2016
DOI: 10.1002/epi4.3
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Not all that glitters is gold: A guide to the critical interpretation of drug trials in epilepsy

Abstract: SummaryClinical trials represent the best source of evidence on which to base treatment decisions. For such evidence to be utilized meaningfully, however, it is essential that results are interpreted correctly. This requires a good understanding of strengths and weaknesses of the adopted design, the clinical relevance of the outcome measures, and the many factors that could affect such outcomes. As a general rule, uncontrolled studies tend to provide misleading evidence as a result of the impact of confounders… Show more

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Cited by 28 publications
(44 citation statements)
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References 72 publications
(148 reference statements)
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“…These trials are often referred to as “seeding trials,: that is, trials of little or no scientific value that are intended to familiarize clinicians with the use of recently introduced products, increase the utilization of the same products through enrolment of patients in a “study,” generate misleading information about the value of specific drugs and, at times, promote off‐label use for nonapproved indications . The overwhelming majority of clinical trials conducted postmarketing consists of uncontrolled trials, and these trials can represent an excellent tool for drug promotion because they typically overestimate the clinical benefit of any treatment …”
Section: Nonregulatory Trialsmentioning
confidence: 99%
See 3 more Smart Citations
“…These trials are often referred to as “seeding trials,: that is, trials of little or no scientific value that are intended to familiarize clinicians with the use of recently introduced products, increase the utilization of the same products through enrolment of patients in a “study,” generate misleading information about the value of specific drugs and, at times, promote off‐label use for nonapproved indications . The overwhelming majority of clinical trials conducted postmarketing consists of uncontrolled trials, and these trials can represent an excellent tool for drug promotion because they typically overestimate the clinical benefit of any treatment …”
Section: Nonregulatory Trialsmentioning
confidence: 99%
“…A more insidious way to generate data useful for drug promotion consists of conducting RCTs that incorporate bias favoring the sponsor's product . These bias can affect any aspect of a trial design, from the choice of eligibility criteria to the interpretation of the results (Table ).…”
Section: Nonregulatory Trialsmentioning
confidence: 99%
See 2 more Smart Citations
“…Observational data can be collected in routine clinical practice but often have poor procedural quality and are prone to confounding, leading to overestimation of treatment effects 1. Randomised controlled trials (RCTs) are the gold standard for determining a causal effect of interventions, but they can have a critical limitation: the results may not be applicable to other settings 2. Two factors that prevent generalisability of RCT results are strict participant selection criteria and the informed consent process—both can lead to a patient group that bears little resemblance to the population the treatment will be used in.…”
mentioning
confidence: 99%