A multi-laboratory preclinical trial to assess treatment candidates for acute ischemic stroke

Human diseases may be modeled in animals to allow preclinical assessment of putative new clinical interventions. Recent, highly publicized failures of large clinical trials called into question the rigor, design, and value of preclinical assessment. We established the Stroke Preclinical Assessment Network (SPAN) to design and implement a randomized, controlled, blinded, multi-laboratory network for the rigorous assessment of candidate stroke treatments combined with intravascular thrombectomy. Futility boundaries in a Multi-Arm Multi-Stage statistical design aimed to exclude less effective interventions, and efficacy boundaries allowed early declaration of success after each of four sequential stages. Six independent research laboratories performed a standard focal cerebral ischemic insult in five animal models that included equal numbers of males and females: young mice, young rats, aging mice, mice with diet-induced obesity, and spontaneously hypertensive rats. The laboratories adhere..., SPAN consists of six research laboratories to conduct preclinical stroke modeling and a coordinating center to mask drugs, conduct centralized randomization, assess blinded outcomes, collect data, and perform statistics. The aim of SPAN was to determine whether such rigor is feasible and practical on a large scale in a multi-laboratory controlled, randomized preclinical study of six investigator-initiated putative interventions for acute ischemic stroke, selected through a rigorous NIH-peer review. Here we report the primary results of SPAN., Tables contain the results of the corner test and the MR imaging organized by subject ID. Treatment group data is available in the feasibility file. These are contained in the following files:
dt_feasibility_stm_paper 2023-08-21dt_outcome_corner_stm_paper 2023-08-21dt_outcome_mri_stm_paper 2023-08-21report_stm_paper 2023-07-29
The first 3 files are Excel files that contain data listings in tab 1 and data definition dictionary in tab 2. The treatment group variables can be found in the first file and applied to the remaining files by matching on the animal identity variable \"enro_animal_id. The variable 'txas_tx_group' contains a code that gives the treatment group to which the subject was assigned. The variable 'txas_tx_group_actual' gives a code for the treatment group actually received. The corresponding drug treatment names can be found in tab 2 and in the main paper itself. The final html file is a report used to define the various study populations, including  the enrolled (pop_enr..., A multi-laboratory preclinical trial to assess treatment candidates for acute ischemic stroke
---

All data needed for the graphs published in Science Translational Medicine are provided.

## Description of the data and file structure

Tables contain the results of the corner test, the MR imaging organized by subject ID. Treatment group data is available in the feasibility file. These are contained in the following files:

dt\_feasibility\_stm\_paper\_2023-08-21.xls
dt\_outcome\_corner\_stm\_paper\_2023-08-21.xls
dt\_outcome\_mri\_stm\_paper 2023-08-21.xls
report\_stm\_paper\_2023-07-29.html

The first 3 files are Excel files that contain data listings in tab 1 and data definition dictionay in tab 2. The treatment group variables can be found in the first file and applied to the remaining files by matching on the animal identity variable 'enro\_animal\_id'. The variable 'txas\_tx\_group' contains a code that gives the treatment group to which the subject was assigned. The variable 'txas...