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Defining the role of real-world data in cancer clinical research : the position of the European Organisation for Research and Treatment of Cancer

Robbe Saesen, Mieke Van Hemelrijck, Jan Bogaerts, Christopher M. Booth, Jan J. Cornelissen, Andre Dekker, Elizabeth A. Eisenhauer, Andre Freitas, Alessandro Gronchi, Miguel A. Hernan, et al.
(2023) EUROPEAN JOURNAL OF CANCER. 186. p.52-61
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Abstract
The emergence of the precision medicine paradigm in oncology has led to in-creasing interest in the integration of real-world data (RWD) into cancer clinical research. As sources of real-world evidence (RWE), such data could potentially help address the un-certainties that surround the adoption of novel anticancer therapies into the clinic following their investigation in clinical trials. At present, RWE-generating studies which investigate antitumour interventions seem to primarily focus on collecting and analysing observational RWD, typically forgoing the use of randomisation despite its methodological benefits. This is appropriate in situations where randomised controlled trials (RCTs) are not feasible and non -randomised RWD analyses can offer valuable insights. Nevertheless, depending on how they are designed, RCTs have the potential to produce strong and actionable RWE themselves. The choice of which methodology to employ for RWD studies should be guided by the nature of the research question they are intended to answer. Here, we attempt to define some of the questions that do not necessarily require the conduct of RCTs. Moreover, we outline the strategy of the European Organisation for Research and Treatment of Cancer (EORTC) to contribute to the generation of robust and high-quality RWE by prioritising the execution of pragmatic trials and studies set up according to the trials-within-cohorts approach. If treat-ment allocation cannot be left up to random chance due to practical or ethical concerns, the EORTC will consider undertaking observational RWD research based on the target trial principle. New EORTC-sponsored RCTs may also feature concurrent prospective cohorts composed of off-trial patients.(c) 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Keywords
Oncology, Cancer, Clinical research, Add-on cohorts, Trials within cohorts, Cohort multiple randomised controlled trials, Pragmatic trials, Randomised controlled trials, Real-world evidence, Real-world data

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MLA
Saesen, Robbe, et al. “Defining the Role of Real-World Data in Cancer Clinical Research : The Position of the European Organisation for Research and Treatment of Cancer.” EUROPEAN JOURNAL OF CANCER, vol. 186, 2023, pp. 52–61, doi:10.1016/j.ejca.2023.03.013.
APA
Saesen, R., Van Hemelrijck, M., Bogaerts, J., Booth, C. M., Cornelissen, J. J., Dekker, A., … van der Graaf, W. T. (2023). Defining the role of real-world data in cancer clinical research : the position of the European Organisation for Research and Treatment of Cancer. EUROPEAN JOURNAL OF CANCER, 186, 52–61. https://doi.org/10.1016/j.ejca.2023.03.013
Chicago author-date
Saesen, Robbe, Mieke Van Hemelrijck, Jan Bogaerts, Christopher M. Booth, Jan J. Cornelissen, Andre Dekker, Elizabeth A. Eisenhauer, et al. 2023. “Defining the Role of Real-World Data in Cancer Clinical Research : The Position of the European Organisation for Research and Treatment of Cancer.” EUROPEAN JOURNAL OF CANCER 186: 52–61. https://doi.org/10.1016/j.ejca.2023.03.013.
Chicago author-date (all authors)
Saesen, Robbe, Mieke Van Hemelrijck, Jan Bogaerts, Christopher M. Booth, Jan J. Cornelissen, Andre Dekker, Elizabeth A. Eisenhauer, Andre Freitas, Alessandro Gronchi, Miguel A. Hernan, Frank Hulstaert, Piet Ost, Petr Szturz, Helena M. Verkooijen, Michael Weller, Roger Wilson, Denis Lacombe, and Winette T. van der Graaf. 2023. “Defining the Role of Real-World Data in Cancer Clinical Research : The Position of the European Organisation for Research and Treatment of Cancer.” EUROPEAN JOURNAL OF CANCER 186: 52–61. doi:10.1016/j.ejca.2023.03.013.
Vancouver
1.
Saesen R, Van Hemelrijck M, Bogaerts J, Booth CM, Cornelissen JJ, Dekker A, et al. Defining the role of real-world data in cancer clinical research : the position of the European Organisation for Research and Treatment of Cancer. EUROPEAN JOURNAL OF CANCER. 2023;186:52–61.
IEEE
[1]
R. Saesen et al., “Defining the role of real-world data in cancer clinical research : the position of the European Organisation for Research and Treatment of Cancer,” EUROPEAN JOURNAL OF CANCER, vol. 186, pp. 52–61, 2023.
@article{01HY0E617KJG2E862WD6PVJTV1,
  abstract     = {{The emergence of the precision medicine paradigm in oncology has led to in-creasing interest in the integration of real-world data (RWD) into cancer clinical research. As sources of real-world evidence (RWE), such data could potentially help address the un-certainties that surround the adoption of novel anticancer therapies into the clinic following their investigation in clinical trials. At present, RWE-generating studies which investigate antitumour interventions seem to primarily focus on collecting and analysing observational RWD, typically forgoing the use of randomisation despite its methodological benefits. This is appropriate in situations where randomised controlled trials (RCTs) are not feasible and non -randomised RWD analyses can offer valuable insights. Nevertheless, depending on how they are designed, RCTs have the potential to produce strong and actionable RWE themselves. The choice of which methodology to employ for RWD studies should be guided by the nature of the research question they are intended to answer. Here, we attempt to define some of the questions that do not necessarily require the conduct of RCTs. Moreover, we outline the strategy of the European Organisation for Research and Treatment of Cancer (EORTC) to contribute to the generation of robust and high-quality RWE by prioritising the execution of pragmatic trials and studies set up according to the trials-within-cohorts approach. If treat-ment allocation cannot be left up to random chance due to practical or ethical concerns, the EORTC will consider undertaking observational RWD research based on the target trial principle. New EORTC-sponsored RCTs may also feature concurrent prospective cohorts composed of off-trial patients.(c) 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).}},
  author       = {{Saesen, Robbe and  Van Hemelrijck, Mieke and  Bogaerts, Jan and  Booth, Christopher M. and  Cornelissen, Jan J. and  Dekker, Andre and  Eisenhauer, Elizabeth A. and  Freitas, Andre and  Gronchi, Alessandro and  Hernan, Miguel A. and  Hulstaert, Frank and Ost, Piet and  Szturz, Petr and  Verkooijen, Helena M. and  Weller, Michael and  Wilson, Roger and Lacombe, Denis and van der Graaf, Winette T.}},
  issn         = {{0959-8049}},
  journal      = {{EUROPEAN JOURNAL OF CANCER}},
  keywords     = {{Oncology,Cancer,Clinical research,Add-on cohorts,Trials within cohorts,Cohort multiple randomised controlled trials,Pragmatic trials,Randomised controlled trials,Real-world evidence,Real-world data}},
  language     = {{eng}},
  pages        = {{52--61}},
  title        = {{Defining the role of real-world data in cancer clinical research : the position of the European Organisation for Research and Treatment of Cancer}},
  url          = {{http://doi.org/10.1016/j.ejca.2023.03.013}},
  volume       = {{186}},
  year         = {{2023}},
}
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