The BR Template has three features that assist the user in locating selected pages within the document, namely, the tabs at the top of each page, the “Go to page” button, and the page thumbnails (Fig. 5.2).

The thumbnails were not used, while the tabs and “Go to page” buttons were rated either good or excellent (Table 5.1). The agencies suggested that the use of bookmarks for the sections and subsections would be preferable, as well as a search function for identifying keywords within the document.

In addition to navigation features, the BR Template incorporates four functions to print, e-mail, view the form (Fig. 5.3), and auto-populate information for fields requiring the same inputs (Fig. 5.4).

Conclusion on the usefulness of the print, e-mail, and view functions were not provided as Agency A did not use the former two functions, Agency B experienced a technical issue that prevented them from getting back to the document after using these three functions, while Agency C rated these support functions as good. However, the auto-population function was considered useful by all, being rated as good or fair (Table 5.2).

The User Manual was provided as a guide to help the reviewer in completing the BR Template and included a glossary of commonly used terms. Agencies A and C rated the manual as good or fair in terms of clarity, comprehensiveness, and applicability (Table 5.3). Overall, the agencies believed more details are needed, e.g., case studies and examples to improve the usefulness of the User Manual. Agency B would like to have more guidance regarding the intention of the BR Template, the level of details of the outcomes, and the type of information required. Agency C commented on the need for examples to show how weighting and valuing may be carried out as this concept is new to the agency.

Other comments received on enhancing the technical aspects of the template include:

The BR Template incorporates five conclusions that are considered important in making a benefit–risk decision, namely, the background (decision context), quality, nonclinical, human pharmacology, and clinical conclusions. Of the five, the agencies believed the clinical conclusion is fit for this purpose (Table 5.4). For the remaining four, the template could allow for more details as the actual benefit–risk assessment was carried out in much greater depth and the sections may not accommodate such a level of information.

Agency B commented that these were the only sections to discuss the contributions from quality, nonclinical, and human pharmacology in the entire template, whereas the rest of the template is dedicated to clinical benefits and risks. However, Agency B believed that if the intention of the BR Template was to feature only a high-level summary of the significant findings, then it would suffice. It was mentioned that a considerable amount of evaluation was conducted for those aspects for a new active substance and that this section would not be able to accommodate these findings. Without allowing the reviewer to provide details on the relevant studies, it would be difficult to explain the relevance of the reported issues and concerns. For completeness, Agency A recommended the inclusion of subheadings for pharmacokinetics, pharmacodynamics, and drug interactions to further guide the reviewer. Agency C preferred the background information to allow a discussion on related applications and products that may contribute to decision-making.

It should be noted that the BR Template was designed to present and communicate only the significant findings that would affect the benefit–risk decision and that the corresponding details would be expected to be available from the original assessment report for the product.

The template was seen by the agencies as being able to document benefits and risks identified by sponsors and the reasons for including or excluding them (Table 5.5).