Decision impact studies, evidence of clinical utility for genomic assays in cancer: A scoping review

Parker, Gillian; Hunter, Sarah C.; Ghazi, Samer; Hayeems, Robin Z.; Rousseau, François; Miller, Fiona A.

doi:10.1371/journal.pone.0280582

Cited by 2 publications

(8 citation statements)

References 87 publications

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“…Publications for inclusion in our bibliometric and funding analyses were systematically identified using a search strategy developed for our previously conducted scoping review focused on decision impact studies in genomic medicine research [ 4 ] (see also S1 Appendix ). Four databases that were expected to return publications most relevant to decision impact studies in genomic medicine were searched: Medline, Embase, Scopus, and Web of Science (WoS).…”

Section: Methodsmentioning

confidence: 99%

“…Most of the prognostic multi-marker genomic tests commonly used today are proprietary products, meaning these tests have been conceived of and developed by private sector companies. Indeed, the top five genomic breast cancer prognostics are all proprietary products: Oncotype Dx (Genomic Health/ Exact Sciences), followed by Mammaprint (Agendia), Prosigna (Nanostring), Breast Cancer Index (Biothernostics) and Endopredict (Myriad) [ 4 ]. The top prognostic products in other cancer care are, as well, propriety products: Envisia (Veracyte) and Percepta (Veracyte) for lung cancer, and Decipher (Veracyte) for prostate cancer [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

“…Indeed, the top five genomic breast cancer prognostics are all proprietary products: Oncotype Dx (Genomic Health/ Exact Sciences), followed by Mammaprint (Agendia), Prosigna (Nanostring), Breast Cancer Index (Biothernostics) and Endopredict (Myriad) [ 4 ]. The top prognostic products in other cancer care are, as well, propriety products: Envisia (Veracyte) and Percepta (Veracyte) for lung cancer, and Decipher (Veracyte) for prostate cancer [ 4 ]. As these new health technologies enter the market, production of evidence demonstrating their utility in practice is key to supporting their integration in routine clinical practice and to obtaining coverage and reimbursement from private and public payors.…”

Section: Introductionmentioning

confidence: 99%

“…In recent years, a new type of study has been published in the field of genomic medicine research. Decision impact studies report on the impact of a genomic test on decision-making and other aspects of the test’s clinical utility [ 4 ]. Though new, decision impact studies have already been included as evidence in support of various international health technology assessments [ 5 – 8 ], and have been used in funding decisions for collectively financed health services.…”

Section: Introductionmentioning

confidence: 99%

“…While these studies have proliferated in genomic medicine, no synthesis or analysis of this new form of evidence had been generated. This gap in knowledge prompted us to conduct a scoping review of decision impact studies for genomic assays in cancer care to begin to understand and interrogate this new form of evidence [ 4 ]. The scoping review found that decision impact studies in genomic medicine report on a range of potential indicators of clinical utility, primarily for proprietary genomic tests.…”

Section: Introductionmentioning

confidence: 99%

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Industry involvement in evidence production for genomic medicine: A bibliometric and funding analysis of decision impact studies

Parker¹,

Hunter²,

Hogarth³

et al. 2023

PLoS ONE

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Background Decision impact studies have become increasingly prevalent in genomic medicine, particularly in cancer research. Such studies are designed to provide evidence of clinical utility for genomic tests by evaluating their impact on clinical decision-making. This paper offers insights into understanding of the origins and intentions of these studies through an analysis of the actors and institutions responsible for the production of this new type of evidence. Methods We conducted bibliometric and funding analyses of decision impact studies in genomic medicine research. We searched databases from inception to June 2022. The datasets used were primarily from Web of Science. Biblioshiny, additional R-based applications, and Microsoft Excel were used for publication, co-authorship and co-word analyses. Results 163 publications were included for the bibliometric analysis; a subset of 125 studies were included for the funding analysis. Included publications started in 2010 and increased steadily over time. Decision impact studies were primarily produced for proprietary genomic assays for use in cancer care. The author and affiliate analyses reveal that these studies were produced by ‘invisible colleges’ of researchers and industry actors with collaborations focused on producing evidence for proprietary assays. Most authors had an industry affiliation, and the majority of studies were funded by industry. While studies were conducted in 22 countries, the majority had at least one author from the USA. Discussion This study is a critical step in understanding the role of industry in the production of new types of research. Based on the data collected, we conclude that decision impact studies are industry-conceived and -produced evidence. The findings of this study demonstrate the depth of industry involvement and highlight a need for further research into the use of these studies in decision-making for coverage and reimbursement.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Industry involvement in evidence production for genomic medicine: A bibliometric and funding analysis of decision impact studies

Parker¹,

Hunter²,

Hogarth³

et al. 2023

PLoS ONE

View full text Add to dashboard Cite

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Heterogeneity in precision oncology

Tomasik,

Garbicz,

Braun

et al. 2023

Camb. prisms Precis. med.

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Precision oncology is a rapidly evolving concept that holds great promise in cancer treatment. However, a cancer complexity attributed to genomic and acquired tumour heterogeneity limits treatment effectiveness and increases toxicity. These limitations refer to both systemic therapies and radiotherapy, which are two mainstays of non-invasive cancer treatment. By understanding cancer heterogeneity and utilising advanced tools to personalise treatment strategies, precision oncology has the potential to revolutionise cancer care. In this article, we review the current status of precision oncology in solid tumours, specifically focusing on the impact of tumour heterogeneity and genomic patient features on systemic therapies and radiation. We also discuss the implementation of novel tools, such as next-generation sequencing and liquid biopsies, to overcome this problem.

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Decision impact studies, evidence of clinical utility for genomic assays in cancer: A scoping review

Cited by 2 publications

References 87 publications

Industry involvement in evidence production for genomic medicine: A bibliometric and funding analysis of decision impact studies

Industry involvement in evidence production for genomic medicine: A bibliometric and funding analysis of decision impact studies

Heterogeneity in precision oncology

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