Enhancing Reproducibility in Drug Development Research

January 11th, 2024,
Abstract image evoking drug development research

In a recent feature in the Journal of Clinical Investigation, Tim Errington, the Director of Research at the Center for Open Science, delves into the pressing necessity for enhancing replicability in preclinical research, with a specific focus on the drug-development pipeline. His article, titled "Building Reproducible Bridges to Cross the 'Valley of Death’," sheds light on the significant failure rate encountered when translating promising preclinical discoveries into human trials, commonly referred to as the "valley of death”.

Errington identifies key challenges, including inadequate replicability, lack of transparency, and misalignment between preclinical and clinical phases. This contribution is pivotal in discussions about bolstering the credibility of preclinical research for healthcare advancements.

Highlighting a 90% failure rate for drugs progressing from phase 1 trials to final approval, Errington emphasizes the urgent need to address translational gaps. He advocates for a proactive stance in identifying failures earlier in the drug-development pipeline, especially in the preclinical stage.

"Research is cumulative. New investigations build on, challenge, or qualify claims based on prior evidence," notes Errington. "This self-corrective process is a hallmark of research."

Errington advocates for the need for a robust foundation of credible evidence to accelerate discovery, necessitating a proactive approach to identify and rectify failures in the drug-development pipeline.

The article outlines strategies to enhance replicability, focusing on improved research methods, heightened transparency, and structured phases requiring successful replications before progression. Errington calls for a comprehensive reassessment and innovative approaches to ensure the translation of discoveries into viable healthcare solutions.

Addressing replicability challenges reveals a 90% failure rate for drugs passing from phase 1 trials to final approval. The "valley of death" represents the lack of translation from promising preclinical findings to success in human trials. Errington highlights reasons for this failure rate, including challenges in translating models to humans and friction in goals and incentives between preclinical and clinical phases.

Errington stresses the importance of addressing replicability challenges, considering factors like small sample sizes, lack of blinding, reagent quality control issues, and transparency. Despite improvements in standards, transparency hurdles persist in preclinical studies.

Errington notes, "No single finding provides definitive evidence; inherently, we need multiple lines of evidence." 

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