After two years of virtual meetings due to the COVID-19 pandemic, it was with great pleasure to attend the in-person SCRS ANZ Site Solutions Summit in Melbourne, Australia in July 2022. With an equal representation of sites and industry, important topics spanned from site collaboration, clinical research profession and compensation changes, as well as diversity in clinical trials related specifically to the ANZ region.

As a representative from Total Diversity Clinical Trial Management, takeaways relating to diversity & inclusion in clinical trials specifically relevant to the ANZ region were of key priority to my learnings and subsequent actions to best serve our important clients. Having met with regional representatives from pharma, such as Sanofi, Regeneron, Pfizer, MSD, and Bayer, it became apparent that most diversity initiatives are initially being driven from the US, with not much direction yet given to the APAC region.

Nonetheless, in February 2022, all Australian jurisdictions agreed to implement “The National Clinical Trials Governance Framework1, which embeds clinical trials into routine health service provision and increases efficiency, cohesion, and productivity across the clinical trials sector in Australia. As a part of this framework to be implemented by 2023, the collection of diversity metrics by clinical research sites will be required.

Action 1.15

The health service organization or trial site:

  1. Identifies the diversity of the consumers using its services
  2. Identifies groups of patients using its services who are at higher risk of harm
  3. Incorporates information on the diversity of its consumers and higher-risk groups into the planning and delivery of care

This is a significant step to advancing diversity & inclusion in clinical trials for the ANZ region as sites do not currently collect racial/ethnic metrics beyond Aboriginal or non-Aboriginal as a standard practice. Furthermore, this region presents unique diversity needs, such as:

  1. Non-English-Speaking Patients
  2. Rural Patients
  3. Socioeconomic Diversity
  4. Aboriginal and Torres Strait Islander

As one way to address diversity and inclusion in clinical trials, Australia and New Zealand have long since been ahead of the curve when it comes to offering Decentralized Clinical Trials (DCTs) through the use of telemedicine and remote visit options to reach underrepresented patient populations.

To take it one step further, a new focus highlighted during the conference is the need to standardize training for new Principal Investigators, as much of their onboarding at research naïve sites consists simply of “hands-on learning” while on the job. As represented in the recent SCRS ANZ Summit ReflectionsPublication2, one of the top two second underfunded categories reported is training and education, with an overwhelming expressed desire from site representatives to have access to more formalized PI training programs.

With diversity training and education (DTEACH©) being one of TOTAL’s key product and service offerings, I was fortunate to present on the data-driven backbone of the training program during the session titled “The Diversity Site Assessment Tool (DSAT) for Best Practices to Enroll Diverse Populations in Clinical Trials Among Asia Pacific Countries”. The DSAT is “THE” gold standard and only validated and reliable tool in the industry and is authored by Diana L. Foster, Ph.D., TOTAL’s CEO and Chief Diversity Officer. The tool evaluates site’s present ability and potential for conducting diverse study enrollment and the resulting data can be utilized to accurately assess and quantify site improvement strategy. This has led to a curriculum based on evidence, not assumptions.

While TOTAL’s DSAT and diversity training and education program have initially been developed for North America, great strides have been taken in the last 12 months to expand this research across the world, especially in Asia Pacific, Europe, and South America as depicted in the graphic below.

*TOTAL/SCRS Partnership Data Within the Last 12 Months – 450 sites

The data collected thus far is substantial and will continue to evolve. Furthermore, with the expressed need for more formalized PI and site training programs in the ANZ region, TOTAL is poised to work in collaboration with regional sponsors, CROs, and sites in laying the foundational groundwork so sites can proactively begin integration of Diversity Best Practices. Sites overwhelmingly responded to a willingness to benchmark their capabilities with the DSAT to identify gaps and begin progress forward due to the impending implementation of The National Clinical Trials Governance Framework. I am looking forward to participating in the forward progress of this progressive region in the betterment of diversity and inclusion in clinical trials.

Amanda Rangel, MS, CCRC, SVP, Business Development, Total Diversity

References:

  1. The National Clinical Trials Governance Framework. 30 May 2022. https://www.safetyandquality.gov.au/sites/default/files/2022-05/final_design_-_national_clinical_trials_governance_framework_and_user_guide_-_30_may_2022.pdf
  2. Site Solutions Summit Reflections. 16 Aug 2022. https://myscrs.org/resources/site-solutions-summit-reflections/
  3. The Diversity Site Assessment Tool (DSAT), Reliability and Validity of the Industry Gold Standard for Establishing Investigator Site Ranking. 2020. https://totaldiversity.com/wp-content/uploads/2021/06/Foster_IJMS_OCT2020_DSAT-2.pdf.