Objectives <p>High-quality clinical research relies on the adequate recruitment of trial participants. The success of this underpins Evidence-Based Medicine. Trials participation is recommended however few patients have the opportunity to participate. The purpose of this study was to evaluate completed trials with the same sponsor to identify, define and evaluate various sponsor-led methods that can be applied to improve recruitment.</p> Methods <p>Building upon the Theories of Evidence-Based Medicine and Implementation Research, this study evaluated published data with the same Australian academic trial sponsor to identify, define and evaluate recruitment methods used in completed trials. Methods were ranked using a novel scale. Ethical and patient activation timeliness were considered. Data was extracted and tabulated (grouped, deidentified). Using descriptive statistics, a multi-disciplinary team synthesised and interpreted the data.</p> Results <p>Between 2008–2020, 56 trials sponsored by the Australian skin cancer network were screened; three studies met the criteria. We identified, described and ranked four recruitment methods (Trial design, Trial promotion, education and training, Site selection and feasibility, Trial resourcing and incentivization, supported by 27 specific initiatives). Timely ethics administration was shown to be important. Despite some methods being more effortful than others, all methods contributed patients. There are a number of study limitations.</p> Conclusions <p>Clinical trials are complex to run. Insufficient accrual is commonplace, including for Australian skin cancer trials. Four distinct recruitment methods with examples were identified. The results of this study may help trial sponsors and any other researcher to improve trial recruitment and completion, as well as patient outcomes.</p>

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Effectiveness of recruitment methods in cancer clinical trials: an Australian experience

  • Elizabeth J. Paton,
  • Anthony G. Shannon,
  • Gerald B. Fogarty

摘要

Objectives

High-quality clinical research relies on the adequate recruitment of trial participants. The success of this underpins Evidence-Based Medicine. Trials participation is recommended however few patients have the opportunity to participate. The purpose of this study was to evaluate completed trials with the same sponsor to identify, define and evaluate various sponsor-led methods that can be applied to improve recruitment.

Methods

Building upon the Theories of Evidence-Based Medicine and Implementation Research, this study evaluated published data with the same Australian academic trial sponsor to identify, define and evaluate recruitment methods used in completed trials. Methods were ranked using a novel scale. Ethical and patient activation timeliness were considered. Data was extracted and tabulated (grouped, deidentified). Using descriptive statistics, a multi-disciplinary team synthesised and interpreted the data.

Results

Between 2008–2020, 56 trials sponsored by the Australian skin cancer network were screened; three studies met the criteria. We identified, described and ranked four recruitment methods (Trial design, Trial promotion, education and training, Site selection and feasibility, Trial resourcing and incentivization, supported by 27 specific initiatives). Timely ethics administration was shown to be important. Despite some methods being more effortful than others, all methods contributed patients. There are a number of study limitations.

Conclusions

Clinical trials are complex to run. Insufficient accrual is commonplace, including for Australian skin cancer trials. Four distinct recruitment methods with examples were identified. The results of this study may help trial sponsors and any other researcher to improve trial recruitment and completion, as well as patient outcomes.