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Methodology Monday February Roundup
To promote the hard work of those supporting inclusivity in clinical trials SENSITISE will endeavour to share an interesting publication from the field weekly on Methodology Monday on its LinkedIn channel. Below you can find the recap of the posts for the month of February that focus on eligibility criteria as a whole and in particular through the lens of three different medical fields.
The first publication is: "Inclusivity in Randomised Clinical Trials: Myth or Reality?"
This article scrutinises the real-world applicability of inclusion and exclusion criteria from several landmark cardiovascular trials. The authors question the generalisability of these trials to the broader population, noting significant discrepancies in inclusivity related to gender, age, and ethnicity, which may not reflect the true diversity of patients affected by cardiovascular diseases.
Ref. Iannaccone M, Gamardella M, Chieffo A. Inclusivity in randomised clinical trials: myth or reality? Heart. 2024 Apr 1;110(7):459-60. Under licence.
Next up "Making a COVID-19 Vaccine that Works for Everyone: Ensuring Equity and Inclusivity in Clinical Trials".
Pepperrell and colleagues address the critical issue of demographic imbalances in COVID-19 vaccine trials. Their analysis reveals a stark underrepresentation of Black, Asian, and Minority Ethnic groups, demonstrating how these disparities could hinder the global applicability of vaccine efficacy and safety results, potentially perpetuating inequities in healthcare outcomes.
Direct from one of our consortium members is the next article: "Under-served Groups Remain Underserved as Eligibility Criteria Routinely Exclude Them from Breast Cancer Trials”.
This study exposes how eligibility criteria in phase III breast cancer trials systematically exclude under-served populations, including the elderly, ethnic minorities, and those with comorbidities. Moloney and Shiely argue for a re-evaluation of these criteria to enhance the representativeness and fairness of clinical research, promoting better treatment outcomes across all patient demographics.
To close out the first series on eligibility criteria: "Clinical Trial Exclusion Criteria Affect Trial Inclusivity by Race and Sex".
In this SENSITISE #MethodologyMonday article Stanton and his team explore how standard exclusion criteria in stroke clinical trials disproportionately impact women and Black individuals. Their findings highlight the need for more inclusive trial designs that can address and mitigate these biases, ensuring that clinical research reflects and benefits a more diverse population.
