Facilitators and barriers to the clinical trial recruitment of older people: A qualitative study

Abstract

Older people are consistently under-represented or excluded from clinical trials investigating treatments for conditions that commonly affect them. The main objective of this thesis is to explore how accepted, socially constructed ‘truths’ about ageing and older people inform key stakeholders’ perspectives and subsequently affect clinical trial recruitment practices. Key stakeholders include researchers, ethics committee members and older people with and without trial experience. The thesis also reviews Australian and international clinical trial guidance relating to the inclusion of older participants and analyses Australian clinical trial protocols for criteria that may exclude older participants. Findings revealed that many stakeholders had absorbed common age stereotypes which influenced their assumptions and expectations about older people as clinical trial participants. There was a level of disinterest and lack of engagement with the issue of under-representation among some general researchers and ethics committee members. Researchers who work closely with older people were aware of and largely challenged negative assumptions and beliefs through recruitment approaches built on inclusivity and purposeful, targeted actions. Most older people constructed an identity that was not defined by age or age stereotypes. They wanted to contribute to the greater good and advance medical knowledge through trial participation, with many speaking against the homogenisation of older people and the inequitable exclusion of older trial participants. Analysis of clinical trial guidelines revealed that Australian guidance is out of step with similar countries in that they do not specifically address the issue of older people’s under-representation in clinical trials. Analysis of registered Australian trial protocols showed the use of upper age limits and exclusion criteria that are likely to disproportionately exclude older people from trial participation.