Advances in Site Self-Assessment Tools Aim to Bolster Equity in Clinical Trials

Carmen E. Guerra, MD, MSCE, FACP

National Cancer Institute (NCI)-designated comprehensive cancer centers routinely perform clinical trial site self-assessments. These assessments include evaluations of trial portfolios and statuses, enrollment metrics, and patient demographics. However, participation in these types of assessments is far less commonplace among community oncology sites.^1,2

To address this unmet need, clinical trial site self-assessment tools have been developed to assist sites evaluate and improve their recruitment processes.

“These tools help you [evaluate] the large categories: structural, clinical, physician, patient policy, [and] leadership, to try and make sure that all of those practices, policies, and procedures are supportive of enrollment of underrepresented minorities,” Carmen E. Guerra, MD, MSCE, FACP, said in an interview with OncologyLive^®.

Guerra is the vice chair of diversity and inclusion in the Department of Medicine, and associate director of diversity and outreach of the Abramson Cancer Center at Penn Medicine in Philadelphia, Pennsylvania.

Historic Tools Still Hold Value

Racial and ethnic minority groups of patients are less likely to enroll in clinical trials. Despite Black and Hispanic individuals representing 13.4% and 18.5% of patients with cancer, only up to 6% of each minority are enrolled in clinical trials. More than half (55%) of patients, however, will agree to enroll in a trial if participation is offered to them, irrespective of their race or ethnicity.^1,2

In January 2022, Guerra et al performed a literature review to identify scored evaluation tools that provide objective or subjective benchmarks of cancer clinical trial site fairness. Investigators identified over 600 articles and organized nonscored tools and strategies into broad categories.³

Two primary cancer clinical trial site self-assessment tools were identified: the NCI Clinical Trials Assessment of Infrastructure Matrix (CT-AIM) and the Society for Clinical Research Sites (SCRS) Diversity Site Assessment Tool (DSAT).

The NCI CT-AIM is an unvalidated questionnaire which includes 37 items or indicators across 11 attribute classifications including trial characteristics such as physician engagement, education standards, and quality assurance.⁴ Each attribute contains multiple items that aid sites in evaluating their efficiency in each area. The items are scored from prelevel (lowest rating) to level 3 (highest rating).

Shortcomings of the NCT CT-AIM tool include clinical trial portfolio diversity and management, in which indicators are related to trial characteristics phases, purpose types, and disease types.

“[With NCI CT-AIM,] there is not [much] attention paid to the diversity and inclusion of patients, which is why the SCRS DSAT was proposed in 2020,” Guerra said. “NCI CT-AIM is focused on [helping sites] have the infrastructure needed to recruit patients to trials. The [SCRS DSAT] is entirely focused on best practices for recruiting and meeting the needs of more diverse patient populations.”

SCRS DSAT is a validated 25-item questionnaire divided into 3 domains: site overview, site recruitment and outreach, and patient-focused services. Each item prompts the participant to score their site on a 6-point scale with higher scores being an indication of increased use of best practices for recruiting diverse patient populations into clinical trials. Background information is also collected for the participants in a fourth section.⁵

In 2020, a study was conducted evaluating the reliability and validity of the SCRS DSAT. Approximately 17,000 representatives from SCRS member sites were surveyed. Investigators found that the tool displayed “exceptional reliability.” Cronbach’s alpha for internal consistency reliability was 0.929. No statistically significant relationship was observed between site characteristics and their DSAT scores.

The mean score on the site overview section was 51.0 (range, 24-60; standard deviation [SD], 8.14). Mean scores of 43.42 (range, 10-54; SD, 9.36) and 26.83 (range, 10-36; SD, 6.80) were reported for site recruitment/outreach and patient-focused services, respectively. Overall, the mean DSAT score was 121.7 (range, 54-150; SD, 20.7).

The study authors concluded that the DSAT can confidently be used to identify areas of improvement for site best practices.

“Both [the CT-AIM and the DSAST] have their pluses and minuses,” Guerra said, adding that the appropriate tool depends on the goals of the site. “If you are a new site and you want to understand what it [will] take to perform at the very best [level] and what those best practices are, CT-AIM is a place to start. But as you begin to establish this infrastructure, you might want to think about what it takes to be inclusive and enroll a diverse set of patients, because that is what excellence is being defined as by our sponsors and our accrediting and other external bodies. [In that case], the DSAT is what you want to [use].”

Innovations Lead to Improvements

On July 25, 2022, the American Society of Clinical Oncology (ASCO) and the Association of Community Cancer Centers (ACCC) announced the release of 2 new tools to aid clinical trial sites in addressing racial and ethnic disparities in clinical trials: the Just ASK Increasing Diversity in Cancer Clinical Research: An ACCC-ASCO Training Program and the ASCO-ACCC Equity, Diversity, and Inclusion (EDI) Research Site Self-Assessment.⁶

The Just ASK training program is adapted from a course developed at Duke University in Durham, North Carolina on implicit bias. The program is applicable to all members of the clinical trial site research team and can be completed in approximately 90 minutes. Five interactive modules provide information on structural and systemic racism, the role of implicit bias in clinical trial recruitment, and recommendations for addressing racial and ethnic disparities in clinical trial settings.

The ASCO-ACCC EDI site self-assessment tool is being rolled out following a successful pilot study with 75 participating research sites across the United States which was initiated in May 2021. The tool was refined and revised using feedback collected during the testing period.

The EDI site self-assessment tool helps sites perform an internal review of existing practices and policies and offers evidence-based strategies to improve patient diversity in clinical trials. There are 7 domains in which respondents evaluate their institutions on a 5-point scale of strongly disagree to strongly agree. The domains include the following: supporting patient retention, supporting patient participation, offering cancer treatment trials, screening patients for cancer treatment trials, availability of cancer treatment trials, mission and leadership, and patient access. An annotated reference list of detailed strategies for improvement is available to assist in developing an action plan based on results.

A poster from Pressman et al presented at the 2022 ASCO Annual Meeting showed that there is room for improvement in the systemic collection and types of data needed to diversify trial populations. These findings underscore the need for tools such as the ASCO-ACCC EDI site self-assessment.⁷

To understand the feasibility of EDI site-self assessment tools, a pilot study was conducted to aggregate data and 62 sites from the academic (61%), hospital/health system (26%), and independent (13%) settings participated.

Only 18% of sites who completed the assessment were able to provide initial screening data and none of these sites were able to show they routinely collected this data. “Most sites in this study did not collect, or routinely collect, data for screening, offering, and consenting patients to clinical trials,” the study authors wrote. “Without these data, sites are unable to evaluate and monitor whether their patients have equitable access to clinical trials or establish strategies to address any inequities.”

Less than half of the sites reported eligibility screening (31%), eligibility confirmation (42%), onsite trials offered (18%), or offsite trials offered (6%). All sites had low rates of routinely collecting this data; 6%, 15%, 5%, and 0%, respectively.⁷

Most sites were able to provide patient consent data (65%) and 39% of these sites routinely collected this information. Study authors noted that as many as 29% of the sites across steps did not systematically collect the requested data and some sites noted that it would be too burdensome to manually review charts to extract the necessary data.

The ASCO-ACCC Equity, Diversity, and Inclusion Research Site Self-Assessment and the Just ASK training program are available for free online and ASCO plans to continue to use feedback from the community to continue to revise and enhance the tools. Guerra noted that future studies will evaluate the efficacy of the tool in recruiting traditionally underrepresented minorities as data matures and becomes available.

References

1. Guerra CE, Fleury ME, Byatt LP, Lian T, Pierce L. Strategies to advance equity in cancer clinical trials. Am Soc Clin Oncol Educ Book. 2022;42:127-137. doi:10.1200/EDBK_350565
2. Unger JM, Hershman DL, Till C, et al. "When offered to participate": a systematic review and meta-analysis of patient agreement to participate in cancer clinical trials. J Natl Cancer Inst. 2021;113(3):244-257. doi:10.1093/jnci/djaa155
3. Guerra CE. Strategies to advance equity in cancer clinical trials: site self-assessments and institutional strategies. Presented at: 2022 American Society of Clinical Oncology Annual Meeting; June 3-7, 2022; Chicago, Illinois. Accessed July 28, 2022.
4. Dimond EP, Zon RT, Weiner BJ, et al. Clinical trial assessment of infrastructure matrix tool to improve the quality of research conduct in the community. J Oncol Pract. 2016;12(1):63-e35. doi:10.1200/JOP.2015.005181
5. Foster D. The diversity site assessment tool (DSAT), reliability and validity of the industry gold standard for establishing investigator site ranking. Integrative Journal of Medical Sciences. 2020;7(266). doi:10.15342/ijms.7.266
6. Diversify your cancer clinical trials with new recruitment and retention resources. News release. ASCO. July 25, 2022. Accessed July 27, 2022. bit.ly/3zDNw9a
7. Pressman AR, Hurley PA, Kaltenbaugh M, et al. Availability of data for screening, offering, and consenting patients to cancer clinical trials: report from an ASCO-ACCC collaboration. J Clin Oncol. 2022;40(suppl 16):6530. doi:10.1200/JCO.2022.40.16