Developing Protocols [Spirit-Pro]

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

The paper Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension recommends best practices for writing the PRO aspects of randomized controlled trial protocols by specifying the items that are critical to address when PROs are primary or key secondary outcomes.

The SPIRIT-PRO Extension builds on the general 2013 SPIRIT clinical trial protocols guidance by addressing the minimum elements related to PROs that should be included.

In addition to the SPIRIT-PRO Extension,  guidance documents from the U.S. Food & Drug Administration (here) and European Medicines Agency (here and here) provide their perspectives on the use of PROMs for regulatory submissions.

SPIRIT-PRO Benefits

Using SPIRIT-PRO guidance provides benefits to stakeholders by: