Rebecca Mercieca-Bebber, PhD
NHMRC Clinical Trials Centre
The University of Sydney

Clinical trials are increasingly being listed on trial registries, allowing patients and stakeholders to search for relevant trials to participate in, and to keep informed of research activities and medical advances that may impact clinical practice. A review of the registry (largely based in North America) between 2007 and 2013 found that 27% of registered clinical trials included a patient-reported outcome (PRO). The ISOQOL Australian New Zealand Special Interest Group (ANZ SIG) was inspired to search The Australia New Zealand Clinical Trial Registry (ANZCTR), to describe PRO research activity in the ANZ region, noting that the ANZCTR and registries have a small overlap of approximately 1.9%.

We found that the use of PROs increased over time in ANZ, which suggests growing recognition of the importance of PROs in the comprehensive assessment of patient outcomes.

Key findings:

  1. Of 13,666 trials registered on the ANZCTR database, 6,168 (45.1%) included at least one PRO endpoint.
  2. There were nearly 18,000 individual PRO endpoints in total across the 6,168 trials. Of these PRO endpoints, the PRO was the primary endpoint 26.3% of the time.

The three condition categories with the highest proportion of trials including PROs were mental health (99.8% of mental health trials included PROs), stroke (83.7%) and physical medicine/rehabilitation (65.6%). A total of 54.2% of cancer trials included a PRO.

We also found that more trials were including PRO endpoints over time. Trials with PROs were recruiting from 95 unique countries.

The majority of PRO endpoints were evaluating patient-reported symptoms, functional outcomes or condition-specific QOL (65.6%). Generic QOL (13.2%), patient-reported experiences (9.9%), and self-reported behaviour (7.9%) outcomes were the next most common types of PROs assessed.

Our findings suggest a high level of PRO research activity within ANZ overall, particularly when compared to the review of (27.2% of all trials registered on between 2007 and 2013 included a PRO, compared to 43.4% of trials registered on ANZCTR in the same period).

See our references in the full journal article here.

This research was conducted by the International Society for Quality of Life Research (ISOQOL) ANZ SIG. The manuscript was endorsed by the ISOQOL Board of Directors as an ISOQOL publication and does not reflect an endorsement of the ISOQOL membership.

This newsletter editorial represents the views of the author and does not necessarily reflect the views of ISOQOL. 

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