Hybrid-control arm construction using historical trial data for an early-phase, randomized controlled trial in metastatic colorectal cancer

Hybrid-control arm construction using historical trial data for an early-phase, randomized controlled trial in metastatic colorectal cancer

Li et al. report outcomes from the atezolizumab/isatuximab arm of the phase Ib/II MORPHEUS-CRC trial in patients with metastatic colorectal cancer. In addition, the authors leverage historical control data from the phase III IMblaze370 study to provide more precise treatment effect estimates.

Bibliographic Details
Main Authors:	Chen Li, Ana Ferro, Shivani K. Mhatre, Danny Lu, Marcus Lawrance, Xiao Li, Shi Li, Simon Allen, Jayesh Desai, Marwan Fakih, Michael Cecchini, Katrina S. Pedersen, Tae You Kim, Irmarie Reyes-Rivera, Neil H. Segal, Christelle Lenain
Format:	Article
Language:	English
Published:	Nature Portfolio 2022-07-01
Series:	Communications Medicine
Online Access:	https://doi.org/10.1038/s43856-022-00155-y

Similar Items

Augmenting control arms with real-world data for cancer trials: Hybrid control arm methods and considerations
by: W. Katherine Tan, et al.
Published: (2022-12-01)

Trunk extensors endurance with arms parallel to the trunk is superior to other arms positions: randomized- controlled trial
by: Samiha Mohamed Ibrahim Abd Elkader, et al.
Published: (2022-04-01)

Efficacy of antidepressants over placebo is similar in two-armed versus three-armed or more-armed randomized placebo-controlled trials.
by: Ogawa, Y, et al.
Published: (2017)

Utilization of anonymization techniques to create an external control arm for clinical trial data
by: Juha Mehtälä, et al.
Published: (2023-11-01)

Changing trends in phase 1 oncology clinical trials
by: Richard Kelly, et al.
Published: (2024-02-01)

Efficacy and safety of community‐based moxibustion for primary hypertension: A randomized controlled trial with patient preference arms
by: Xu Zhou, et al.
Published: (2023-12-01)

Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review
by: Wartolowska, K, et al.
Published: (2016)

Biometric Assessment of Temporomandibular Disorders in Orthodontics: A Multi-arm Randomized Controlled Trial
by: Raj Kumar Maurya, et al.
Published: (2022-12-01)

Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol
by: Winstein Carolee J, et al.
Published: (2013-01-01)

A single-arm phase II clinical trial of anlotinib combined with chemotherapy for the treatment of metastatic triple-negative breast cancer
by: Jia-Yi Huang, et al.
Published: (2023-04-01)

Use of suboptimal control arms in randomized clinical trials of investigational cancer drugs in China, 2016–2021: An observational study
by: Yichen Zhang, et al.
Published: (2023-12-01)

Restoring walking ability in older adults with arm-in-arm gait training: study protocol for the AAGaTT randomized controlled trial
by: Mathilde Gigonzac, et al.
Published: (2023-09-01)

Should the Food and Drug Administration Limit Placebo-Controlled Trials?
by: Max Goodman, et al.
Published: (2022-07-01)

Should the Food and Drug Administration Limit Placebo-Controlled Trials?
by: Max Goodman, et al.
Published: (2022-07-01)

Virtual Feedback for Arm Motor Function Rehabilitation after Stroke: A Randomized Controlled Trial
by: Silvia Salvalaggio, et al.
Published: (2022-06-01)

An open-label, single-arm trial of cryoneurolysis for improvements in pain, Activities of Daily Living and Quality of Life in patients with symptomatic ankle osteoarthritis
by: Perry, TA, et al.
Published: (2022)

Bayesian network meta-analysis methods for combining individual participant data and aggregate data from single arm trials and randomised controlled trials
by: Janharpreet Singh, et al.
Published: (2022-07-01)

Metastatic pattern is a prognostic factor in BRAFV600E mutant colorectal cancer
by: Jingran Ji, et al.
Published: (2023-01-01)

Effects of Dexmedetomidine on Immunomodulation and Pain Control in Videolaparoscopic Cholecystectomies: A Randomized, Two-Arm, Double-Blinded, Placebo-Controlled Trial
by: Gustavo Nascimento Silva, et al.
Published: (2023-04-01)

A meta-analysis of temporal changes of response in the placebo arm of surgical randomized controlled trials: an update
by: Wartolowska, KA, et al.
Published: (2017)

Homeopathy for seasonal allergic rhinitis: rationale, design and methods of the three-armed randomized controlled HOMEOSAR trial
by: J. Siewert, et al.
Published: (2022-12-01)

An open-label, single-arm trial of cryoneurolysis for improvements in pain, activities of daily living and quality of life in patients with symptomatic ankle osteoarthritis
by: Thomas A. Perry, et al.
Published: (2022-09-01)

Single-arm trials for domestic oncology drug approvals in China
by: Hong Zhang, et al.
Published: (2023-11-01)

Multiply efficient trials: combining multiple trial arms and critical secondary questions increases trial efficiency
by: Goldsmith, K, et al.
Published: (2017)

TALASUR trial: a single arm phase II trial assessing efficacy and safety of TALazoparib and Avelumab as maintenance therapy in platinum-Sensitive metastatic or locally advanced URothelial carcinoma
by: Elodie Coquan, et al.
Published: (2022-11-01)

Comparative Efficacy Randomized Controlled Trials in Rheumatology Guidelines
by: Katie Henry, et al.
Published: (2022-10-01)

Arms control /
by: Open University. Control Engineering Course Team, et al.
Published: (1978)

Fifty years of trials in bipolar disorder: A survey of controlled trials in the Cochrane Controlled Trials Register
by: Clement, S, et al.
Published: (2006)

Anlotinib as a third-line or further treatment for recurrent or metastatic nasopharyngeal carcinoma: a single-arm, phase 2 clinical trial
by: Yu Fang, et al.
Published: (2023-11-01)

Safety and efficacy of the tumor-selective adenovirus enadenotucirev, in combination with nivolumab, in patients with advanced/metastatic epithelial cancer: a phase I clinical trial (SPICE)
by: Daruka Mahadevan, et al.
Published: (2023-04-01)

Camrelizumab combined with apatinib in patients with first-line platinum-resistant or PD-1 inhibitor resistant recurrent/metastatic nasopharyngeal carcinoma: a single-arm, phase 2 trial
by: Li Yuan, et al.
Published: (2023-08-01)

The ethics of using a placebo arm in randomized controlled trials: a case of in a primaquine antirelapse study
by: Cheah, P, et al.
Published: (2017)

Clinical validation of the ‘C-arm rotational view (CARV)’: study protocol of a prospective randomised controlled trial
by: Mostafa El Moumni, et al.
Published: (2023-11-01)

School-based universal mental health promotion intervention for adolescents in Vietnam: Two-arm, parallel, controlled trial
by: Thach Duc Tran, et al.
Published: (2023-01-01)

Designing Ruby: Protocol for a 2-Arm, Brief, Digital Randomized Controlled Trial for Internalized Weight Bias
by: Christina M Hopkins, et al.
Published: (2021-11-01)

Efficacy of Jatyadi, Madhughrita and honey tulle in wound management: a three-arm randomized controlled clinical trial
by: Dhrushnu Prasannan, et al.
Published: (2023-05-01)

Pulsatile dry cupping in chronic low back pain – a randomized three-armed controlled clinical trial
by: M. Teut, et al.
Published: (2018-04-01)

An appraisal of the SDIR as an estimate of true individual differences in training responsiveness in parallel‐arm exercise randomized controlled trials
by: Jacob T. Bonafiglia, et al.
Published: (2019-07-01)

Controlled trials of physiotherapy
by: Editorial Office
Published: (1978-12-01)

Randomised controlled trials and retrospective controls.
by: Doll, R, et al.
Published: (1980)