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The 'reproducibility crisis' in life sciences continues to make headlines. A recent publication in the ILAR journal explores this issue investigating Biomonitoring and Digital data technology as opportunity for enhancing animal study translation [1].

Recent analysis has reported irreproducibility rates in pre-clinical research to
range from 51%-89%.

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Many factors contribute to irreproducible research, from poor experimental practices to the pressure to publish. Growing concern about reproducibility and an overwhelming desire for consistent, repeatable science has led labs to sharpen their focus on the documentation and standardisation of experimental methods, and to explore debiasing techniques and ways to remove human error to make research more reliable.

Using digital technology to create the lab of the future has a fundamental role to play in solving the reproducibility crisis and will ultimately fuel more scientific breakthroughs and more effective drug development. Nowhere is this more important than in cancer research.  

The desire for more consistent data has been a key driver in the development of BioVolume®. It was conceived to enable faster, smarter and more confident decisions to be made in the identification and development of new cancer therapeutics. 

Replacing the use of handheld manual callipers, our 3D subcutaneous tumour measurement system rapidly and accurately captures and reconstructs 3D tumour surface changes, enabling the analysis of texture, colour, shape and volume. It improves the reproducibility of data and brings tumour measurement and analysis into the 21st century by: 
 

Significantly reducing human bias  
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The smallest inaccuracy and variable can have a major impact on the outcome of a result, especially for pre-clinical studies with data sets captured on multiple days across multiple sites. Consistent and accurate data collection is essential.  

BioVolume reduces operator and inter-operator bias in a statistically significant way when measuring subcutaneous tumours, to ensure a level of consistency from individual to individual and site to site that is not possible with callipers. 

Different technicians measure the dimensions of tumours differently when using callipers so it is essential that the same person undertakes every measurement throughout the course of a study to ensure consistency. This poses problems if the scientist or technician needs to take time off for holiday or due to illness. Studies have shown that inter-operator variability can be as high as 20% when using callipers, as observed by Soon Ho Yoon,etal in 2016 European Journal of Cancer research paper[1]. European Journal of Cancer 

 

In studies repeated across different organisations, BioVolume inter-operator variability is significantly better than callipers (averaging below 10%) allowing non named lab animal support team members, scientists and even CRO staff to switch in and out during a study with little effect on the results. 

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Improving the reliability of data with digital Biomarkers  
 

Greater precision means more reliable data - particularly for irregular shaped tumours which are difficult to measure accurately with callipers - giving laboratory managers and technicians greater confidence in the results of the drug therapy trials they are undertaking. We have recently explored the impact on study reproducibility in a poster with St Judes Children’s Research hospital. Benefits include improved accuracy of tumour volume by capturing height and adding further digital biomarkers such as the animals condition and tumours thermal properties in a consistent and automated digital workflow, allowing for greater interrogation of therapeutic efficacy in a more repeatable and consistent way.  

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Better traceability 
 

Traceability is becoming ever more important in life sciences with stricter regulatory and compliance requirements. With BioVolume, standardised scanned tumour images can be recorded and saved with a time and date stamp, providing full transparency and traceability for every study, and greater confidence in the audit trail for pharmaceutical companies using their own labs or outsourcing studies to CROs. 3D models make it possible to revisit any data point in a trial while providing compliance evidence for every measurement. Calliper measurements simply consist of numbers in a spreadsheet, providing no opportunity to reconfirm and further analyse the data if required.

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A digital approach to recording, measuring and monitoring subcutaneous tumours not only tackles reproducibility head-on, introducing more consistent standards and ultimately, greater confidence in the results. Currently it is difficult for labs to collaborate due to the subjectivity and inconsistency in measuring tumours. 

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So what does this innovation mean for the lab of the future and for science? BioVolume is a step forward for cancer research, improving the transparency and veracity in collection and storage of trial data. Ultimately it could lead to more effective management of trials, resources being maximised due to greater confidence in data leading to fewer repeat trials being required. Most importantly it could improve the time to market for vital new cancer drugs as a result of reduction in the length of preclinical trials. Digital transformation has many benefits in the quest for consistent, reproducible data and in fuelling science. 

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[1] Erwin B Defensor, Maria A Lim, Laura R Schaevitz, Biomonitoring and Digital Data Technology as an Opportunity for Enhancing Animal Study Translation, ILAR Journal, 2021;, ilab018, https://doi.org/10.1093/ilar/ilab018

 

[2] Soon Ho Yoon, Kyung Won Kim, Jin Mo Goo, Dong-Wan Kim, Seokyung Hahn,

Observer variability in RECIST-based tumour burden measurements: a meta-analysis, European Journal of Cancer, Volume 53, 2016, Pages 5-15, ISSN 0959-8049, https://doi.org/10.1016/j.ejca.2015.10.014