Improving Transparency in Animal Studies: The Case for Preclinical Study Registration

What is it about?

Protocol registration in clinical trials has been mandatory for human studies for decades, but uptake in animal studies has been minimal. Registration could improve transparency, reduce redundancy, and address biases in preclinical research. External organizations have successfully influenced registration decisions in human studies; similar approaches can be applied to animal research. Integrating study registration within the animal use protocol (AUP) review process could increase uptake. This would involve harmonizing AUP and animal registry requirements and addressing perceived barriers such as increased regulatory burden and intellectual property concerns. Collaborative efforts between researchers and animal ethics committees, along with educational workshops and technical assistance, can facilitate implementation. Evaluation of the approach through working groups, surveys, interviews, and before-after assessments can help refine future implementation initiatives.

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Why is it important?

Protocol registration in clinical trials is important to increase transparency, reduce redundancy, and improve the overall quality of research. However, the same level of transparency and rigor has not been applied to preclinical animal studies. This can lead to biases and inaccurate conclusions in the preclinical literature, which can then hinder the translation of these findings to human clinical trials. By integrating preclinical study registration within animal use protocol (AUP) review processes, similar to the successful implementation in clinical trials, the uptake and benefits of preclinical study registration can be increased. Key Takeaways: 1. Protocol registration in clinical trials has increased significantly due to legal mandates, journal policies, and funding requirements. 2. Preclinical animal studies, however, have seen little uptake of study registration. 3. Integrating preclinical study registration within AUP review processes could increase uptake and improve the quality of preclinical research. 4. Successful implementation will require collaboration between researchers, animal ethics committees, and institutional stakeholders, as well as addressing perceived barriers such as regulatory burden and intellectual property concerns. 5. Evaluation of the efficacy of this approach will involve engaging stakeholders, monitoring registration numbers, and assessing publication bias.