scholarly journals Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey

BMJ ◽  
2016 ◽  
pp. i493 ◽  
Author(s):  
Lars G Hemkens ◽  
Despina G Contopoulos-Ioannidis ◽  
John P A Ioannidis
Keyword(s):  
Treatment Effects ◽  
Randomized Trials ◽  
Epidemiological Survey ◽  
Routinely Collected Data

Progression-free survival (PFS) as a surrogate endpoint for overall survival (OS) in advanced/recurrent gastric cancer (AGC) treatment: Individual-patient-data (IPD) based meta-analysis of randomized trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16506-e16506
Author(s):  
Koji Oba ◽  
Xavier Paoletti ◽  
Yung-Jue Bang ◽  
Olivier Bouché ◽  
Michel Ducreux ◽  
...  
Keyword(s):  
Treatment Effects ◽  
Randomized Trials ◽  
Meta Analysis ◽  
Surrogate Endpoint ◽  
Threshold Effect ◽  
Patient Data ◽  
Individual Level ◽  
Measurable Disease ◽  
Surrogate Threshold Effect ◽  
The Individual

e16506 Background: In 2013, the GASTRIC (Global Advanced/Adjuvant Stomach Tumor Research through International Collaboration) evaluated the surrogacy of PFS based on IPD of 4,069 patients from 20 randomized trials of AGC. Treatment effects on PFS and on OS were only moderately correlated, and we could not validate PFS as a surrogate endpoint for OS. More recent trials, with refined inclusion criteria and higher standards for evaluating progression, may allow for a more accurate estimate of the correlation. The 2nd round of the GASTRIC sought to re-evaluate the surrogacy of PFS for OS in AGC. Methods: The GASTRIC database was updated with trials published after 2010 which used RECIST (Response Evaluation Criteria in Solid Tumors). Since the proportional hazards assumption was questionable for PFS, we primarily used mean-time ratio as a treatment effect measure, estimated by using the log-logistic model. Using the meta-analytic approach, correlations between PFS and OS at the individual level (Rindiv), and between treatment effects on PFS and on OS at the trial level (Rtrial), were estimated using Spearman’s rank-correlation and estimation-error-adjusted regression, respectively. Surrogate threshold effect was estimated as well. Results: We analyzed 10,912 patient data (1st round 4,069 patients from 20 trials and 2nd round 6,843 patients from 17 trials). Overall, moderate correlations were found at the individual level (Rindiv = 0.75, 95%CI = 0.75 to 0.76 in Hougaard copula) and at the trial level (Rtrial = 0.77, 95%CI = 0.32 to 1.00), respectively. Surrogate threshold effect was equal to 1.29, i.e., observing 29% increase in mean PFS time would predict a significant increase of the OS time. In the subgroup of patients with measurable disease in the 2nd round dataset (4,866 patients), Rtrial was higher and equal to 0.93 (95%CI = 0.70 to 1.00), with STE equal to 1.21. These results were same for 1st and 2nd line trials. Conclusions: The meta-analysis indicates a strong correlation between treatment effects (expressed as log-mean-ratios) on PFS and OS in patients with measurable disease.

Reporting of treatment effects from randomized trials: A plea for multivariable risk ratios

2011 ◽  
Vol 32 (3) ◽  
pp. 399-402 ◽  
Author(s):  
Rolf H.H. Groenwold ◽  
Karel G.M. Moons ◽  
Linda M. Peelen ◽  
Mirjam J. Knol ◽  
Arno W. Hoes
Keyword(s):  
Treatment Effects ◽  
Randomized Trials ◽  
Risk Ratios

scholarly journals Years-needed-to-treat to add 1 year of life: a new metric to estimate treatment effects in randomized trials

2009 ◽  
Vol 11 (3) ◽  
pp. 256-263 ◽  
Author(s):  
Wayne C. Levy ◽  
Dariush Mozaffarian ◽  
David T. Linker ◽  
Kenneth W. Kenyon ◽  
John G.F. Cleland ◽  
...  
Keyword(s):  
Treatment Effects ◽  
Randomized Trials

scholarly journals Routinely collected data for randomized trials: promises, barriers, and implications

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Kimberly A. Mc Cord ◽  
Rustam Al-Shahi Salman ◽  
Shaun Treweek ◽  
Heidi Gardner ◽  
Daniel Strech ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Routinely Collected Data
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