Clinical Trial Design Issues: At Least 10 Things You Should Look For in Clinical Trials

Glasser, Stephen P.; Howard, George

doi:10.1177/0091270006290336

Cited by 26 publications

(24 citation statements)

References 37 publications

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“…Design elements are implemented in clinical trials to correct for the high observed placebo effect. Blinding is one basic but difficult‐to‐implement tool that can reduce the chance of ascertainment bias, but it can only be effective if the characteristics of drug and placebo are both similar and undetectable . In one analysis of almost 2000 trials, a 13% increase in positive outcomes was seen among inadequately blinded studies which suggested the presence of ascertainment bias …”

Section: Introductionmentioning

confidence: 99%

Adverse events appear to unblind clinical trials in irritable bowel syndrome

Shah

Triantafyllou

Hana

et al. 2013

Neurogastroenterology Motil

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Section: Introductionmentioning

confidence: 99%

Adverse events appear to unblind clinical trials in irritable bowel syndrome

Shah

Triantafyllou

Hana

et al. 2013

Neurogastroenterology Motil

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“…Disagreements were resolved by consensus. We designed a semi-structured checklist, based on previous methodological reviews of clinical trials [19], [20], [21], [22], [23] to address the following aspects:…”

Section: Methodsmentioning

confidence: 99%

Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology

2010

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BackgroundThere have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years.Methodology/Principal FindingsWe performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine). All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time.Conclusions/SignificanceClinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.

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“…However, nonpayment for direct expenses and inconvenience of trial participation may create unnecessary financial obstacles for participation and risks hindering essential paediatric research [45, [117][118][119]. The ethics committees, investigators and sponsors need to ensure that payment for trial participation of children is fair by keeping payments reasonable [98,120].…”

Section: Payment For Participationmentioning

confidence: 99%

Clinical trials in children

Joseph

Craig

Caldwell

2015

Brit J Clinical Pharma

307

274

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Safety and efficacy data on many medicines used in children are surprisingly scarce. As a result children are sometimes given ineffective medicines or medicines with unknown harmful side effects. Better and more relevant clinical trials in children are needed to increase our knowledge of the effects of medicines and to prevent the delayed or non-use of beneficial therapies. Clinical trials provide reliable evidence of treatment effects by rigorous controlled testing of interventions on human subjects. Paediatric trials are more challenging to conduct than trials in adults because of the paucity of funding, uniqueness of children and particular ethical concerns. Although current regulations and initiatives are improving the scope, quantity and quality of trials in children, there are still deficiencies that need to be addressed to accelerate radically equitable access to evidence-based therapies in children.

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Clinical Trial Design Issues: At Least 10 Things You Should Look For in Clinical Trials

Cited by 26 publications

References 37 publications

Adverse events appear to unblind clinical trials in irritable bowel syndrome

Adverse events appear to unblind clinical trials in irritable bowel syndrome

Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology

Clinical trials in children

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