Perceptions of Women that Prevent Participation in Clinical Trials in the Affluent Versus Impoverished Communities of Miami, Florida

Download Article

DOI: 10.21522/TIJCR.2014.05.02.Art001

Authors : Lois Collie-Acasio

Abstract:

A gender gap exists in biomedical research because more Caucasian men take part than women. As a result, recommended dosages are based on the male physiology with the risks to women unknown. The symptoms, severity, prevalence and age of onset of many diseases may be different in men. Warning signs, and adverse effects may also be different in women and the number of women who have Adverse Events from taking male based recommended dosages is unknown. The gender gap may contribute to medication errors which cause an increasingly large amount of deaths each year. Although women participants are needed and mandated, they may be underrepresented because of child-bearing age and its fluctuating hormones. The possible long-term effect of study drugs on women's gonads is unknown. Women may have a knowledge gap that needs to be bridged as they may not be aware of biomedical medicine research, are unfamiliar with the terms being used to describe the topic, and when faced with multiple therapeutic options, may worry about making informed decisions. Shareholders and women benefit when the gender gap is decreased, safety and efficacy is increased and the result of research become more generalizable. This study investigated perception barriers to participation in Clinical Trials of the women of Liberty City who were 94% African-American, were contrasted with the women of Coral Gables who were 90% Latin-American. This study has never been done before and investigates the barriers that prevent women who are ambulatory patients, from participating in clinical studies.

Keywords: Gender gap, Women’s health research, Barriers to participation.

References:

[1]. Aliyar, C. (2004). Research, Evidence and Recommendations, Michael Littlejohns, Peter (Eds,), Rawlins, (Author) Delivering Quality in the NHS (p.161). Oxon. UK: Radcliffe Medical Press

[2]. Bain, L. J., (2005, July). Crossroads in Clinical Trials. The Journal of the American Society for Experimental Neuro Therapies (NeuroRx), 2(3), 525-528, Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1144496/

[3]. Bill-Axelson, A., Christensson, A., Carlsson, M., Norlén, B. J., & Holmberg, L. (2008). Experiences of Randomization: Interviews with Patients and Clinicians in the SPCG-IV Trial. Scandinavian Journal of Urology & Nephrology, 42(4), 358-363. Retrieved from

http://www.tandfonline.com/doi/abs/10.1080/00365590801950253?scroll=top&needAccess=true&journalCode=isju19

[4]. Briggs, L. (2002). Reproducing Empire: Race, Sex, Science, and U.S. Imperialism in Puerto Rico. University of California Press: Berkeley, 2002. Retrieved from http://stanford.edu/group/womenscourage/cgi-bin/blogs/familyplanning/2008/10/30/puerto-rico-revisited/

[5]. CDC., (2018). Syphilis Study at Tuskegee, US Public Health Service, Retrieved from https://www.cdc.gov/tuskegee/timeline.htm

[6]. CDC., (2018). High blood Pressure in the United States. Retrieved from https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_bloodpressure.htm

[7]. CISCRP, (2017). Most important information influencing decision to participate. Center for Information and Study on Clinical Research Participation. Retrieved from https://www.ciscrp.org/education-center/charts-and-statistics/before-participation/

[8]. CISCRP, (2006). Recruitment and Retention, Center for Information and Study on Clinical Research Participation. Retrieved from http://www.ciscrp.org/professional/facts_pat.html.

[9]. Coakley, M., Fadiran, E. O., Parrish, L. J., Griffith, R. A., Weiss, E., & Carter, C. (2012). Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials, Journal of Women's Health, 21(7), 713-716. Retrieved from http://online.liebertpub.com/doi/full/10.1089/jwh.2012.3733,

[10]. Costenbader, K. H., Brome, D., Blanch, D., Gall, V., Karlson, E., & Liang, M. H. (2007).

[11]. Factors Determining Participation in Prevention Trials Among Systemic Lupus Erythematosus Patients: Qualitative Study. Arthritis & Rheumatism-Arthritis Care & Research, 57(1), 49-55. Retrieved from http://onlinelibrary.wiley.com/doi/10.1002/art.22480/full

[12]. Davis, S, (2003), Recruitment and Retention of Women in Clinical Studies, and the Critical Role of Relevance, A Report of the Task Force sponsored by the NIH Office of Research on Women’s Health, Retrieved from https://repository.library.georgetown.edu/bitstream/handle/10822/547438/SMR_Final.pdf?sequence=1

[13]. Drennan, K. B. (2002). Patient Recruitment: The Costly and Growing Bottleneck in Drug Development. Drug Discovery Today, 7(3), 167-170. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/11815229

[14]. FDA, (2018) Regulations, Guidance, and Reports related to Women’s Health, Retrieved from https://www.fda.gov/scienceresearch/specialtopics/womenshealthresearch/ucm472932.htm

[15]. Getz, K. A. (2008). Public Confidence and Trust Today, A Review of Public Opinion Polls. Monitor. Retrieved from http://www.ciscrp.org/downloads/articles/Getz_publicopinion.pdf

[16]. HRSA, (2013) Women’s Health USA 2013. Retrieved from https://mchb.hrsa.gov/whusa13/index.html

[17]. Jenkinson, C., et al., (2005). Patient Attitudes to Clinical Trials: Development of a Questionnaire and Results from Asthma and Cancer Patients. Health Expectations, 8(3), 244-252.

[18]. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5060299/Lui, K., Mager, N., (2016) Women’s involvement in clinical trials: historical perspective and future implications, Pharmacy Practice (Granada). 2016 Jan-Mar; 14(1): 708. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800017/

[19]. NCI, (2004). What is Randomization? Retrieved from http:// cancer.gov/clinical trials/learningabout/what-is-randomization

[20]. NIH, (2012). NIH Policy and Guidelines in the Inclusion of Women and Minorities as Subjects in Clinical Research – Amended, October, 2001. The NIH Revitalization Act of 1993, Retrieved from http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

[21]. NIH, (2018). What health issues or conditions are specific to women only? Retrieved from https://www.nichd.nih.gov/health/topics/womenshealth/conditioninfo/whatconditions

[22]. Schroeder, R, et al., (2018) Sex and Gender Differences in Migraine—Evaluating Knowledge Gaps, Journal of Women's Health Vol. 27, No. 8, Retrieved from: https://www.liebertpub.com/doi/pdf/10.1089/jwh.2018.7274 SWHR, (2008). Survey of US Adults on Clinical Trials Research Participation. Society for Women’s Health Research. Retrieved from http://www.womenshealthresearch.org/site/DocServer/WomensHealthWeekSurveyResults.pdf?docID=2041

[23]. Sood A, et al., (2009). Patients' Attitudes and Preferences About Participation and Recruitment Strategies in Clinical Trials, Mayo Clinic Proc. 2009, 84(3), 243-247.

[24]. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2664601/?tool=pubmed and http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2664601/bin/supp_ 84_3_243__index.html

[25]. Sperling, B. (2017). Coral Gables, Florida, Research Tools. Retrieved from http://www.bestplaces.net/people/city/florida/coral_gables

[26]. University of Miami Health System. (2008). Liberty City Community Advisory Board. Retrieved from http://sylvester.org/documents/Oct_newsletter08.pdf

[27]. US Census. (2012) Retrieved from https://www.census.gov/Williams, S., (2004). Clinical Trials Recruitment and Enrolment: Attitudes, Barriers, and Motivating Factors, A Summary of Literature and Market Research Reports

[28]. National Cancer Institute. Clinical Research Organization, University of Medicine and Dentist of New Jersey. Retrieved from http://cro.umdnj.edu/documents/clinical_trials_recruitment_ and_enrollment.pdf

[29]. Wittes, J, (2002) Sample Size Calculations for Randomized Controlled Trials, Epidemiologic Reviews, Retrieved from https://faculty.washington.edu/jelmore/articles_online/Wittes-Sample_size_calc.pdf

[30]. Women's Health Initiative Investigators, (2002) Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women Principal Results.

[31]. Women's Health Initiative Randomized Controlled Trial, Retrieved from

https://jamanetwork.com/journals/jama/fullarticle/195120

[32]. Worrall, B., (2009). Stroke Risk Factor Profiles in African American Women, An Interim Report from the African-American Anti-Platelet Stroke Prevention Study

[33]. Stroke. 2002 Apr; 33(4): 913–919.Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2614287/

[34]. Wright, J. et al., (2006). Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. The Lancet Oncology, 7(2), 141- 148. Retrieved from http://www.thelancet.com/pdfs/journals/lanonc/PIIS1470- 2045(06)70576-9.pdf Available appendices

[35]. Exemption Notification- IRB ID: 2018/02/19

[36]. Letters of Approval by Ethics Committee, Oct.13, 2012

[37]. Introduction and Consent Page for Survey

[38]. and the Survey Questionnaire English and Spanish versions