Table 2 Summary of specific recommendations for robust and reproducible preclinical research in personalised medicine and identification of the stakeholder(s) they address
From: Recommendations for robust and reproducible preclinical research in personalised medicine
Number | Recommendation | Stakeholder addressed |
|---|---|---|
1 | It is imperative that preclinical translational models are assessed and developed to ensure they capture clinically relevant aspects of the disease and are aimed towards the prediction of treatment outcome or prevention | Researchers |
2 | The selection of preclinical models must be evidence-based, and researchers should demonstrate awareness of the limitations of the model(s) when interpreting results. | Researchers |
3 | Several models must be used when modelling complex disease, to represent different features of the disease. | Researchers |
4 | There should be a common implementation framework for robust and rigorous research, to provide reliable preclinical data prior to clinical trials. | Researchers Funders |
5 | Public funders must support and promote robust model development through specific funding and policies. | Funders |
6 | Further efforts should be made to validate, qualify, and adopt innovative technologies. | Funders |
7 | Transparent and reliable reporting and data sharing must be a requirement for both the academic and commercial sectors to improve the quality, credibility, and responsiveness of research | Researchers |
8 | Pre-registration of preclinical study protocols in open-access databases should be required by research funding bodies and/or research organisations. | Researchers |
9 | All stakeholders must ensure that the education and training of researchers promote methods for high-quality and reproducible preclinical research. | All |
10 | Regulators should ensure that preclinical evidence is clinically relevant and encourage incorporation of patient-derived models. | Regulators |
11 | Regulators and ethics committees reviewing and approving clinical trials should have harmonised guidelines and standards for evaluating preclinical evidence. | Regulators |
12 | Regulators should facilitate the incorporation of novel patient-derived methods in the drug development pipeline. | Regulators |
13 | Active patient involvement in PM preclinical research should be facilitated and incentivised through public funders. | Researchers and funders |
14 | The development and infrastructure of dedicated patient-focused interdisciplinary translational centres should be supported by targeted public funding. | Funders |
15 | All relevant stakeholders in translational PM development should encourage and facilitate interdisciplinary interactions to address the causes of translational failure and enhance efforts to develop robust research models | All |