GRADE guidelines: 18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence

HJ Schünemann, C Cuello, EA Akl, RA Mustafa… - Journal of clinical …, 2019 - Elsevier
Objective To provide guidance on how systematic review authors, guideline developers, and
health technology assessment practitioners should approach the use of the risk of bias in …

Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials

T Mathes, S Buehn, P Prengel, D Pieper - Journal of clinical epidemiology, 2018 - Elsevier
Objectives The objective of this study was to analyze the features of registry-based
randomized trials (rRCTs). Study Design and Setting We systematically searched PubMed …

Heterogeneity of treatment effects: implications for guidelines, payment, and quality assessment

S Greenfield, R Kravitz, N Duan, SH Kaplan - The American journal of …, 2007 - Elsevier
Randomized controlled trial results are needed for developing guidelines, payment rules,
and quality-of-care measures; however, 2 phenomena reduce the usefulness of randomized …

[HTML][HTML] Pragmatic randomized clinical trials: best practices and statistical guidance

V Gamerman, T Cai, A Elsäßer - Health Services and Outcomes Research …, 2019 - Springer
Randomized clinical trials often serve the purpose of assessing the efficacy and safety of a
compound. By combining real-world evidence and randomization, pragmatic randomized …

[HTML][HTML] Can real-world data really replace randomised clinical trials?

SV Ramagopalan, A Simpson, C Sammon - BMC medicine, 2020 - Springer
Background Classically, randomised controlled trials (RCTs) are considered the gold
standard for demonstrating product efficacy for the regulatory approval of medicines …

A substantial and confusing variation exists in handling of baseline covariates in randomized controlled trials: a review of trials published in leading medical journals

PC Austin, A Manca, M Zwarenstein, DN Juurlink… - Journal of clinical …, 2010 - Elsevier
OBJECTIVE: Statisticians have criticized the use of significance testing to compare the
distribution of baseline covariates between treatment groups in randomized controlled trials …

[HTML][HTML] Preclinical efficacy studies in investigator brochures: do they enable risk–benefit assessment?

S Wieschowski, WWL Chin, C Federico, S Sievers… - PLoS …, 2018 - journals.plos.org
Human protection policies require favorable risk–benefit judgments prior to launch of clinical
trials. For phase I and II trials, evidence for such judgment often stems from preclinical …

Addressing the issue of channeling bias in observational studies with propensity scores analysis

FS Lobo, S Wagner, CR Gross… - Research in Social and …, 2006 - Elsevier
Randomized Clinical Trials (RCTs) remain the gold standard for determining the utility of
pharmaceuticals especially from a safety and efficacy standpoint. However, restrictive entry …

Core concepts in pharmacoepidemiology: confounding by indication and the role of active comparators

R Sendor, T Stürmer - Pharmacoepidemiology and drug safety, 2022 - Wiley Online Library
Confounding by indication poses a significant threat to the validity of nonexperimental
studies assessing effectiveness and safety of medical interventions. While no different from …

[HTML][HTML] Routinely collected data and comparative effectiveness evidence: promises and limitations

LG Hemkens, DG Contopoulos-Ioannidis… - Cmaj, 2016 - Can Med Assoc
Extensive resources have been invested in this field: they include the set-up of disease
registries and clinical databases at regional, national or international levels; the promotion of …