As a member of the Alliance for Human Relevant Science, Safer Medicines Trust calls for a fresh approach to biomedical research and drug discovery.
New approach methodologies (NAMs) that are human relevant have the potential to improve the efficiency of drug research and development and to deliver safer, cheaper and more effective medicines to patients.
In the new White paper ‘Accelerating the Growth of Human Relevant Life Sciences in the United Kingdom’, the Alliance calls for support from the Government to assist businesses in the transition to NAMs by providing supportive infrastructure, strategic funding, education, collaboration between industries and regulatory engagement.
There is an opportunity for the UK to be a world leader in developing and evaluating NAMs. Investment in human relevant methods is good for both business and public health.
This new study by Pandora Pound and Rebecca Ram from Safer Medicines, published in BMJ Open Science, analyses the opinions of scientists who conduct animal studies of stroke. At present there is only one drug available for patients with acute stroke, a ‘clot buster’ called Alteplase (and this drug was not directly dependent upon animal research for its development). Alteplase can only be given to a minority of stroke patients, half of whom will not benefit from it, so there is an urgent need for effective treatments in this area. Given the failure to develop treatments for acute stroke despite decades of animal research in this field, the study aimed to explore scientists’ views about the way forward.
We found that scientists conducting animal studies of stroke agreed that the field was in crisis, and many robustly criticised the science in this area. When it came to identifying the causes of this crisis, most scientists focused on the poor quality of animal studies. Similarly, when it came to solutions, most proposed improving the quality of animal studies in the hope that this would ultimately translate into benefits for stroke patients. A small number of researchers proposed using human in vitro methods alongside animal studies and one proposed using human focused methods instead of animal studies. Although there is evidence then, that a minority of scientists are beginning to consider human focused approaches, our study indicates a strong resistance to relinquishing the use of animal models in stroke research, despite decades of their failure to produce any benefits for stroke patients.
Read the paper in full here
A systematic review is a way of systematically bringing together the findings from research studies in a particular field and this paper is about the appropriate use of systematic reviews in the field of animal studies. Some researchers suggest that systematic reviews of animal studies conducted prior to human trials (i.e. prospective systematic reviews of animal studies) would allow scientists to scrutinise data on the safety and efficacy from animal studies, helping them decide whether or not human trials should proceed. However Pandora Pound from Safer Medicines Trust, together with Merel Ritskes-Hoitinga from Radboud University in the Netherlands, argue that while prospective systematic reviews can make the evidence obtained from animal studies more transparent, individual studies in animals are not necessarily able to reliably predict the safety and efficacy of an intervention when trialled in humans, and so systematic reviews of these individual studies would likewise fail to offer reliable predictions of safety and efficacy. As a result they would not be able to reliably safeguard humans participating in clinical trials. The authors also note that animal and human studies are often conducted concurrently, which not only makes prospective systematic reviews of animal studies impossible, but suggests that animal studies do not inform human studies in the expected way. They argue that it is time to review expectations of what animal studies can deliver and focus instead on investigating how clinical knowledge is actually produced. Read the full paper here
The open access journal ‘Animals’ is running a Special Issue guest edited by Pandora Pound of Safer Medicines. The topic for the Special Issue is ‘Are Animal Models Needed to Discover, Develop and Test Pharmaceutical Drugs for Humans in the 21st Century?’ Original manuscripts that address this question are invited for the Special Issue. The deadline is May 15th 2020. More information can be found here: http://www.mdpi.com/journal/animals/special_issues/animal_models_2020
Background to call for papers
Despite many decades of research, much of which has focused on studies in animals, humans continue to suffer from 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. 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.