic-assisted psychotherapy: a review of the literature. BMC Psychiatry. 2018;18:245.

175. Martinez LS, Freeman ER, Winkfield KM. Perceptions of cancer care and clinical trials in the black community: implications for care coordination between oncology and primary care teams. Oncologist. 2017;22(9):1094-1101.

176. U.S. Census Bureau. Facts for Features: Women's History Month: March 2019. Available at https://www.census.gov/newsroom/facts-for-features/2019/womens-history.html Last accessed July 5, 2019.

177. Statistica. Total Population in the United States by Gender from 2010 to 2024 (in Millions). Available at https://www.statista.com/statistics/737923/us-population-by-gender. Last accessed July 5, 2019.

178. Centers for Disease Control and Prevention. CDC Health Disparities and Inequalities Report. Available at https://www.cdc.gov/minorityhealth/CHDIReport.html. Last accessed July 5, 2019.

179. Coakley M, Fadiran EO, Parrish LJ, Griffith RA, Weiss E, Carter C. Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials. J Womens Health (Larchmt). 2012;21(7):713-716.

180. Lyerly AD. Should Pregnant Women be Included in Clinical Trials? Available at https://news.aamc.org/research/article/should-pregnant-women-be-included-clinical-trials. Last accessed July 5, 2019.

181. Liu KA, Dipietro NA. Women's involvement in clinical trials: historical perspective and future implications. Pharm Pract (Granada). 2016;14(1):1-9.

182. National Institute on Drug Abuse. The Importance of Including Women in Research. Available at https://www.drugabuse.gov/publications/research-reports/substance-use-in-women/importance-including-women-in-research. Last accessed July 5, 2019.

183. Geana M, Erba J, Krebill H, et al. Searching for cures: inner-city and rural patients' awareness and perceptions of cancer clinical trials. Contemp Clin Trials Commun. 2017;5:72-79.

184. Kim S, Tanner A, Friedman DB, Foster C, Bergeron C. Barriers to clinical trial participation: comparing perceptions and knowledge of African American and white South Carolinians. J Health Commun. 2015;20(7):816-826.

185. Myles S, Tocci C, Falk M, et al. (2018). A multicenter investigation of factors influencing women's participation in clinical trials.J Womens Health (Larchmt). 2018;27(3):258-270.

186. Salman A, Nguyen C, Lee Y, Cooksey-James T. A review of barriers to minorities' participation in cancer clinical trials: implications for future cancer research. J Immigr Minor Health. 2016;18(2):447-453.

187. Tanner A, Kim SH, Friedman DB, Foster C, Bergeron CD. Barriers to medical research participation as perceived by clinical trial investigators: communicating with rural and African American communities. J Health Commun. 2015;20(1):88-96.

188. Masood Y, Bower P, Waheed MW, Brown G, Waheed W. Synthesis of researcher reported strategies to recruit adults of ethnic minorities to clinical trials in the United Kingdom: a systematic review. Contemp Clin Trials. 2019;78:1-10.

189. Borno HT, Zhang L, Siegel A, Chang E, Ryan CJ. At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical trials. Oncologist. 2018;23(10):1242-1249.

190. Price A, Liew SM, Kirkpatrick J, Price J, Lopreto T, Nelken Y. Mind the gap in clinical trials: a participatory action analysis with citizen collaborators. J Eval Clin Pract. 2017;23(1):178-184.

191. Hammer MJ, Eckardt P, Barton-Burke M. Informed consent: a clinical trials perspective. Oncol Nurs Forum. 2016;43(6):694-696.

192. Regnante JM, Richie NA, Fashoyin-Aje L, et al. US cancer centers of excellence strategies for increased inclusion of racial and ethnic minorities in clinical trials. Journal of Oncology Practice. 2019;15(4):e289-e299.

193. Singler L, McAdams P, Uhlenbrauck G, Jernigan K, Schulman J. Models of engagement: patients as partners in clinical research: exploring three distinct patient partnership models to help researchers assess which methods of engagement could work best for their clinical programs. Applied Clinical Trials. 2018;27(6):28-31.

194. Winter SS, Page-Reeves JM, Page KA, et al. Inclusion of special populations in clinical research: important considerations and guidelines. J Clin Transl Res. 2018;4(1):56-69.

195. Smith A, Agar M, Delaney G, et al. Lower trial participation by culturally and linguistically diverse (CALD) cancer patients is largely due to language barriers. Asia Pac J Clin Oncol. 2018;14(1):52-60.

196. Flocke SA, Antognoli E, Daly BJ, et al. The role of oncology nurses in discussing clinical trials. Oncol Nurs Forum. 2017;44(5): 547-553.

197. Peterson EB, Chou WS, Falisi A, Ferrer R, Mollica MA. The role of medical social workers in cancer clinical trial teams: a group case study of multidisciplinary perspectives. Soc Work Health Care. 2018;57(8):688-704.

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