Reanalyses of randomized clinical trial data

S Ebrahim, ZN Sohani, L Montoya, A Agarwal… - Jama, 2014 - jamanetwork.com
Importance Reanalyses of randomized clinical trial (RCT) data may help the scientific
community assess the validity of reported trial results. Objectives To identify published …

[HTML][HTML] Improving transparency to build trust in real-world secondary data studies for hypothesis testing—why, what, and how: recommendations and a road map from …

LS Orsini, M Berger, W Crown, G Daniel, HG Eichler… - Value in Health, 2020 - Elsevier
Real-world data (RWD) and the derivations of these data into real-world evidence (RWE)
are rapidly expanding from informing healthcare decisions at the patient and health system …

Recommendations for assessing the risk of bias in systematic reviews of health-care interventions

M Viswanathan, CD Patnode, ND Berkman… - Journal of clinical …, 2018 - Elsevier
Objectives Risk-of-bias assessment is a central component of systematic reviews, but little
conclusive empirical evidence exists on the validity of such assessments. In the context of …

[HTML][HTML] Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis

E Mayo-Wilson, N Fusco, T Li, H Hong… - Journal of clinical …, 2017 - Elsevier
Objective To identify variations in outcomes and results across reports of randomized clinical
trials (RCTs). Study Design and Setting Eligible RCTs examined gabapentin for neuropathic …

Comparison of registered and published outcomes in randomized controlled trials: a systematic review

CW Jones, LG Keil, WC Holland, MC Caughey… - BMC medicine, 2015 - Springer
Background Clinical trial registries can improve the validity of trial results by facilitating
comparisons between prospectively planned and reported outcomes. Previous reports on …

Reporting and interpretation of randomized clinical trials

H Bauchner, RM Golub, PB Fontanarosa - Jama, 2019 - jamanetwork.com
High-quality randomized clinical trials (RCTs) occupy the highest position on the evidence
pyramid, either as standalone studies or as part of meta-analyses. However, the …

Registries for robust evidence

NA Dreyer, S Garner - Jama, 2009 - jamanetwork.com
ALTHOUGH RANDOMIZED CLINICAL TRIALS (RCTS) ARE the bedrock for establishing
which interventions are efficacious, there is increasing recognition that they cannot address …

A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results

T Kennedy-Martin, S Curtis, D Faries, S Robinson… - Trials, 2015 - Springer
Randomized controlled trials (RCTs) are conducted under idealized and rigorously
controlled conditions that may compromise their external validity. A literature review was …

Transparency and reproducibility of observational cohort studies using large healthcare databases.

SV Wang, P Verpillat, JA Rassen… - Clinical …, 2016 - Wiley Online Library
The scientific community and decision‐makers are increasingly concerned about
transparency and reproducibility of epidemiologic studies using longitudinal healthcare …

A framework for methodological choice and evidence assessment for studies using external comparators from real-world data

CM Gray, F Grimson, D Layton, S Pocock, J Kim - Drug safety, 2020 - Springer
Several approaches have been proposed recently to accelerate the pathway from drug
discovery to patient access. These include novel designs such as using controls external to …