Table 3.

The potential impact of eligibility criteria on the recruitment of underserved groups, according to NIHR-INCLUDE guidance

Underrepresented groups	Relevant criteria identified	Quotes from inclusion/exclusion criteria
Demographic factors
Age extremes (e.g. under 18 and over 75)	• 6/68 trials included participants under 18 • 2/68 trials excluded participants over 70
Social and economic factors
People living in remote areas	• One trial noted geographical location as a potential exclusion criterion	• “Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol”
People not fluent in the majority language	• Two trials discussed language as a potential barrier to completing quality of life questionnaires o One trial stipulated fluency for inclusion, and one did not	• “Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires” • “Has completed the health-related quality of life questionnaires or is unable to complete them because of literacy, insufficient English or limited vision”
Health status
Mental health conditions	• 10/68 trials explicitly exclude patients with psychiatric, social, or addiction disorders • 32/68 trials exclude patients with any condition the principal investigator deems incompatible with participation	• “Has a known psychiatric or substance abuse disorder” • “Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant’s safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator”
People who lack capacity to consent for themselves, or those with cognitive impairment	• 9/68 trials stated exclusion criteria for patients unable to provide informed consent • 3/68 trials allowed consent to be given by a caregiver or legal representative for those without capacity • 4/68 trials excluded patients without the cognitive ability to complete quality of life questionnaires • 4/68 trials using quality of life questionnaires did not stipulate cognitive ability as an inclusion criterion	• “Able to give informed consent, indicating the patient has been informed of and understands the experimental nature of the study” • “Must sign an informed consent form (or their legally acceptable representative must sign)” • “The capacity to understand the patient information sheet” • “Adequate cognitive ability to complete quality of life assessments” “Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol”
Pregnant women	• 47/68 trials excluded people who are pregnant or lactating	• “Female participants: must not be pregnant, not breastfeeding, and… agree to use a method of birth control from 30 days prior to randomization and for at least 120 days after the last dose of study treatment”
Too severely ill	• 53/68 trials excluded patients with a PS of >2
Disease-specific factors
Rare diseases and genetic disease subtypes	• 11/68 trials included patients based on their HPV or PD-L1 status, or presence of FGFR alterations
People in cancer trials with brain metastases	• 28/68 trials were in the metastatic setting o 21/28 excluded patients with active CNS metastases o 3/28 excluded patients with inactive CNS metastases o 4/28 did not specify that this group should be excluded