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A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
Published on: September 20, 2018
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When to include clinical study reports and regulatory documents in systematic reviews.
Tom Jefferson1,2, Peter Doshi2,3, Isabelle Boutron4,5
1Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, Primary Sciences Division, University of Oxford, Oxford, UK.
BMJ Evidence-Based Medicine
|October 13, 2018
Summary
Accessing clinical study reports (CSRs) and regulatory data can mitigate reporting bias in systematic reviews. Organizations like Cochrane should promote CSR use for pharmaceutical intervention reviews, especially for high-impact drugs.
Area of Science:
- Medical research methodology
- Evidence-based medicine
- Systematic review integrity
Background:
- Reporting bias compromises the validity and credibility of systematic reviews.
- Systematic reviews are crucial for evidence-based medicine and clinical decision-making.
Purpose of the Study:
- To outline the rationale for using clinical study reports (CSRs) and regulatory data to address reporting bias.
- To identify factors influencing the inclusion of regulatory data in systematic reviews.
- To summarize current practices and challenges in accessing and utilizing regulatory data.
Main Methods:
- Literature review on reporting bias and regulatory data access.
- Survey of systematic reviewers regarding their practices with regulatory data.
- Analysis of the origins and current state of regulatory data accessibility.
Main Results:
- Reporting bias poses a significant threat to systematic review quality.
- Factors for deciding on regulatory data inclusion were identified.
- Current practices of systematic reviewers concerning regulatory data were summarized.
Conclusions:
- Encouraging the use of CSRs is vital for pharmaceutical intervention systematic reviews.
- Regulatory data can enhance the comprehensiveness and reduce bias in systematic reviews.
- Stakeholders like Cochrane should advocate for the integration of CSR data.
Keywords:
public health
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