. 2024 Dec 19;22:171. doi: 10.1186/s12961-024-01270-z

Table 2.

Major themes and sub-themes arising from interviews

Interview topic	Themes ▪ Sub-themes
Education and training	Variation in clinical trial training received with GCP the minimum standard. ▪ On-the-job training was reported to be the most common form of training. ▪ Learning environment for training depended on types of trials and the people in the environment. ▪ GCP training and study protocol training were reported to be the minimum standard training required for site trial staff.
Clinical trial training is relative to clinical trial activity, and thus limited in RRR. ▪ RRR health services without active trials did not have exposure to or need for staff training. ▪ More sharing of knowledge, mentoring and training is needed in RRR health services where clinical trial activity is developing.
Workforce	Trial workforce challenges are complex, persistent and across the board. ▪ Competitive funding models contributes to insecure and fractional work for trial staff. ▪ Lack of professional recognition and career progression affects the attraction and retention of clinical trial staff. ▪ Clinician researchers feel under-supported due to increasing clinical workloads and lack of protected and remunerated research time. ▪ More support is needed to stabilize the clinical trial workforce.
Unique workforce challenges in RRR health services exist alongside an appetite for trials. ▪ Low to no clinical trial workforce in RRR health services with variation across departments. ▪ Severe workforce shortages risks destabilizing clinical trial capacity in RRR health services. ▪ Call for trial staff to be consolidated across whole of RRR health services. ▪ RRR clinicians reported being passionate about providing their patients access to a clinical trial.
Equipment and services	Metropolitan sites generally have access to more resources to conduct clinical trials. ▪ Well-established health services that have a partnership with research institutes are better resourced to run clinical trials. ▪ Unpartnered health services or siloed research groups are likely to face challenges of sharing equipment and services with routine clinical care. ▪ Unexplored issues with clinical trial digital infrastructure.
By contrast, RRR health services are insufficiently resourced for clinical trials. ▪ Lack of physical space, specialized services and capacity of services limited clinical trial capacity in RRR health services. The degree of limitation increased with remoteness. ▪ Regional university infrastructure might provide opportunity for providing space.
Clinical trial sites	An enabling culture, capacity and system is essential to running a successful site. ▪ Well-established clinical trial units are currently funded by a combination of grants and commercial sponsored funding. ▪ Understanding clinical trial business is important for all health services wanting a sustainable and financially stable trial site. ▪ Research culture of the health service is essential to a productive and sustainable clinical trial site. ▪ Investment, engagement and support by executives/directors that aligns with a well-considered research strategy is needed.
Highly variable clinical trial capacity and capability across RRR regions. ▪ Low to no levels of clinical trial activity outside capital cities, particularly in NT, WA, SA and TAS. ▪ Frustration felt by RRR clinicians who are not able to provide trials to their patients due to lack of site capacity. ▪ Growing optimism and momentum for more equitable access to clinical trials at RRR sites.
Participant recruitment	Always challenging, but work is being done to break down the barriers. ▪ Streamlined and efficient processes to identify, recruit and involve participants is important to successful recruitment. ▪ General challenges to recruitment include participant burden, strict criteria, attitudes towards trials and language and cultural barriers. ▪ Thorough consumer engagement, careful protocol planning, monitoring risks and adapting when needed were identified as key elements to prevent recruitment challenges.
Unique challenges in RRR health services but retention might be better than metropolitan sites. ▪ RRR clinical trial participants travel vast distances to take part. ▪ Clinical trial participation of RRR patients in cities is impractical and disruptive to care. ▪ Recruitment and retention of participants in RRR areas might be equivalent or better than cities. ▪ Cultural factors need to be taken into consideration.
Clinical trial approval processes	The approval process is long and variable across Australia. ▪ Significant reforms underway in Australia at state and national levels that aim to improve the capacity and capability of health services to conduct high-quality clinical trials. ▪ Variation in research governance approval process between health services and across jurisdictions. ▪ Long delays are reported throughout the research governance process. ▪ Conflicting expectations between health service research governance and clinician researchers.
Lack of clinical trial maturity is an additional challenge for RRR health services. ▪ Potential for ATM to support RRR health services.

Interview topic

Themes
▪ Sub-themes

Education and training

Variation in clinical trial training received with GCP the minimum standard.

▪ On-the-job training was reported to be the most common form of training.

▪ Learning environment for training depended on types of trials and the people in the environment.

▪ GCP training and study protocol training were reported to be the minimum standard training required for site trial staff.

Clinical trial training is relative to clinical trial activity, and thus limited in RRR.

▪ RRR health services without active trials did not have exposure to or need for staff training.

▪ More sharing of knowledge, mentoring and training is needed in RRR health services where clinical trial activity is developing.

Workforce

Trial workforce challenges are complex, persistent and across the board.

▪ Competitive funding models contributes to insecure and fractional work for trial staff.

▪ Lack of professional recognition and career progression affects the attraction and retention of clinical trial staff.

▪ Clinician researchers feel under-supported due to increasing clinical workloads and lack of protected and remunerated research time.

▪ More support is needed to stabilize the clinical trial workforce.

Unique workforce challenges in RRR health services exist alongside an appetite for trials.

▪ Low to no clinical trial workforce in RRR health services with variation across departments.

▪ Severe workforce shortages risks destabilizing clinical trial capacity in RRR health services.

▪ Call for trial staff to be consolidated across whole of RRR health services.

▪ RRR clinicians reported being passionate about providing their patients access to a clinical trial.

Equipment and services

Metropolitan sites generally have access to more resources to conduct clinical trials.

▪ Well-established health services that have a partnership with research institutes are better resourced to run clinical trials.

▪ Unpartnered health services or siloed research groups are likely to face challenges of sharing equipment and services with routine clinical care.

▪ Unexplored issues with clinical trial digital infrastructure.

By contrast, RRR health services are insufficiently resourced for clinical trials.

▪ Lack of physical space, specialized services and capacity of services limited clinical trial capacity in RRR health services. The degree of limitation increased with remoteness.

▪ Regional university infrastructure might provide opportunity for providing space.

Clinical trial sites

An enabling culture, capacity and system is essential to running a successful site.

▪ Well-established clinical trial units are currently funded by a combination of grants and commercial sponsored funding.

▪ Understanding clinical trial business is important for all health services wanting a sustainable and financially stable trial site.

▪ Research culture of the health service is essential to a productive and sustainable clinical trial site.

▪ Investment, engagement and support by executives/directors that aligns with a well-considered research strategy is needed.

Highly variable clinical trial capacity and capability across RRR regions.

▪ Low to no levels of clinical trial activity outside capital cities, particularly in NT, WA, SA and TAS.

▪ Frustration felt by RRR clinicians who are not able to provide trials to their patients due to lack of site capacity.

▪ Growing optimism and momentum for more equitable access to clinical trials at RRR sites.

Participant recruitment

Always challenging, but work is being done to break down the barriers.

▪ Streamlined and efficient processes to identify, recruit and involve participants is important to successful recruitment.

▪ General challenges to recruitment include participant burden, strict criteria, attitudes towards trials and language and cultural barriers.

▪ Thorough consumer engagement, careful protocol planning, monitoring risks and adapting when needed were identified as key elements to prevent recruitment challenges.

Unique challenges in RRR health services but retention might be better than metropolitan sites.

▪ RRR clinical trial participants travel vast distances to take part.

▪ Clinical trial participation of RRR patients in cities is impractical and disruptive to care.

▪ Recruitment and retention of participants in RRR areas might be equivalent or better than cities.

▪ Cultural factors need to be taken into consideration.

Clinical trial approval processes

The approval process is long and variable across Australia.

▪ Significant reforms underway in Australia at state and national levels that aim to improve the capacity and capability of health services to conduct high-quality clinical trials.

▪ Variation in research governance approval process between health services and across jurisdictions.

▪ Long delays are reported throughout the research governance process.

▪ Conflicting expectations between health service research governance and clinician researchers.

Lack of clinical trial maturity is an additional challenge for RRR health services.

▪ Potential for ATM to support RRR health services.

GCP, Good Clinical Practice; NT, Northern Territory; WA, West Australia; SA, South Australia; TAS, Tasmania