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Patient based methods for assessing adverse events in clinical trials in rheumatology. Progress report for the
M Gazarian1, P Tugwell, M Boers
1School of Paediatrics, University of New South Wales and Sydney Children's Hospital, Sydney, Australia. M.Gazarian@unsw.edu.au
Abstract:
There has been increasing recognition in recent years that the measurement of drug related toxicities in rheumatology clinical trials has been sub-optimal. The OMERACT Drug Toxicity Working Party was established to address this issue. The first task of the working party was to identify a minimum set of attributes of drug related toxicity that would be important to patients, clinicians, investigators, and policymakers. The working party then developed consensus on a standard set of properties for instruments to measure these attributes. Existing instruments in the field of rheumatology were ascertained by literature review and by contact with experts in the field. Four instruments were ascertained and evaluated using the guidelines developed by the working party. This report outlines the progress and preliminary results of these activities.
Insights
Measuring drug toxicity in rheumatology trials is improving. The OMERACT Drug Toxicity Working Party identified key toxicity attributes and evaluated existing instruments to standardize measurement for better patient outcomes.
Area of Science:
- Rheumatology
- Clinical Trials
- Drug Safety
Background:
- Current methods for measuring drug-related toxicities in rheumatology clinical trials are often suboptimal.
- This highlights a need for standardized and improved toxicity assessment in research.
Purpose of the Study:
- To address the sub-optimal measurement of drug toxicity in rheumatology.
- To establish a minimum set of essential toxicity attributes important to all stakeholders.
- To develop consensus on standard properties for toxicity measurement instruments.
Main Methods:
- Formation of the OMERACT Drug Toxicity Working Party.
- Identification of key drug toxicity attributes through stakeholder input.
- Literature review and expert consultation to identify existing rheumatology instruments.
- Evaluation of identified instruments against consensus-developed guidelines.
Main Results:
- A minimum set of drug toxicity attributes has been identified.
- Consensus was reached on desirable properties for toxicity measurement tools.
- Four existing rheumatology instruments were identified and evaluated.
- Preliminary results of the instrument evaluation are available.
Conclusions:
- Progress has been made in standardizing drug toxicity measurement in rheumatology.
- The working party's activities lay the groundwork for improved data collection in clinical trials.
- Further refinement and adoption of standardized instruments are recommended.