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March 8, 2021updated 12 Jul 2022 11:22am

Globalisation of US cancer trials is reducing enrolment of Black patients, study finds

The increasing globalisation of US-initiated cancer clinical trials is linked to lower enrolment of Black patients, a new study has found.

By Kezia Parkins

The increasing globalisation of US-initiated cancer clinical trials is linked to lower enrolment of Black patients, a new study has found.

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Clinical investigators in the US have been expanding clinical trials to sites all over the world to aid in accelerating the drug approval process, expedite patient enrolment and reduce costs. However, a new study published by Wiley in Cancer, a peer-reviewed journal of the American Cancer Society, finds that this trend may be exacerbating racial disparities in US cancer clinical trials.

Black patients have historically been underrepresented in clinical trials, especially in the area of oncology. Despite much industry discussion around bucking this trend and improving diversity among trial participants, the disparity of some US cancer trials appears to have worsened and the globalisation of clinical trials could be a driver of this unequal representation, the study finds.

To examine the problem, a team led by Dr Matthew Galsky and Dr Serena Tharakan of the Icahn School of Medicine at Mount Sinai in New York City investigated the demographic data from 21 cancer clinical trials leading to US Food and Drug Administration approvals between 2015 and 2018.

Their analysis found that clinical trials conducted primarily outside the US were significantly less likely to recruit Black participants than trials held on home soil. On average, global trials enrolled less than half the number of Black patients than trials conducted primarily within the US.

Of the 21 clinical trials supporting 18 FDA drug approvals where race and location data were available, 64% of patients were enrolled outside the US, with Black patients making up only an average of 3.2% of enrolment.

The study’s findings are a cause for concern, as patient diversity in clinical trials is imperative for assessing whether a drug will be safe and effective for the whole treatment population.

“The enrolment of Black patients in cancer clinical trials continues to trend far below the true prevalence of disease in Black patients in the United States, limiting the generalizability of trial results,” the study states.

In Wiley’s press release on the study, Tharakan said: “There have been a number of studies investigating factors such as access to healthcare, physician biases, and socioeconomic status that may lead to underrepresentation of Black patients.

“However, to our knowledge, our findings are the first to quantitatively demonstrate that the globalization of cancer clinical trials may also be a key driver of racial disparities in the US drug approval process.”

The study’s findings are in line with a number of similar investigations highlighting the stark disparities in cancer trials.

In June 2020, a study published online in the journal Cancer Epidemiology, Biomarkers & Prevention examined 72 global phase III and IV prevention, screening, and treatment prostate cancer clinical trials with enrolment start dates between 1987 and 2016 and found them to be “overwhelmingly white.”

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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