Phase II trials in drug development and adaptive trial design

GA Van Norman - JACC: Basic to Translational Science, 2019 - jacc.org
… would: 1) reap enough returns to pay for their own development … understanding why so few
initially promising drugs fail to pass … of phase II trials makes it difficult to identify long-term side …

A review of perspectives on the use of randomization in phase II oncology trials

MJ Grayling, M Dimairo, AP Mander… - JNCI: Journal of the …, 2019 - academic.oup.com
… in the long term we all … phase II trials to predict long-term survival benefits. Kola and Landis
(52) highlighted that 60% of regimens that had “promising” activity in single-arm phase II trials

[HTML][HTML] Comparison of treatment effect from randomised controlled phase II trials and subsequent phase III trials using identical regimens in the same treatment …

F Liang, Z Wu, M Mo, C Zhou, J Shen, Z Wang… - European journal of …, 2019 - Elsevier
trials, randomised phase II trials without a control group and randomised phase II trials of
surgery, radiotherapy, life style … II trials, our study showed that promising results from …

Using randomized controlled trials to estimate long-run impacts in development economics

A Bouguen, Y Huang, M Kremer… - Annual Review of …, 2019 - annualreviews.org
… We observe some heterogeneity in rates of return for … on promising approaches to estimating
long-term impacts, both … We provide lessons from our experience in conducting long-term

Precision medicine needs randomized clinical trials

ED Saad, X Paoletti, T Burzykowski… - Nature reviews Clinical …, 2017 - nature.com
… that the majority of randomized phase II trials in oncology are … but the main goal of
randomization in phase II is either to select … promising results with that therapy in phase I and/or II

Randomized phase II selection design with order constrained strata

Y Chen, M Yu - Biometrics, 2024 - academic.oup.com
… Many phase II trials are now designed to assess the promise of a molecularly targeted or
an immuno-biological agent, given either alone or in combination with another regimen. In …

Optimal, minimax and admissible two-stage design for phase II oncology clinical trials

F Qin, J Wu, F Chen, Y Wei, Y Zhao, Z Jiang… - BMC Medical Research …, 2020 - Springer
… drugs or warrant promising new drugs for future evaluation. … randomized phase II counterparts.
Therefore, single-arm … always require less time to complete and less resources invested [3]…

Bayesian optimal designs for multi-arm multi-stage phase II randomized clinical trials with multiple endpoints

G Mulier, S Chevret, R Lin, L Biard - Statistics in Biopharmaceutical …, 2024 - Taylor & Francis
… We aim to adapt the Bayesian optimal phase II (BOP2) design to multi-arm trials for both …
Randomized phase II trials: a long-term investment with promising returns. Journal of the …

[HTML][HTML] Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC)

MB Atkins, H Abu-Sbeih, PA Ascierto… - … for Immunotherapy of …, 2022 - ncbi.nlm.nih.gov
… Because of the small size of randomized phase II trials, it is … long-term follow-up results
emerging for the registration trials … To maximize the return on investment for phase III trials and …

Learning from clinical trials of neoadjuvant checkpoint blockade

JM Versluis, GV Long, CU Blank - Nature Medicine, 2020 - nature.com
… associated with long-term survival 19 . Furthermore, in a … in preclinical mouse models and
finally returned to the clinic in the … Below, we discuss promising approaches to achieve this. …