Female Participation in Clinical Trials Based on Race and Children
Anita Kurt, PhD, RN 1,2
1Emergency Research Department, Lehigh Valley Health Network
2Research Scholar Program Mentor
Females tend to be underrepresented in clinical trials because of risk to fetus and child-bearing potential. Those that do participate tend to be Caucasian and beyond child-bearing age. Several studies including The Multi-Center Diversity Study have begun to address this issue and delve into other barriers that inhibit participation such as demographics, race, religion and socioeconomic status. Several questions of the survey pertain to the patients race, prior participation in clinical trials, and if they are currently pregnant or have children. The data from the surveys shows that Hispanics and Asians are less likely to participate in clinical trials than Caucasians. It also shows that there is no statistically significant difference in participation in clinical trials between Caucasians who are currently pregnant or have children and minorities that meet the same criteria.
Clinical trials are the gateway to finding more effective treatment and medication for all members of society regardless of race, ethnicity, religion, gender and socioeconomic status. In order to be all inclusive, a clinical trial must show a true sampling of the population showing diversity in the aforementioned areas. In prior studies, females and minorities tend to be underrepresented or excluded from clinical trials. It is important to include these groups because not all medication is effective or has the same side-effects that are presented in Caucasian males. One example that shows the variability is that after twenty years on the market the Food and Drug Administration (FDA) “cut the recommended dosage of Ambien for women in half” because women “process the drug more slowly than men” in turn causing them to have prolonged drowsiness” (Jacoby).
Women and minorities stray away from clinical trials because of their beliefs, attitude and knowledge of prior studies. For example, in the Tuskegee syphilis study “400 illiterate, black, syphilitic male subjects had been denied treatment for syphilis for more than 30 years” (McCarthy). Studies such as the Tuskegee syphilis study influence the attitudes and distrust of African Americans in today’s society; therefore, knowledge of research that has been performed in the past tends to result in future generations declining to participate in clinical trials.
The underrepresentation of females and minorities stems not only from the individual’s attitude and knowledge, but also the unwillingness of researchers to enroll these individuals because of increased variability and vulnerability. Many women are excluded from clinical trials because of fear that it will affect future child-bearing. Pregnant women are also less likely to participate in clinical trials because of increase risk to the fetus as well as the mother. The fear of causing harm to the fetus can be attributed to past studies such as the Thalidomide tragedy which caused severe birth defects and lead to the FDA “prohibiting pharmaceutical companies and others engaged in testing of drugs from including pregnant women and women of childbearing potential in Phase I drug trials" (McCarthy). Besides Thalidomide, Accutane, a drug used to treat acne, was found to cause birth defects even if it was taken “briefly during the first trimester, a time when many women do not yet know they are pregnant” (Krause). The vulnerability of the fetus makes pregnant women less likely to partake in research. Besides for risk to future pregnancy and current pregnancy, many women decide not to participate in research because they already have children at home that need their support and time.
Various factors influence whether or not an individual will be willing to participate in a clinical trial. In order to bridge the gap and increase participation of women and minorities in clinical trials, we must analyze what factors motivate them intrinsically and extrinsically, in turn shedding light on what needs to be provided to these individuals in order for them to participate. The Multi-Center Diversity Study aims to delve into factors that motivate individuals to participate in clinical trials while taking into account demographics and race.
An IRB approved survey was used to assess various factors that influence female participation in research. The survey was offered in English, Spanish, Traditional Chinese and Simplified Chinese. Qualified individuals were trained to administer the survey at Lehigh Valley Health Network, Drexel University, Christiana Care, Saint Peter’s University Hospital, Columbia University, and Virtua. The surveys were administered in the waiting room to female patients who were at least eighteen years of age and were both mentally and physically able to complete the survey independently. Data collected from the surveys was entered in a database and analyzed.
The data that was used for analysis was preliminary. See data tables located in the appendix.
Out of the 400 patients that were surveyed 75% were minorities, 25% were Caucasian and 4% non-categorizable (Figure 1). The data shows that the majority of patients who were surveyed were minorities; however, only 21/300 (7.0%) of the minorities that were surveyed were pregnant or had children and had participated in a clinical trial before compared to 8/84 (9.25%) of Caucasians that meet the same criteria (Figure 2). Based on this data it is clear that Caucasians that are pregnant or have children are more likely to participate in research than minorities that meet the same criteria.
For further analysis, minorities were categorized as follows: Black or African American, Asian, Native Hawaiian or Pacific Islander, American Indian or Alaska Native, Hispanic/Latina/Mexican/Puerto Rican/Dominicana/ Columbian/Spanish and Other. A multiple regression analysis was then performed to determine if race was a significant barrier to participation in clinical trials. The p-values that were found to be significant were the following: Hispanic p=.06 and Asian p=.004. All other p-values were found to be insignificant (Figure 5). Based on the p-values obtained from Asians and Hispanics these patients are less likely to participate in clinical trials then Caucasians.
Another multiple regression analysis was performed to determine if minorities who were pregnant or have children are less likely to participate in research than Caucasians that meet the same criteria. Both were found to be insignificant with the following p-values: pregnant p=.72 and has children p=.16 (Figure 6). Based on this data it is clear that there is no statistical difference between participation in clinical trials in Caucasians who are pregnant or have children and minorities that meet the same criteria.
The data shows that Hispanics and Asians are less likely to participate in clinical trials than Caucasians. It also shows that there is no statistically significant difference in participation in clinical trials between Caucasians who are currently pregnant or have children and minorities that meet the same criteria. However, since preliminary data was used in the analysis, no final conclusions can be drawn at this point because the final analysis might reveal a different outcome.
Even though 400 patients were surveyed, some limitations existed. One limitation is that the majority of the patients who were surveyed were Hispanic. Many other minorities such as Native Hawaiian and American Indian were not represented in the data set. A larger more diverse study would be needed to obtain more conclusive data. Another limitation is that many patients declined to fill out the survey.
For further investigation one can look to see if there is a correlation between minorities and how often they decide to seek care and which family member has the biggest impact in determining if they should participate in a clinical trial.
Jacoby, S. (2015, July 14). The Upsetting Reason Why We Don't Always Know How Meds Affect Women. Retrieved July 18, 2015, from http://www.refinery29.com/2015/07/90501/women-medication-clinical-trials
Joan H. Krause, Accutane: Has Drug Regulation in the United States Reached Its Limits, 6 J.L. & Health 1 (1991-1992)
McCarthy, Charles. "Historical Background of Clinical Trials Involving Women and Minorities." Association of American Medical Colleges 69, no. 9 (1994): 695-97. Accessed July 18, 2015. http://journals.lww.com/academicmedicine/Abstract/1994/09000/Historical_background_of_clinical_trials_involving.2.aspx.Introduction/Background
Preliminary data was used to complete the following analysis.
Figure 1 shows that out of 400 patients surveyed 75% were minorities, 25% were Caucasian and 4% were non-categorizable.
Figure 2 shows how many female minorities and Caucasian females have participated in clinical trials in the past and were currently pregnant/have children. Minorities: 21/300, Caucasians 8/84.
Figure 3 represents Figure 2 in percent form.
Figure 4 represents the specific races of the minorities that participated in clinical trials before, were currently
Native Hawaiian/Pacific Islander
Figure 5 represents whether or not there is a significant difference between Caucasians who participated in clinical trials versus minorities who participated in clinical trials.
Native Hawaiian/Pacific Islander
Figure 6 represents whether or not there is a significant difference between Caucasians who participated in clinical trials and are pregnant/have kids and minorities who meet the same criteria.
Published In/Presented At
Besz, K. (2015, July 31). Female Participation in Clinical Trials Based on Race and Children. Poster presented at LVHN Research Scholar Program Poster Session, Lehigh Valley Health Network, Allentown, PA.
Research Scholars (Acknowledgements and Co-authored Publications), Research Scholars - Posters