Background and Aims
Within the last years, there has been growing awareness of the negative repercussions of unstandardized planning, conduct and reporting of preclinical research. Several initiatives have set the aim of increasing validity and reliability in reporting of studies and publications [Hirst et al., 2014, Percie du Sert et al., 2017, Hooijmans et al., 2014, Simera et al., 2010]. While these overlap significantly, they differ in detail, and show variance in generalizability or specific challenges for a single field. Additionally, reporting guidelines do not cover planning and conduct of studies, which face a similar situation [Henderson et al., 2013]. Consequently, it is hard for researchers to decide which guidelines to follow, especially at the stage of planning future studies.
Aim of the EQIPD (European Quality in Preclinical Data) framework was to unify current suggestions, find a basis in evidence behind their rationale, and prospectively test the newly set framework for feasibility in multi-center animal experiments.

Methods
In a first step, in a systematic review of guidelines, a systematic search yielded 13,863 results, in which 62 publications fit to the inclusion criteria. From these, a list of 58 unique items were extracted, and in a two-round Delphi process with a subsequent consensus meeting, 33 of these items were included in the final framework. This framework was constructed into five major domains.

Results
DOMAIN 1: Exploratory vs. confirmatory research: Answer the following question: Is your experiment testing a predefined scientific hypothesis which is statistically testable (confirmatory research) or is it exploring a space of interesting options to generate hypotheses (exploratory research)?
DOMAIN 2: Pre-planning and standard operating procedures (SOPs): Prespecify, document and standardize all methods and analyses before the experiment.
DOMAIN 3: Statistics: Think about which form of aggregate measures are meaningful for your data and choose appropriate statistical methods, and plan your sample size accordingly.
DOMAIN 4: Randomization and blinding: Randomize and blind your processes to avoid the introduction of confounding and systematic error.
DOMAIN 5: Documentation: Not all bias can be avoided, but most can be uncovered: use full and comprehensive documentation.

Conclusions
The EQIPD framework is currently prospectively tested for feasibility and blind spots in a multi-center animal study, which will further inform the final version. In parallel, a literature search is conducted to identify the provenance of diligence – the evidence for an impact of the proposed items, and the history of their application. While, for the moment, the framework is being developed around animal work, its applicability to in vitro studies will also be assessed.
 
Conflicts of Interest
No relevant conflicts of interest.

Source of Financial Support for the Project
This work is part of the European Quality In Preclinical Data (EQIPD) consortium. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

THE EQIPD FRAMEWORK FOR RIGOUR IN THE DESIGN, CONDUCT AND ANALYSIS OF BIOMEDICAL EXPERIMENTS