Tuesday, June 18, 2024

The Evolution of Adverse Event Data Reporting in Clinical Trials: From Clinical Observation to Patient Experience

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In the realm of clinical trials, the practice of collecting and reporting adverse event data has undergone significant changes, moving towards a more patient-centered approach. Traditionally, the collection of safety data in clinical studies was conducted by investigators, relying on standardized frameworks like the Common Terminology Criteria for Adverse Events (CTCAE) to report side effects. However, a shift towards incorporating patient-reported adverse events into safety and tolerability analyses marks a pivotal step in aligning research methodologies with the patient-centered care model. This systematic scoping review delves into how patient-reported adverse event data are being integrated into clinical trials, highlighting the variations in collection and reporting practices as well as the instruments utilized for this purpose.

The review’s methodology involved a comprehensive database search and analysis using the Covidence platform, resulting in the inclusion of sixty-eight studies. A notable trend was the increase in studies incorporating patient-reported data over time. Despite the growing interest in patient-reported adverse events, the transition to including such data in published reports remains slow. The review found a wide range of instruments being employed to collect patient-reported data, with significant variability in recall periods, modes, frequency, and sites of administration. The duration for collecting patient-reported adverse event data also varied greatly, ranging from 28 days to six years.

The analysis revealed that frequently, studies did not provide detailed information on the collection and reporting methodologies for patient-reported adverse event data. This lack of standardization presents a challenge in accurately assessing and comparing study outcomes. The review emphasizes the necessity for a purpose-built, validated instrument tailored specifically for the collection of patient-reported adverse events. Such standardization is crucial for ensuring consistent, reliable data that can effectively contribute to safety and tolerability analyses in clinical trials.

Adverse Event Data

Harmonizing Patient-Reported Adverse Event Data: The Quest for Standardization in Clinical Trial Reporting

There is a growing trend toward including patient-reported data in clinical trials, yet significant gaps remain in standardized reporting. Seventy different instruments were identified for collecting patient-reported adverse events, indicating a lack of consistency across studies. The need for a validated, purpose-built instrument for collecting patient-reported adverse events is critical for the advancement of patient-centered research methodologies.

In conclusion, while the move towards patient-reported adverse events in clinical trials is a positive development, there are still considerable hurdles to overcome in terms of standardization and reporting. The findings from this review underscore the importance of developing and implementing a standardized instrument specifically designed for the collection of patient-reported adverse event data. Such an instrument would not only enhance the accuracy and reliability of safety data but also align clinical research practices more closely with the principles of patient-centered care.

 

Original Article: Patient. 2024 Apr 8. doi: 10.1007/s40271-024-00689-4. Online ahead of print.

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