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Animal to human translation: a systematic scoping review of reported concordance rates
Cathalijn H C Leenaars1,2,3, Carien Kouwenaar4, Frans R Stafleu4
1Department of Animals in Science and Society, Faculty of Veterinary Sciences, Utrecht University, Utrecht, The Netherlands. Leenaars.Cathalijn@mh-hannover.de.
Background:
Drug development is currently hampered by high attrition rates; many developed treatments fail during clinical testing. Part of the attrition may be due to low animal-to-human translational success rates; so-called "translational failure". As far as we know, no systematic overview of published translational success rates exists.
Systematic Scoping Review:
The following research question was examined: "What is the observed range of the animal-to-human translational success (and failure) rates within the currently available empirical evidence?". We searched PubMed and Embase on 16 October 2017. We included reviews and all other types of "umbrella"-studies of meta-data quantitatively comparing the translational results of studies including at least two species with one being human. We supplemented our database searches with additional strategies. All abstracts and full-text papers were screened by two independent reviewers. Our scoping review comprises 121 references, with various units of measurement: compound or intervention (k = 104), study/experiment (k = 10), and symptom or event (k = 7). Diagnostic statistics corresponded with binary and continuous definitions of successful translation. Binary definitions comprise percentages below twofold error, percentages accurately predicted, and predictive values. Quantitative definitions comprise correlation/regression (r2) and meta-analyses (percentage overlap of 95% confidence intervals). Translational success rates ranged from 0 to 100%.
Conclusion:
The wide range of translational success rates observed in our study might indicate that translational success is unpredictable; i.e. it might be unclear upfront if the results of primary animal studies will contribute to translational knowledge. However, the risk of bias of the included studies was high, and much of the included evidence is old, while newer models have become available. Therefore, the reliability of the cumulative evidence from current papers on this topic is insufficient. Further in-depth "umbrella"-studies of translational success rates are still warranted. These are needed to evaluate the probabilistic evidence for predictivity of animal studies for the human situation more reliably, and to determine which factors affect this process.
Insights
Drug development faces high failure rates due to poor animal-to-human translation. This review found a wide 0-100% range in translational success, highlighting unpredictability and the need for more reliable evidence.
Area of Science:
- Biomedical research
- Translational science
- Drug discovery and development
Background:
- High attrition rates in drug development are a significant challenge.
- A key factor contributing to treatment failure is poor animal-to-human translational success.
- Existing literature lacks a systematic overview of published translational success rates.
Purpose of the Study:
- To determine the observed range of animal-to-human translational success and failure rates.
- To synthesize the empirical evidence on the predictability of animal studies for human outcomes.
Main Methods:
- Conducted a systematic scoping review of literature indexed in PubMed and Embase up to October 2017.
- Included "umbrella"-studies and meta-analyses quantitatively comparing translational results across species, including humans.
- Screened 121 references using independent reviewers and analyzed data based on various definitions of translational success.
Main Results:
- The reviewed studies reported a broad spectrum of translational success rates, ranging from 0% to 100%.
- Success was defined using binary metrics (e.g., prediction accuracy) and quantitative metrics (e.g., correlation coefficients, meta-analyses).
- The data encompassed 104 compounds/interventions, 10 studies/experiments, and 7 symptoms/events.
Conclusions:
- The wide variability in success rates suggests that animal-to-human translation may be unpredictable.
- High risk of bias and outdated evidence in included studies limit the reliability of current findings.
- Further in-depth reviews are necessary to reliably evaluate the predictive value of animal studies and identify influencing factors.
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