CHEST Guidelines-The-St.-George’s-Respiratory-Questionnaire-

The-St.-George’s-Respiratory-Questionnaire-

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The article focuses on the importance of incorporating the St. George’s Respiratory Questionnaire (SGRQ) into the FDA's draft guidance for Chronic Obstructive Pulmonary Disease (COPD), highlighting the challenges and advancements in qualifying new drug development tools (DDTs) for regulatory purposes. Despite rapid advancements in biological understanding and treatment development, particularly in oncology, many diseases like COPD suffer from outdated clinical assessment tools, slowing new drug development.<br /><br />Regulatory bodies like the FDA and the European Medicines Agency have established programs to address these challenges, but the process of qualifying new DDTs is complex, time-consuming, and expensive, often mirroring the effort required for new drug applications. Key stakeholders, including pharmaceutical companies, academics, and patient groups, play crucial roles in this collaborative process. The COPD Biomarker Qualification Consortium (CBQC), led by the COPD Foundation, exemplifies this collaboration by developing and qualifying DDTs for public use.<br /><br />The SGRQ's inclusion in regulatory guidance addresses previous uncertainties about its use as a clinical outcome assessment measure, specifically permitting its use as a co-primary outcome in COPD drug applications. While this marks progress, it is a small step, reflecting the slow nature of the regulatory process which has drawn criticism for resource constraints and backlog in qualifications. The article emphasizes the need for a more streamlined process, as further advances in DDT qualification could significantly impact public health by facilitating new treatments.<br /><br />The incorporation of the SGRQ into FDA guidance demonstrates a successful navigation of the qualification process and offers a foundation for future measures. Despite current challenges, including resource limitations, the authors express hope that legislative changes, such as the 21st Century Cures Act, could accelerate advancements in patient-focused drug development, ultimately reducing morbidity and mortality linked to conditions like COPD.

Keywords

St. George’s Respiratory Questionnaire

FDA guidance

Chronic Obstructive Pulmonary Disease

drug development tools

regulatory process

COPD Biomarker Qualification Consortium

clinical outcome assessment

21st Century Cures Act

pharmaceutical collaboration

patient-focused drug development