2024
DOI: 10.21203/rs.3.rs-4321838/v1
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Assessing the Value of Integrated Evidence Approaches in Drug Development

Joseph A. DiMasi,
Melvon Olson,
Zachary Smith
et al.

Abstract: Background The use of Integrated Evidence Packages (IEPs) by the pharmaceutical industry has expanded in recent years with the aim of optimizing healthcare and patient outcomes. The evidence base of IEPs goes beyond traditional randomized controlled trials (RCTs) to provide holistic evidence suitable for all stakeholders. However, this approach to drug development is not systematically adopted by all sponsors because of perceived uncertainty in its investment value. Methods We introduce the concept of value … Show more

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“…On the other hand, standard metrics used in the financial world and in pharma itself include the expected net present value (eNPV) and return on investment (ROI) offer a promise for a holistic value estimation. Both of these metrics can easily be calculated by following an evaluation of the impact of an IEP on the value drivers above and allow for the use of a common metric to be used as an aid to value-based decision-making [ 5 ].…”
Section: Value-based Decision-makingmentioning
confidence: 99%
“…On the other hand, standard metrics used in the financial world and in pharma itself include the expected net present value (eNPV) and return on investment (ROI) offer a promise for a holistic value estimation. Both of these metrics can easily be calculated by following an evaluation of the impact of an IEP on the value drivers above and allow for the use of a common metric to be used as an aid to value-based decision-making [ 5 ].…”
Section: Value-based Decision-makingmentioning
confidence: 99%