10. Clinical evidence analysis — Benefit-risk profile
Source: CER Template.pdf pages 23-24 (document: Mantra Systems Free CER Template, Edition 2)
A further objective of the CER is to examine whether available clinical evidence demonstrates a favourable benefit-risk profile for the subject device. In this section, an analysis of identified and appraised clinical evidence must be performed to address this question.
Benefit-risk should be expressed as a quantitative ratio. Methodology will vary between devices, as risk profiles and risk analysis techniques will likewise be variable. Our CER experts can assist with all aspects of conducting quantitative benefit-risk analysis.
10.1 Risk management system
Provide a summary of the risk management processes within the organisation or refer the reader to relevant technical documents.
10.2 Known risks and acceptability analysis
Write a summary of known risks and how their acceptability has been determined. Identify any significant residual risks.
10.3 Clinical evidence review - impact on risk analysis
Did the clinical evidence review conducted for the clinical evaluation reveal any new risks that have not previously been discovered, or otherwise impact known risks? Outline a review of risks observed in relation to the subject device and similar devices. Conduct a quantitative analysis to determine an overall (weighted) risk score.
10.4 Clinical benefits
Summarise the demonstrated benefits to patients (positive impacts) flowing from use of the device, as supported by evidence appraised in the CER. Quantify benefits using a benefit evaluation scheme that, preferentially, mirrors that used for risk evaluation. Develop a table that outlines observed frequency of identified benefits, weights benefit levels and determines an overall benefit score.
10.5 Benefit-risk analysis
Employing the analysis methods described previously, outline whether, on an overall assessment, any residual risks (individually and collectively) are acceptable and outweighed by demonstrated clinical benefit.
Calculate a quantitative benefit-risk ratio using:
A value greater than 1 denotes an acceptable benefit-risk ratio.