The scientific communication industry has advanced leaps and bounds. However, things have changed little regarding the drug development process. Many researchers and scientists do not publish the negative findings of a preclinical study.
All forms of research – preclinical, clinical, animal or human based, and with both positive and negative outcomes demand a reliable reporting. But, this doesn’t happen due to the absence of specific requirements/guidelines for reporting the research studies. This is more important regarding the preclinical studies which form the base for further research on a particular drug.
Therefore, the National Centre for the Replacement, Refinement and Reduction of Animals in Research has planned the ARRIVE guidelines to improve the way preclinical studies are reported, to maximize the information published and minimize the unnecessary details.
What are ARRIVE guidelines?
ARRIVE (Animal Research: Reporting In-Vivo Experiments) guidelines are a set of minimum requirements to report every research study that uses animals as a drug model.
The objectives of ARRIVE guidelines are:
- Improve the reporting of research using animals
- Guide the authors about the essential information to include in their manuscript
- Provide flexibility to accommodate various research areas and experimental protocols irrespective of their findings
- Promote transparent, accurate, complete, concise, well-written, and reproducible manuscripts
- Improve the communication of the research findings to the scientific community
ARRIVE Guidelines Checklist
As per the checklist, each section of the manuscript has a pre-defined recommendation on what to include and what to avoid.
Write a concise and accurate description of what the article contains
Write an accurate summary of the background and research objectives. It should include details of the species or the strain of the animal used, key methods, principal findings, and conclusions of the study
- Provide sufficient and relevant references to the previous work related to the research topic
- Explain the experimental approach and its rationale
- Explain how and why the species of animals used in the experiment can address the scientific objectives and its relevance to human biology
- Describe the primary and secondary objectives of the study
4) Methods Used
- Give an ethical statement about the review permissions, relevant licences and guidelines taken care of for the use of animals in the study
- Give a brief of the study design and include the number of experimental and control groups, the experimental unit, and the steps taken to reduce bias in conducting the study or reporting the results
- Write all the details about the experimental and control groups like the site of drug administration, time of the day, details of any specific equipment used, etc.
- Give details of the species, strain, sex, weight and the developmental stage of the animals used in the study. Also provide relevant information about the source of the animals, international strain nomenclature, genetic modification status, genotype, and their health status.
- Include details about the housing or cage, bedding material, and husbandry conditions of the animals
- Details about the sample size calculations
- How the animals were divided into the different experimental groups and how they were treated/assessed
- Describe the primary and the secondary experimental outcomes
- Details about the statistical methods used to analyse the data along with the units of analysis
- Report the number of animals in each analysis in absolute numbers
- Explain if youexclude any animals or data in the analysis
- Report the results of each analysis with a measure of precision
- Quote any important adverse events that occur during an experiment. Describe the modifications made in the experimental protocols to control these adverse events
- While quoting the results interpretations, take into account the study objectives and hypotheses, current theory, and other relevant studies in the literature.
- Describe any study limitations like potential sources of bias, limitations of the animal model, and any inaccuracy of results
- Include the implications of your experimental methods or findings for the replacement, refinement and reduction (the 3Rs) of the use of animals in research.
- Comment how the findings of the study apply to the human biology.
- List all the sources that provided funds and the role of the funders in the study.
Though some items on the checklist can’t be applied to all the studies, it provides a valuable reference to those who prepare or review the manuscript of a preclinical study.