8. Clinical evidence review

Source: CER Template.pdf pages 19-20 (document: Mantra Systems Free CER Template, Edition 2)

This section is intended to set out all available clinical evidence relating specifically to the subject device. If making a claim of equivalence, adapt this section as necessary so that it also includes outcomes relating to the equivalent device.

8.1. Introduction

Section 8 should include data generated and held by the manufacturer, as well as clinical evidence produced independently and published in the literature. In the introduction, provide the scope of the data provided and list the dates and credentials of the section authors.

8.2. Clinical review questions and search terms

State a set of clinical review questions that will be investigated by the clinical evidence review. Use the PICO format when formulating research questions.

Specify search terms used. Record the number of initial and relevant (included) results against each term. Account for all exclusions.

8.3. Data generated and held by the manufacturer

In this section, all clinical data generated and held by the manufacturer needs to be identified and disclosed (whether favourable or unfavourable), from pre-release developmental and pre-clinical studies through to pivotal clinical investigations.

8.3.1. Information from PMS, Vigilance systems & PMCF activities

Data from vigilance systems and from PMCF activities must also be included.

• Details of any known adverse events
• FSCAs and FSNs
• Complaints data
• Trends analysis (frequency and severity)
• Data from MAUDE database and other adverse events databases

8.4. Clinical data from literature

8.4.1 Search terms and results

Each article (having passed inclusion/exclusion criteria) must be summarised, appraised, and placed into context. Maintain a record of all exclusions.

8.5. Summary of clinical data

Comment on overall:

• Adequacy of the sample size
• Adequacy and relevance of endpoints
• Adequacy of controls/comparators
• Adequacy of the follow-up period, including if the follow-up was long enough for outcomes to occur

8.6 Analysis of clinical data

Conduct a meta-analysis of outcomes relating to the subject device using robust and justified methodology. The intention is to determine weighted mean outcomes that may be meaningfully compared with safety and performance objectives derived from the state-of-the-art review in Section 6. The comparison will be performed in Section 9 below.