Perspectives on inclusion, diversity, equity, and access in clinical trials: findings from a 6-continent survey.

Abstract

Objective: Clinical trials require the inclusion of all relevant demographic groups, including under-represented populations, to ensure accurate and representative findings. The aim of the study was to assess the status quo of inclusion, diversity, equity, and access in clinical trials across various countries.

Methods: An 18-item online survey was developed and administered to 5 people. The questionnaire was distributed to delegates from gynecologic research groups in the Gynecologic Cancer Intergroup Network worldwide. All the analyses are purely descriptive.

Results: A total of 73 participants (86.3% physicians and 47.9% female) from 33 countries participated in the survey; 91.8% deemed the inclusion of under-represented groups in clinical trials important, and 91.2% supported increasing representation in phase III trials. Most participants believed that language barriers (68.7%) and restricted eligibility criteria (56.7%) were the main reasons for under-representation. Language barriers are seen as more significant in Africa and Europe than in Asia (83.3% and 75.0% vs 58.6%, respectively). Limited patient knowledge about clinical trials (73.1%) was also cited as a key issue. Only 20.5% reported having a minimal data set to document demographic groups. The most helpful measure was the provision of trial information in various languages (69.7%). Overall, women were more supportive of all the suggested improvement measures than were men.

Conclusions: There is a need for better strategies to improve diversity in clinical trials, focusing on overcoming language barriers and eligibility constraints.