Bypassing phase 2 in cancer drug development erodes the risk/benefit balance in phase 3 trials
H Moyer, M Bittlinger, A Nelson, L Fernandez… - Journal of Clinical …, 2023 - Elsevier
Objectives Drug developers sometimes launch phase 3 (P3) trials without supporting
evidence from phase 2 (P2) trials. We call this practice “P2 bypass.” The aims of this study …
evidence from phase 2 (P2) trials. We call this practice “P2 bypass.” The aims of this study …
Predicting intervention approval in clinical trials through multi-document summarization
G Katsimpras, G Paliouras - arXiv preprint arXiv:2204.00290, 2022 - arxiv.org
Clinical trials offer a fundamental opportunity to discover new treatments and advance the
medical knowledge. However, the uncertainty of the outcome of a trial can lead to …
medical knowledge. However, the uncertainty of the outcome of a trial can lead to …
Correlation Between Early Trends of a Prognostic Biomarker and Overall Survival in Non–Small-Cell Lung Cancer Clinical Trials
H Loureiro, TM Kolben, A Kiermaier… - JCO Clinical Cancer …, 2023 - ascopubs.org
PURPOSE Overall survival (OS) is the primary end point in phase III oncology trials. Given
low success rates, surrogate end points, such as progression-free survival or objective …
low success rates, surrogate end points, such as progression-free survival or objective …