There is much discussion on the lack of diversity in the clinical trial patient population. For this paper you will read three articles that address the challenges in patient recruitment and the many obstacles that prevent a more diverse demographic from participating in clinical trials. After careful reading of the provided articles, please respond to the questions listed in the prompt.
**** The Attached “PDF’S” need to used in this paper*****
Prompt (Question to address) – Needs to set up in this fashion
1)
After reading
the different articles on diversity issues in clinical trials, why do you think it is important to address these disparity issues?
2)
What do you think is/are the best solutions to resolve these disparity issues?
3)
Can you think of a potential solution that is not mentioned in these articles?
Overcoming Pharma's Diversity Problem Source: IQVIA Research & Development Solutions Article | March 11, 2021 Erica Prowisor, Global Head, Patient Recruitment & Retention Decentralized clinical trials and a more patient-centric approach can make trials more appealing to all demographics In 2001, the U.S. National Institute of Health (NIH) mandated that women and members of minority groups must be included in all NIH-funded clinical research, unless developers could make a compelling rationale otherwise. It was a foundational moment in clinical research, requiring the biopharmaceutical industry to acknowledge that diverse studies deliver safer and more effective new drugs. 20 years later, sponsors are still struggling to recruit diverse populations in a truly representative way based on therapeutic incidence levels. Among new molecular entities and biologics approved in 2020, just 11 percent of participants were Hispanic, eight percent were Black, and only six percent were Asian. Sponsors have discovered that it is not easy to assemble a perfectly diverse patient population that also meets all inclusion/exclusion criteria. Facing the simultaneous pressure to lower costs and accelerate timelines, diversity goals can often slide down the priority list. However, the growing adoption of decentralized clinical trials (DCTs) may now help make recruiting diverse, representative groups of participants more achievable – without adding significant time and cost to the trial. Miles to go Studies show that excessive travel is one of the most significant barriers to trial participation – and that underserved minority communities often face the biggest burden. One 2018 report found that while trial participants traveled an average of 25.8 miles to get to a trial site, patients from lower-income areas traveled more than twice that distance – 58.3 miles vs. 17.8 miles for affluent participants. The time and cost associated with that level of travel quickly becomes untenable, causing patients from these communities to decline enrollment, or to drop-out when the commitment becomes too great. This results in sites limiting their recruiting efforts to patients who live within the local community, which can skew the population to a homogenous demographic. DCTs eliminate much of this travel burden, by cutting some or all on-site visits from the trial experience. If patients only need to travel to a site a handful of times, the occasional multi-hour trip can feel more reasonable. And if the trial is completely virtual, any patient with internet access can participate from anywhere in a targeted geography – no travel required. This opens recruiting to far-flung communities, and to those who don’t have a car or access to public transportation. It also means sites can rethink their recruiting paradigm to focus more on outreach in diverse communities, using new channels to attract new patients to a trial such as digital patient communities. However, dealing with travel burden is only the first step. While DCTs dramatically reduce logistical barriers, sponsors and recruiters must address patients’ fears about trial participation, and do more to bolster awareness about trials as a source of care. Unconscious bias: The hidden barrier The National Academy of Sciences found that people identifying as black, indigenous, and people of color (BIPOC) are still less likely to receive appropriate medical services, and that they experience a lower quality of health care than whites. This disparity is often the result of unconscious bias among healthcare providers, who tend to display more positive attitudes toward white patients. These disparities have been reinforced throughout history, but they have been in the spotlight during the pandemic as data shows people Overcoming Pharma’s Diversity Problem https://www.clinicalleader.com/doc/overcoming-pharma-s-diversity-pro... 1 of 2 8/12/2021, 11:01 PM https://www.clinicalleader.com/ https://www.clinicalleader.com/ https://www.clinicalleader.com/ecommcenter/iqvia https://www.clinicalleader.com/ecommcenter/iqvia https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm#:~:text=It%20is%20the%20policy%20of,that%20inclusion%20is%20inappropriate%20with https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm#:~:text=It%20is%20the%20policy%20of,that%20inclusion%20is%20inappropriate%20with https://www.fda.gov/media/145718/download https://www.fda.gov/media/145718/download https://pubmed.ncbi.nlm.nih.gov/29700209/ https://pubmed.ncbi.nlm.nih.gov/29700209/ https://ascopubs.org/doi/10.1200/JCO.2001.19.6.1728 https://ascopubs.org/doi/10.1200/JCO.2001.19.6.1728 https://ascopubs.org/doi/10.1200/JCO.2001.19.6.1728 https://ascopubs.org/doi/10.1200/JCO.2001.19.6.1728 https://www.ncbi.nlm.nih.gov/books/NBK220347/ https://www.ncbi.nlm.nih.gov/books/NBK220347/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4638275/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4638275/ of color experience consistently higher rates of hospitalization and death from COVID-19 than those in white communities. These are disturbing trends that have caused many BIPOC to be skeptical of clinical trial participation. But drug developers can overcome these concerns through authentic outreach, education, and transparency about what the trial will involve, and how patients and the community will benefit. These solutions will require some rethinking of the recruiting and trial process. Initial steps can include: Ensuring the investigator teams and trial recruiting staff are diverse and representative of the communities they serve. Hosting focus groups with targeted patient demographics to discuss their trust concerns and listen to their past experiences with bias. These focus groups can be a learning opportunity for sponsors and recruiters and give minority communities a chance to be heard and become the catalyst to implement positive changes. Working with physicians and healthcare facilities in communities of color to engage patients and educate them about the benefits of clinical trials as a care option. As with any population, patients are more inclined to consider trial participation if the suggestion comes from a professional who they trust. Offering flexible options for participation, including telehealth meetings, e-diaries and connected devices that reduce the amount of time and travel required to participate in a trial. Worth the effort When sponsors include representative patients in their trials – to truly reach those who are impacted by a disease - it can result in more effective treatments. That is beneficial for sponsors, sites and patients. DCTs give sponsors the technology to overcome the physical barriers that limit diversity in clinical trials. When DCTs are combined with more diverse recruiting strategies and personnel, research will be well-positioned to achieve better outcomes. Overcoming Pharma’s Diversity Problem https://www.clinicalleader.com/doc/overcoming-pharma-s-diversity-pro... 2 of 2 8/12/2021, 11:01 PM https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769369?utm_source=STAT+Newsletters&utm_campaign=5148646e37-MR_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-5148646e37-150709213 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769369?utm_source=STAT+Newsletters&utm_campaign=5148646e37-MR_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-5148646e37-150709213 ACRP The Association of Clinical Research Professionals Diversity Issues Hinder Clinical Trial Efficacy, Data Value BlogJune 28, 2021 The COVID-19 pandemic “exposed severe disparities in our healthcare system,” including the relative lack of diversity in the clinical trial patient population, Bashar Shihabuddin, MD, MS, a professor of emergency medicine at Nationwide Children’s Hospital, told attendees of a recent ACRP webinar. “This disparity affects minority populations negatively” and disproportionally, Shihabuddin said, adding that trials for Pfizer and Moderna vaccines featured a patient population that was more than 70% white. “Unfortunately, these results are not unprecedented,” he said, pointing out that similar diversity problems exist in a wide swath of clinical trial study areas, especially cancer and cardiovascular research. Among other downsides, lack of diversity weakens the science behind the trials and dilutes data value, experts generally agree. A root cause of the problem is the lack of diversity among the principal investigator (PI) population, Shihabuddin said. While that issue is relatively acknowledged in industry, he called on industry not to forget that the same lack of diversity among the clinical research coordinator (CRC) population is also a negative factor in terms of widening the clinical trials patient inclusion tent. “CRCs are involved closely in patient recruitment, informed consent, and follow- up,” he noted. Language and other cultural barriers are also likely obstacles, according to a recent survey of more than 50 CRCs in a pediatric research network conducted by Nationwide Children’s https://acrpnet.org/news/blog/ ACRP The Association of Clinical Research Professionals Hospital. For example, more than 80% of the CRCs who spoke Spanish said it helped them attain more success retaining patients. The survey also found some female professionals felt they were at a disadvantage during the conduct of a clinical trial. Calling it an “alarming finding,” Jessica Fritter, MACPR, ACRP-CP, a clinical research administration manager at Nationwide Children’s Hospital, said more must be done to address the problem. “Our survey shows how challenging it can be for women to feel included in a research team,” she said. Fritter cited two responses from the survey as troubling evidence of the problem: • “As a female, I sometimes feel as though I am treated differently than my male counterparts both in rooms and working within the research team.” • “I believe my gender, as a female, hinders my job due to my experiences with my male counterparts. I’ve seen the differences in the way patients/families interact with male CRCs when they approach for consent versus when I approach for consent. It seems to be that they trust my male counterparts more and are more willing to do studies with male CRCs.” Shihabuddin called on industry to learn from its past mistakes and raise the bar on both diversity and addressing cultural differences. “We need to learn from our experiences and ask subjects what worked and what didn’t for those who opted in and those who opted out of a study,” he said. “It’s about building authentic relationships by listening and learning” from each other, he added. “ACRP has taken the reins” to help evaluate cultural competency in the workforce through a working group, Fritter told attendees, with an objective to evaluate existing resources for clinical research professionals “and identify how to best make those more accessible and actionable for key roles,” including PIs, CRCs, and clinical research associates. She praised the efforts of the working group as it also focuses on organizational effectiveness and engagement on the value of diversity, equity, and inclusion as an important step forward. A replay of the webinar on “Diversity of Research Personnel: Knowing Who We Are to Know Who We Serve” is available free for ACRP members. Author: Michael Causey https://acrpnet.org/courses/webinar-replay-diversity-of-research-personnel-knowing-who-we-are-to-know-who-we-serve/ https://acrpnet.org/courses/webinar-replay-diversity-of-research-personnel-knowing-who-we-are-to-know-who-we-serve/ Research & Development Addressing Demographic Disparities in Clinical Trials by Kathy Giusti, Richard G. Hamermesh, and Mark Krasnow June 11, 2021 Summary. Martin Barraud/Getty Images Disparities in health care are not just limited to the delivery of care. They also exist in the way that clinical trials are structured. Women, people of color, and the elderly often are not adequately represented. This article offers three strategies for addressing this... Most clinical trials are not representative of the general population or of those with a particular disease. Clinical trials primarily enroll white, male patients, with consistent underrepresentation of women, more https://hbr.org/topic/research-and-development https://hbr.org/search?term=kathy%20giusti https://hbr.org/search?term=richard%20g.%20hamermesh https://hbr.org/search?term=mark%20krasnow https://hopkinsbio.org/academic/diversity-in-clinical-trials/ https://medcitynews.com/2019/07/as-precision-medicine-grows-so-does-the-importance-of-clinical-trial-diversity/?rf=1 the elderly, and people of color — especially Black and Hispanic patients. While people of color make up about 39% of the U.S. population, these groups represent from 2% to 16% of patients in trials. This underrepresentation emerged as an issue during the trial of Moderna’s Covid-19 vaccine. When it was reported that Black Americans represented only 7% of the trial versus 13% of