scholarly journals The Contribution of Economic Evaluation to Decision-Making in Early Phases of Product Development: A Methodological and Empirical Review

2007 ◽  
Author(s):  
Susanne Hartz ◽  
Jürgen John
Keyword(s):  
Decision Making ◽  
Economic Evaluation ◽  
Product Development ◽  
Early Phases

scholarly journals Contribution of economic evaluation to decision making in early phases of product development: A methodological and empirical review

2008 ◽  
Vol 24 (04) ◽  
pp. 465-472 ◽  
Author(s):  
Susanne Hartz ◽  
Jürgen John
Keyword(s):  
Decision Making ◽  
Economic Evaluation ◽  
Product Development ◽  
Portfolio Management ◽  
Economic Evaluations ◽  
Decision Context ◽  
Actual Use ◽  
Pricing And Reimbursement ◽  
Analytical Tools ◽  
Early Phases

Background:Economic evaluation as an integral part of health technology assessment is today mostly applied to established technologies. Evaluating healthcare innovations in their early states of development has recently attracted attention. Although it offers several benefits, it also holds methodological challenges.Objectives:The aim of our study was to investigate the possible contributions of economic evaluation to industry's decision making early in product development and to confront the results with the actual use of early data in economic assessments.Methods:We conducted a literature research to detect methodological contributions as well as economic evaluations that used data from early phases of product development.Results:Economic analysis can be beneficially used in early phases of product development for various purposes including early market assessment, R&D portfolio management, and first estimations of pricing and reimbursement scenarios. Analytical tools available for these purposes have been identified. Numerous empirical works were detected, but most do not disclose any concrete decision context and could not be directly matched with the suggested applications.Conclusions:Industry can benefit from starting economic evaluation early in product development in several ways. Empirical evidence suggests that there is still potential left unused.

Formulating Industry-Academic Collaborations That Work: Best Practices to Ensure a Strong Relationship After the Agreements are Signed

2020 ◽  
Vol 21 (2) ◽  
pp. 169-177
Author(s):  
Michael B. Dilling ◽  
Anne C. DiSante ◽  
Ross Durland ◽  
Christine E. Flynn ◽  
Leonid Metelitsa ◽  
...  
Keyword(s):  
Decision Making ◽  
Best Practices ◽  
Product Development ◽  
Strong Relationship ◽  
Governance Structure ◽  
Collaborative Relationships ◽  
Skill Sets ◽  
Pragmatic Aspects

Collaborations between academia and industry are growing in scope, duration, and sophistication. The best collaborations recognize the unique strengths and skill sets of both parties and are structured to leverage what each party does best. In many cases, these collaborations develop into long-term relationships, and it is important to develop the systems and structures needed to support these relationships to ensure that they meet the needs of both sides. Successful collaborations require the formulation of a governance structure to facilitate communication, decision-making, assessment of progress, and the inevitable changes of direction that accompany product development. This panel explored the pragmatic aspects of successfully structuring collaborations and managing the relationships after the deal is done. Several dominant themes associated with successful collaborative relationships emerged from the discussion, and these will be explored in this article.

scholarly journals The Use of External Controls in FDA Regulatory Decision Making

2021 ◽  
Author(s):  
Mahta Jahanshahi ◽  
Keith Gregg ◽  
Gillian Davis ◽  
Adora Ndu ◽  
Veronica Miller ◽  
...  
Keyword(s):  
Decision Making ◽  
Natural History ◽  
Product Development ◽  
Rare Diseases ◽  
The United States ◽  
External Control ◽  
Common Source ◽  
Published Data ◽  
History Data ◽  
Benefit Risk Assessment

AbstractThe regulatory standards of the United States Food and Drug Administration (FDA) require substantial evidence of effectiveness from adequate and well-controlled trials that typically use a valid comparison to an internal concurrent control. However, when it is not feasible or ethical to use an internal control, particularly in rare disease populations, relying on external controls may be acceptable. To better understand the use of external controls to support product development and approval, we reviewed FDA regulatory approval decisions between 2000 and 2019 for drug and biologic products to identify pivotal studies that leveraged external controls, with a focus on select therapeutic areas. Forty-five approvals were identified where FDA accepted external control data in their benefit/risk assessment; they did so for many reasons including the rare nature of the disease, ethical concerns regarding use of a placebo or no-treatment arm, the seriousness of the condition, and the high unmet medical need. Retrospective natural history data, including retrospective reviews of patient records, was the most common source of external control (44%). Other types of external control were baseline control (33%); published data (11%); and data from a previous clinical study (11%). To gain further insights, a comprehensive evaluation of selected approvals utilizing different types of external control is provided to highlight the variety of approaches used by sponsors and the challenges encountered in supporting product development and FDA decision making; particularly, the value and use of retrospective natural history in the development of products for rare diseases. Education on the use of external controls based on FDA regulatory precedent will allow for continued use and broader application of innovative approaches to clinical trial design, while avoiding delays in product development for rare diseases. Learnings from this review also highlight the need to update regulatory guidance to acknowledge the utility of external controls, particularly retrospective natural history data.

HEALTH TECHNOLOGY ASSESSMENT AND PERSONALIZED MEDICINE: ARE ECONOMIC EVALUATION GUIDELINES SUFFICIENT TO SUPPORT DECISION MAKING?

2014 ◽  
Vol 30 (2) ◽  
pp. 179-187 ◽  
Author(s):  
Don Husereau ◽  
Deborah A. Marshall ◽  
Adrian R. Levy ◽  
Stuart Peacock ◽  
Jeffrey S. Hoch
Keyword(s):  
Decision Making ◽  
Economic Evaluation ◽  
Personalized Medicine ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Population Based ◽  
New Paradigm ◽  
Current Guidance ◽  
Support Decision Making

Background: Many jurisdictions delivering health care, including Canada, have developed guidance for conducting economic evaluation, often in the service of larger health technology assessment (HTA) and reimbursement processes. Like any health intervention, personalized medical (PM) interventions have costs and consequences that must be considered by reimbursement authorities with limited resources. However, current approaches to economic evaluation to support decision making have been largely developed from population-based approaches to therapy—that is, evaluating the costs and consequences of single interventions across single populations. This raises the issue as to whether these methods, as they are or more refined, are adequate to address more targeted approaches to therapy, or whether a new paradigm for assessing value in PM is required.Objectives: We describe specific issues relevant to the economic evaluation of diagnostics-based PM and assess whether current guidance for economic evaluation is sufficient to support decision making for PM interventions.Methods: Issues were identified through literature review and informal interviews with national and international experts (n = 10) in these analyses. This article elaborates on findings and discussion at a workshop held in Ottawa, Canada, in January 2012.Results: Specific issues related to better guiding economic evaluation of personalized medicine interventions include: how study questions are developed, populations are characterized, comparators are defined, effectiveness is evaluated, outcomes are valued and how resources are measured. Diagnostics-based PM also highlights the need for analyses outside of economic evaluation to support decision making.Conclusions: The consensus of this group of experts is that the economic evaluation of diagnostics-based PM may not require a new paradigm. However, greater complexity means that existing approaches and tools may require improvement to undertake these more analyses.

A new fuzzy decision-making approach for selecting new product development project

2016 ◽  
Vol 24 (3) ◽  
pp. 240-250 ◽  
Author(s):  
Chiu-Chi Wei ◽  
Agus Andria ◽  
Houn-Wen Xiao ◽  
Chiou-Shuei Wei ◽  
Ting-Chang Lai
Keyword(s):  
Decision Making ◽  
Product Development ◽  
New Product Development ◽  
New Product ◽  
Development Project ◽  
Fuzzy Decision Making ◽  
Fuzzy Decision ◽  
Product Development Project

scholarly journals Exploitation Policy in the Aspect of Industry 4.0 Concept – Overview of Selected Research

2018 ◽  
Vol 1 (1) ◽  
pp. 353-359
Author(s):  
Anna Timofiejczuk ◽  
Jaroslaw Brodny ◽  
Andrzej Loska
Keyword(s):  
Decision Making ◽  
Product Development ◽  
Industry 4.0 ◽  
Maintenance Management ◽  
Research Results ◽  
Production Processes ◽  
Decision Making Processes ◽  
Technical Systems

Abstract The article is a review of completed research on developed and implemented innovative and technologically advanced technical systems. According to the Industry 4.0 concept they can have a significant impact on the efficiency of production processes and product development. In this perspective, the key aspect seems to be maintenance management of technical systems, realized both in the operate phase as well as during service and repair works. There were discussed research results of authors and developed application solutions supporting decision-making processes, in terms of three main periods of realization of exploitation processes: short, medium and long-term.

scholarly journals Alternative Materials and Methodology in Contemporary Design

2019 ◽  
Vol 11 (1) ◽  
pp. 39-42
Author(s):  
Anita Darabos ◽  
Judit Szalai
Keyword(s):  
Decision Making ◽  
Product Development ◽  
Natural Resources ◽  
New Products ◽  
Natural Materials ◽  
Ecological Requirements ◽  
Industrial Sectors ◽  
Alternative Materials ◽  
Environmental Considerations ◽  
The Creation

Abstract Nowadays, concerns related to mankind’s increasing and destructive impact on the environment have influenced and changed the paradigms of product development; this in turn has brought about the appearance of environmental considerations in the creation and design of new products. Numerous industrial sectors have changed their processes of product development and production to meet the ecological requirements. Issues such as the scarcity of natural resources, increasing consumption and increasing pollution also present a number of problems. This article presents a process of comparing new alternatives with a specific methodology of decision-making. It is primarily focused on the use of rare natural materials and resources that are extracted and processed.

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