Inclusion of Women and Marginalised Groups in Medical Trials

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I.  Overview of the Health Problem:

 

Regarding clinical trials and research, there is a very clear difference between how many tests are done for individuals in marginalized groups and those within the majority group. This is considered a form of health disparity. Health disparities are the inequalities that occur in the provision of healthcare and access to healthcare across different groups of people (Shavers, 2007). These health disparities significantly affect ongoing research as well as subsequent research on patients. The reason for health disparities vary: it can be due to an individual’s socioeconomic status, racial and ethnic background, education level, or a combination of multiple factors (Braveman, 2006). This inadequate representation of minority individuals in research has an extremely negative effect on their health because they are incorrectly portrayed from a public health standpoint. By refusing the use of minority individuals for research, the results are lacking various crucial distinctions. These distinctions may be necessary in order to create a safe and effective treatment for all individuals, no matter the socioeconomic status, gender, race, and so on (Bailey, Scantlebury & Smyth, 2009). This information is clear evidence that health disparities impact most individuals that belong to a minority. According to the 2010

U.S. Census, approximately 36.3% of the population currently belongs to a racial or ethnic minority group (Humes, Jones, and Ramirez, 2010). These statistics only represent racial and ethnic minority individuals, but there are also gender inequalities in clinical trials. For example, in the U.S. Census, statistics found that 50.8% of people in America are females (U.S. Census Bureau, 2014). This means that at least half of the United States population has been affected by past bills regarding health disparities, and these same people will be affected by the outcome of this proposed bill.

 

II.  Severity of the Health Problem:

 

Researchers agree that there is an issue with inaccurate representations among clinical research. According to a study in the Journal of Women's Health done in 2006, women made up less than 25% of all enrolled patients in 46 tested clinical trials and analyses completed in 2004. Another example of a distorted sample for clinical trials is shown in a study from 2008. The Journal of the American College of Cardiology found that within 19 heart-related pilot studies, women only made up 10% to 47% of the sample individuals (2008). In addition, only 31% of cardiovascular clinical trials include report results categorized by sex, according to a 2014 report done by the Brigham and Women’s Hospital in Boston. This is a health issue because there is a lack of representation of women in clinical trials which can lead to inaccurate results.

The U.S. Food and Drug Administration has even expressed concerns about the health disparities in connection to minority groups. One representative explained that clinical trials are the way to verify the approval of many aspects of a product (U.S. Food and Drug Administration, 2015). Therefore, potential responses to certain drugs caused by a racial, ethnic, or gender difference are important to consider (FDA, 2015). This causes a large problem because treatments may perform differently on males and females. Gender health disparities affect many females from receiving proper treatment. It also stops the development of treatments to successfully aid both males and females because once a certain treatment works for a majority of individuals in a clinical trial, researchers consider it a success. Unfortunately, the minority of individuals with unsuccessful results may be due to the fact that they are women or in association with another minority group (Brigham and Women’s Hospital, 2014). Due to these disparities, the proposed bill is an excellent example of how the health trials can be changed in order to benefit women.

 

III.  Overview of the Bill and Stakeholders

Assembly member Bonilla introduced Assembly Bill No. 1174 and in this proposed bill, four sections are being added to the Health and Safety Code, relating to health research for women and minority groups. The main item of this proposed bill is the creation of the State Contingency Fund for Ancillary Costs (section 100241 added) and the Ancillary Costs Committee (section 100240 added). The Ancillary Costs Committee will “be made up of private and public health stakeholders” (Bonilla, 2015). These stakeholders may include health researchers, women and minorities, and health fund representatives.

The State Contingency Fund for Ancillary Costs is “created in the State Treasury to be made up of private donations” (Bonilla, 2015). All money within this fund will be distributed by the Ancillary Costs Committee (Bonilla, 2015). Through these two agencies being created through this bill, more funds towards health clinical trials will be disbursed in order to avoid the currently prominent factors of “low patient participation, recruitment difficulties…[and] ancillary costs of participating” (Bonilla, 2015). Another section that potentially will be added to the health and safety code is section 100242 which regards grant awards. This section proposes that the Ancillary Costs Committee will “determine grant parameters and criteria” based on any unspecified amounts of money that gets donated to the fund (Bonilla, 2015). Through this section being added, the organized funds will be used towards costs for patients in clinical trials so that they are able to participate in clinical trials without needing to support their own activities. The promoters’ goal through this bill is to prevent a lack of participation in clinical trials due to patients not being able to afford activities like airfare, meals, or child care (Bonilla, 2015). The patients are dedicating their time to help research, so their experience should be made as simple and comfortable as possible. These donations and funds will not only be directed towards the patient's well being, but also to “institutions that conduct cancer trials,” and for a non-profit organization directed towards “direct patient support for improved clinical trial enrollment” (Bonilla, 2015). The last section (100243) that this bill promotes is added to the health and safety code, which revolves around the certainty that all funds are utilized appropriately. This section requires that the “grant recipients...report to the committee to ensure the appropriate use of the funds” (Bonilla, 2015). This section, though short, is important to the bill’s overall purpose. The donation funds that are given are supposed to be used towards clinical trial successes, so this part of the bill gives the certainty that all funds will not be used for unauthorized cases.

 

This bill affects numerous stakeholders. As briefly explained earlier, women and minorities are less commonly found in medical clinical trials. Due to this, not only is there discrimination towards a certain group of people, but also the information concluding the trials could be inaccurate because the results aren’t based off of different groups of people. As the Journal of Women's Health explains through observing the people in studies, women, for example, aren’t participating in many clinical trials due specifically to their gender. They’re seen as a group of minorities that aren’t necessary enough for medical research unless the studies are only possible with women being involved (ovarian cancer, cervical cancer, etc.). Also, women are not being asked to participate in these studies mostly because with having families at home, they can’t take the time out of their daily scheduled lives to be a part of the research. But with this bill, women (and other minority groups) will be able to be a part of medical research trials due to there expenses being paid for and their child care being taken care of. The money distribution is the biggest part because these minority groups are now being welcomed to take part in health research without financial costs being of any problem. The only thing the patients need to worry about is getting them treated. Also, the researchers are benefitting from this potential bill because the information obtained through their trials will become more accurate due to having a more diverse group of people to research upon. Not only is this bill allowing for equality in health research amongst all people of different races, socioeconomic status’, and genders, but they are also making their research environment more reasonable, doable, and welcoming for their potential patients. Most clinical trials aren’t easy to go through, and the patients need to be at their most right mind so that the information obtained by researchers is at it’s most accurate.

 

IV.  Promises and Expected Outcomes

Assembly member Bonilla is one of many members and organizers who are promoting this bill. She, among others, believes that by passing this bill, clinical research pertaining to women would be advanced. For centuries women and minorities have not been included in clinical research that could ultimately help their health. Now that women and minorities are allowed to participate in medical clinical research, the next step is to help make the process of research easier for the participants. In fact, a fund called the “State Contingency Fund for Ancillary Costs... and the Ancillary Cost Committee will allow for privates donations to be accepted” and used towards women and minorities in research.

Furthermore, the bill goes on to discuss the increase to patient access to cancer clinical research trials. According to the people of the state of California, “50 percent of clinical trial studies do not finish on time due to low patient participation, recruitment and navigation difficulties and other barriers for patients.” In addition to the lack of patient participation due to recruitment failures, “3 percent of eligible cancer patients participate in clinical trials and of those, only 5 percent of patients are from racial or ethnic minority communities” (Bonilla, 2015). As briefly mentioned in the paragraph above, once this bill is passed, health care agencies will do better at encouraging and engaging minority women in participating in clinical research by showing them the greater financial stability.

 

V.  Problems

Though not many groups of people are or would be opposed to the passing of this bill, the administration that would work for The State Contingency Fund for Ancillary Costs may not agree all with what the bill promises. As assembly bill number 1174 explains, this fund is made up of all donations from private entities. And, the Ancillary Costs Committee will be in charge of allocating the money. Explaining these new committees and what they will behold, the bill also explains that “no more than 10 percent of funds made available for the grant program” are going to be used by the board for administrative costs (Bonilla, 2015). Those that plan to work for this new committee may not want to dedicate their time for their job knowing that only 10 percent of funds will be going towards their work. It’s understandable that the fund is only allowing 10 percent to go to administrative costs because they want to use the majority of their fund for the grant program to build up the program. But, the people working for the administration may need additional funds to help build them up in order for them to work for the program, and since they can’t go beyond 10 percent, there may be some opposition.

Besides the administration being the ones to possibly oppose the bill, there really are no special interest groups that have oppositions towards this bill, mainly because of how private this bill is. This bill doesn’t necessarily apply to a certain group of people because its ultimate goal is to uplift a new fund and committee so that it can benefit women and minorities in clinical research in the long run. But directly, the bill only applies to those that would build up and work for the committee. The bill isn’t public enough for it to be discussed through different interest groups and for those interest groups to actually be directly affected.

 

VI.  Unintended Consequences

Some unintended consequences that could arise resulting from passage of this bill are confounding and the law of unintended consequences. Confounding may lead to confusion of someone or something. According to the journal article Confounding (2010), authors van Stralen, Dekker, Zoccali, and Jager state, "in confounding, the effect of the exposure of interest is mixed with the effect of another variable" (van Stralen, Dekker, Zoccali, Jager, 2010-pg 1). If this bill is passed and if the minority group of women and women of all color are able to participate in clinical trial research and testing/s with this extra funding, mixing of the data may occur between both genders due to the involvement of males and females. In the medical science field, confounding has become an intrinsic issue that is constantly discussed, but often ignored in policy debates.

Confounding has also lead to other unanticipated outcomes or errors such as unmeasured confounders. In observational studies, unmeasured confounders have resulted in biased effects. Since the male figure has always been involved in clinical trial research and testing/s, men have a better chance of giving accurate information rather than women. Additionally, if this bill were to pass, another negative impact that can go wrong is women not be able to give the correct data because they have no experience leading them to a lack of testing. Also, there is a chance that due to lack of testing and not having much experience, women will not be able to give that of the same result as men. This means that the two committees would be receiving more money for women and minorities who will not be able to give the proper data. Both committees would just be wasting their money on useless individuals to participate in their clinical trials.

 

VII.  Recommendations

We have learned women and minority groups are not as highly represented in clinical research projects, according to information in AB-1174 (Bonilla, 2015). This proposed bill regarding women’s health should be passed to encourage more women participation along with the help of minority groups, as they are valuable to future medical discoveries and oncology solutions. Clinical research regarding women’s and minorities’ health are failing to complete successfully due to low number of participants and the lack of knowledge may be contributing to this health disparity. Given that only 3% of cancer patients participate in clinical trials, one of the main factors creating a barrier between the gain of participants and completing these research trials is the lack of encouragement, says Judy Stone, a Forbes Magazine contributor (2015). In order for women and people considered from a minority group to feel as if they can help by participating in cancer clinical trials, state agencies and public health contributors should promote more information about the ongoing clinical research and inform this particular group for eligibility hence higher rates of trial participation.

We learned it is imperative to have patient’s “informed consent” from the documentary Deadly Deception: The Tuskegee Syphilis Experiment, otherwise it is considered unethical within clinical trials and in the public health sector (DiAnni, 1993). Women of all ages are to be included if this bill is passed, meaning if more women at younger ages before their mid twenties participate in oncology trials, we may be buying ourselves a bit of time. As an aging society, more people are being diagnosed with cancer as they get older (Stone, 2015). However with more women being active and consistent participants in such oncology trials, they will be the future’s key to finding effective solutions. According to AB-1174 as proposed by assembly member Bonilla, ancillary costs are a burden to potential participants and the State Contingency Fund for Ancillary Costs Committee will solely consist of funds donated by public and private health partners (2015). Yet if the Ancillary Costs Committee is authorized to accept generous donations from public non-health shareholders, their number of patients may rise. In regard of recommendations and allocating additional funds for women’s health research, participants are more likely to participate in clinical trials benefiting cancer research if financial advisors are provided to explain and reassure what is limited within ancillary costs as eligible participants. Participants should also be given possible side effects and/or risk factors, and should be allowed to ask questions at any time during the clinical trial. Furthermore, there should be security officials working for clinical trials to enforce grant criteria and ancillary costs from participants. Individuals with the title of ‘Security Official’ would be responsible to prevent any type of fraud regarding ancillary costs and would report directly to the Ancillary Costs Committee as part of AB-1174. Security Officials would also administer anyone who is prescribed not to participate in projects of clinical research because that would interfere with anticipated results (Bonilla, 2015.)

Reference List

  • Assembly member Bonilla. (2015). AB-1174 Health research: women’s health. http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201520160AB1174& search_keywords=women%27s+health.
  • Braveman, P. (2006). Health disparities and health equity: concepts and measurement. Annual Review of Public Health, 27(1), 167-194.
  • Bailey A., Scantlebury D., Smyth, S. (2009). Arteriosclerosis, thrombosis, and vascular biology. Go Red for Women. 29(2). 284-288. doi:10.1161/ATVBAHA.108.179788.
  • Brigham and Women’s Hospital. (2014). Sex-specific medical research: why women’s health can’t wait. The Boston Foundation. 10-19.
  • DiAnni, D. (1993). Deadly deception. Retrieved 12/11 from PBS/WGBH NOVA documentary video.
  • Geller S., Adams M., & Carnes M. (2006). Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials. J Womens Health (Larchmt). 15(7). 1123–1131.
  • Stone, J. (2015). How can we encourage participation in clinical trials? Retrieved 12/10 from Forbes Online Magazine. http://www.forbes.com/sites/judystone/2015/01/06/how-can-we-encourage-participation-i n-clinical-trials/.
  • Shavers, V. (2007). Measurement of socioeconomic status in health disparities research. Journal of the National Medical Association, 99(9), 1013-1023.
  • van Stralen, K. , Dekker, F. , Zoccali, C. , & Jager, K. (2010). Confounding. Nephron Clinical Practice, 116(2), C143-C147.
  • Humes K., Jones N., and Ramirez, R. (2010). Overview of race and hispanic origin. U.S. Census Bureau. 4-7.
  • U.S. Census Bureau. (2014). State and county quickfacts. U.S. Census Bureau. 2-3.

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