Public contributions to R&D of medical innovations: A framework for analysis.

Background And Objective: Article 57 of the proposed European Union (EU) Pharmaceutical Legislation (PL, Directive) will require market authorization applicants to publicly declare any direct financial support for R&D received from public authorities. Our research aims to identify the categories needed to capture direct or indirect public contributions to R&D, provide a framework for standardized reporting of public contributions, and reduce ambiguity in the interpretation of "direct" and "indirect" public contributions.

Methods: An iterative mixed-methods approach is applied: a targeted literature review was conducted, complemented by interviews with representatives of different stakeholder groups to identify categories of public contributions to R&D, followed by searches for relevant data sources.

The role of health economics within health technology assessment: past, present, and future - an Austrian perspective.

In many countries, the economics domain forms a routine part of health technology assessments (HTA) next to analyzing the comparative effectiveness and safety of a technology. The method applied most often is economic evaluation, such as cost-effectiveness analysis, which is supposed to support the efficient use of resources. In Austria, economic evaluation has played a negligible role in HTA and reimbursement decisions, even though the country faces the same public healthcare sustainability challenges as others.

Robot-assisted surgery in thoracic and visceral indications: an updated systematic review.

Background: In surgical advancements, robot-assisted surgery (RAS) holds several promises like shorter hospital stays, reduced complications, and improved technical capabilities over standard care. Despite extensive evidence, the actual patient benefits of RAS remain unclear. Thus, our systematic review aimed to assess the effectiveness and safety of RAS in visceral and thoracic surgery compared to laparoscopic or open surgery.

Twelve years of European cancer drug approval-a systematic investigation of the 'magnitude of clinical benefit'.

Background: The magnitude of clinical benefit of solid cancer drugs can be standardly assessed via the Magnitude of Clinical Benefit Scale (MCBS) developed by the European Society for Medical Oncology (ESMO). We applied two ESMO-MCBS versions to the last 12 years of European cancer drug approval and compared two predefined marketing authorisation timeframes to identify potential score changes over time.

Material And Methods: Originator solid cancer drugs and indication extensions that were approved between 1 January 2009 and 31 October 2020 by the European Medicines Agency (EMA) were included in our analyses.

Developing a quality management system for the European Network for Health Technology Assessment (EUnetHTA): toward European HTA collaboration.

Objectives: The European Network for Health Technology Assessment (EUnetHTA) was established in 2006 and comprises over eighty organizations from thirty European countries. In its fifth project phase (Joint Action 3), EUnetHTA set up a quality management system (QMS) to improve the efficiency and standardization of joint work. This article presents EUnetHTA's new QMS and outlines experiences and challenges during its implementation.

Cancer care near the end-of-life in Austria: A retrospective data analysis.

Objective: Since end-of-life care (EOL) is an internationally accepted indicator for the quality of oncological care we aimed to investigate the current EOL care situation for Austrian cancer patients especially concerning the place of death cancer treatment hospitalisation near death and palliative care.

Methods: A retrospective data analysis was carried out based on Austrian routine inpatient data of the years 2012 to 2016. Data including the date of death of adult patients with a main hospital discharge diagnosis of a neoplasm were included.

Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment.

Aim: To summarize the evidence on the clinical effectiveness and safety of coronary sinus reducing stent (CSRS) therapy in refractory angina pectoris (AP) patients.

Methods: We performed a systematic literature search in common databases (n=4). The evidence obtained was summarized according to GRADE methodology.