By James Leong, Sam Salek, Stuart Walker
This booklet proposes and investigates a common framework, and accompanying documentation process, to facilitate and catalogue benefit-risk judgements; a important addition to the benefit-risk toolbox.
Over the prior decade, pharmaceutical businesses and regulatory companies were reviewing the benefit-risk evaluation of medications on the way to constructing a based, systematic, standardized process. reading the review of such an procedure by way of a number of mature regulatory experts guarantees that the reader profits a special perception into the continued debate during this area.
The box of benefit-risk review maintains to conform at a fast velocity as a result of political and societal strain, as is mirrored within the fresh FDA PUDFA contract in addition to within the EMA 2015 Roadmap. instead of supply a accomplished snap-shot of this continually altering surroundings, this ebook evaluates chosen present ways to benefit-risk evaluation. The strengths and weaknesses of publicly on hand files in speaking benefit-risk judgements to stakeholders are reviewed and those reviews are used to notify improvement of a potential framework that may be used to harmonise strategies globally.
Read or Download Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication PDF
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Extra info for Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication
36 3 Benefit–Risk Assessment of Medicines Data Collection The assessment tool was finalized into a questionnaire consisting of 13 questions. Out of these, the following 4 questions required the participant to rate or rank a list of statements found within each question: • • • • Perceived advantages of the benefit–risk framework Barriers to implementing a formal benefit–risk framework Perception of the need for an appropriate benefit–risk framework Factors for reviewing benefit–risk frameworks Eight questions were included using checkboxes for information collection: • The current system employed by the organization for the benefit–risk assessment of a new medicine during review (qualitative, semiquantitative, or quantitative) • The use of values, weights, and selected parameters during assessment of benefits and risks • Satisfaction with current system • Reasons for not using a semiquantitative or quantitative system • Plans to implement a semiquantitative or quantitative system • Construction of the benefit–risk framework • Opinions of various models and approaches • Development of visualization tools for communicating benefit–risk balance An open-ended question was also used to solicit the potential hurdles and solutions, to be provided in a free-text manner.
Eichler from the EMA also commented that as methodology and presentation evolve from providing implicit to explicit value judgments and from being a reflection of regulators’ values to those of patients, the development of a toolkit for benefit–risk assessment will further enhance the predictability and auditability of regulatory decisions (CIRS 2011). However, in order for the best practices to emerge and thus identify the appropriate tools, time should be allowed for these to be developed, refined, and validated for use.
20 1 Overview Participants at the workshop, however, agreed that the validated framework would accommodate individual circumstances and the various stages of the medicine’s life cycle (CIRS 2012b). In the recent workshop to look into the role of frameworks in facilitating the provision of quality decisions, stakeholders again agreed that a decision framework is a “structured, flexible, systematic and scientific approach to organising, evaluating, quality assuring, summarising and re-assessing over time both the known and the unknown information and the subjective values and judgements that form the basis of the decision” (CIRS 2013b).