Good Decision Making Requires Good Communication

Fischhoff, Baruch

doi:10.1007/bf03261986

Cited by 12 publications

(12 citation statements)

References 37 publications

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“…A key challenge in conducting a BR assessment is integrating evidence from various sources in a scientifically appropriate, credible, and replicable manner, one that takes into account the disparate data collection methods, data quality, and evidence strength . This evidence integration is critical for determining the BR profile of a therapeutic product and may be carried out in a qualitative and/or quantitative fashion.…”

Section: Evidence Integration and Analysismentioning

confidence: 99%

Benefit–Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist

Radawski

Morrato

Hornbuckle

et al. 2015

Pharmacoepidemiology and Drug

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Section: Evidence Integration and Analysismentioning

confidence: 99%

Benefit–Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist

Radawski

Morrato

Hornbuckle

et al. 2015

Pharmacoepidemiology and Drug

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“…[28] He proposes a framework for decision making on the benefit-risk balance of medicines, which both requires and facilitates communication. The framework integrates calculations and statistics with judgement on the quality and strength of the evidence, based on transparently agreed values and criteria.…”

mentioning

confidence: 99%

Focusing on Risk Communication About Medicines

Bahri¹,

Harrison‐Woolrych

2012

Drug Safety

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“…Processes for good decision making enable improved communication to stakeholders [9]; however, neither the SFDA nor the HSA publish a summary of the grounds on which approval is granted; that is, a Summary Basis of Approval or similar documentation. Should the SFDA consider the provision of such documentation, this would provide transparency to patients and healthcare providers regarding internal decision making.…”

Section: Discussionmentioning

confidence: 99%

The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore

et al. 2015

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ObjectiveThis study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and Singapore and identifies opportunities for developing the SFDA as a Regional Centre of Excellence.MethodsA questionnaire completed by the SFDA included data regarding the organisation, key milestones, review timelines, and good review practices of the agency. Similar information was obtained within the same timeframe (2014/2015) through the same standard questionnaire regarding the processes and practices for Health Canada, Singapore’s Health Sciences Authority, and Australia’s Therapeutic Goods Administration.ResultsAll four regulatory agencies have established target times for scientific assessment and regulatory review, examine dossier sections in parallel, and separate company response time from overall timing. Additionally, all four agencies have instituted good review practices including standard operating procedures, templates, dossier monitoring, and continuous improvement processes, and assign a high priority to transparency in their relationships with the public, healthcare professionals and industry. Of the four agencies, however, only the SFDA requires a Certificate of Pharmaceutical Product (CPP) at the time of the submission and pricing negotiations before final product approval.ConclusionsTo assist the SFDA in its efforts to become a Regional Centre of Excellence, it is suggested that the agency explore a risk stratification approach to select dossiers for verification, abridged, or full reviews; use forms of certification other than the CPP; make pricing negotiations independent to the review process; and introduce a feedback process for the quality of the dossier.

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Good Decision Making Requires Good Communication

Cited by 12 publications

References 37 publications

Benefit–Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist

Benefit–Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist

Focusing on Risk Communication About Medicines

The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore

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