The new article describes in detail different types of data related to clinical evaluation. In particular, the present article addresses the matters related to the data generated through clinical experience, and the data from clinical investigations.
Table of Contents
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the clinical evaluation of medical devices. The document highlights the most important aspects related to the respective regulatory requirements and also provides recommendations to be followed by study sponsors to ensure compliance thereto. The scope of the guidance covers, inter alia, the matters related to various types of data used in or deriving from clinical evaluation. It is important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new requirements, so in case of any inconsistencies with provisions of the underlying legislation the latter should prevail.
Clinical Experience Documentation
One of the aspects covered by the guidance is related to the scope of clinical experience data/documentation to be used in the clinical evaluation. Should a party responsible for a medical device decide to use clinical experience data, it would be important to ensure the information provided is comprehensive and sufficient to proceed with further assessment. The authority furthermore emphasizes that only the reports supported by the respective data could be used.
For instance, a party responsible for a medical device may compile post-market surveillance reports containing the following information:
- Details of the medical device’s regulatory status (countries in which the medical device is marketed and date of commencement of supply);
- Regulatory actions were undertaken during the reporting period (e.g., recalls, notifications);
- Tabulation of adverse events (particularly serious events, stratified into whether the product owner considers them to be medical device-related or not) and estimates of the incidence of adverse events.
The authority also mentions that when assessing post-market data the local reporting requirements should be considered, as they could be different and, consequently, the scope of data and its completeness could be different as well. However, in most cases, the data deriving from post-marketing reports could be solid enough to assess the safety and effectiveness of the medical device. The HSA also encourages the parties responsible for medical devices to submit a summary table outlining the adverse events associated with the device in a structured way. In such a table, special attention should be paid to serious incidents, as well as to the risks and hazards that were not addressed properly in the initial risk management documentation. The information to be submitted should also contain details regarding the measures to be taken to mitigate the said risks and hazards.
Data From Clinical Investigations
Apart from the above, the guidance provides recommendations regarding the use of data deriving from clinical investigations conducted by a medical device manufacturer or by a third party acting on its behalf in the context of conformity assessment of the products are subject to. According to the guidance, the aforementioned investigations should be carried out by provisions of ISO 14155, Parts 1 and 2, Clinical Investigations of Medical Devices for Human Subjects, or another applicable standard, and also by the regulatory requirements set forth by the respective national legislation.
The documentation related to clinical investigation, that could further be used to assess the safety and effectiveness of the device includes, inter alia, the following elements:
- The clinical investigation plan;
- Clinical investigation plan amendments and the rationale for these changes;
- The relevant Ethics Committee documentation, opinion(s) and comments for each investigation site, including a copy of the approved informed consent form(s) and patient information documents;
- Case report forms, monitoring, and audit records;
- Regulatory Authority approvals and associated correspondence as required by applicable regulations; and
- The signed and dated final report.
The guidance further provides additional clarifications regarding each of the documents listed hereinabove. For instance, HSA explains that the clinical investigation plan should prescribe the way the study should be carried out, including the details regarding the design, or the way the effect should be measured, and the steps to be taken to prevent bias and ensure the accuracy and reliability of the results. Apart from that, a comparison of the initial investigation plan and the final report allows for identifying any deviations that occurred during a study, and the impact caused by such deviations. The responsible representatives of the party conducting the study should duly sign the aforementioned final report.
The authority mentions that special attention should be also paid to maintaining compliance with the applicable ethical standards and respective regulatory requirements. Should the non-compliance be identified, the results of such a study could not be used.
Clinical Data Appraisal
The document also describes the approach to be applied to the appraisal of clinical data to identify the merits and limitations associated thereto. According to the guidance, each piece of data is appraised to determine its suitability to address questions about the medical device, and its contribution to demonstrating the safety and performance of the medical device (including any specific claims about safety or performance). In the course of this process, the data in question should be subject to assessment of its quality and relevance, while the information accompanying the data should be sufficient to assess its significance. The scope of the appraisal should cover the methods used to collect the data, and the effects observed.
As further explained by the HSA, the particular appraisal method to be applied should be determined on a case-by-case basis depending on the data in question and other specific aspects. At the same time, the data available depends on the product in question and its specific features, including the risks associated thereto, or the technology it is based on. The authority also mentions that the criteria used should be duly justified.
In summary, the present HSA guidance describes in detail various types of data related to clinical investigations, and the ways such data should be used. The document highlights the most important aspects to be considered to ensure the accuracy and reliability of any decisions based on the assessment of such data.
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