Clinical Trial Registration

DeAngelis, Catherine D.; Drazen, Jeffrey M.; Frizelle, Frank; Haug, Charlotte; Hoey, John; Horton, Richard; Kotzin, Sheldon; Lainé, Christine; Marušić, Ana; Overbeke, A. John P.M.; Schroeder, Torben V.; Sox, Hal C.; Weyden, Martin B Van Der

doi:10.1001/jama.292.11.1363

Cited by 508 publications

(129 citation statements)

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“…Unfortunately, these reports may be imprecise since only approximately 17% of completed trials publish results in peer reviewed journals [17]. To address this issue of publication bias, in 2004 the International Committee of Medical Journal Editors required trial registration with the ClinicalTrials.gov database prior to publication of study results [18]. Thus, data from this comprehensive registry may provide more precise estimates of PROM use.…”

Section: Introductionmentioning

confidence: 99%

Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007–2013)

Vodicka

Kim²,

Devine

et al. 2015

Contemporary Clinical Trials

165

105

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Section: Introductionmentioning

confidence: 99%

Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007–2013)

Vodicka

Kim²,

Devine

et al. 2015

Contemporary Clinical Trials

165

105

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“…One of the easiest ways for investigators to insure good design is to carefully predefine their endpoints and statistical plan, preferably with the input of a biostatistician 21, 34, 71. The International Committee of Medical Journals Editors (ICMJE) requires registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication 72, 73. For United States journals, this means investigators leading RCTs in humans are required to make their study endpoints and statistical plan public before the start of the study by registering the study on a publically accessible website 1.…”

Section: Other Issues In Clinical Trials In Veterinary Patientsmentioning

confidence: 99%

Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges

Oyama

Ellenberg

Shaw

2017

Veterinary Internal Medicne

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Randomized clinical trials (RCTs) are among the most rigorous ways to determine the causal relationship between an intervention and important clinical outcome. Their use in veterinary medicine has become increasingly common, and as is often the case, with progress comes new challenges. Randomized clinical trials yield important answers, but results from these studies can be unhelpful or even misleading unless the study design and reporting are carried out with care. Herein, we offer some perspective on several emerging challenges associated with RCTs, including use of composite endpoints, the reporting of different forms of risk, analysis in the presence of missing data, and issues of reporting and safety assessment. These topics are explored in the context of previously reported veterinary internal medicine studies as well as through illustrative examples with hypothetical data sets. Moreover, many insights germane to RCTs in veterinary internal medicine can be drawn from the wealth of experience with RCTs in the human medical field. A better understanding of the issues presented here can help improve the design, interpretation, and reporting of veterinary RCTs.

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“…These steps ensure that there is sufficient transparency, for example, for later assessment of the trial in a systematic review/meta-analysis. Furthermore, the registration of a trial is claimed by many international journals prior to the beginning of its conduct [11]. After termination, the main results should also be entered in the trial registry.…”

Section: Planning Phasementioning

confidence: 99%

Study Methods in Evidence-Based Surgery: Methodological Impediments and Suggested Approaches for the Creation and Transfer of Knowledge in Surgery

et al. 2014

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Background: Since its introduction more than 20 years ago, evidence-based medicine has become an important principle in the daily routine of clinicians around the globe. Nevertheless, many surgical interventions are still not based on high-quality evidence from clinical trials. This is partially due to the fact that surgical trials pose some specific obstacles, which have to be overcome during the planning and conduct of such a trial. Objective: In this study, we will highlight specific challenges and discuss explicit obstacles of surgical clinical research. Moreover, potential solutions will be substantiated by the experience of the Study Centre of the German Surgical Society (SDGC) in surgical clinical research. Conclusions: Surgical researchers should be equipped with a basic knowledge of research methodology to be able to overcome the common impediments posed by surgical trials. Collaborations between surgeons and methodologists as well as trial networks have proven to be useful in accomplishing high-quality surgical research in various randomized controlled trials. By maintaining and refining this work and with sufficient and prompt translation of investigational knowledge into daily practice, the treatment of surgical patients should result in an improved outcome in the future.

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Clinical Trial Registration

Abstract: The following full text is a publisher's version. For additional information about this publication click this link.

Cited by 508 publications

References 0 publications

Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007–2013)

Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007–2013)

Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges

Study Methods in Evidence-Based Surgery: Methodological Impediments and Suggested Approaches for the Creation and Transfer of Knowledge in Surgery

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