Reporting of Participant Diversity in Global Rehabilitation Clinical Trials Reveals Inequities, Lack of Standardization

Ensuring diversity in clinical research is crucial since treatments can work differently in various patient groups, such as older or pregnant people and individuals with disabilities or medical co-morbidities. Julie K. Silver, MD, of the Department of Physical Medicine and Rehabilitation based at Spaulding Rehabilitation Hospital, and colleagues, have published six papers studying inclusion in clinical trials for vaccines, blood transfusions, rehabilitation and more by studying patient characteristics using ClinicalTrials.gov, the registry for United States clinical trials.

A new paper, published by first author Danielle L. Sarno, MD, of Brigham and Women’s Hospital’s Department of Neurosurgery, explored global registries. Sarno worked on the paper with Silver as well as colleagues from Mass General Brigham and other collaborating institutions. They found that there is a lack of standardized guidelines for reporting results from clinical research in global registries.

In this study, researchers systematically characterized patient sex, age, race, and ethnicity in clinical trials for rehabilitation studies across the world. They searched the registries for studies with available results about physical medicine and rehabilitation diagnoses, interventions, and primary outcomes. A total of 93 studies from eight global registries were included. Sex was reported in 61.3 percent of trials, and participation of women ranged from 0 to 75 percent. Information about race and ethnicity was absent in most registries. Six registries did not include information about age, and reporting of age was not uniform across trials. Of note, there was variable inclusion of older adults.

Limitations included heterogeneity of how results were reported in the registries as well as variations in race and ethnicity classifications in different countries. However, these limitations further validate the authors’ conclusion. The authors recommend policies to foster greater inclusion of underrepresented groups like women, older patients, and racial and ethnic minority individuals in rehabilitation clinical trials and beyond.

“The uniform reporting of clinical research results is an important component of advancing rehabilitation science and health equity,” said Sarno. “As the population becomes more diverse and ages, we must have inclusion of various groups in clinical trials. Our work has the potential to support important global registry and policy changes.”