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Italian Study Highlights Disparities Between Clinical Trials Participants and Real-World Cancer Patients

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In a significant study published recently, researchers in Italy have uncovered notable differences between the characteristics of cancer patients enrolled in clinical trials and those treated in everyday clinical practice. This study, titled “Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study,” examined data from both Italian Medicines Agency (AIFA) registries and clinical trials listed in the European Public Assessment Reports (EPAR).

Spanning from January 2013 to April 2023, the study compared data from 419,461 unique patient cases recorded in 129 AIFA registries against 87,452 patients enrolled in 140 clinical trials. The research focused on several key patient characteristics, such as age, sex, and performance status.

Key findings from the study include:

  • A higher median age and a greater proportion of elderly patients (aged 65 and above) were noted in the real-world registries compared to the clinical trial, with a mean age difference of 5.3 years.
  • There was minimal difference in the gender distribution between registry data and clinical trial data.
  • Real-world registries showed a slightly higher prevalence of patients with deteriorated performance status compared to those in clinical trials.

Clinical Trials

The Need for Inclusive Clinical Trials Reflecting Real-World Patients

The study utilized multivariate analysis, identifying two distinct clusters that reflect these differences, indicating structural disparities between clinical trial populations and those seen in routine clinical settings. The findings suggest that the patients typically enrolled in clinical trials do not fully represent those seen in everyday clinical practice in Italy. This discrepancy can potentially limit the generalizability of clinical trial results, which might not fully translate into effectiveness in the broader patient population.

Researchers advocate for more inclusive clinical trial protocols that better reflect the demographic and clinical profiles of the general patient population. Such changes could help ensure that new treatments are effective and applicable to all patients, not just those who fit the narrow criteria of clinical trials.

This study calls for ongoing research to further understand how these disparities between clinical trial data and real-world data affect patient outcomes, emphasizing the need for adjustments in clinical trial designs to enhance their relevance to real-world clinical practice.

Original Article: The Lancet. 2024 April 22;41:100912. doi: 10.1016/j.lanepe.2024.100912.

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