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Designing Gene Therapy Study Protocols Based on Patient Burden Scores


Patient burden in clinical trials is especially impactful for those suffering from genetic conditions. For example, the rigors of gene therapy for patients with genetic conditions—especially compared to a number of other trials for conventional treatments—can extend studies for years and involve potentially hundreds of procedures over several dozen patient visits.  

This raises the question: Is it possible to quantify such burden and assess the impact it would have on patient recruitment and retention? If so, are there ways companies can change protocols to make a material difference to patients with an optimal trial, while remaining cognizant of the impact of each aspect of the trial on patient recruitment and retention? 

Read this article to learn how a proprietary decision aide can help drug developers assess and recommend ways to alleviate patient burden in clinical trial participation. 

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