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Methodology Monday June Roundup
To kick off Methodology Monday this June we focus on the article by van Rijessel and colleagues that elaborates how diversity should be integrated into decentralised clinical trials (DCTs).
The two are often associated as DCTs are seen as a tool to remove barriers but what should be really considered in the design of such a trial? The authors list two key areas linked to participant selection that should be prioritized.
As we continue the discussion for Methodology Monday on the role that Decentralised Clinical Trials play in including underserved populations we turn to this article by Khozin & Coravos which highlights the new considerations to ensure that the decentalised aspects lead to safe and valid research such as data protection and cybersecurity but also limitations linked to technical validation of the tools used, and their durability.
For Methodology Monday, we revisit the impact of exclusion criteria on sex and race. Stanton et al investigated the potential impact that common exclusion criteria by race and sex have on trial eligibility of patients with ischemic stroke. Investigating the population that was hospitalised with an ischemic stroke in the perimeter of their study, they found that common stroke clinical trial exclusion criteria have the potential to exclude more women and Black individuals from stroke clinical trials.
Following on last week’s Methodology Monday on exclusion criteria and the impact on research outputs, Daho et al highlight through a systematic review of European cancer trials (prostate, breast, and lung) that a large majority exclude populations with psychiatric and neurological disorders. Often, compliance concerns and understanding of informed consent are cited as reasons to exclude these populations, among other reasons listed in the article.
To close out this month's Methodology Monday round up we have a call to action from Reza and colleagues who are calling for the inclusion of all populations impacted by heart failure with reduced ejection fraction in clinical trials. To further their message they catalogue barriers and propose strategies to increase inclusivity in future trials in the field.
