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Stakeholder Perspectives on Potential Open-Label Bias in Patient-Reported Outcome Results From Cancer Clinical
Fabio Efficace1, Daniela Krepper2, Francesco Sparano1
1Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy.
Summary
Stakeholders have varied views on open-label bias in cancer trial patient outcomes. Factors like patient expectations and clinician interactions may contribute, necessitating careful trial design to mitigate risks.
Area of Science:
- Clinical Trials Methodology
- Patient-Reported Outcomes Research
- Oncology Research
Background:
- Open-label bias is a concern in patient-reported outcomes (PROs) within cancer randomized controlled trials (RCTs).
- Understanding stakeholder perspectives is crucial for addressing this bias.
- This study is the initial phase of the international IMPROvE project.
Purpose of the Study:
- To explore stakeholder views on open-label bias in cancer trial PROs.
- To identify potential risk factors contributing to open-label bias.
- To inform the development of strategies for mitigating bias in clinical trial design.
Main Methods:
- Conducted semi-structured interviews with 20 international stakeholders (PRO experts and patients).
- Utilized thematic content analysis of interview data.
- Complemented findings with a targeted narrative literature review.
Main Results:
- Stakeholders presented diverse opinions on the existence and impact of open-label bias.
- Identified potential contributors include patient expectations, treatment type, disease stage, and clinician-patient interactions.
- Experts focused on methodological concerns, while patients emphasized experiential and relational factors.
Conclusions:
- Stakeholder perspectives reveal both methodological and experiential aspects of open-label bias in cancer RCT PROs.
- Findings suggest that robust trial methodology and validated PRO instruments can help mitigate bias.
- Results will inform future evidence generation and the creation of an 'open-label bias PRO checklist'.
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