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INTERVENTION challenges two of the most sacred tenets of modern
society, innovation and technology, from the perspective of the
unique risks they present. Using genetic engineering as its model,
it paints a vivid picture of the scientific uncertainties that
biotech risk evaluations dismiss or ignore, and lays bare the power
and money conflicts between academia, industry and regulators that
have sped these risky innovations to the market. Intervention
champions an alternative method for assessing the risks of
technology, developed by the world's top risk experts, that can
eliminate such conflicts, help regain public trust in science and
government, and drive research and development toward more useful,
safer products.
Despite the extensive body of evidence that informs regulatory
decisions on pharmaceutical products, significant uncertainties
persist, including the underlying variability in human biology,
factors associated with the chemistry of a drug, and limitations in
the research and clinical trial process itself that might limit the
generalizability of results. As a result, regulatory reviewers are
consistently required to draw conclusions about a drug's safety and
efficacy from imperfect data. Efforts are underway within the drug
development community to enhance the evaluation and communication
of the benefits and risks associated with pharmaceutical products,
aimed at increasing the predictability, transparency, and
efficiency of pharmaceutical regulatory decision making.
Effectively communicating regulatory decisions necessarily includes
explanation of the impact of uncertainty on decision making. On
February 12 and May 12, 2014, the Institute of Medicine's Forum on
Drug Discovery, Development, and Translation held public workshops
to advance the development of more systematic and structured
approaches to characterize and communicate the sources of
uncertainty in the assessment of benefits and risks, and to
consider their implications for pharmaceutical regulatory
decisions. Workshop presentations and discussions on February 12
were convened to explore the science of identifying and
characterizing uncertainty in scientific evidence and approaches to
translate uncertainties into decisions that reflect the values of
stakeholders. The May 12 workshop presentations and discussions
explored tools and approaches to communicating about scientific
uncertainties to a range of stakeholders in the drug development
process. Characterizing and Communicating Uncertainty in the
Assessment of Benefits and Risks of Pharmaceutical Products
summarizes the presentation and discussion of both events. This
report explores potential analytical and communication approaches
and identifies key considerations on their development, evaluation,
and incorporation into pharmaceutical benefit- risk assessment
throughout the entire drug development lifecycle. Table of Contents
Front Matter 1 Introduction 2 Identifying and Characterizing
Uncertainty 3 The Regulators' Challenge 4 Basic Methodologies and
Applications for Understanding and Evaluating Uncertainty 5
Communicating Uncertainty 6 Final Reflections on Ways to
Characterize and Communicate Uncertainty References Appendix A:
Workshop Agenda Appendix B: FDA Case Studies Appendix C:
Bibliography Appendix D: Participant Biographies
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