Special Issue "Are Animal Models Needed to Discover, Develop and Test Pharmaceutical Drugs for Humans in the 21st Century?"

A special issue of Animals (ISSN 2076-2615). This special issue belongs to the section "Animal Ethics".

Deadline for manuscript submissions: 15 May 2020.

Special Issue Editor

Dr. Pandora Pound
E-Mail Website
Guest Editor
Safer Medicines Trust, PO Box 122, Kingsbridge, TQ7 9AX, UK
Interests: preclinical animal research; animal models; clinical translation; new approach methodologies

Special Issue Information

Dear Colleagues,

Despite many decades of research, much of which has focused on studies in animals, humans continue to suffer from a multiplicity of diseases and illnesses for which there are no cures or treatments. It is now clear that insights provided by animal studies do not often translate to humans, explaining the very high failure rate observed when new medicines are evaluated in human clinical trials. In addition, there is increasing evidence that animal studies are frequently conducted so poorly that no clear conclusions may be drawn from them. Some claim that if only the quality of animal studies was improved, and animal models were made to more faithfully capture the relevant human disease, then these models would begin to translate and deliver clinical benefits. Others argue that research focusing on humans is necessary to gain a better understanding of human disease and to develop safe and effective drug treatments. These scientists point to developments in human biology during the last decade that have yielded in vitro and in silico techniques capable of providing novel insights into human disease mechanisms, as well as human-relevant disease models for developing and testing drug treatments for humans. Against this backdrop, the Netherlands and the US have recently announced concrete proposals for significantly reducing laboratory animal use by 2025 and 2035 respectively, whilst accelerating a transition towards, human-focused methodologies. A key question is whether there is value in refining animal models, or whether these should be relinquished in favour of new, human-focused research approaches.

Original manuscripts that address this point are invited for this special issue. Associated topics, for example, papers discussing the use of both animal and human-focused approaches, are also of interest.

Dr. Pandora Pound
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All papers will be peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Animals is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.


Clinical translation

New approach methodologies

Human focused methods

Human biology

In vitro

In silico

Animal models

Animal research

Published Papers

This special issue is now open for submission, see below for planned papers.

Planned Papers

The below list represents only planned manuscripts. Some of these manuscripts have not been received by the Editorial Office yet. Papers submitted to MDPI journals are subject to peer-review.

  • The Use of Animals in Alzheimer, Breast and Prostate Cancer Research: Translational Failures and the Importance to Monitor Return on Investment

Francesca Pistollato, Camilla Bernasconi, Ivana Campia, Clemens Wittwehr and Maurice Whelan

European Commission, Joint Research Centre (JRC), Ispra, Italy

Abstract: Animal models of Alzheimer’s disease (AD), breast cancer (BC) and prostate cancer (PC) have been traditionally used to recapitulate human disease features and develop new drugs, as they are generally purported to resemble some of the major hallmarks of these human diseases. However, animal models do not physiologically develop the disease as it occurs in humans, and their use has not often, in some cases never, paved the way to the development of drugs effective in human patients. Despite conspicuous research and economical endeavours, the clinical failure rate in drug development remains still very high, with an overall likelihood of approval from Phase I of about 9.6%. On the other hand, the expanding toolbox of non-animal methods, accounting for e.g., induced pluripotent stem cells derived from patients, next-generation sequencing, omics and integrated computer modelling can be used to study human diseases in human-based settings, identify new potential druggable targets, and evaluate treatment effects. The rise of new technological tools and models in life science, and the increasing need for multidisciplinary approaches, have encouraged many research initiatives and the launch of new EU calls for proposals. In particular, research proposals on AD, BC and PC based on the use of both animal and/or non-animal approaches have been extensively funded in the last two decades. Nowadays, it is becoming pivotal to define and apply indicators suitable to measure return on investment of research funding strategies to monitor contribution to innovation, retrospectively assess public health trends, and readdress funding strategies when needed. Here we discuss such issues, describing a list of indicators to measure return on investment in biomedical research, considering AD, BC and PC as case studies.

  • A Systematic Review Comparing Experimental Design between Animal and Human Methotrexate Efficacy Studies for Rheumatoid Arthritis: Lessons for the Translational Value of Animal Studies

CHC Leenaars, FR Stafleu, DH de Jong, M van Berlo, T Geurts, CJJ Coenen-de Roo, A Bleich, RBM de Vries, FLB Meijboom and M Ritskes‐Hoitinga

Abstract: This paper will describe our results from a systematic review of methotrexate studies, in which we compare several aspects of clinical trial design between animal and human studies. We will discuss the findings in light of the value of animal studies for development of human drugs. Besides, we will discuss the value and limitations of systematic reviews.

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