Archives des mots-clés : transparency

Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis

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Authors : Sydney A Axson, Michelle M Mello, Deborah Lincow, Catherine Yang, Cary P Gross, Joseph S Ross, Jennifer Miller

Objectives

To examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.

Design

Cross-sectional descriptive analysis.

Setting and participants

Novel drugs and biologics Food and Drug Administration (FDA) approved in 2016 and 2017 and their company sponsors.

Main outcome measures

Using established Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination and FDA Amendments Act (FDAAA) implementation; companies were ranked using these measures and a multicomponent data sharing measure.

Associations between company transparency scores with company size (large vs non-large), location (US vs non-US) and sponsored product type (drug vs biologic) were also examined.

Results

26% of products (16/62) had publicly available results for all clinical trials supporting their FDA approval and 67% (39/58) had public results for trials in patients by 6 months after their FDA approval; 58% (32/55) were FDAAA compliant.

Large companies were significantly more transparent than non-large companies (overall median transparency score of 95% (IQR 91–100) vs 59% (IQR 41–70), p<0.001), attributable to higher FDAAA compliance (median of 100% (IQR 88–100) vs 57% (0–100), p=0.01) and better data sharing (median of 100% (IQR 80–100) vs 20% (IQR 20–40), p<0.01). No significant differences were observed by company location or product type.

Conclusions

It was feasible to apply the GPS transparency measures and ranking tool to non-large companies and biologics. Large companies are significantly more transparent than non-large companies, driven by better data sharing procedures and implementation of FDAAA trial reporting requirements.

Greater research transparency is needed, particularly among non-large companies, to maximise the benefits of research for patient care and scientific innovation.

URL : Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis

DOI : http://dx.doi.org/10.1136/bmjopen-2021-053248

Integrating Qualitative Methods and Open Science: Five Principles for More Trustworthy Research

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Authors : Lee Humphreys, Neil A Lewis Jr, Katherine Sender, Andrea Stevenson Won

Recent initiatives toward open science in communication have prompted vigorous debate. In this article, we draw on qualitative and interpretive research methods to expand the key priorities that the open science framework addresses, namely producing trustworthy and quality research.

This article contributes to communication research by integrating qualitative methodological literature with open communication science research to identify five broader commitments for all communication research: validity, transparency, ethics, reflexivity, and collaboration.

We identify key opportunities where qualitative and quantitative communication scholars can leverage the momentum of open science to critically reflect on and improve our knowledge production processes.

We also examine competing values that incentivize dubious practices in communication research, and discuss several metascience initiatives to enhance diversity, equity, and inclusion in our field and value multiple ways of knowing.

URL : Integrating Qualitative Methods and Open Science: Five Principles for More Trustworthy Research

DOI : https://doi.org/10.1093/joc/jqab026

Transparency, provenance and collections as data: the National Library of Scotland’s Data Foundry

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Author : Sarah Ames

‘Collections as data’ has become a core activity for libraries in recent years: it is important that we make collections available in machine-readable formats to enable and encourage computational research. However, while this is a necessary output, discussion around the processes and workflows required to turn collections into data, and to make collections data available openly, are just as valuable.

With libraries increasingly becoming producers of their own collections – presenting data from digitisation and digital production tools as part of datasets, for example – and making collections available at scale through mass-digitisation programmes, the trustworthiness of our processes comes into question.

In a world of big data, often of unclear origins, how can libraries be transparent about the ways in which collections are turned into data, how do we ensure that biases in our collections are recognised and not amplified, and how do we make these datasets available openly for reuse?

This paper presents a case study of work underway at the National Library of Scotland to present collections as data in an open and transparent way – from establishing a new Digital Scholarship Service, to workflows and online presentation of datasets.

It considers the changes to existing processes needed to produce the Data Foundry, the National Library of Scotland’s open data delivery platform, and explores the practical challenges of presenting collections as data online in an open, transparent and coherent manner.

URL : Transparency, provenance and collections as data: the National Library of Scotland’s Data Foundry

Original location : https://www.liberquarterly.eu/article/10.18352/lq.10371/

Assessment of transparency indicators across the biomedical literature: How open is open?

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Authors : Stylianos Serghiou, Despina G. Contopoulos-Ioannidis, Kevin W. Boyack, Nico Riedel, Joshua D. Wallach, John P. A. Ioannidis

Recent concerns about the reproducibility of science have led to several calls for more open and transparent research practices and for the monitoring of potential improvements over time. However, with tens of thousands of new biomedical articles published per week, manually mapping and monitoring changes in transparency is unrealistic.

We present an open-source, automated approach to identify 5 indicators of transparency (data sharing, code sharing, conflicts of interest disclosures, funding disclosures, and protocol registration) and apply it across the entire open access biomedical literature of 2.75 million articles on PubMed Central (PMC).

Our results indicate remarkable improvements in some (e.g., conflict of interest [COI] disclosures and funding disclosures), but not other (e.g., protocol registration and code sharing) areas of transparency over time, and map transparency across fields of science, countries, journals, and publishers.

This work has enabled the creation of a large, integrated, and openly available database to expedite further efforts to monitor, understand, and promote transparency and reproducibility in science.

URL : Assessment of transparency indicators across the biomedical literature: How open is open?

DOI : https://doi.org/10.1371/journal.pbio.3001107

Survey study of research integrity officers’ perceptions of research practices associated with instances of research misconduct

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Author : Michael Kalichman

Background

Research on research integrity has tended to focus on frequency of research misconduct and factors that might induce someone to commit research misconduct.

A definitive answer to the first question has been elusive, but it remains clear that any research misconduct is too much. Answers to the second question are so diverse, it might be productive to ask a different question: What about how research is done allows research misconduct to occur?

Methods

With that question in mind, research integrity officers (RIOs) of the 62 members of the American Association of Universities were invited to complete a brief survey about their most recent instance of a finding of research misconduct.

Respondents were asked whether one or more good practices of research (e.g., openness and transparency, keeping good research records) were present in their case of research misconduct.

Results

Twenty-four (24) of the respondents (39% response rate) indicated they had dealt with at least one finding of research misconduct and answered the survey questions. Over half of these RIOs reported that their case of research misconduct had occurred in an environment in which at least nine of the ten listed good practices of research were deficient.

Conclusions

These results are not evidence for a causal effect of poor practices, but it is arguable that committing research misconduct would be more difficult if not impossible in research environments adhering to good practices of research.

URL : Survey study of research integrity officers’ perceptions of research practices associated with instances of research misconduct

DOI : https://doi.org/10.1186/s41073-020-00103-1

Research transparency promotion by surgical journals publishing randomised controlled trials: a survey

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Authors : Nicolas Lombard, A. Gasmi, L. Sulpice, K. Boudjema, Damien Bergeat

Objective

To describe surgical journals’ position statements on data-sharing policies (primary objective) and to describe key features of their research transparency promotion.

Methods

Only “SURGICAL” journals with an impact factor higher than 2 (Web of Science) were eligible for the study. They were included, if there were explicit instructions for clinical trial publication in the official instructions for authors (OIA) or if they had published randomised controlled trial (RCT) between 1 January 2016 and 31 December 2018.

The primary outcome was the existence of a data-sharing policy included in the instructions for authors. Data-sharing policies were grouped into 3 categories, inclusion of data-sharing policy mandatory, optional, or not available.

Details on research transparency promotion were also collected, namely the existence of a “prospective registration of clinical trials requirement policy”, a conflict of interests (COIs) disclosure requirement, and a specific reference to reporting guidelines, such as CONSORT for RCT.

Results

Among the 87 surgical journals identified, 82 were included in the study: 67 (82%) had explicit instructions for RCT and the remaining 15 (18%) had published at least one RCT. The median impact factor was 2.98 [IQR = 2.48–3.77], and in 2016 and 2017, the journals published a median of 11.5 RCT [IQR = 5–20.75].

The OIA of four journals (5%) stated that the inclusion of a data-sharing statement was mandatory, optional in 45% (n = 37), and not included in 50% (n = 41).

No association was found between journal characteristics and the existence of data-sharing policies (mandatory or optional). A “prospective registration of clinical trials requirement” was associated with International Committee of Medical Journal Editors (ICMJE) allusion or affiliation and higher impact factors.

Journals with specific RCT instructions in their OIA and journals referenced on the ICMJE website more frequently mandated the use of CONSORT guidelines.

Conclusion

Research transparency promotion is still limited in surgical journals. Standardisation of journal requirements according to ICMJE guidelines could be a first step forward for research transparency promotion in surgery.

URL : Research transparency promotion by surgical journals publishing randomised controlled trials: a survey

DOI : https://doi.org/10.1186/s13063-020-04756-7

Low availability of code in ecology: A call for urgent action

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Authors : Antica Culina, Ilona van den Berg, Simon Evans, Alfredo Sánchez-Tójar

Access to analytical code is essential for transparent and reproducible research. We review the state of code availability in ecology using a random sample of 346 nonmolecular articles published between 2015 and 2019 under mandatory or encouraged code-sharing policies.

Our results call for urgent action to increase code availability: only 27% of eligible articles were accompanied by code. In contrast, data were available for 79% of eligible articles, highlighting that code availability is an important limiting factor for computational reproducibility in ecology.

Although the percentage of ecological journals with mandatory or encouraged code-sharing policies has increased considerably, from 15% in 2015 to 75% in 2020, our results show that code-sharing policies are not adhered to by most authors.

We hope these results will encourage journals, institutions, funding agencies, and researchers to address this alarming situation.

URL : Low availability of code in ecology: A call for urgent action

DOI : https://doi.org/10.1371/journal.pbio.3000763