Clinical trial design in the era of precision medicine

E Fountzilas, AM Tsimberidou, HH Vo, R Kurzrock - Genome medicine, 2022 - Springer
Recent rapid biotechnological breakthroughs have led to the identification of complex and
unique molecular features that drive malignancies. Precision medicine has exploited next …

Top 10 challenges in cancer immunotherapy

PS Hegde, DS Chen - Immunity, 2020 - cell.com
Cancer immunotherapy is a validated and critically important approach for treating patients
with cancer. Given the vast research and clinical investigation efforts dedicated to advancing …

Pathologic complete response after neoadjuvant chemotherapy and impact on breast cancer recurrence and survival: a comprehensive meta-analysis

LM Spring, G Fell, A Arfe, C Sharma, R Greenup… - Clinical cancer …, 2020 - AACR
Purpose: While various studies have highlighted the prognostic significance of pathologic
complete response (pCR) after neoadjuvant chemotherapy (NAT), the impact of additional …

Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: an analysis of the ongoing …

R Nanda, MC Liu, C Yau, R Shatsky, L Pusztai… - JAMA …, 2020 - jamanetwork.com
Importance Approximately 25% of patients with early-stage breast cancer who receive (neo)
adjuvant chemotherapy experience a recurrence within 5 years. Improvements in therapy …

Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial

L Pusztai, C Yau, DM Wolf, HS Han, L Du, AM Wallace… - Cancer cell, 2021 - cell.com
The combination of PD-L1 inhibitor durvalumab and PARP inhibitor olaparib added to
standard paclitaxel neoadjuvant chemotherapy (durvalumab/olaparib/paclitaxel [DOP]) was …

Master protocols to study multiple therapies, multiple diseases, or both

J Woodcock, LM LaVange - New England Journal of Medicine, 2017 - Mass Medical Soc
Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both | New England Journal of
Medicine Skip to main content The New England Journal of Medicine homepage Advanced …

Toil enables reproducible, open source, big biomedical data analyses

J Vivian, AA Rao, FA Nothaft, C Ketchum… - Nature …, 2017 - nature.com
9.128 (Jones and Bartlett Publishers, 2006). 6. Storch, M. et al. BASIC: a new biopart
assembly standard for idempotent cloning provides accurate, singletier DNA assembly for …

The REMAP-CAP (randomized embedded multifactorial adaptive platform for community-acquired pneumonia) study. Rationale and design

DC Angus, S Berry, RJ Lewis, F Al-Beidh… - Annals of the …, 2020 - atsjournals.org
There is broad interest in improved methods to generate robust evidence regarding best
practice, especially in settings where patient conditions are heterogenous and require …

Advancing precision medicine for acute respiratory distress syndrome

JR Beitler, BT Thompson, RM Baron… - The Lancet …, 2022 - thelancet.com
Acute respiratory distress syndrome (ARDS) is a heterogeneous clinical syndrome.
Understanding of the complex pathways involved in lung injury pathogenesis, resolution …

Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols

JJH Park, E Siden, MJ Zoratti, L Dron, O Harari… - Trials, 2019 - Springer
Background Master protocols, classified as basket trials, umbrella trials, and platform trials,
are novel designs that investigate multiple hypotheses through concurrent sub-studies (eg …