Category

Clinical Trials

Minority Patients Recruitment in Clinical Trials

By | Clinical Trials, Diversity & Inclusion, Informed Patient, Patient Engagement, Patients | No Comments

The FDA has approved 22 new drugs in 2016, and there are 31,468 patients participated in clinical trials in total. We have been encouraging patients to join clinical trials by showing patients the benefits for them and future generations. However, we should also focus on the diversity of patients in clinical trials, rather than only increasing the total number of patients. Among all the patients participated in clinical trials in 2016, 48% were female patients and 24% were patients with color, which does not correlate with the population percentages of women and people of color in the nation. According to 2010 census, there are approximately 51% women and 30% people of color in the U.S. It is evident that women and people of color are under-presented in clinical trials, which could lead to different drug effects on women and people of color. Therefore, it is essential to encourage more minority patients to participate in clinical trials.

To recruit minority patients in clinical trials, there are serious barriers that need to be addressed. According to a Forbes report, the biggest obstacle is the lack of encouragement or support from the attending physician. Many doctors are either unaware of relevant clinical trials for their patients or not spending sufficient time on each patient. In a 2000 Harris Interactive survey, 80% of cancer patients were unaware of their potential clinical trial options. Additionally, in a 2013 Zogby survey, more than 50% of patients were still unaware of clinical trials, and only a quarter of patients learned of clinical trials from their physicians. Thus, raising the awareness of the existence and benefits of clinical trials is extremely necessary. One big reason that patients are not aware of clinical trials is due to their physicians failing to introduce clinical trials to their patients. Forbes pointed out that “with the increasing pressure to see patients more and more quickly, they simply don’t have the time to engage in lengthy discussions with patients.” However, as a physician, listening to their patients, asking for patients’ needs and helping patients as much as possible is crucial. Especially for minority patients, their diverse backgrounds may require special needs from their physician. Also, the effect of the same treatment can vary enormously across different patients. Therefore, it is vital for physicians to communicate properly with each minority patient. One communicating strategy is that doctors should transfer their language to one that different patients can understand, which will help awareness amongst minority patients. Besides, during the whole process of clinical trials, patients should decide how they want to be part of any of the processes, and physician takes the significant role of guiding and suggesting their patients. Another possible reason that stop minority patients from joining clinical trials are that many patients misunderstand and believe that an experimental treatment must be better than the standard, hence, they would rather take a placebo than finding a standard treatment through clinical trials.

We are a nation of immigrants and diversity is our reliable weapon to support society’s stability. To perfect our healthcare industry, we need to raise and spread the awareness of diversity and inclusion. Physicians are encouraged to engage with their minority patients, communicate with them, and provide the best treatments and clinical trials options for them. Physicians’ efforts can not only help minority patients at present but also benefit their future generations since there are biological changes as generations live and grow in our country. In the end, building trust and communication between physician and minority patients are the keys to recruiting more minority patients in clinical trials.

To further explore the importance of increasing minority patients recruitment in clinical trials, CHI is organizing 2nd Annual Breakthroughs in Healthcare Diversity Symposium on 1/9/18 in San Francisco, CA. The symposium is a leading collaborative symposium for patients, patient groups, clinicians, researchers, technologists, healthcare and life science executives, and diversity and inclusion advocates to discuss diversity and inclusion in healthcare. The symposium will discuss best practices, and exchange new ideas related to making healthcare more diverse, with a specific focus on understanding how to serve underserved patient groups, including racial and ethnic minorities, women, and the LGBT community. The symposium will also focus on helping provider, pharma, and other organizations who serve patients with the latest ideas and insights on how these organizations can become more diverse and inclusive in order to best understand the unique and diverse needs of the patients they serve. Attendees will learn the newest insights and ideas, discuss practical solutions, and meet industry and marketplace colleagues. Please click here for more information.

 

References:

Stone, Judy. “How Can We Encourage Participation in Clinical Trials?” Forbes, Forbes Magazine, 8 Jan. 2015, www.forbes.com/sites/judystone/2015/01/06/how-can-we-encourage-participation-in-clinical-trials/#1146b57c4d0c.

Tate, Wendy. “Diversity in Clinical Trials: Recruiting Women and Minorities in Research.” Forte Research Systems, Forte Research Systems Inc., 12 Apr. 2017, forteresearch.com/news/diversity-clinical-trials-women-minorities-research/.

Need for Diversity in Clinical Trials

By | Clinical Trials, Diversity & Inclusion, Drug Costs | No Comments

Clinical trials are essential to bringing new medicines to patients. An important aspect of clinical trials is to make sure that the drug is effective for a diverse group of people. Diversity in clinical trials has recently been a key issue. There is no comprehensive way of defining diversity, as it could include gender, race, ethnicity, sexual orientation, and more, depending on the dimension from which it is viewed. Unfortunately, many clinical trials lack diversity in representation.

A diverse nation like the United States has an assortment of populations, with White Americans forming the ethnic majority. Hispanic and Latino Americans amount to 16% of the population, making up the largest racial minority1. African Americans are the second largest racial minority, accounting for 12% of the population1. Adding to this is the international community which lands in the U.S in search of opportunities. Already diverse cities are becoming increasingly mixed with immigrants from Asia, Africa, and Latin America. The U.S. is a diverse country, so why do our clinical trials not reflect the same level of diversity?

Clinical trials are an essential part of drug development. These provide a base of evidence for evaluation of a drug. Each drug needs to be tested for its efficacy, ease of application, side effects, and many other factors before being launched into the market. The average drug developed by a major pharmaceutical company costs billions of dollars to develop. In general, the drugs are not specifically designed with every racial group in mind due to the cost of production. That is why clinical trials are an important tool to determine the drug’s effectiveness on the population as a whole. The trials are performed on a sample population and researchers try to prove its statistical significance on the entire population. Hence, it is very much essential for clinical trials to be diverse to represent the population. People from diverse cultures differ among factors such as their predisposition to diseases or the environment they are exposed to. To create awareness, the FDA announced 2016 as “The Year of Diversity in Clinical Trials.” Despite an increase in awareness, the current trend is unsatisfactory. According to the FDA, African Americans represent 12 % of the U.S. population, but only 7% of clinical trial participants. Additionally, Hispanics represent 16% of the U.S. population but only 1% percent of clinical trial participants2. In a country where minorities are estimated to outnumber white Americans by 2044, the inclusion of individuals of varied races, ethnicities, ages, gender, and sexual orientation in clinical trials can help to prevent disparities in the evaluation of potential new medicines2. Clinical trials ensure top quality drugs and diversity in clinical trials should be considered to provide better treatment.

The 7th Annual Diversity, Inclusion, and Life Sciences Symposium will discuss the trends, facts, insights, and best practices regarding diversity in clinical trials. Attendees will learn the newest insights and ideas, discuss practical solutions, and meet industry and marketplace colleagues. Please visit http://chisite.org/dilss/ for more info or to register.

 

  1. Source: Wikipedia
  2. Source: Center for Healthcare Innovation – DILSS 2016 Executive Summary

What Healthcare Diversity Looks Like in The 21st century

By | Clinical Trials, Diversity & Inclusion, Global Healthcare Trends, Patients | No Comments

Diversity is a key word in the healthcare system. It can be defined as the blending of different backgrounds, with representation across gender, race/ethnicity, generation, and sexual orientation. Diversity is undeniably one of the most important topics in today’s society. In fact, according to an article published in Becker’s Hospital Review, millennials are the most diverse generation in the U.S. Population [1]. This change has brought the demand for a better quality of life across every social aspect, such as healthcare[2].

Despite the focus on relatively high economic factors in our healthcare system, many issues on the social spectrum remain unaddressed. One of the issues that our healthcare system faces today is the lack of representation for our ever-growing, diverse, population. As stated in an article published in Modern Healthcare, the lack of true diversity among leaders in this industry has stayed consistent[3]. How consistent? Well, according to Kevin E. Lofton, CEO of Englewood, Colorado-based Catholic Health Initiatives, this has been an issue since he started his career back in 1978. The healthcare industry has done a poor job of adjusting to the rapid demographic changes in recent years.

According to a survey conducted in 2013 by the American Hospital Association’s Institute for Diversity, minority representation on healthcare boards across the nation stood at 14 percent [4]. Furthermore, the same survey reported that minorities represented 31 percent of patients nationally. This is an issue that needs to change in the next couple of years. In an article published by David Ferguson, he mentions that a lack of diverse leadership in the healthcare industry can present a cultural gulf that must be overcome if the industry plans on switching to patient-centered care[5]. Emphasizing the crucial importance of diversity is critical if we ever hope to have an adequate health care system that is inclusive and represents the diverse set of people living in this nation.

Change must start at the top of the executive pyramid. Why? Well, those at the top are the ones with the power to make decisions.  In addition, increasing the number of physicians of color can foster higher levels of patient satisfaction among underrepresented groups in the community[6]. Most importantly, it is key to let minority groups know that the resources are there for them to take initiative. This can only work if both healthcare providers and patients work together to bring much-needed change to a system as sophisticated as the healthcare industry.

We must look at different initiatives that in the long-term can foster a system where the gap between healthcare inequality is minimal or non-existent. These initiatives must produce a system that is not only inclusive but effective as well. Shedding light on this issue is a must among healthcare leaders since they become the voice of the underrepresented populations. In the end, it is important to push for change and create something meaningful in an industry where change is long overdue.

To further explore these diversity trends, CHI is organizing our 7th annual Diversity, Inclusion, & Life Sciences Symposium on 6/15/17 in Chicago. The Symposium is the leading annual, collaborative event for life sciences and healthcare executives, physicians, HR professionals, clinical trial professionals and patients, entrepreneurs, patient groups, researchers, academics, and diversity and inclusion advocates to discuss diversity and inclusion in healthcare. The symposium focuses on the latest trends, challenges, opportunities, and best practices for implementing strategies and tactics to make these industries more diverse and inclusive, as well as understand how to better serve diverse patient groups. Attendees will learn the newest insights and ideas, discuss practical solutions, and meet new industry and marketplace colleagues. See a video at http://www.snip.ly/fxln8. This year’s symposium will include topics such as the role of coaching and mentoring in executive success, diversity and inclusion in clinical trials and research, and expanding definitions of diversity. Please visit http://chisite.org/dilss/ for more info or to register. Register before 5/13 to receive early registration discount.

 

References

[1] Jayanthi A. The new look of diversity in healthcare: Where we are and where we’re headed. Becker’s Hospital Review. http://www.beckershospitalreview.com/hospital-management-administration/the-new-look-of-diversity-in-healthcare-where-we-are-and-where-we-re-headed.html. Accessed January 25, 2017.

 

[2] Dorning J. The U.S. Health Care System: An International Perspective. Department For Professional Employees. http://dpeaflcio.org/programs-publications/issue-fact-sheets/the-u-s-health-care-system-an-international-perspective/#_edn24. Accessed January 25, 2017.

 

[3] Lofton K. Need for more diversity in healthcare leadership represents a moral and business imperative. Modern Healthcare. http://www.modernhealthcare.com/article/20161119/MAGAZINE/311199945. Accessed January 25, 2017.

 

[4] Diversity and Disparities. Diversity Connection. http://www.diversityconnection.org/diversityconnection/leadership-conferences/diversity_disparities_Benchmark_study_hospitals_2013.pdf. Accessed January 25, 2017.

 

[5] Ferguson D. Diversity in healthcare leadership drives better patient outcomes and community connection. Fierce Healthcare. http://www.fiercehealthcare.com/healthcare/diversity-healthcare-leadership-drives-better-patient-outcomes-and-community-connection. Accessed January 25, 2017.

 

[6] King M. The importance of cultural diversity in healthcare | Brainwaves. The University of Vermont. https://learn.uvm.edu/blog-health/cultural-diversity-in-healthcare. Accessed January 25, 2017.

 

What Changing U.S. Demographics Mean for Clinical Trials

By | Clinical Trials, Diversity & Inclusion, Healthcare Access, Informed Patient, Patients | No Comments

The Food and Drug Administration has declared a renewed focus for 2016 exploring diversity in clinical trials. [1] Data gathered from FDA shows that there is still a significant lack of patient diversity in clinical trials.  “While African-Americans/Blacks represent 12% of the total U.S. population, they comprise just 5% of clinical trial participants. Hispanics account for 16% of the total population but just 1% of trial participants.” [2]

 

As researchers aim to understand how a drug’s effectiveness can vary in different patient groups, it is important to consider how U.S. demographics have begun dramatically shifting. According to the U.S. Census Bureau’s latest projection “It is predicted that by 2043, the U.S. will be a majority non-white nation. [3] White Americans will have gone from comprising 85% of the U.S. population in 2012 to just 43%. Hispanic and African Americans/Blacks will have grown substantially over that period, together making up 45 percent of the population with Hispanics being one of the fastest growing groups making up 31%.”[4] Therefore the inclusion of minorities in clinical trials will only become more critical. To demonstrate the safety and effectiveness of a new treatment, healthcare industry leaders should ensure the inclusion of a diverse population in clinical trials. Underrepresentation of minorities can skew vital trial and treatment data.

 

Some causes for lack of diversity and inclusion in clinical trials stem from lack of trust in trials, lack of awareness of what trials are, and barriers to participation of minority population in trials. For example, based on the history of medical research in the Tuskegee study, an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service studying the natural progression of untreated syphilis in rural African-American men in Alabama under the guise of receiving free health care from the United States government, there is a fear of exploitation in medical research.[5] Second, there is often a lack of misunderstanding about the process of clinical trials. Third, there are barriers to participation or feasibility for minority populations to enroll in clinical trial.

 

To attempt solve these complex diversity and inclusion issues, it is critical to go beyond the current one-size fits all approach and raise awareness, build trust, and reach out to under-represented population. Increased diversity in the population pool of clinical trials might just even result in greater confidence in the results and benefits of drugs to the population.

 

The Center for Healthcare Innovation’s Diversity, Inclusion, & Life Sciences Symposium on June 22, 2016 will address these issues in-depth. The Symposium is the leading annual, collaborative event for life sciences and healthcare executives, physicians, HR professionals, clinical trial professionals and patients, entrepreneurs, patient groups, researchers, academics, and diversity and inclusion advocates to discuss diversity and inclusion in healthcare. Please visit chisite.org/education/diversity-symposium/ for more information.

 

 

References

  1. 2016: The Year of Diversity in Clinical Trials | FDA Voice. http://blogs.fda.gov/fdavoice/index.php/2016/01/2016-the-year-of-diversity-in-clinical-trials/.
  2. Bridging the Diversity Gap in Clinical Trials | Thought leadership and innovation for the Pharmaceutical Industry – EyeforPharma. http://social.eyeforpharma.com/clinical/bridging-diversity-gap-clinical-trials.
  3. Census: White majority in U.S. gone by 2043 – U.S. News. http://usnews.nbcnews.com/_news/2013/06/13/18934111-census-white-majority-in-us-gone-by-2043.
  4. A Study On The Changing Racial Makeup Of “The Next America.” http://www.huffingtonpost.com/2014/04/13/changing-racial-makeup-_n_5142462.html.
  5. https://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment

 

Improving Access for LGBT Clinical Trial Initiatives

By | Clinical Trials, Diversity & Inclusion, Patients | No Comments

In early April of 2016, Washington State lawmakers passed a bill to improve health research for individuals of the Lesbian, Gay, Bisexual, and Transgender community. Since the state of Washington has a significant LGBT population (more than 173,000 LGBT individuals in Seattle alone), Washington State lawmakers felt it was time to include the LGBT community into patient-centered research initiatives. The legislation requires the National Institutes of Health to coordinate a research strategy that addresses the lack of minority patient populations in current clinical trials in the state of Washington, promoting a more inclusive health-research environment where the needs of the LGBT community are specifically assessed in different clinical trial initiatives.

 

The importance of inclusive legislation in regards to clinical trial participants cannot be understated. A large percentage of clinical trials are failing to meet benchmarks necessary to represent patient populations as a whole. In fact, for clinical trials across the United States, it was determined that less than two percent of trials funded by the National Cancer Institute reached the benchmarks the NIH has set for including minority participants. By excluding minority populations from clinical trials, the health of LGBT members, as well as the health of men and women of color, are put at risk.

 

While Washington State has passed legislation to require inclusive clinical trials for LGBT members, the vast majority of the U.S. has not seen a similar progression. To accurately represent the U.S. patient population, both the federal government and state governments should make it a priority to pass legislation that requires LGBT member participation in clinical trials. Other state governments and the federal government could utilize the bill passed in Washington State as a model to catalyze bipartisan collaboration between the NIH and the minority populations across the nation. Diversity in clinical trials is not just a necessity for the LGBT population, but it is also a necessity for men and women of color and expecting mothers. Legislation is necessary to ensure the validity of clinical trial findings; clinical trials must represent patient populations in their entire diverse nature. The state of Washington has taken a step in the right direction towards promoting more inclusive clinical trials, will the rest of the nation follow suit?

 

The Center for Healthcare Innovation’s Diversity, Inclusion, & Life Sciences Symposium on June 22, 2016 will address these issues in-depth. The Symposium is the leading annual, collaborative event for life sciences and healthcare executives, physicians, HR professionals, clinical trial professionals and patients, entrepreneurs, patient groups, researchers, academics, and diversity and inclusion advocates to discuss diversity and inclusion in healthcare. Please visit chisite.org/education/diversity-symposium/ for more information.

 

 

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http://www.bizjournals.com/seattle/blog/health-care-inc/2016/04/washington-state-lawmaker-pushes-bill-to-improve.html

 

The Urgency in Increasing Diversity in Clinical Trials

By | Clinical Trials, Diversity & Inclusion, Health Insurance, Healthcare Access, Healthcare Quality, Patients | No Comments

 

The Food and Drug Administration (FDA), the key regulatory authority in bringing new drugs to the market, must balance between introducing life-saving treatments to people 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. These trials document how well the treatment works on individuals and also of the likelihood of the occurrence of severe side effects.1 The FDA has programs to accelerate the usually rigorous process needed to test drugs that are the first proven treatment of an ailment or have a significant advantage over already approved drugs.2

Often clinical trials fail to achieve adequate representation for minorities. 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.3 Caucasians are still overly represented in clinical trials.4 The FDA and National Institute of Health (NIH) must urgently address this situation.

Significant genetic variations in various ethnic groups may cause different reactions to certain treatments. This difference puts people at risk as certain treatments’ side effects affect various groups differently. Differences in individuals’ genetic codes can alter the effectiveness of drugs as genes affect how a drug is metabolized and how an individual responds to a drug.5 A recent study on anti-HIV drugs revealed that genetic differences could render drugs completely ineffective in patients.6 These genetic differences can differ between individuals of difference races and/or ethnicities.5 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 with that drug in the clinical trials.

One of the reasons as to why there is a lack of minority representation is mistrust of the established medical system. This is most notably seen with the infamous Tuskegee Syphilis Study in which physicians knowingly withheld treatment for African Americans infected with syphilis.7 Physicians’ bias also plays 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 treat their current patients.8 Physicians use this bias to determine 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.9 In addition, minority populations have historically had poor access to healthcare. Minorities are less likely than Caucasians to have access to health insurance, a requirement for some Phase III clinical trials. This lack of insurance restricts many minorities to only receive health care in emergency rooms and unable to participate in trials.10

These and other obstacles prevent accurate minority representation in clinical trials need to be addressed and solved. 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 are not promising as the proportion of minorities in clinical trials is still significantly lower than the proportion of minorities in the United States.11 Thus, before different methods other than passing acts in Congress will be implemented, minorities will continue to be at risk with their treatments.

References

  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.