scholarly journals Bringing onco-innovation to Europe’s healthcare systems: the unexploited potential of biomarker testing, real world evidence and the potential of Tumour Agnostics. The lesson from BRCA1/2 genetic testing

2020 ◽  
Author(s):  
Denis Horgan ◽  
Gennaro CILIBERTO ◽  
Pierfranco Conte ◽  
Giuseppe CURIGLIANO ◽  
Luis Seijo ◽  
...  
Keyword(s):  
Health Systems ◽  
Real World ◽  
Universal Access ◽  
Personalised Medicine ◽  
Policy Framework ◽  
Real World Evidence ◽  
Biomarker Testing ◽  
Policy Alignment ◽  
Prostate Cancers

Rapid and continuing advances in biomarker testing are not being matched by take-up in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. The potential that genomics has brought to biomarker testing in diagnosis, prediction and research is being realised, pre-eminently in many cancers, but also in an ever-wider range of conditions. One of the paradigmatic examples is BRCA1/2 testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, development is impeded by data deficiencies, and lack of policy alignment on standards, approval – and the role of real-world evidence in the process - and reimbursement. The acute nature of the problem is compellingly illustrated by the particular challenges facing the development and use of tumour agnostic therapies, where the gaps in preparedness for taking advantage of this innovative approach to cancer therapy are sharply exposed. Europe should already have in place a guarantee of universal access to a minimum suite of biomarker tests and should be planning for an optimum testing scenario with a wider range of biomarker tests integrated into a more sophisticated health system articulated around personalised medicine. Improving healthcare and winning advantages for Europe's industrial competitiveness and innovation require an appropriate policy framework – starting with an update to outdated recommendations.

scholarly journals Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine

Cancers ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 583
Author(s):  
Denis Horgan ◽  
Gennaro Ciliberto ◽  
Pierfranco Conte ◽  
Giuseppe Curigliano ◽  
Luis Seijo ◽  
...  
Keyword(s):  
Health Systems ◽  
Real World ◽  
Universal Access ◽  
Personalised Medicine ◽  
Policy Framework ◽  
Advisory Boards ◽  
Real World Evidence ◽  
Biomarker Testing ◽  
Policy Alignment ◽  
Prostate Cancers

Rapid and continuing advances in biomarker testing are not being matched by uptake in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. The potential that genomics has brought to biomarker testing in diagnosis, prediction and research is being realised, pre-eminently in many cancers, but also in an ever-wider range of conditions—notably BRCA1/2 testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, the implementation of genetic testing in clinical routine setting is still challenging. Development is impeded by country-related heterogeneity, data deficiencies, and lack of policy alignment on standards, approval—and the role of real-world evidence in the process—and reimbursement. The acute nature of the problem is compellingly illustrated by the particular challenges facing the development and use of tumour agnostic therapies, where the gaps in preparedness for taking advantage of this innovative approach to cancer therapy are sharply exposed. Europe should already have in place a guarantee of universal access to a minimum suite of biomarker tests and should be planning for an optimum testing scenario with a wider range of biomarker tests integrated into a more sophisticated health system articulated around personalised medicine. Improving healthcare and winning advantages for Europe’s industrial competitiveness and innovation require an appropriate policy framework—starting with an update to outdated recommendations. We show herein the main issues and proposals that emerged during the previous advisory boards organised by the European Alliance for Personalized Medicine which mainly focus on possible scenarios of harmonisation of both oncogenetic testing and management of cancer patients.

scholarly journals Bringing Greater Accuracy to Europe’s Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology

2020 ◽  
Vol 5 (3) ◽  
pp. 1-42
Author(s):  
Denis Horgan ◽  
Gennaro Ciliberto ◽  
Pierfranco Conte ◽  
David Baldwin ◽  
Luis Seijo ◽  
...  
Keyword(s):  
Health System ◽  
Health Systems ◽  
Universal Access ◽  
Personalised Medicine ◽  
National Policy ◽  
Healthcare Systems ◽  
Policy Framework ◽  
Colon Cancers ◽  
Biomarker Testing ◽  
The Many

Rapid and continuing advances in biomarker testing are not being matched by take-up in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. This paper sets out the potential of biomarker testing, the unfolding precision and range of possible diagnosis and prediction, and the many obstacles to adoption. It offers case studies of biomarker testing in breast, ovarian, prostate, lung, thyroid and colon cancers, and derives specific lessons as to the potential and actual use of each of them. It also draws lessons about how to improve access and alignment, and to remedy the data deficiencies that impede development. And it suggests solutions to outstanding issues – notably including funding and the tangled web of obtaining reimbursement or equivalent coverage that Europe’s fragmented health system implies. It urges a European evolution towards an initial minimum testing scenario, which would guarantee universal access to a suite of biomarker tests for the currently most common conditions, and, further into the future, to an optimum testing scenario in which a much wider range of biomarker tests would be introduced and become part of a more sophisticated health system articulated around personalised medicine. For exploiting genomics to the full, it argues the need for a new policy framework for Europe. Biomarker testing is not an issue that can be treated in isolation, since the purpose of testing is to improve health. Its use is therefore always closely linked to specific health challenges and needs to be viewed in the broader policy context in the EU and more widely. The paper is the result of extensive engagement with experts and decision makers to develop the framework, and consequently represents a wide consensus of views on how healthcare systems should respond from push and pull factors at local, national and cross-border and EU level. It contains strong views and clear recommendations springing from the convictions of patients, clinicians, academics, medicines authorities, HTA bodies, payers, the diagnostic, pharmaceutical and ICT industries, and national policy makers.

scholarly journals The Expanding Role of Real-World Evidence Trials in Health Care Decision Making

2019 ◽  
Vol 14 (1) ◽  
pp. 174-179 ◽  
Author(s):  
David C. Klonoff
Keyword(s):  
Real World ◽  
Clinical Evidence ◽  
Real World Data ◽  
Medical Products ◽  
Advantages And Disadvantages ◽  
Randomized Controlled ◽  
Real World Evidence ◽  
Care Decision

Real-world evidence (RWE) is the clinical evidence about benefits or risks of medical products derived from analyzing real world data (RWD), which are data collected through routine clinical practice. This article discusses the advantages and disadvantages of RWE studies, how these studies differ from randomized controlled trials (RCTs), how to overcome barriers to current skepticism about RWE, how FDA is using RWE, how to improve the quality of RWE, and finally the future of RWE trials.

The role of real-world evidence in clinical care: A survey of oncology leaders.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e18515-e18515
Author(s):  
Melissa Stahl ◽  
Alissa M Winzeler ◽  
Ali Zaman ◽  
Nicole Shelby ◽  
James Lin Chen ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Care ◽  
Real World Evidence

scholarly journals Role of Gliclazide MR in the Management of Type 2 Diabetes: Report of a Symposium on Real-World Evidence and New Perspectives

2020 ◽  
Vol 11 (S2) ◽  
pp. 33-48 ◽  
Author(s):  
Kamlesh Khunti ◽  
Mohamed Hassanein ◽  
Moon-Kyu Lee ◽  
Viswanathan Mohan ◽  
Aslam Amod
Keyword(s):  
Type 2 Diabetes ◽  
Real World ◽  
Real World Evidence

scholarly journals Market Access and Reimbursement: The Increasing Role of Real-World Evidence

2014 ◽  
Vol 17 (7) ◽  
pp. A450-A451 ◽  
Author(s):  
G. Pietri ◽  
P. Masoura
Keyword(s):  
Real World ◽  
Market Access ◽  
Real World Evidence

scholarly journals Role of real-world evidence in informing cancer care: lessons from colorectal cancer

2019 ◽  
Vol 26 (1) ◽  
Author(s):  
A. Batra ◽  
W. Y. Cheung
Keyword(s):  
Colorectal Cancer ◽  
Real World ◽  
Cancer Care ◽  
Clinical Care ◽  
Real World Data ◽  
Cancer Management ◽  
Randomized Controlled ◽  
Real World Evidence ◽  
Research Questions

The term “real-world evidence” (rwe) describes the analysis of data that are collected beyond the context of clinical trials. The use and application of rwe have become increasingly common and relevant, especially in oncology, because there is growing recognition that randomized controlled trials (rcts) might not be sufficiently representative of the entire patient population that is affected by cancer, and that specific clinical research questions might be best addressed by real-world data. In this brief review, our main aim is to highlight the role of rwe in informing cancer care, particularly focusing on specific examples from colorectal cancer. Our hope is to illustrate the ways in which rwe can complement rcts in improving the understanding of cancer management and how rwe can facilitate cancer treatment decisions for real-world patients encountered in routine clinical care.

Sign in / Sign up

Export Citation Format

Share Document