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Creating a pragmatic trials program for breast cancer patients: Rethinking Clinical Trials (REaCT)

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Abstract

Background

The proportion of breast cancer patients enrolled in clinical trials is falling. The Rethinking Clinical Trials (REaCT) program was developed to challenge some of the contemporary barriers responsible for this fall in accrual. In this article, we review the successes and challenges our program has faced.

Methods

The REaCT program was created to improve care and outcomes for cancer patients through surveys of patients and healthcare providers, systematic reviews, economic evaluations, and the performance of pragmatic randomized trials with patient-centered outcomes. Likely, the greatest difference to conventional trial methodologies has been our widespread use of the integrated consent model (ICM) incorporating oral consent.

Results

Between 2014 and 2018, the program has recruited over 2000 patients to 15 randomized studies at 11 Canadian cancer centers. The REaCT program has completed and published five patient surveys, six healthcare provider surveys, ten systematic reviews, performed four economic evaluations, opened 15 clinical trials comparing standard of care interventions (two surgical, two adjuvant chemotherapy, five adjuvant supportive care, one radiology, two vascular devices, two palliative supportive care, and one molecular diagnostics). Patient surveys have shown high levels of satisfaction with the ICM.

Conclusion

The REaCT program was developed to tackle important practice questions that will better guide optimal practice and to increase the availability of pragmatic clinical trials. While many challenges remain, future strategies will involve including more study sites and efforts to integrate novel information technology strategies.

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Funding

We would like to acknowledge the funding support from the Canadian Cancer Society Research Institute grant funding (ILIAD trial, Dr. Mark Clemons); the Canadian Institutes of Health Research—Strategy for Patient-Oriented Research grant funding (Dr. Dean Fergusson); the Cancer Care Ontario through funding provided by the Government of Ontario—Clinical Program and Quality Initiatives grant funding (REaCT Program, 2017 and 2018, Dr Clemons); and donations to The Ottawa Hospital Foundation in support of the REaCT Program. Funding and operational support was made available through the Canadian Cancer Clinical Trials Network (3CTN) that continues to foster the capability for conducting multicenter academic clinical trials at cancer centers across Canada.

Author information

Authors and Affiliations

  1. Division of Medical Oncology, The Ottawa Hospital Cancer Centre, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada

    Bassam Basulaiman, Arif Ali Awan, John Hilton & Mark Clemons

  2. Department of Medicine, University of Ottawa, Ottawa, Canada

    Bassam Basulaiman, Arif Ali Awan, Dean Fergusson, John Hilton, Brian Hutton & Mark Clemons

  3. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada

    Dean Fergusson, Angel Arnaout, Brian Hutton, Kednapa Thavorn & Mark Clemons

  4. Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada

    Lisa Vandermeer, Angel Arnaout, Carol Stober, Marta Sienkiewicz & Mark Clemons

  5. Department of Surgery, The Ottawa Hospital and the University of Ottawa, Ottawa, Canada

    Angel Arnaout

  6. Department of Oncology, Division of Medical Oncology, Cross Cancer Institute, University of Alberta, Edmonton, Canada

    Anil Abraham Joy

  7. Department of Oncology, Division of Medical Oncology, Queen’s University, Kingston, Canada

    Andrew Robinson

  8. Grand River Regional Cancer Centre, Kitchener, Canada

    Nadia Califaretti

Authors
  1. Bassam Basulaiman
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  2. Arif Ali Awan
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  6. John Hilton
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  7. Brian Hutton
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  8. Anil Abraham Joy
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  9. Andrew Robinson
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  10. Nadia Califaretti
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  11. Carol Stober
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  12. Marta Sienkiewicz
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  13. Kednapa Thavorn
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  14. Mark Clemons
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Corresponding author

Correspondence to Mark Clemons.

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Conflict of interest

Dr. Awan reports participating in the Novartis Canada Advisory Board on the use of Ribociclib. Dr. Hutton reports personal fees from Cornerstone Research, outside the submitted work. The remaining authors declare that they have no conflicts of interest to disclose (Basulaiman, Fergusson, Vandermeer, Arnaout, Hilton, Joy, Robinson, Califaretti, Stober, Sienkiewicz, Thavorn, and Clemons).

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Basulaiman, B., Awan, A.A., Fergusson, D. et al. Creating a pragmatic trials program for breast cancer patients: Rethinking Clinical Trials (REaCT). Breast Cancer Res Treat 177, 93–101 (2019). https://doi.org/10.1007/s10549-019-05274-0

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  • DOI: https://doi.org/10.1007/s10549-019-05274-0

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