Australia’s Therapeutic Goods Administration published a draft version of the Clinical Evidence Guidelines on March 15th 2016. The purpose of this document is to provide sponsors and manufacturers of medical devices and IVDs guidance on what clinical evidence is, how to generate clinical data and most importantly, how to evaluate it and present it in the form of a clinical evidence report.
As per Essential principle 14, TGA expects every medical device manufacturer to hold evidence that demonstrates that:
- The device achieves its intended purpose during normal conditions of clinical use
- Any known and foreseeable clinical risks have been mitigated
- The risk: benefit ratio of the device for its intended use is acceptable
- Any clinical claims about the device’s performance and safety are supported by clinical data
In essence, clinical evidence must provide TGA’s clinical assessor with accurate scientific information relating to the modality of treatment to which the device relates to, and with respect to the particular device under evaluation. This clinical evidence should be periodically updated and reviewed based on post-market surveillance and should be evaluated and critiqued by a competent expert. Clinical data can be obtained from clinical investigations (trials), literature review and post-market data, either for the device under evaluation or for a predicate/similar marketed device.
For a more detailed review on preparation of a Clinical Evidence Report- see this earlier blog.
So what does this new guideline emphasize on? Lots, including:
- Use of a Predicate Although clinical investigation and literature review data directly related to the device is preferred, TGA understands that this is not always possible, in which case, it is suggested that clinical data from a ‘substantially equivalent’ device can be used to support the safety and performance of the device under evaluation. One of the key points that this guidance emphasizes is that the report should document how the device is substantially equivalent and specifically why data from the predicate device support the safety and performance of the device under review. The TGA guidance provides a sample summary table that can be used to summarize the equivalence argument, to discuss any clinical, technical and biological differences between the device under evaluation and the predicate/similar marketed device, and how the difference would impact the safety and performance.
- How to write the literature review The literature review should be compiled using a documented method and should be balanced – considering both favorable and unfavorable scientific literature. It should provide information relating to risks associated with the use of the device, and any possibilities of misuse of the device. TGA recommends the use of a systematic review and meta-analysis approach. The search strategy must contain enough details so that the TGA assessor can reproduce the search if required. Most importantly, it needs to be critically evaluated by a clinical expert to discuss the strengths and weaknesses of the investigations and the literature presented.
- When presenting post-market data, it is suggested that the data is compiled into an adverse event rate and a device complaint rate to give the assessor a better understanding of the benefit: risk profile of the device.
- The guidelines also provide a recommended structure for the report detailing the topics that need to be discussed in the report and any supporting documentation that is to be provided along with the report.
What not to do….
Some of the common errors that can quite easily be avoided are
- Details of the author (clinical expert) not provided, or wrong choice of a clinical expert – It is the clinical expert who needs to critically evaluate the data and discuss the safety and performance of the device, hence it is essential to choose someone who has direct experience in the usage of the device or performing similar procedures.
- Poor quality literature search, where the results cannot be reproduced or where the choice and relevance of the search strategy is not discussed.
- Inadequate critique of the clinical data to establish the benefit: risk ratio
TGA has always had high expectations for Clinical Evidence and the Agency clearly has no intention of relaxing their requirements. If you are in the process of preparing a CER, the guidance should be your mandatory bedtime reading!
GHTF document, Clinical Evaluation SG5/N2R8:2007 Appendix E: A Possible Format for a Clinical Evaluation Report (available at http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n2r8-2007-clinical-evaluation-070501.pdf)
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