Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/17831
Title: Standard of care in immunotherapy trials: Challenges and considerations.
Authors: Rivalland, Gareth;Scott, Andrew M;John, Thomas
Affiliation: Department of Medical Oncology, Austin Health, Olivia-Newton John Cancer and Wellness Research Centre, Heidelberg, Victoria, Australia
University of Melbourne, Victoria, Australia
The Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia
School of Cancer Medicine, La Trobe University, Victoria, Australia
Issue Date: 2-Sep-2017
EDate: 2017-03-01
Citation: Human vaccines & immunotherapeutics 2017; 13(9): 2164-2178
Abstract: The success of immunotherapeutics over the past decade has fundamentally altered the therapeutic landscape in melanoma and non-small cell lung (NSCLC) cancer care. Multiple clinical trials have confirmed significant improvements in survival with a variety of immunotherapeutic strategies. The careful and appropriate selection of standard of care (SOC) therapies is key to the successful design and interpretation of these trials. To date immunotherapeutic trials have used best supportive care, matched placebo, chemotherapy, targeted therapy or, more recently, established immunotherapeutics in melanoma clinical trials as SOCs. Each of these SOC choices has a fundamental impact on the selection and validity of response assessment criteria and clinical endpoints. As yet there is no established approach, thus new data must be interpreted with an understanding of the limitations of the current paradigm. Additionally, the pace of development has mandated the use of novel clinical trial designs, answering multiple therapeutic questions simultaneously and designed to expedite regulatory approval. This review addresses the most important challenges in the selection of SOC in immunotherapeutic trials and the current and future challenges in trial design.
URI: http://ahro.austin.org.au/austinjspui/handle/1/17831
DOI: 10.1080/21645515.2016.1277845
ORCID: 0000-0002-6656-295X
PubMed URL: 28267397
Type: Journal Article
Review
Subjects: clinical trial design
immune-related response
immunotherapy
immunotherapy trials
standard of care
Appears in Collections:Journal articles

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