Lokavant's AI and data science team is shedding light on critical issues in clinical trial design and execution, revealing how decisions made during the planning phase can lead to skewed conclusions and highlighting significant diversity gaps in participant selection. These insights, shared by Aaron Mackey, Vice President of AI & Data Science at Lokavant, during a recent discussion, underscore the need for more careful consideration of trial design and patient demographics.
Unintended Consequences of Trial Planning
According to Mackey, decisions made early in trial planning can have unintended consequences that compromise the validity of trial results. By analyzing trial protocols and data, Lokavant's AI can identify potential biases and limitations that may not be immediately apparent. This proactive approach allows researchers to address these issues before the trial begins, improving the reliability and generalizability of the findings.
Addressing Diversity Gaps in Cancer Studies
Recent research published in JAMA Network Open has highlighted the exclusion of individuals with the Duffy-null phenotype, who are predominantly of African or Middle Eastern descent, from cancer studies. This exclusion is often unintentional but stems from eligibility criteria that do not adequately account for genetic diversity. Mackey emphasized the importance of using AI and ML to identify and mitigate these biases, ensuring that clinical trials are more representative of the patient population.
AI and ML for Enhanced Diversity
To combat the diversity issue, AI and ML are being employed to broaden trial participation. These technologies can help identify and recruit diverse patient populations, ensuring that trial results are applicable to a wider range of individuals. By analyzing demographic data and identifying potential barriers to participation, AI can facilitate more inclusive and equitable clinical research.
Phase 3 Trial for Graves’ Disease
In other news, a large Phase 3 treatment trial for Graves’ disease is pending launch. This trial represents a significant step forward in addressing this autoimmune disorder, which affects millions worldwide. The trial will evaluate the efficacy and safety of a novel treatment, offering hope for improved outcomes for patients with Graves’ disease.
