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Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products Workshop Summary (2014) / Chapter Skim
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6 Final Reflections on Ways to Characterize and Communicate Uncertainty
Pages 61-66

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From page 61...
... • Patients and providers could benefit from receiving quantita tive information on benefits and risks of pharmaceutical prod ucts, as well as clear statements about inherent uncertainties. As part of the final session of the May 12, 2014, workshop, several speakers and workshop participants reflected on what they had heard over the course of the workshops.
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From page 62...
... Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) to study and address limitations of current methods in the fields of pharmacoepidemiology and pharmacovigilance.1 Several workshop participants also highlighted "low-hanging fruit" opportunities to improve the value of evidence generated from clinical trials to reduce uncertainty.
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From page 63...
... Horwitz, Senior Vice President, Clinical Sciences Evaluation, GlaxoSmithKline, suggested expanding the scope of information used in regulatory decisions to include not just the traditional placebo-controlled efficacy trials, but pragmatic trials that provide richer information about how a drug might actually be used in clinical settings. John Jenkins, Director, Office of New Drugs, CDER, FDA, indicated that FDA supports the elimination of unnecessary exclusion criteria in clinical trials to bring the information closer to what patients would experience in the real world.
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From page 64...
... . Some workshop participants suggested that there could be an important role for patient groups to develop PRO instruments outside of the regulatory process for a particular product and ideally before a new drug is contemplated for development.
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From page 65...
... ," "distinctly possible," and "apparently." Such uncertain words are not well suited to the complex task of communicating uncertainty about benefit–risk assessments in pharmaceutical products. Some workshop participants discussed the idea that conveying information numerically can provide greater clarity, but also presents its own challenges.
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From page 66...
... Patrick J Frey of FDA indicated that as part of FDA's implementation of the benefit–risk framework, the agency can consider opportunities to improve how it currently communicates information about benefit, risk, and uncertainty when posting review documents on the FDA website.
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  • levitan suggested
  • trial data

  • scientifically acceptable
  • communicating uncertainty
  • effects table
  • pharmacoepidemiological research
  • clinical practice

  • innovative medicines
  • dartmouth medical
  • european consortium
  • acceptable method
  • inherent uncertainties

  • real world
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  • fda indicated
  • trial portfolio


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