Strategies addressing barriers to clinical trial enrollment of underrepresented populations: A systematic review

In 2010, the National Cancer Institute and the American Society of Clinical Oncology cosponsored a symposium to examine the state of clinical trial accrual science and identify opportunities to facilitate trial enrollment. The authors provide recommendations for best practices and for future research developed from the symposium.

https://ascopubs.org/doi/pdf/10.1200/JOP.2013.001119

The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and recommendations

Cancer clinical trials enable the development of novel agents for the potential benefit of cancer patients. Enrolment in a trial offers patients the chance of superior efficacy coupled to the risk of unanticipated toxicity. For trial results to be generalisable, the data need to be collected in patients' representative of the general cancer population. Socioeconomic deprivation is associated with poor cancer outcomes. In the developed world, the gap between the most and least deprived is widening. This mini-review explores the evidence regarding socioeconomics and access to cancer trials, highlighting the underrepresentation of deprived patients, and exploring reasons for this disparity.

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The impact of socioeconomic status on access to cancer clinical trials

Background or aims:Lack of clinical trial awareness is a known obstacle to clinical trial enrollment. We sought to define the prevalence of clinical trial awareness in the US population, determine characteristics associated with increased trial awareness, and explore potential disparities in trial awareness.Methods:We utilized data from the Health Information National Trends Survey from 2008 and 2012. Logistic regression was utilized to assess predictors of clinical trial awareness, particularly sociodemographic variables and information-seeking preferences. Trial awareness and information-seeking preferences were compared in patient subgroups and between the two time periods.Results:Clinical trial awareness increased from 68% to 74% between 2008 and 2012. In the 2012 dataset, higher education level (odds ratio: 3.52, 95% confidence interval: 2.16–5.74), higher yearly income category (odds ratio: 1.84, 95% confidence interval: 1.17–2.89), and Internet use (odds ratio: 2.13, 95% confidence interval: 1.52–3...

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Clinical trial awareness: Changes over time and sociodemographic disparities:

Background Many clinical trials supporting new drug applications underrepresent minority patients. Trials conducted by the National Cancer Institute's National Clinical Trial's Network (NCTN) have greater outreach to community sites, potentially allowing better representation. We compared the representation of Black patients in pharmaceutical company-sponsored cancer clinical trials with NCTN trials and with the US cancer population. Methods We established a large cohort of study publications representing the results of trials that supported new US Food and Drug Administration drug approvals from 2008 to 2018. NCTN trial data were from the SWOG Cancer Research Network. US cancer population rates were estimated using Surveillance, Epidemiology, and End Results survey data. We compared the proportion of Black patients by enrollment year for each cancer type and overall. Tests of proportions were used. All statistical tests were 2-sided. Results A total 358 trials (pharmaceutical company-sponsored trials, 85; SWOG trials, 273) comprised of 93 825 patients (pharmaceutical company-sponsored trials, 46 313; SWOG trials, 47 512) for 15 cancer types were analyzed. Overall, the proportion of Black patients was 2.9% for pharmaceutical company-sponsored trials, 9.0% for SWOG trials, and 12.1% for the US cancer population (P < .001 for each pairwise comparison). These findings were generally consistent across individual cancer types. Conclusions The poor representation of Black patients in pharmaceutical company-sponsored trials supporting new drug applications could result in the use of new drugs with little data about efficacy or side effects in this key population. Moreover, because pharmaceutical company-sponsored trials test the newest available therapies, limited access to these trials represents a disparity in access to potential breakthrough therapies.

Representativeness of Black Patients in Cancer Clinical Trials Sponsored by the National Cancer Institute Compared With Pharmaceutical Companies.

Only 3% of cancer patients participate in cancer clinical trials (CCTs). A number of barriers to participation, particularly for minority groups, can be addressed through community-focused education and advocacy efforts. Working with community partnerships, a pilot program sought to change knowledge, attitudes, and role behaviors among community leaders, primary care providers (PCPs), and clinical researchers about CCTs, to increase patient awareness of and participation in CCTs. A mixed method evaluation utilized quantitative analysis of surveys administered to participants during the program period (2006-2008) and qualitative data from interviews with key participants. Programmatic efforts were effective in increasing knowledge and training community leaders and PCPs to disseminate messages about clinical trials, and ultimately increasing patient inquiries about local trials. Training improved cultural competency skills among clinical researchers to recruit and retain CCT participants. Partnerships fostered new processes and structures to facilitate CCT participation in their communities. Clinical trials education and advocacy efforts through community partnerships have an important role in enhancing clinical trial access and in increasing clinical trial participation. Oncologists' involvement in and leadership of such partnerships are critical to promoting CCT accrual, particularly for minority groups.

S. Lisbeth Jarama

Papers

"The promise of community-based advocacy and education efforts for increasing cancer clinical trials accrual".