Developing an integrated strategy for evidence generation

Can real-world evidence save pharma US$1 billion per year? A framework for an integrated evidence generation strategy

“…Inform strategy, starting with target product profile and continuing to product differentiation, including regulatory opportunities Enhance and pressure-test clinical trial design and increase probability of success In a previous publication [1], I outlined a strategy for an integrated approach to evidence generation, utilizing RWE to support activities across the product life cycle and among multiple internal functions in order to satisfy the myriad of external stakeholder needs more effectively. Several individual concepts that can be informed by RWE when establishing an integrated evidence strategy were proposed, including end point strategy, Phase III population identification, randomized controlled trial recruitment, patient-reported outcomes, outcome agreements and effectiveness prediction.…”

“…External factors, such as increasing regulatory requirements for real-world data (RWD), the growing role of payer-and patient-relevant end points in reimbursement decisions and rising constraints on healthcare budgets, require a new and integrated approach. This article builds on the previous 'call to action' to transform the mindset of the pharmaceutical industry in utilizing real-world evidence (RWE) [1] by presenting an evidence-powered operating framework (EPOF) for applying an integrated evidence generation strategy within a pharma organization.…”

Introducing Volume 7 of the Journal of Comparative Effectiveness Research

“…In his Editorial, Skip Olson discusses the development of an integrated strategy for evidence generation, bringing together both randomized clinical trial and real-world evidence-based approaches [2].…”

“…Real-world evidence has become an important discussion point, and source of data, in recent times (as shown by some of our most read articles in 2017, see more below). This issue includes an interview from Dr Marc Berger, discussing the reports published by the joint ISPOR-ISPE Special Task Force on real-world evidence in healthcare decision making, with the goal of establishing good procedural practices for real-world data studies and ultimately increase trust in this type of research [1].In his Editorial, Skip Olson discusses the development of an integrated strategy for evidence generation, bringing together both randomized clinical trial and real-world evidence-based approaches [2].In a new White Paper, Hampson et al discuss the outcomes of an Institute for Clinical and Economic Review policy forum, exploring the challenges presented by gene therapies, discussing potential solutions and presenting policy recommendations [3].Also in this issue is a range of research and review content, including a Methodology paper discussing the Platform for Haematology in EMEA: Data for Real World Analysis (PHEDRA) [4]; and research on hemophilia B [5] and hemorrhage following cesarean delivery [6].This issue is completed with a protocol paper describing the dabigatran, apixaban, rivaroxaban, edoxaban, warfarin comparative effectiveness research study [7] and a Systematic Review article examining treatments, quality of life and costs in metastatic breast cancer [8]. …”

Introducing Volume 8 of the Journal of Comparative Effectiveness Research

“…While original research results and methods form the core of our content, it is also important to put information in context, and hear the opinions of experts in the field. In his January editorial, Skip Olson discusses the development of an integrated strategy for evidence generation, bringing together both randomized clinical trial and real-world evidence-based approaches [18]; a perspective article in issue 6 discusses learning healthcare systems, and their transition to learning healthcare communities [19]; and finally, a narrative review article from Waycaster and colleagues discusses recent clinical effectiveness, cost-effectiveness and safety research for the treatment of chronic dermal ulcers with clostridial collagenase ointment [20].…”