AlzPED is designed as a knowledge platform for the dissemination of data and analysis to scientists, from academic centers, industry, disease-focused foundations, in a manner that promotes efficiency, transparency, reproducibility and accuracy of research aimed at preclinical therapy development for AD. AlzPED provides quick access and visibility to integrated preclinical efficacy data from published and unpublished studies. This includes information on:
- AD Tg Models
- Study Design
- Therapeutic Targets
- Therapeutic Agents
- Outcome measures
- Related Clinical Studies
AlzPED provides Tg model and cross-Tg model information across relevant translational criteria data sets such as therapeutic agents, and targets. Additionally and most importantly, AlzPED is designed to help identify the critical data, design elements and methodology missing from studies; making them susceptible to misinterpretation, less likely to be reproduced and reducing their translational value. Through this function AlzPED is intended to influence the development and implementation of reproducibility strategies including guidelines for standardized best practices for the rigorous preclinical testing of AD candidate therapeutics.
One of the major challenges to the successful development of therapies for Alzheimer’s disease (AD) is the poor translation of preclinical efficacy from animal models to the clinic. A number of key factors have been identified as contributors to the unsuccessful translation of therapeutic efficacy, these include the failure of the models to fully recapitulate human AD, poor rigor study design and data analysis, insufficient attention given to using a standard set of “best practices”, failure to match outcome measures used in preclinical animal studies and clinical studies, poor reproducibility of published data and publication bias in favor of reporting positive findings. See Literature Supporting Reproducibility for further reading.
Path Toward Translation
To ameliorate some of the key factors contributing to the preclinical to clinical development gap in AD the National Institute on Aging (NIA) and the National Institutes of Health (NIH) Library have created a publically available data repository, Alzheimer’s Preclinical Efficacy Database, AlzPED. AlzPED is designed as a web-based portal for housing, sharing and mining of preclinical efficacy data. The data are submitted to AlzPED through a curator and gleaned from at least two sources; 1) the scientific literature; 2) directly from researchers. AlzPED houses information on preclinical studies including animal models descriptors, key elements of the study design, information related to the therapeutic target and therapeutic agent, principal findings and information related to funding source(s) and financial conflict of interest. The long term goal for AlzPED is to also serve as a platform for reporting unpublished studies in order to mitigate the publication bias that favors the reporting of positive findings.
Who Can Benefit
AlzPED will provide academic and industry researchers with a facile way to survey existing preclinical therapy development efforts, and raise their awareness about the elements of rigorous study design and requirements for transparent reporting. AlzPED will also enable information scientists to conduct systematic analyses of preclinical efficacy testing studies. Last, but not least this new data resource can be used by funding agencies as a tool for enforcement of requirements for transparent reporting and rigorous study design.
- Health Specialist, Translational Research Branch
- Health Specialist, Office for Strategic Development and Partnerships
- Program Director - Translational Bioinformatics in Drug Development
- Chief - Translational Research Branch, Project Scientist - Alzheimer’s Drug Development Program, MODEL-AD and TREAT-AD Consortia
- Director - Office for Strategic Development and Partnerships, Program Director - Systems Biology & Systems Pharmacology for Targets & Biomarkers Discovery
- Program Director - Alzheimer's Disease Drug Discovery & SBIR/STTR Program
- Scientific Program Manager, Project Manager - AlzPED