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Representative & Diverse Clinical Trial Recruitment Should Be Prioritized, Says Dr. Mitchell

In the latest segment of WCG’s COVID webinar series, Ms. Annick de Bruin compares the results of CISCRPs broad annual survey to the results of their new COVID focused survey. Dr. Edith Mitchell also discusses the disproportionate impact of COVID to people of color and how we can take lessons learned in the pandemic to promote representative enrollment in future trials.

While the pandemic has brought significant disruption to the clinical trial industry, it has also been a time of innovation and change. In the industry wide effort to develop diagnostic tests, treatments and vaccines for COVID-19, the pace of protocol design and initiation has rapidly accelerated. With the uptick in these trials, industry experts have also noted that the public’s awareness of clinical trials has drastically increased.

The Center for Information and Study on Clinical Research Participation (CISCRP) conducts an annual survey to identify trends on how the public views clinical research, understand perceived advantages and disadvantages of participation, identify barriers to enrollment and offer insights to industry players on how to increase engagement. In light of the ongoing pandemic, CISCRP has conducted a 2020 Mini Survey to understand the current environment of clinical research and identify how it has and will continue to impact the public’s understanding of research.

According to Ms. Annick de Bruin, Director of Research Services at CISCRP, participants’ self reported overall understanding of clinical research is generally high, but when you dig deeper… peoples’ knowledge is actually superficial. In the Mini Survey, similar results were observed, but also highlighted that people have been more susceptible to misinformation. For example, more than half of the survey participants (60%) believe that a treatment or vaccine will be developed in under a year and of those participants, more than half (64%) believe it will be less than a year before treatments and vaccines can be administered.

Additionally, while the majority of participants in the 2020 Mini Survey believe that clinical research is safe, there remains a portion of people that do not. They indicated the following reasons for this belief:

  • Medications/therapies may have untoward side effects
  • Current symptoms could be exacerbated by the new therapy
  • They are distrustful of pharmaceutical companies
  • They do not have enough information about clinical research

When we further break down the bullet point “distrust of pharmaceutical companies”, de Bruin explains that between people of different races, there are significantly different levels of trust in the industry and contributes to the underrepresentation of certain communities within clinical trials.

Dr. Edith Mitchell, Director of the Center to Eliminate Cancer Disparities at the Sidney Kimmel Cancer Center at Jefferson, elaborated on how COVID is disproportionately affecting people of color and how we can take lessons learned from the pandemic to address unequal representation across clinical trial enrollment.

So what are some of factors contributing to the unequal impact of COVID?

In her analysis, Dr. Mitchell explains that there are many factors: employment as an essential worker, lack of PPE, multigenerational households, lack of access to healthcare and higher prevalence of conditions that increase risk of serious complications to COVID.

As healthcare organizations become increasingly aware of the disproportionate impact COVID has on people of color, we can also bring awareness to the larger issue of ensuring diversity in clinical research.

To ensure that any future studies, focusing on COVID or non-COVID treatments, have representative enrollment, Dr. Mitchell advises that…

  1. Sites and sponsors get to know and understand minority communities.
  2. Representative enrollment should be discussed as a priority. Assumptions cannot be made based on patient demographics for a site.
  3. Sites and sponsors should have a formal diversity strategy for recruitment.
  4. Partner with local community organizations to disseminate knowledge about ongoing trials and accessibility.
  5. During site selection processes, communicate with institutions that are connected with minority communities.
  6. Create programs for certain populations within those minority communities (e.g., geriatric populations, non-English speaking).

In closing remarks, Dr. Mitchell reminds us:

We need to be aware, aware, aware and fix, fix, fix.

– Dr. Edith Mitchell, Director, Center to Eliminate Cancer Disparities

De Bruin also advises sites and sponsors to explore solutions that will work for a diverse patient community as one size will not fit all.

Panel Members:

  • Annick de Bruin, Director of Research Services at the Center for Information and Study on Clinical Research Participation (CISCRP)
  • Dr. Edith P. Mitchell, Clinical Professor of Medicine and Medical Oncology, Director of the Center to Eliminate Cancer Disparities at the SIdney Kimmel Cancer Center at Jefferson and 116th President of the National Medical Association
  • Lindsay McNair, Chief Medical Officer at WCG (Moderator)

Watch the full WCG webinar here.

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