Non-publication and publication bias in reproductive medicine: a cohort analysis

Lensen, Sarah; Jordan, Vanessa; Showell, Marian; Showell, Emily; Shen, V; Venetis, Christos A.; Farquhar, Cindy

doi:10.1093/humrep/dex236

Cited by 9 publications

(2 citation statements)

References 15 publications

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“…Most conferences understand this policy and accept most --if not allabstracts. Unfortunately, this does not always result in a high-quality peer-reviewed paper and may serve only as an entrance ticket for participation (Lensen et al, 2017). Such a policy does not encourage senior researchers to act as reviewers and may in the long term reduce the quality of the reviewing process.…”

Section: The Missing Links To a New Generation Of Reproductive Scientmentioning

confidence: 99%

Education, education, education—now more than ever?

Andersen

Kristensen

Mamsen

et al. 2018

MHR: Basic Science of Reproductive Medicine

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The generation of scientists and physicians that took part in starting the whole era of modern-assisted reproduction is currently close to retirement or has already left research. A new generation is about to take over and the profession is facing a massive transgenerational transition. Since current treatments have reached a plateau in success rates and costs, new research and development is required to further advance the field. Today, multi-disciplinary platforms including numerous research areas, not previously integrated in our field, are fundamental to achieve new clinical approaches. Structured, broader and purposeful education of young researchers should be intensified and prioritized, and innovative educational initiatives are needed to facilitate 'thinkers' and advance developments in the field of assisted reproduction.

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Section: The Missing Links To a New Generation Of Reproductive Scientmentioning

confidence: 99%

Education, education, education—now more than ever?

Andersen

Kristensen

Mamsen

et al. 2018

MHR: Basic Science of Reproductive Medicine

View full text Add to dashboard Cite

show abstract

“…A study of clinical trials conducted in Canada, including trials registered in ClinicalTrials.gov and completed between 2009 and 2019, found that only 39% of trials had reported results in the registry by early October 2021 5. Moreover, the problem of non-publication of clinical trials has been documented across many areas of medicine6–10 and, although more frequent in earlier phase trials, for all phases of clinical trials 2. Selective reporting of trials has led to less informed patient care, unnecessary harm to patients and a waste of research resources 11–13…”

Section: Introductionmentioning

confidence: 99%

Public reporting of clinical trial findings as an ethical responsibility to participants: a qualitative study

et al. 2023

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ObjectiveTo understand how the experiences and views of trial participants, trial investigators and others connected to clinical trial research relate to whether researchers have a duty to participants to publicly report research findings.DesignQualitative interview study.SettingSemistructured interviews held in person or by telephone between March 2019 and April 2021 with participants in the Canadian provinces of Alberta, British Columbia and Ontario.Participants34 participants, including 10 clinical trial participants, 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators and 3 research ethics board members.AnalysisWe conducted a thematic analysis, including qualitative coding of interview transcripts and identification of key themes.Main outcome measuresKey themes identified through qualitative coding of interview data.ResultsMost clinical trial participants felt that reporting clinical trial results is important. Accounts of trial participants suggest their contributions are part of a reciprocal relationship involving the expectation that research will advance medical knowledge. Similarly, comments from trial investigators suggest that reporting trial results is part of reciprocity with trial participants and is a necessary part of honouring informed consent. Accounts of trial investigators suggest that when drug trials are not reported, this may undermine informed consent in subsequent trials by withholding information on harms or efficacy relevant to informed decisions on whether to conduct or enroll in future trials of similar drugs.ConclusionThe views of trial participants, trial investigators and others connected to clinical trial research in Canada suggest that researchers have an obligation to participants to publicly report clinical trial results and that reporting results is necessary for honouring informed consent.

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Challenges of Obtaining Evidence-Based Information Regarding Medications and Male Fertility

Drobnis

Nangia

2017

Impacts of Medications on Male Fertility

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In the clinic, the existing literature is insufficient to counsel our infertile men on medication use. Most studies have flaws that limit their application to evidence-based practice. In this chapter, we discuss the limitations of the current literature and the challenges to designing more useful studies. Among the most important weaknesses of existing studies is lack of power; that is, too few men are included to draw conclusions about the existence and size of medication effects. Adequate power is particularly important when confirming an absence of medication effect. Bias is also a problem in most studies. Early studies were rarely randomized, placebo-controlled, or blinded; a common example is patients receiving different medication regimes based on the severity of their symptoms-making it impossible to attribute differences between treated and untreated men to the medications. Additional bias is introduced by failing to include other factors that influence the outcome in the experimental design. A uniform population amenable to randomization and placebo-control are experimental species, and useful information has been gained from these models. However, application to humans is limited by differences from other species in route of drug administration, absorption of the drug, concentration in the male genital tract tissues, and genital tract physiology. To a lesser degree, there is variation among individual men in their response to drugs. In addition, drugs in the same class may have different effects, limiting the applicability of data across drugs of a single class. Complicating matters further, a toxic medication may seem to improve fertility endpoints by improving a disease condition that diminishes fertility. Finally, drug interactions have not been studied, and actual fertility data (pregnancy/fecundity) in humans are rare. A healthy dose of skepticism is warranted when evaluating studies of medications and male reproductive health.

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Non-publication and publication bias in reproductive medicine: a cohort analysis

Abstract: Not applicable.

Cited by 9 publications

References 15 publications

Education, education, education—now more than ever?

Education, education, education—now more than ever?

Public reporting of clinical trial findings as an ethical responsibility to participants: a qualitative study

Challenges of Obtaining Evidence-Based Information Regarding Medications and Male Fertility

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