A team of researchers from the University of Birmingham and the University of Sydney developed new international guidelines for the inclusion of patient-reported outcomes in clinical trial protocols. The SPIRIT-PRO protocol checklist, which was recently published in the Journal of American Medical Association, was developed with the goal of providing high-quality evidence and enhancing patient care, Outsourcing-Pharma.com reports.1
The protocol checklist builds upon the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement published in 2013. The 33-item SPIRIT checklist applies to protocols for all clinical trials, focuses on content rather than format, and recommends a full description of what is planned but does not prescribe how to design or conduct a trial.2 The SPIRIT-PRO protocol checklist “provide[s] information that should be included in a clinical protocol when a patient-reported outcome (PRO) is a primary or key secondary outcome,” Professor Melanie Calvert, Director of the Center for Patient-Reported Outcomes Research (CPROR) at the University of Birmingham told Outsourcing-Pharma.com.1
The new guidelines include sixteen items specific to patient-reported outcomes. Calvert explained that these items focus on issues relating to trial rationale, objectives, eligibility criteria, time points for assessment, patient-reported outcomes instrument selection and measurement properties, data collection plans, translation, strategies to minimize missing data, and whether patient-reported outcomes data will be monitored during the study to inform clinical care.1
Calvert hopes that “endorsement and international implementation of the guidance will make a real difference to patients, providing high quality evidence on which to base decisions regarding their care.”1 Implementation of the new guidance is currently being discussed between the authors and various parties including regulatory agencies, ethics committees, patient groups, etc.
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