Find out how CTI can support the entire life cycle of your drug development project
Systematic literature reviews are conducted for a wide variety of purposes that support development through post market surveillance of a medication or device. At CTI, our team of experts frequently conduct literature reviews which provide the basis for drug development planning, clinical study design and have become a significant element of regulatory submissions, especially in rare diseases.
Background: A biotech company is seeking approval for a new treatment for a rare disease. The company is experiencing an evidence gap regarding the relationship between biomarker levels in adults with the rare disease and outcomes. The developer needs evidence to support their clinical trial endpoint (biomarker) with the FDA.
Ultimate Goal: To fill the evidence gap that lowering blood levels of the biomarker in individuals with the rare disease reduces the prevalence of symptoms.
A systematic literature review identified studies that linked the biomarker and symptoms. The studies supported the position that effecting blood levels of the biomarker correlated to symptom reduction. This evidence together with a review of the burden of illness of this rare disease made a compelling case for the new treatment. The results of the systematic review and meta-analysis have been incorporated into a FDA submission, accepted by the FDA, presented at a conference and published in a manuscript.