The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting,
and appraisal. However, trial protocols and existing protocol guidelines vary greatly in …

Summary The SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for
Interventional Trials) contains guidance for authors of protocols for randomized and …

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting,
and appraisal. However, trial protocols and existing protocol guidelines vary greatly in …

Importance Complete information in a trial protocol regarding study outcomes is crucial for
obtaining regulatory approvals, ensuring standardized trial conduct, reducing research …

High quality protocols facilitate proper conduct, reporting, and external review of clinical
trials. However, the completeness of trial protocols is often inadequate. To help improve the …

Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable
evidence to inform shared decision making, labeling claims, clinical guidelines, and health …

The protocol is an important document that details the background, methods, ethical
considerations, and administration of a clinical trial. 1 The information contained in the …

Background Recent evidence has highlighted deficiencies in clinical trial protocols, having
implications for many groups. Existing guidelines for randomized clinical trial (RCT) protocol …

Background All randomized clinical trials (RCTs) require a protocol; however, numerous
studies have highlighted protocol deficiencies. Reporting guidelines may improve the …

Background Qualitative evidence suggests patient-reported outcome (PRO) information is
frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data …