Table 1 Gap analysis and outline of recommendations for the translational step of personalised medicine
From: Recommendations for robust and reproducible preclinical research in personalised medicine
Gap identified | Cause of gap | Recommendation |
|---|---|---|
Lack of clinically relevant experimental models. | Clinically relevant models not emphasised. Complexity of personalised medicine. Need further technological advances. | Clinically relevant translational research Standards for model relevance. Evidence-based use of model systems. Combination of models to represent inter-patient variability. |
Lack of standardised protocols, validation procedures, and quality assessment. | Preclinical models often not robust enough for translation. Model validation not academically rewarded, time consuming, and expensive. | Robust model development Implementation systems for robust and rigorous research. Validation, qualification, and adoption of innovative technologies. Funding and reward for work with data robustness. |
Lack of accurate reporting, and reporting of negative results, leading to a lack of systematic reviews and meta-analyses on methods. | Non-compliance with reporting recommendations. Academic reward system for publishing positive results. Competitive secrecy from industry. | Transparency and education Transparent and reliable reporting, data sharing from all stakeholders. Preregistration of preclinical experiments in open databases. Education and training to promote robust methods. |
Regulation—lack of standards for relevance and robustness of preclinical evidence. | Regulators and ethical committees lack harmonised guidelines on preclinical assessment. | Revised regulation Patient centric, clinically relevant preclinical data. Standards for evaluating models for relevance. Incorporate novel methods in the existing pipeline. |
Lack of involvement between preclinical and clinical research. | Mindset of the medical and scientific communities. Need for better definition of patient engagement. | Interaction with clinical research and patient engagement Active patient involvement in preclinical research. Dedicated clinical translational centres. Interdisciplinary interactions. |