Spotlight: Trial Methodologies

Welcome to The Evidence Base Spotlight on ‘Trial Methodologies’, looking at best practices and innovative methodologies to conduct clinical studies that promote patient-centricity and advance real-world evidence research.

We’ll feature expert insights, news, articles and more to bring our readers the latest developments in this area.

Read our Expert Insight interviews here:

Towards the next generation of decentralized trials: an interview with Emily Lewis, MS, CCRP

 

 

 

Putting the patient at the heart of decentralized clinical trials: an interview with Henrik Vincentz, James Lind Care

 

 

 

Evaluating the role of single-arm trials in oncology decision-making: an interview with Sorrel Wolowacz, RTI Health Solutions

 

 

 

Understanding real-world evidence generation from point-of-care trials: an interview with Kraig Kinchen, Eli Lilly

 

 

 

Two years of the Decentralized Trials and Research Alliance: an interview with Craig Lipset

 

 

 

Latest findings from the RCT-DUPLICATE demonstration project: an interview with Shirley Wang, Harvard Medical School

 

 

 

eCOA, BYOD and digital health in clinical trials: an interview with Katie Garner, Signant Health

 

 

 

Get in touch to discuss the opportunities available to share your expertise, contribute to this theme or to become a theme sponsor.

 

Find articles published in the Journal of Comparative Effectiveness Research

Unmeasured confounding in nonrandomized studies: quantitative bias analysis in health technology assessment
Adjusting for treatment crossover in the MAVORIC trial: survival in advanced mycosis fungoides and Sézary syndrome
Recommendations from Cochrane reviews for improving future trials on anesthesia and pain: a meta-research study
Bridging the gap between oncology clinical trials and real-world data: evidence on replicability of efficacy results using German claims data
Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients’ and public attitudes
Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC
To replicate or not to replicate? Insights and interpretations from a randomized trial duplication initiative
Single-arm oncology trials and the nature of external controls arms
Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia
A systematic review of noninferiority margins in oncology clinical trials
Replication of randomized clinical trial results using real-world data: paving the way for effectiveness decisions
Guidance for a causal comparative effectiveness analysis emulating a target trial based on big real world evidence: when to start statin treatment
Comparative effectiveness from a single-arm trial and real-world data: alectinib versus ceritinib
Some issues for the evaluation of noninferiority trials
The mixed randomized trial: combining randomized, pragmatic and observational clinical trial designs

Discover more from The Evidence Base here

FDA takes measures to advance decentralized clinical trials with new draft guidance
RCT-DUPLICATE
Can real-world evidence studies replicate the results of randomized clinical trials? Insights from RCT-DUPLICATE
FDA and Duke-Margolis Center for Health Policy to hold workshop on the use of negative controls in real-world data studies
FDA issues latest RWD/RWE draft guidance on the use of externally controlled trials
Journal of Comparative Effectiveness Research welcoming articles describing the design of real-world evidence studies
WEBINAR: Patient centric sampling in pediatric clinical trials – successes, challenges and how to overcome them
Interview with Neil Spooner
Putting patients first: an interview with Neil Spooner on the Patient Centric Sampling Interest Group