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Results for 'failure'

Browse oncology articles matching failure — expert analysis, clinical perspectives, and industry updates from across drug development and care delivery. Use the tabs above for podcasts, press releases, partners, and people for the same search.

Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis
OVN Avatar Jayson L. Parker, Sebnem S. Kuzulugil, Kirill Pereverzev, Stephen Mac, Gilberto Lopes, Zain Shah, Ashini Weerasinghe, Daniel Rubinger, Adam Falconi, Ayse Bener, Bora Caglayan, Rohan Tangri, Nicholas Mitsakakis
Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis

biomarker, clinical trial, failure, analysis, NSCLC, oncology

Data from clinical trials across four oncology indications (breast cancer, NSCLC, melanoma, and colorectal cancer) from 1998 to 2017 were analyzed to assess drug approval likelihood based on biomarker status. Using multi-state Markov models, which describe stochastic processes, the study…

Feb 23rd • 8 mins read

What decision-makers actually do when they can't evaluate reasoning directly
Partner Avatar Leon Rozen
What decision-makers actually do when they can't evaluate reasoning directly

Medical Strategy, Medical Leadership, Medical Affairs

There is a scene most advisory professionals will recognise. A recommendation that took weeks to produce — drawing on regulatory environment, market dynamics, scientific evidence, competitor positioning — gets four minutes in a senior forum. A question or two. A decision. The people in that roo…

Apr 12th • 5 mins read

The advice was good. It didn't matter.
Partner Avatar Leon Rozen
The advice was good. It didn't matter.

Medical Strategy, Medical Leadership, Medical Affairs

There is a particular kind of professional frustration that doesn't have a clean name. It isn't failure — the work was sound. It isn't incompetence. The reasoning was careful, the constraints were weighed, the recommendation was defensible. It is something more specific: the experience of having d…

Apr 12th • 5 mins read

Pediatric Oncology Clinical Trials and Collaborative Research in Africa: Current Landscape and Future Perspectives
OVN Avatar Jaques van Heerden, MD, Mohamed Zaghloul, MD, Anouk Neven, MSc, Teresa de Rojas, MD, PhD, Jennifer Geel, MD, Catherine Patte, MD, Joyce Balagadde-Kambugu, MD, Peter Hesseling, MD, Francine Tchintseme, MD, Eric Bouffet, MD, and Laila Hessissen, MD
Pediatric Oncology Clinical Trials and Collaborative Research in Africa: Current Landscape and Future Perspectives

pediatric oncology, clinical trials, research, Africa, collaborative research

Current childhood cancer survival rates in African countries range from 8.1% to 30.3%. The review focuses on pediatric oncology trials in Africa, highlighting challenges and suggesting research collaboration opportunities. Data were collected from the SIOP global mapping survey, ClinicalT…

Aug 7th • 10 mins read

Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study
OVN Avatar Benjamin Gregory Carlisle, Adélaïde Doussau, Jonathan Kimmelman
Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study

clinical advances, monotherapy cancer drug trials, FDA

Objective: The study investigates the efforts to extend the uses of new drugs by testing them for new, non-approved indications and examines the patient burden and clinical impact. Design and Setting: A retrospective cohort study focused on post-approval trials of anticancer drugs approved betwee…

Feb 17th • 7 mins read

Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval
OVN Avatar Ravi B. Parikh, MD, MPP Rebecca A. Hubbard, PhD Erkuan Wang, MA Trevor J. Royce, MD, MPH Aaron B. Cohen, MD, MSCE Amy S. Clark, MD, MSCE Ronac Mamtani, MD, MSCE
Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval

US, FDA, approval, drugs, benefits, cancer

Among 5 oncology indications, 26.1% of eligible treatment initiations involved an Accelerated Approval (AA) indication that was later withdrawn due to lack of benefit. There is an inherent trade-off between expediting access to promising cancer drugs and the potential withdrawal of some indicatio…

Dec 8th • 2 mins read

Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?
OVN Avatar Timothy Qi, Tyler Dunlap, Yanguang Cao1
Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?

oncology, precision medicine, tumor evolution, dosing, FDA

Focus on tumor evolution, which leads to therapeutic failure and disease relapse. Emphasis on the effect of tumor evolution on the exposure-response (E-R) relationships of oncology drugs. Advocacy for prioritizing tumor evolution during clinical development to select optimal doses for targeted t…

Sep 2nd • 10 mins read

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