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Background <p>Parkinson’s disease is a male-prevalent neurodegenerative disorder that affects a substantial proportion of the population. The primary objective of this study is to evaluate gender representation and the occurrence of serious adverse events associated with currently available therapeutic agents by analyzing Phase IV clinical trials. This phase was specifically selected to capture real-world evidence, as it reflects the safety and impact of these drugs following their widespread use in the general population.</p> Method <p>The USFDA clinical trial database was utilized to extract 54 Parkinson’s disease phase IV clinical trials conducted between 2004 and 2022. In this study, the yearly Participation-to-Prevalence Ratios (PPRs) were calculated to represent the level of male participation in these clinical trials.</p> Result <p>Among the 54 completed clinical trials analyzed, a total of 6,054 participants were enrolled, comprising 3,498 males and 2,556 females, resulting in an overall male Participation-to-Prevalence Ratio (PPR) of 0.96. However, notable underrepresentation of men was observed in specific years. In 2015, a single clinical trial reported a PPR of 0.33; in 2017, two trials had a combined PPR of 0.77; and in 2022, one trial reported a PPR of 0.79. These findings indicate instances of male underrepresentation in Parkinson’s disease Phase IV clinical trials during those years. Moreover, levodopa-carbidopa intestinal gel (LCGI) was associated with the highest number of reported serious adverse events (SAEs) among the evaluated interventions. In contrast, drugs like droxidopa and some placebo-based therapies showed minimal SAE reports.</p> Discussion <p>The yearly male Participation-to-Prevalence Ratio (PPR) in Parkinson’s disease clinical trials ranged from 0.33 to 1.22, indicating variability in male representation. These findings highlight the need for greater transparency in the SAE database, particularly with respect to gender-specific reporting.</p> Graphical Abstract <p></p>

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Gender Representation and Reporting in Post-Marketing Surveillance: A Review of FDA Regulatory Perspectives on Clinical Trials for Parkinson’s Disease

  • 期刊论文

  • 发表日期：

    2026年5月16日

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  • Vishal Sachin Gangawane,
  • Simran Simran,
  • Vaishnavi Milind Kalokhe,
  • Fathima Musthafa,
  • Aftab Ahmad,
  • Chandraiah Godugu,
  • Saurabh Srivastava

摘要

Background

Parkinson’s disease is a male-prevalent neurodegenerative disorder that affects a substantial proportion of the population. The primary objective of this study is to evaluate gender representation and the occurrence of serious adverse events associated with currently available therapeutic agents by analyzing Phase IV clinical trials. This phase was specifically selected to capture real-world evidence, as it reflects the safety and impact of these drugs following their widespread use in the general population.

Method

The USFDA clinical trial database was utilized to extract 54 Parkinson’s disease phase IV clinical trials conducted between 2004 and 2022. In this study, the yearly Participation-to-Prevalence Ratios (PPRs) were calculated to represent the level of male participation in these clinical trials.

Result

Among the 54 completed clinical trials analyzed, a total of 6,054 participants were enrolled, comprising 3,498 males and 2,556 females, resulting in an overall male Participation-to-Prevalence Ratio (PPR) of 0.96. However, notable underrepresentation of men was observed in specific years. In 2015, a single clinical trial reported a PPR of 0.33; in 2017, two trials had a combined PPR of 0.77; and in 2022, one trial reported a PPR of 0.79. These findings indicate instances of male underrepresentation in Parkinson’s disease Phase IV clinical trials during those years. Moreover, levodopa-carbidopa intestinal gel (LCGI) was associated with the highest number of reported serious adverse events (SAEs) among the evaluated interventions. In contrast, drugs like droxidopa and some placebo-based therapies showed minimal SAE reports.

Discussion

The yearly male Participation-to-Prevalence Ratio (PPR) in Parkinson’s disease clinical trials ranged from 0.33 to 1.22, indicating variability in male representation. These findings highlight the need for greater transparency in the SAE database, particularly with respect to gender-specific reporting.

Graphical Abstract