ORCID Profile
0000-0001-5315-284X
Current Organisation
Universiteit Utrecht
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Publisher: Elsevier BV
Date: 06-2021
Publisher: eLife Sciences Publications, Ltd
Date: 20-05-2021
Publisher: eLife Sciences Publications, Ltd
Date: 24-05-2021
DOI: 10.7554/ELIFE.63294
Abstract: While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union’s Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides ex les of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use.
Publisher: MDPI AG
Date: 13-10-2022
DOI: 10.3390/ANI12202757
Abstract: Even with the introduction of the replacement, reduction, refinement (the three Rs) approach and promising technological developments in animal-testing-free alternatives over the past two decades, a significant number of animal tests are still performed in medical science today. This article analyses which factors could accelerate the transition to animal-free medical science, applying the multi-level perspective (MLP) framework. The analysis was based on qualitative research, including a desk study (literature review and document analysis), lectures from experts, and nine online focus group sessions with experts on 26 July 2021. These were undertaken as part of an honours project between May and September 2021 to identify barriers, levers, and opportunities for accelerating this transition. The MLP framework identifies required changes at three levels: innovations and new practices (niche level), the current (bio)medical research system (regime level), and larger societal forces (landscape level). All three levels interact in a non-linear fashion. The model enabled us to identify many relevant factors influencing the transition to animal-testing-free medical science and enabled priority setting. Our findings supported the formulation of six “focus areas” to which stakeholders could devote efforts in order to accelerate the transition to animal-testing-free medical science: (1) thorough and translatable new approach methods (NAMs) for human-relevant medical research (2) open science and sharing data (3) targeted funding for NAMs (4) implementing and modernising legislation for NAMs (5) interdisciplinary education on animal-testing-free medical science and (6) facilitating a shift in societal views, as this would be of benefit to both animals and humans. It is proposed that these focus areas should be implemented in parallel.
Location: Netherlands
No related grants have been discovered for Merel Ritskes-Hoitinga.