ArticleAnnals of internal medicine2010
Clinical trials: discerning hype from substance.
Article in Annals of internal medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 20 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Reporting of Design Features and Analysis Details in Randomized Clinical Trials of Procedural Treatments for Cancer Pain: An ACTTION Systematic Review.Regional anesthesia and pain medicinePooled it
- The ACTTION Guide to Clinical Trials of Pain Treatments, part II: mitigating bias, maximizing value.Pain reportsTrial
- Exploratory analyses of clinical trials - what can they tell us and what are the potential pitfalls?Nature communications · 2026Article
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.BMJ (Clinical research ed.) · 2025Article
- CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials.BMJ (Clinical research ed.) · 2025Article
- Finding the (biomarker-defined) subgroup of patients who benefit from a novel therapy: No time for a game of hide and seek.Clinical trials (London, England) · 2023Article
- Application of Bayesian approaches in drug development: starting a virtuous cycle.Nature reviews. Drug discovery · 2023Review
- Exploratory analyses of clinical trial data used for health technology assessments: a retrospective evaluation.BMJ open · 2022Article
- Review
- Discussion: The role, position, and function of the FDA-The past, present, and future.Biostatistics (Oxford, England) · 2017Article
- In Pursuit of Greater Reproducibility and Credibility of Early Clinical Biomarker Research.Clinical and translational science · 2017Article
- Trials in adult critical care that show increased mortality of the new intervention: Inevitable or preventable mishaps?Annals of intensive care · 2016Article
- Evaluating interventions for Ebola: The need for randomized trials.Clinical trials (London, England) · 2016Article
- Treatment effect heterogeneity for univariate subgroups in clinical trials: Shrinkage, standardization, or else.Biometrical journal. Biometrische Zeitschrift · 2016Article
- Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov.Journal of the American Heart Association · 2013Article
- SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.BMJ (Clinical research ed.) · 2013 · on this mapArticle
- Some essential considerations in the design and conduct of non-inferiority trials.Clinical trials (London, England) · 2011Article
- Adjuvant trastuzumab for breast cancer: uncertainties in clinical and economic evidence following early stopping of the HERA trial.PharmacoEconomics · 2011Article
- Adjuvant chemotherapy in 2011 for patients with soft-tissue sarcoma.Nature reviews. Clinical oncology · 2011Review
- Ethical considerations in the design, execution, and analysis of clinical trials of chronic pain treatments.Pain reportsArticle
Corrections and comments
- Erratum issued
Authors and funding
1 author.
Funding
Abstract
The interest in being able to interpret and report results in clinical trials as being favorable is pervasive throughout health care research. This important source of bias needs to be recognized, and approaches need to be implemented to effectively address it. The prespecified primary analyses of the primary and secondary end points of a clinical trial should be clearly specified when disseminating results in press releases and journal publications. There should be a focus on these analyses when interpreting the results. A substantial risk for biased conclusions is produced by conducting exploratory analyses with an intention to establish that the benefit-to-risk profile of the experimental intervention is favorable, rather than to determine whether it is. In exploratory analyses, P values will be misleading when the actual sampling context is not presented to allow for proper interpretation, and the effect sizes of outcomes having particularly favorable estimates are probably overestimated because of "random high" bias. Performing exploratory analyses should be viewed as generating hypotheses that usually require reassessment in prospectively conducted confirmatory trials. Awareness of these issues will meaningfully improve our ability to be guided by substance, not hype, in making evidence-based decisions about medical care.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.