Is Clinical Research Serving the Needs of the Global Cancer Burden? An Analysis of Contemporary Global Radiation Therapy Randomized Controlled Trials

Joanna Dodkins; Wilma M. Hopman; John Connor Wells; Yolande Lievens; R. A. Malik; C. S. Pramesh; Bishal Gyawali; Nazik Hammad; Deborah Mukherji; Richard Sullivan; Jeannette Parkes; Christopher M. Booth; Ajay Aggarwal

doi:10.1016/j.ijrobp.2022.01.053

Is Clinical Research Serving the Needs of the Global Cancer Burden? An Analysis of Contemporary Global Radiation Therapy Randomized Controlled Trials

Joanna Dodkins^*, Wilma M. Hopman, John Connor Wells, Yolande Lievens, R. A. Malik, C. S. Pramesh, Bishal Gyawali, Nazik Hammad, Deborah Mukherji, Richard Sullivan, Jeannette Parkes, Christopher M. Booth, Ajay Aggarwal

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

14 Citations (Scopus)

Abstract

Purpose: Randomized controlled trials (RCTs) are the cornerstone of delivering sustained improvements in cancer outcome. To inform radiation therapy research policy and prioritization, we analyze the radiation therapy RCT landscape including comparison with trials of systemic therapies over the same period, with a specific focus on funding and disparities across income settings. Methods and Materials: This retrospective cohort study identified all phase 3 RCTs evaluating anticancer therapies published from 2014 to 2017. RCTs were classified according to anticancer modality and country of origin. Descriptive statistics were used to compare key characteristics of radiation therapy RCT studies according to study design characteristics, tumor types evaluated, types of intervention appraised, treatment intent and main funding sources. Results: The study cohort included 694 RCTs of which 64 were radiation therapy RCTs (9%) compared with 601 systemic therapy RCTs (87%). Among all radiation therapy RCTs, 47% of them focused on 2 areas of evaluation: (1) combining radiation therapy with systemic agents (25%) and (2) changes in dose fractionation (22%). The most common cancers studied were head and neck (22%), lung (22%), and breast (14%), with cervical cancer trials representing only 3% of the cohort. Among the radiation therapy RCTs, 33% of them met their primary endpoint, and 62% assessed interventions in the curative setting compared with 31% in systemic therapy RCTs. For their country locations, 77% of radiation therapy RCTs took place in high-income countries, 13% in low-and-middle-income countries, and 11% in both high-income and low-and-middle-income countries. For funding, 17% of radiation therapy RCTs received funding from industry compared with 79% of systemic therapy RCTs. Conclusions: This study highlights the need for greater investment in radiation therapy RCTs and the need to look at the disparities in conducting RCTs globally. The study emphases the urgent need for more capacity building for cancer clinical trials in low-and-middle-income countries and more sustainable funding sources.

Original language	English
Pages (from-to)	500-508
Number of pages	9
Journal	International Journal of Radiation Oncology Biology Physics
Volume	113
Issue number	3
DOIs	https://doi.org/10.1016/j.ijrobp.2022.01.053
Publication status	Published - 1 Jul 2022

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10.1016/j.ijrobp.2022.01.053

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Dodkins, J., Hopman, W. M., Wells, J. C., Lievens, Y., Malik, R. A., Pramesh, C. S., Gyawali, B., Hammad, N., Mukherji, D., Sullivan, R., Parkes, J., Booth, C. M., & Aggarwal, A. (2022). Is Clinical Research Serving the Needs of the Global Cancer Burden? An Analysis of Contemporary Global Radiation Therapy Randomized Controlled Trials. International Journal of Radiation Oncology Biology Physics, 113(3), 500-508. https://doi.org/10.1016/j.ijrobp.2022.01.053

@article{3f2674b4c7414ed7af5fbc5f06fb3e0f,

title = "Is Clinical Research Serving the Needs of the Global Cancer Burden? An Analysis of Contemporary Global Radiation Therapy Randomized Controlled Trials",

abstract = "Purpose: Randomized controlled trials (RCTs) are the cornerstone of delivering sustained improvements in cancer outcome. To inform radiation therapy research policy and prioritization, we analyze the radiation therapy RCT landscape including comparison with trials of systemic therapies over the same period, with a specific focus on funding and disparities across income settings. Methods and Materials: This retrospective cohort study identified all phase 3 RCTs evaluating anticancer therapies published from 2014 to 2017. RCTs were classified according to anticancer modality and country of origin. Descriptive statistics were used to compare key characteristics of radiation therapy RCT studies according to study design characteristics, tumor types evaluated, types of intervention appraised, treatment intent and main funding sources. Results: The study cohort included 694 RCTs of which 64 were radiation therapy RCTs (9%) compared with 601 systemic therapy RCTs (87%). Among all radiation therapy RCTs, 47% of them focused on 2 areas of evaluation: (1) combining radiation therapy with systemic agents (25%) and (2) changes in dose fractionation (22%). The most common cancers studied were head and neck (22%), lung (22%), and breast (14%), with cervical cancer trials representing only 3% of the cohort. Among the radiation therapy RCTs, 33% of them met their primary endpoint, and 62% assessed interventions in the curative setting compared with 31% in systemic therapy RCTs. For their country locations, 77% of radiation therapy RCTs took place in high-income countries, 13% in low-and-middle-income countries, and 11% in both high-income and low-and-middle-income countries. For funding, 17% of radiation therapy RCTs received funding from industry compared with 79% of systemic therapy RCTs. Conclusions: This study highlights the need for greater investment in radiation therapy RCTs and the need to look at the disparities in conducting RCTs globally. The study emphases the urgent need for more capacity building for cancer clinical trials in low-and-middle-income countries and more sustainable funding sources.",

author = "Joanna Dodkins and Hopman, {Wilma M.} and Wells, {John Connor} and Yolande Lievens and Malik, {R. A.} and Pramesh, {C. S.} and Bishal Gyawali and Nazik Hammad and Deborah Mukherji and Richard Sullivan and Jeannette Parkes and Booth, {Christopher M.} and Ajay Aggarwal",

note = "Funding Information: Disclosures: R.M. has contracts with Astra Zeneca (L-MOCA study), Novartis (EPIK-O study), and Zeria Pharmaceutical Co, Ltd (Z-100 study). Y.L. is UGent Chair ESTRO Value-Based Radiation Oncology, member of the ESTRO Scientific Committee, and member of the EORTC Radiation Oncology Science Council. J.P. reports a Varian education grant (HREC 633/2020 SC) from University of Cape Town. D.M. reports payment from Astellas, Bayer, Merck Sharp and Dohme, Janssen, and Bristol Meyers Squibb. B.G. reports salary support from the Ontario Institute for Cancer Research as funded by the government of Ontario and support for his work in global oncology from the Conquer Cancer Foundation Global Oncology Young Investigator Award. A.A. reports financial support from National Institute for Health Research Advanced Fellowship (NIHR300599). C.B. is the Canada Research Chair in Population Cancer Care. Funding Information: Disclosures: R.M. has contracts with Astra Zeneca (L-MOCA study), Novartis (EPIK-O study), and Zeria Pharmaceutical Co, Ltd (Z-100 study). Y.L. is UGent Chair ESTRO Value-Based Radiation Oncology, member of the ESTRO Scientific Committee, and member of the EORTC Radiation Oncology Science Council. J.P. reports a Varian education grant (HREC 633/2020 SC) from University of Cape Town. D.M. reports payment from Astellas, Bayer, Merck Sharp and Dohme, Janssen, and Bristol Meyers Squibb. B.G. reports salary support from the Ontario Institute for Cancer Research as funded by the government of Ontario and support for his work in global oncology from the Conquer Cancer Foundation Global Oncology Young Investigator Award. A.A. reports financial support from National Institute for Health Research Advanced Fellowship (NIHR300599). C.B. is the Canada Research Chair in Population Cancer Care. Publisher Copyright: {\textcopyright} 2022 Elsevier Inc.",

year = "2022",

month = jul,

day = "1",

doi = "10.1016/j.ijrobp.2022.01.053",

language = "English",

volume = "113",

pages = "500--508",

journal = "International Journal of Radiation Oncology Biology Physics",

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Dodkins, J, Hopman, WM, Wells, JC, Lievens, Y, Malik, RA, Pramesh, CS, Gyawali, B, Hammad, N, Mukherji, D, Sullivan, R, Parkes, J, Booth, CM & Aggarwal, A 2022, 'Is Clinical Research Serving the Needs of the Global Cancer Burden? An Analysis of Contemporary Global Radiation Therapy Randomized Controlled Trials', International Journal of Radiation Oncology Biology Physics, vol. 113, no. 3, pp. 500-508. https://doi.org/10.1016/j.ijrobp.2022.01.053

Is Clinical Research Serving the Needs of the Global Cancer Burden? An Analysis of Contemporary Global Radiation Therapy Randomized Controlled Trials. / Dodkins, Joanna; Hopman, Wilma M.; Wells, John Connor et al.
In: International Journal of Radiation Oncology Biology Physics, Vol. 113, No. 3, 01.07.2022, p. 500-508.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Is Clinical Research Serving the Needs of the Global Cancer Burden? An Analysis of Contemporary Global Radiation Therapy Randomized Controlled Trials

AU - Dodkins, Joanna

AU - Hopman, Wilma M.

AU - Wells, John Connor

AU - Lievens, Yolande

AU - Malik, R. A.

AU - Pramesh, C. S.

AU - Gyawali, Bishal

AU - Hammad, Nazik

AU - Mukherji, Deborah

AU - Sullivan, Richard

AU - Parkes, Jeannette

AU - Booth, Christopher M.

AU - Aggarwal, Ajay

N1 - Funding Information: Disclosures: R.M. has contracts with Astra Zeneca (L-MOCA study), Novartis (EPIK-O study), and Zeria Pharmaceutical Co, Ltd (Z-100 study). Y.L. is UGent Chair ESTRO Value-Based Radiation Oncology, member of the ESTRO Scientific Committee, and member of the EORTC Radiation Oncology Science Council. J.P. reports a Varian education grant (HREC 633/2020 SC) from University of Cape Town. D.M. reports payment from Astellas, Bayer, Merck Sharp and Dohme, Janssen, and Bristol Meyers Squibb. B.G. reports salary support from the Ontario Institute for Cancer Research as funded by the government of Ontario and support for his work in global oncology from the Conquer Cancer Foundation Global Oncology Young Investigator Award. A.A. reports financial support from National Institute for Health Research Advanced Fellowship (NIHR300599). C.B. is the Canada Research Chair in Population Cancer Care. Funding Information: Disclosures: R.M. has contracts with Astra Zeneca (L-MOCA study), Novartis (EPIK-O study), and Zeria Pharmaceutical Co, Ltd (Z-100 study). Y.L. is UGent Chair ESTRO Value-Based Radiation Oncology, member of the ESTRO Scientific Committee, and member of the EORTC Radiation Oncology Science Council. J.P. reports a Varian education grant (HREC 633/2020 SC) from University of Cape Town. D.M. reports payment from Astellas, Bayer, Merck Sharp and Dohme, Janssen, and Bristol Meyers Squibb. B.G. reports salary support from the Ontario Institute for Cancer Research as funded by the government of Ontario and support for his work in global oncology from the Conquer Cancer Foundation Global Oncology Young Investigator Award. A.A. reports financial support from National Institute for Health Research Advanced Fellowship (NIHR300599). C.B. is the Canada Research Chair in Population Cancer Care. Publisher Copyright: © 2022 Elsevier Inc.

PY - 2022/7/1

Y1 - 2022/7/1

N2 - Purpose: Randomized controlled trials (RCTs) are the cornerstone of delivering sustained improvements in cancer outcome. To inform radiation therapy research policy and prioritization, we analyze the radiation therapy RCT landscape including comparison with trials of systemic therapies over the same period, with a specific focus on funding and disparities across income settings. Methods and Materials: This retrospective cohort study identified all phase 3 RCTs evaluating anticancer therapies published from 2014 to 2017. RCTs were classified according to anticancer modality and country of origin. Descriptive statistics were used to compare key characteristics of radiation therapy RCT studies according to study design characteristics, tumor types evaluated, types of intervention appraised, treatment intent and main funding sources. Results: The study cohort included 694 RCTs of which 64 were radiation therapy RCTs (9%) compared with 601 systemic therapy RCTs (87%). Among all radiation therapy RCTs, 47% of them focused on 2 areas of evaluation: (1) combining radiation therapy with systemic agents (25%) and (2) changes in dose fractionation (22%). The most common cancers studied were head and neck (22%), lung (22%), and breast (14%), with cervical cancer trials representing only 3% of the cohort. Among the radiation therapy RCTs, 33% of them met their primary endpoint, and 62% assessed interventions in the curative setting compared with 31% in systemic therapy RCTs. For their country locations, 77% of radiation therapy RCTs took place in high-income countries, 13% in low-and-middle-income countries, and 11% in both high-income and low-and-middle-income countries. For funding, 17% of radiation therapy RCTs received funding from industry compared with 79% of systemic therapy RCTs. Conclusions: This study highlights the need for greater investment in radiation therapy RCTs and the need to look at the disparities in conducting RCTs globally. The study emphases the urgent need for more capacity building for cancer clinical trials in low-and-middle-income countries and more sustainable funding sources.

AB - Purpose: Randomized controlled trials (RCTs) are the cornerstone of delivering sustained improvements in cancer outcome. To inform radiation therapy research policy and prioritization, we analyze the radiation therapy RCT landscape including comparison with trials of systemic therapies over the same period, with a specific focus on funding and disparities across income settings. Methods and Materials: This retrospective cohort study identified all phase 3 RCTs evaluating anticancer therapies published from 2014 to 2017. RCTs were classified according to anticancer modality and country of origin. Descriptive statistics were used to compare key characteristics of radiation therapy RCT studies according to study design characteristics, tumor types evaluated, types of intervention appraised, treatment intent and main funding sources. Results: The study cohort included 694 RCTs of which 64 were radiation therapy RCTs (9%) compared with 601 systemic therapy RCTs (87%). Among all radiation therapy RCTs, 47% of them focused on 2 areas of evaluation: (1) combining radiation therapy with systemic agents (25%) and (2) changes in dose fractionation (22%). The most common cancers studied were head and neck (22%), lung (22%), and breast (14%), with cervical cancer trials representing only 3% of the cohort. Among the radiation therapy RCTs, 33% of them met their primary endpoint, and 62% assessed interventions in the curative setting compared with 31% in systemic therapy RCTs. For their country locations, 77% of radiation therapy RCTs took place in high-income countries, 13% in low-and-middle-income countries, and 11% in both high-income and low-and-middle-income countries. For funding, 17% of radiation therapy RCTs received funding from industry compared with 79% of systemic therapy RCTs. Conclusions: This study highlights the need for greater investment in radiation therapy RCTs and the need to look at the disparities in conducting RCTs globally. The study emphases the urgent need for more capacity building for cancer clinical trials in low-and-middle-income countries and more sustainable funding sources.

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DO - 10.1016/j.ijrobp.2022.01.053

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JF - International Journal of Radiation Oncology Biology Physics

IS - 3

ER -

Is Clinical Research Serving the Needs of the Global Cancer Burden? An Analysis of Contemporary Global Radiation Therapy Randomized Controlled Trials

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