Purpose
The use and value of screening methods for clinical trial participation is well reported in the literature1-5.
The South Western Sydney Radiation Oncology (RO) departments located at Liverpool and Campbelltown Hospitals have a long history of participation in collaborative and investigator initiated clinical trials.
Historically,
clinical trials screening and participation in clinical trials has been suboptimal.
This led to a change in the clinical trials team structure and development of processes to improve practices.
The aim of this study was to evaluate the impact of...
Methods and materials
In 2015,
a spreadsheet was developed to accurately record the number of screened patients per clinical trial and document reason(s) for ineligibility using a list of pre-defined reasons.
In the same year,
a Screening Assessment Tool was created in the oncology electronic medical record system,
MOSAIQ (Figure 1).
This tool was designed to be completed for all new patients seen in the Radiation Oncology clinic by clinicians,
to document patient’s eligibility for clinical trials.
In 2017,
a customised MOSAIQ report was developed to pre-screen patients...
Results
The number of patients screened and recruited to clinical trials has increased from 2015-2017 (Figures 2 & 3).
The reduction in recruitmentfrom 2016 to 2017 was due to a numberof high recruiting trials closing for recruitment.
Analysis of the screening reports showed that over a 12 month period,
an additional 140 patients were identified in the screening reports that otherwise would have been missed.
With increased frequency of screening,
the analysis showed that on average,
an additional 17 patients were identified for screening per week....
Conclusion
Pro-active screening processes have resulted in a large increase in the number of patients screened and recruited to clinical trials.
The collection of screening data gives us an insight in to reasons for non-eligibility which may need to be addressed to improve clinical trial participation in the future.
The MOSAIQ screening assessment tool needs to be evaluated to assess its value and improve user compliance.
Personal information
Mel Grand
Clinical Trials Manager,
Radiation Oncology
Ingham Institute for Applied Medical Research
South Western Sydney Radiation Oncology
Liverpool & Macarthur Cancer Therapy Centres
Email:
[email protected]
Phone: +61 2 8738 9181
References
Wilson C,
Rooshenas L,
Paramasivan S et al.
Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened,
Eligible,
Approached,
Randomised) framework.
Trials 2018:19:50
Chen L,
Grant J,
Cheung WY,
et al.
Screening intervention to identify eligible patients and improve accrual to phase ii-iv oncology clinical trials.J Oncol Pract.2013;9:e174–e181.
Denicoff AM,
McCaskill-Stevenns W,
Grubbs SS et al.
The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.
J Oncol Pract 2013 Nov;...