Two new programmes have been launched with federal backing in the US as part of a broader effort to improve the participation of medically underserved populations, including racial and ethnic minorities, in clinical trials.

The US Department of Health and Human Services’ Office of Minority Health will work with the National Center on Minority Health and Health Disparities and the Office on Women’s Health on two complementary projects aimed at applying National Standards on Culturally and Linguistically Appropriate Services to the clinical trial process.

While the 14 OMH CLAS standards, which are directed mainly at healthcare organisations, have been in place since 2001, “too few” people involved in running clinical trials are either aware of them or incorporating the standards into their research, noted Dr Armin Weinberg, director of the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine and co-founder of the Intercultural Cancer Council (ICC), a national organisation dedicated to eliminating the unequal burden of cancer among medically underserved populations.

These two bodies jointly conduct the four-year Eliminating Disparities in Clinical Trials initiative, launched in 2005 with a US$5.5 million grant from Genentech. The EDICT programme will now be supplemented with the two federally supported projects, CLAS-ACT (Culturally and Linguistically Appropriate Standards and Clinical Trials), and BackPack, a set of tools and policies for clinical researchers.

New recommendations slated for 2008

The projects, which will be undertaken simultaneously by two separate research teams, should come up with new recommendations and materials for healthcare professionals by April 2008. The CLAS-ACT team will develop guidance on using CLAS standards in designing clinical trials and recruiting minority patients into them. The BackPack researchers will identify and make available vetted resources, examples, models and policies to help trialists reduce ethnic and racial disparities in recruitment and retention.

“From existing data, we know that racial and ethnic minorities, the elderly, those who live in rural areas and the poor represent the smallest percentage of clinical trial participants,” commented Dr John Ruffin, director of the National Center for Minority Health and Health Disparities. As Weinberg noted, without adequate representation of underserved populations in these studies, “patients suffer and so do researchers, who are hindered in their assessment and generalisation of clinical trial results”.

According to ICC statistics, 88.8% of enrollees in US clinical trials between January 2003 and June 2005 were white, while just 8% were African-Americans, 2.8% were Asians/Pacific Islanders, 0.5% were Native Americans/Alaska Natives and 0.1% belonged to other races. In terms of ethnicity, only 5.6% of enrollees over this period were Hispanics while 94.4% were non-Hispanics.

Age is also a distinct obstacle to clinical trial participation. As the ICC’s statistics show, nearly two thirds of cancer patients are aged 65 years and over, yet this demographic accounts for less than one third of all trial enrolleees. Low socioeconomic status is another factor with a negative impact on participation in clinical research.

Addressing a press conference on the CLAS-ACT and BackPack projects, Weinberg said many of the historical barriers to involvement of underserved populations in clinical trials “still exist today”. These included practical obstacles such as lack of awareness, transportation costs, low literacy and language barriers, as well as a history of injustice that had seen minorities either excluded from the clinical trial process or abused by it.

The goal of the new projects was to translate the CLAS standards into active steps, Weinberg explained, adding: “Sharing information is not enough.”