Diversity in Clinical Trials

Clinical trials are the primary research method in which new drugs are tested to evaluate their effectiveness.  The Food and Drug Administration (FDA), the U.S. authority that regulates clinical trials and bringing new drugs to the market, must balance between introducing life-saving treatments to patients who need them as soon as possible and ensuring that these drugs have been thoroughly tested and are safe for the general population. A drug must undergo extensive testing in clinical trials before it gets approved as both safe and effective. Clinical trials document how well new treatments work on individuals and the likelihood of the occurrence of severe side effects.

Clinical trial participants should approximately represent the composition of those patients whom the new treatments are intended to serve. However, often clinical trials fail to achieve adequate representation for minorities. For instance, African Americans represent 12%, and Hispanics represent 16% of the U.S. population but are only represented as 5% and 1% of clinical trial participants, respectively.[i] Caucasians are still overly represented in clinical trials.[ii] The FDA and National Institute of Health (NIH) should address this situation.

Genetic variations in racial and ethnic groups may cause different reactions to treatments. These variations could put people at risk, as certain treatment side effects affect various groups differently. Differences in individuals’ genomes can alter the effectiveness of drugs as genes affect how a drug is metabolized and how individuals respond to a medication.[iii] A recent study on anti-HIV medications revealed that genetic differences could render medicines utterly ineffective in some patients.[iv] These genetic differences can differ between individuals of different races and ethnicities. Thus, it makes difficult for the physician to determine if the drug will be effective for their minority patients if minorities are not tested thoroughly in clinical trials.

One of the causes of the lack of minority representation in clinical trials is mistrust of the established medical system, and this is most notably seen with the infamous Tuskegee Syphilis Study in which physicians knowingly withheld treatment for African Americans infected with syphilis.[v] Physicians’ unconscious biases may play a role in the low amount of minority participants in trials. Physicians combine prior experiences treating patients of similar race, age, gender, and socioeconomic status into a stereotype in how to manage their current patients.[vi] Physicians may be unconsciously, or even consciously, arbitrating which patients to recommend for clinical trials. A study determined that physicians believe African Americans are two-thirds as likely to adhere to a clinical trial regimen compared to their Caucasian counterparts.[vii] Also, minority patient populations have historically had inadequate access to healthcare. Minorities are less likely than Caucasians to have access to health insurance, a requirement for some Phase III clinical trials.

The minority under-representation in clinical trials should be appropriately addressed. The NIH Revitalization Act of 1993 by Congress meant to solve this problem by mandating women and minority representation in clinical trials, but the results have not been promising, as the proportion of minorities in clinical trials is still significantly lower than the percentage of minorities in the U.S.[viii] Thus, before different methods other than passing acts in Congress will be implemented, minorities will continue to be at risk with their treatments. It is up to the entire healthcare establishment, from physicians and hospital administrators to pharmaceutical entities to address the problem. Only by including a representative sample of patients, can we ensure the new novel drugs and treatment being developed are safe and effective for all.

To cut to the heart of the problem, healthcare organizations need to start thinking more strategically about the diverse patient populations they serve. As highlighted in previous blog posts, the U.S. patient base is undergoing dramatic demographic changes. The development of new drugs and treatments should not be based predominantly on just Caucasian patients. Healthcare entities at-large need to understand the changing marketplace and take a proactive, strategic approach to serving the healthcare consumers up today and tomorrow.

To further explore how to think more strategically about the diverse, 21st-st century marketplace, The Kaleidoscope Group, LLC is a full service, diversity and inclusion (D&I) consulting firm. We are committed to providing customized strategic solutions to address the specific needs of an organization’s culture. We pride ourselves in being Real People having Real Conversations about Real Issues to create Real Change.

Join us for our complimentary, 1-hour webinar on July 17th from 11 am to Noon CDT as we discuss Diversity Working:  Building Inclusive Healthcare companies. 

 

Joseph Gaspero is a Consultant with the Kaleidoscope Group. He is a diversity and inclusion expert with a specific focus on the healthcare industry. Joseph has extensive knowledge and expertise in areas such as diverse patient groups, diversity in healthcare organizations, employee and business resource groups, diversity in clinical trials, and shifting U.S. demographics. He also has extensive knowledge and expertise on the intersection of diversity and inclusion with financial performance and other key organizational metrics. Joseph is also the CEO and Co-Founder of the Center for Healthcare Innovation (CHI), an independent, non-profit research and educational institute dedicated to making healthcare more equitable for all patients. CHI’s mission is to bring together experts and ideas from all over the world to improve healthcare for everyone, regardless of socioeconomic status, gender, race, ethnicity, or other social determinants. Joseph’s leadership stems from a wide array of experiences, including founding and operating several non-profit and for-profit organizations, serving in the U.S. Air Force in support of 2 foreign wars. His skills include strategy, management, entrepreneurship, healthcare, clinical trials, diversity & inclusion, life sciences, research, marketing, and finance. Joseph has lived in six countries, traveled to over 30 more, and speaks three languages, which help him view diversity and inclusion through a global lens.

 

  1. “Clinical Trials: MedlinePlus.” S National Library of Medicine. U.S. National Library of Medicine, 21 July 2015. Web. 5 Aug. 2015.”U.S. Food and Drug Administration.”
  2. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. 18 Sept. 2014. Web. 4 Aug. 2015.
  3. “U.S. Food and Drug Administration.” Clinical Trials Shed Light on Minority Health. 1 Apr. 2015. Web. 4 Aug. 2015.
  4. Culp-Ressler, T. “There Are Too Many White People In Clinical Trials, And It’s A Bigger Problem Than You Think.” ThinkProgress RSS. 4 Apr. 2014. Web. 4 Aug. 2015.
  5. Bradford, L. DiAnne. “Race, Genetics, Metabolism: Drug Therapy and Clinical Trials – MIWatch.” Race, Genetics, Metabolism: Drug Therapy and Clinical Trials – MIWatch. MIWatch, 10 Apr. 2008. Web. 18 Aug. 2015.
  6. “New Evidence That Genetic Differences May Help Explain Inconsistent Effectiveness Of Anti-Hiv Drug.” John Hopkins Medicine. 15 July 2015. Web. 4 Aug. 2015.
  7. Corbie-Smith, G., Thomas, S.B., Williams, M.V., Moody-Ayers, S.(1999) Attitudes and beliefs of African Americans toward participation in medical research. Gen. Intern. Med.14, 537–546.
  8. Smedley, B.D., Stith, A.Y., Nelson, A.R., editors. ,Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington, DC: National Academy of Sciences; 2003.
  9. van Ryn, M., Burke, J.(2000) The effect of patient race and socio-economic status on physicians’ perceptions of patients. Sci. Med. 50, 813–828.
  10. Regenstein, M., Huang, J.Stresses to the Safety Net: The Public Hospital Perspective. Washington, DC: Kaiser Family Foundation; 2005.
  11. Chen, M.S., Lara, P.N., Dang, J.H. T., Paterniti, D.A. and Kelly, K. (2014) Twenty years post-NIH Revitalization Act: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual. Cancer 120, 1091–1096.
6 replies
  1. Luodon
    Luodon says:

    We suggest you to start your search specifically on this dating site. If you understand specifically what you are looking for in a person, you can use an extended search. Light and also quite layout, very easy navigation, convenience of usage for our users – primary aspects of our examination. Grown-up customers can enroll in CuteAsianWoman in a few minutes – you need to only supply some fundamental information, no credit score card info or address required. After you create an account, you will require to answer a few questions concerning a match you want to find on the system. Let’s presume that you have actually currently located a couple of Oriental solitary ladies who appear attractive to you. Are you looking to satisfy solitary expats. The date will certainly happen in your match’s nation (if they concur to satisfy you, obviously). Dating Eastern ladies, however, may be different relying on the particular country.

    This philosophical mindset to life may be seen in their modest smiles and also laughter, which never seem to fade off their functions. No matter the kind of Chinese lady you are looking for, you can anticipate your prospective suits to have the following attributes. This will excite your potential partner for certain. AsianKisses can help you discover the day or connection that fits you best, whether it be for enjoyable, friendship or marriage, confident you will discover the best companion for, or have a good time trying. If I they’re someone I want to be in a partnership with, Number out. It is necessary for you to understand what kind of person she is if you want to discover just how to date a Chinese lady. If you intend to figure out just how to date a Vietnamese woman, you more than likely already know how attractive these girlfriends are. So if you want to develop relationships with Chinese girlfriends, you require to see to it her family members likes you, as well! Individuals get careless when it concerns partnerships.

    These are a few of the reasons why Orchid Love is considered among the ideal Asian dating websites for different kinds of connections – users have the possibility to establish up a real date or interact outside the site in various other social networks and carriers. If it is, then probably, you are interacting with actual individuals. From a very early age, Chinese women are instructed to place family members above anything else, so as they grow up, they establish a solid bond with their relatives as well as carry this idea into their grown-up life, also. Although a Chinese girl may appear shy and also timid in public, when it’s simply two of you, you will certainly see her various other side! However, after you develop an account, you will need to address lots of inquiries concerning on your own and also the woman you want to get in touch with as well as start a relationship with. Dating online might be a challenge, specifically if you are trying to begin a serious relationship with a person you satisfied on the web, however this system fixes all the troubles and also provides a superior experience due to lots of extra-special services. However they may be awaiting a message from you, specifically if they liked your account.

    Don’t hesitate to launch conversations – some songs, specifically ladies may be also reluctant to contact you. Used enough credit scores on discussions with them. 10 cost-free credit reports for e-mail verification to examine the costs features. Costs functions are available to those who have enough credit scores. Every pack of debts likewise includes a 1-month free premium subscription (worth $9.99), which includes 5 Initial Mails, 20 Mins Chat, as well as all complete access to participants’ exclusive pictures. 3. Post excellent photos – otherwise, you will not obtain several messages. It’s important to make a great initial perception. If this is a good match for you, many profiles are confirmed and also include enough information for you to understand. What Are Chinese Women Like? Nevertheless, something to calm down prior to we move any type of additionally right into the rewards of dating a Chinese lady is that all women are different. Though Adorable Asian Female gives much more communication tools than many various other Asian dating systems, this is not the only thing that aids the company draw in increasingly more users worldwide. Aids individuals not only locate an Eastern girlfriend however additionally start a strong remote partnership. New individuals get 2 Free Conversation Vouchers and 2 Totally free State Hi greeting coupons after enrollment as well as can get 15 to 60 reward factors for completing their profile.

    Reply
  2. Blogi Edukacyjne
    Blogi Edukacyjne says:

    Hi, Are you looking for any guest writers currently because I might be willing to provide you with high quality articles written specfically for your website.

    Reply
  3. Gordon
    Gordon says:

    Aftеr going over a number of the blog posts on your web page, I truly appreciate your technique
    of writing a blog. I book marked it to my bookmark website
    list and will be checking back soon. Please vіsit my web site as well and tell
    me what you think.

    Reply
  4. Clara
    Clara says:

    Ꮋey there! Woulɗ you mind if I sharе ʏour blog with my zynga group?
    There’s a lot of folks that I think ԝould really enjoy your content.
    Please let me know. Cһeers

    Reply
  5. Azucena
    Azucena says:

    Hi, I do think thіs is an excellent blog.
    I stumbledupon it 😉 I may return once again since I boоk-marked it.
    Money and freedom is the best way to change, may you be rich and continue to help
    other peopⅼe.

    Reply

Trackbacks & Pingbacks

Leave a Reply

Want to join the discussion?
Feel free to contribute!

Leave a Reply

Your email address will not be published.