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

Why Open Access: Economics and Business Researchers’ Perspectives

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Authors : Carmen López-Vergara, Pilar Flores Asenjo, Alfonso Rosa-García

Public research policies have been promoting open-access publication in recent years as an adequate model for the dissemination of scientific knowledge. However, depending on the disciplines, its use is very diverse.

This study explores the determinants of open-access publication among academic researchers of economics and business, as well as their assessment of different economic measures focused on publication stimulus.

To do so, a survey of Spanish business and economics researchers was conducted. They reported an average of 19% of their publications in open-access journals, hybrids or fully Gold Route open access. Almost 80% of the researchers foresee a future increase in the volume of open-access publications.

When determining where to publish their research results, the main criterion for the selection of a scientific journal is the impact factor. Regarding open access, the most valued aspect is the visibility and dissemination it provides.

Although the cost of publication is not the most relevant criterion in the choice of a journal, three out of four researchers consider that a reduction in fees and an increase in funding are measures that would boost the open-access model.

URL : Why Open Access: Economics and Business Researchers’ Perspectives

DOI : https://doi.org/10.3390/publications9030037

Revisiting the digital humanities through the lens of Indigenous studies—or how to question the cultural blindness of our technologies and practices

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Author : Coppélie Cocq

This article examines the benefits of putting Indigenous perspectives and the digital humanities (DH) in conversation with each other in order to elaborate a DH approach that is suitable for Indigenous research and to suggest critical perspectives for a more sustainable DH.

For this purpose, the article examines practices of data harvesting, categorizing, and sharing from the perspectives of groups in the margin, more specifically in relation to Sámi research. Previous research has emphasized the role of cultural and social contexts in the design, use, and adaptation of technologies in general, and digital technologies in particular (Douglas, 1987. Inventing American broadcasting; Nissenbaum, 2001. Computer, 34, 118–120; Powell & Aitken, 2011.

The American literature scholar in the digital age) and several scholars have argued for how the application of critical studies make a fruitful contribution to the DH (Liu, 2012. Debates in the digital humanities; McPherson, 2012. Debates in the digital humanities).

This article suggests an approach that addresses a need to acknowledge the diversity of technoscientific traditions. The perspectives of Indigenous groups bring this matter to a head. In order to make the DH more sustainable and inclusive, the development of the DH should be driven by cultural studies to a greater extent than it has been so far.

A sustainable DH also means a better rendering of the plurality of the cultural values, perspectives, and ethics that characterize our fieldwork and research subjects.

URL : Revisiting the digital humanities through the lens of Indigenous studies—or how to question the cultural blindness of our technologies and practices

DOI : https://doi.org/10.1002/asi.24564

Doctoral Students’ Educational Needs in Research Data Management: Perceived Importance and Current Competencies

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Author : Jukka Rantasaari

Sound research data management (RDM) competencies are elementary tools used by researchers to ensure integrated, reliable, and re-usable data, and to produce high quality research results.

In this study, 35 doctoral students and faculty members were asked to self-rate or rate doctoral students’ current RDM competencies and rate the importance of these competencies.

Structured interviews were conducted, using close-ended and open-ended questions, covering research data lifecycle phases such as collection, storing, organization, documentation, processing, analysis, preservation, and data sharing.

The quantitative analysis of the respondents’ answers indicated a wide gap between doctoral students’ rated/self-rated current competencies and the rated importance of these competencies.

In conclusion, two major educational needs were identified in the qualitative analysis of the interviews: to improve and standardize data management planning, including awareness of the intellectual property and agreements issues affecting data processing and sharing; and to improve and standardize data documenting and describing, not only for the researcher themself but especially for data preservation, sharing, and re-using. Hence the study informs the development of RDM education for doctoral students.

URL : Doctoral Students’ Educational Needs in Research Data Management: Perceived Importance and Current Competencies

DOI : https://doi.org/10.2218/ijdc.v16i1.684

Preprints in times of COVID19: the time is ripe for agreeing on terminology and good practices

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Authors : Raffaella Ravinetto, Céline Caillet, Muhammad H. Zaman, Jerome Amir Singh, Philippe J. Guerin, Aasim Ahmad, Carlos E. Durán, Amar Jesani, Ana Palmero, Laura Merson, Peter W. Horby, E. Bottieau, Tammy Hoffmann, Paul N. Newton

Over recent years, the research community has been increasingly using preprint servers to share manuscripts that are not yet peer-reviewed. Even if it enables quick dissemination of research findings, this practice raises several challenges in publication ethics and integrity.

In particular, preprints have become an important source of information for stakeholders interested in COVID19 research developments, including traditional media, social media, and policy makers.

Despite caveats about their nature, many users can still confuse pre-prints with peer-reviewed manuscripts. If unconfirmed but already widely shared first-draft results later prove wrong or misinterpreted, it can be very difficult to “unlearn” what we thought was true. Complexity further increases if unconfirmed findings have been used to inform guidelines.

To help achieve a balance between early access to research findings and its negative consequences, we formulated five recommendations: (a) consensus should be sought on a term clearer than ‘pre-print’, such as ‘Unrefereed manuscript’, “Manuscript awaiting peer review” or ‘’Non-reviewed manuscript”; (b) Caveats about unrefereed manuscripts should be prominent on their first page, and each page should include a red watermark stating ‘Caution—Not Peer Reviewed’; (c) pre-print authors should certify that their manuscript will be submitted to a peer-review journal, and should regularly update the manuscript status; (d) high level consultations should be convened, to formulate clear principles and policies for the publication and dissemination of non-peer reviewed research results; (e) in the longer term, an international initiative to certify servers that comply with good practices could be envisaged.

URL : Preprints in times of COVID19: the time is ripe for agreeing on terminology and good practices

DOI : https://doi.org/10.1186/s12910-021-00667-7

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

Publication patterns’ changes due to the COVID-19 pandemic: a longitudinal and short-term scientometric analysis

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Authors : Shir Aviv-Reuven, Ariel Rosenfeld

In recent months the COVID-19 (also known as SARS-CoV-2 and Coronavirus) pandemic has spread throughout the world. In parallel, extensive scholarly research regarding various aspects of the pandemic has been published. In this work, we analyse the changes in biomedical publishing patterns due to the pandemic.

We study the changes in the volume of publications in both peer reviewed journals and preprint servers, average time to acceptance of papers submitted to biomedical journals, international (co-)authorship of these papers (expressed by diversity and volume), and the possible association between journal metrics and said changes.

We study these possible changes using two approaches: a short-term analysis through which changes during the first six months of the outbreak are examined for both COVID-19 related papers and non-COVID-19 related papers; and a longitudinal approach through which changes are examined in comparison to the previous four years.

Our results show that the pandemic has so far had a tremendous effect on all examined accounts of scholarly publications: A sharp increase in publication volume has been witnessed and it can be almost entirely attributed to the pandemic; a significantly faster mean time to acceptance for COVID-19 papers is apparent, and it has (partially) come at the expense of non-COVID-19 papers; and a significant reduction in international collaboration for COVID-19 papers has also been identified.

As the pandemic continues to spread, these changes may cause a slow down in research in non-COVID-19 biomedical fields and bring about a lower rate of international collaboration.

DOI : https://doi.org/10.1007/s11192-021-04059-x