Improving and sustaining the site investigator community: Recommendations from the Clinical Trials Transformation Initiative

Fordyce, Christopher B.; Malone, Kaitlin; Forrest, Annemarie; Hinkley, Terri; Corneli, Amy; Topping, James; Roe, Matthew T.

doi:10.1016/j.conctc.2019.100462

Cited by 2 publications

(1 citation statement)

References 5 publications

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“…Different barriers for investigators to participate in CTs have been identified as institutional support, infrastructure issues, staff support, administrative burden, time requirements, workload balance, data and safety reporting requirements, and dissatisfaction with finance-related issues ( 58 – 61 ). Accordingly, to these identified barriers, the Clinical Trials Transformation Initiative (CTTI) Strengthening the Investigator Community Project ( 62 ) has developed some recommendations focused on reinforcement of four critical categories of site-based research activity: developing site-based research infrastructure and staff, optimizing trial execution and conduct, improving site budget development and contract negotiations, and discovering opportunities for conducting additional trials ( 58 , 63 ).…”

Section: Principal Investigatormentioning

confidence: 99%

Navigating the challenges of clinical trial professionals in the healthcare sector

Peralta,

Sánchez-Santiago

2024

Front. Med.

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Clinical trials (CTs) are essential for medical advancements but face significant challenges, particularly in professional training and role clarity. Principal investigators, clinical research coordinators (CRCs), nurses, clinical trial pharmacists, and monitors are key players. Each faces unique challenges, such as maintaining protocol compliance, managing investigational products, and ensuring data integrity. Clinical trials’ complexity and evolving nature demand specialized and ongoing training for these professionals. Addressing these challenges requires clear role delineation, continuous professional development, and supportive workplace environments to improve retention and trial outcomes. Enhanced training programs and a collaborative approach are essential for the successful conduct of clinical trials and the advancement of medical research.

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Section: Principal Investigatormentioning

confidence: 99%

Navigating the challenges of clinical trial professionals in the healthcare sector

Peralta,

Sánchez-Santiago

2024

Front. Med.

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Clinical researchers’ lived experiences with data quality monitoring in clinical trials: a qualitative study

Houston

Martin

et al. 2021

BMC Med Res Methodol

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Background Fundamental to the success of clinical research that involves human participants is the quality of the data that is generated. To ensure data quality, clinical trials must comply with the Good Clinical Practice guideline which recommends data monitoring. To date, the guideline is broad, requires technology for enforcement, follows strict industry standards, mostly designed for drug-registration trials and based on informal consensus. It is also unknown what challenges clinical trials and researchers face in implementing data monitoring procedures. Thus, this study aimed to describe researcher experiences with data quality monitoring in clinical trials. Methods We conducted semi-structured telephone interviews following a guided-phenomenological approach. Participants were recruited from the Australian and New Zealand Clinical Trials Registry and were researchers affiliated with a listed clinical study. Each transcript was analysed with inductive thematic analysis before thematic categorisation of themes from all transcripts. Primary, secondary and subthemes were categorised according to the emerging relationships. Results Data saturation were reached after interviewing seven participants. Five primary themes, two secondary themes and 21 subthemes in relation to data quality monitoring emerged from the data. The five primary themes included: education and training, ways of working, working with technology, working with data, and working within regulatory requirements. The primary theme ‘education and training’ influenced the other four primary themes. While ‘working with technology’ influenced the ‘way of working’. All other themes had reciprocal relationships. There was no relationship reported between ‘working within regulatory requirements’ and ‘working with technology’. The researchers experienced challenges in meeting regulatory requirements, using technology and fostering working relationships for data quality monitoring. Conclusion Clinical trials implemented a variety of data quality monitoring procedures tailored to their situation and study context. Standardised frameworks that are accessible to all types of clinical trials are needed with an emphasis on education and training.

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Improving and sustaining the site investigator community: Recommendations from the Clinical Trials Transformation Initiative

Cited by 2 publications

References 5 publications

Navigating the challenges of clinical trial professionals in the healthcare sector

Navigating the challenges of clinical trial professionals in the healthcare sector

Clinical researchers’ lived experiences with data quality monitoring in clinical trials: a qualitative study

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