Status, use and impact of sharing individual participant data from clinical trials: a scoping review | BMJ Open

Abstract:  Objectives To explore the impact of data-sharing initiatives on the intent to share data, on actual data sharing, on the use of shared data and on research output and impact of shared data.

Eligibility criteria All studies investigating data-sharing practices for individual participant data (IPD) from clinical trials.

Sources of evidence We searched the Medline database, the Cochrane Library, the Science Citation Index Expanded and the Social Sciences Citation Index via Web of Science, and preprints and proceedings of the International Congress on Peer Review and Scientific Publication. In addition, we inspected major clinical trial data-sharing platforms, contacted major journals/publishers, editorial groups and some funders.

Charting methods Two reviewers independently extracted information on methods and results from resources identified using a standardised questionnaire. A map of the extracted data was constructed and accompanied by a narrative summary for each outcome domain.

Results 93 studies identified in the literature search (published between 2001 and 2020, median: 2018) and 5 from additional information sources were included in the scoping review. Most studies were descriptive and focused on early phases of the data-sharing process. While the willingness to share IPD from clinical trials is extremely high, actual data-sharing rates are suboptimal. A survey of journal data suggests poor to moderate enforcement of the policies by publishers. Metrics provided by platforms suggest that a large majority of data remains unrequested. When requested, the purpose of the reuse is more often secondary analyses and meta-analyses, rarely re-analyses. Finally, studies focused on the real impact of data-sharing were rare and used surrogates such as citation metrics.

Conclusions There is currently a gap in the evidence base for the impact of IPD sharing, which entails uncertainties in the implementation of current data-sharing policies. High level evidence is needed to assess whether the value of medical research increases with data-sharing practices.

Where Did the Web Archive Go?

Abstract:  To perform a longitudinal investigation of web archives and detecting variations and changes replaying individual archived pages, or mementos, we created a sample of 16,627 mementos from 17 public web archives. Over the course of our 14-month study (November, 2017 – January, 2019), we found that four web archives changed their base URIs and did not leave a machine-readable method of locating their new base URIs, necessitating manual rediscovery. Of the 1,981 mementos in our sample from these four web archives, 537 were impacted: 517 mementos were rediscovered but with changes in their time of archiving (or Memento-Datetime), HTTP status code, or the string comprising their original URI (or URI-R), and 20 of the mementos could not be found at all.

 

North Carolina invents math crimes against the state | Washington Examiner

“The math police told Nutt to keep his answers to himself. If he offers testimony that requires “engineering knowledge,” the state will bust him like a math outlaw because he lacks a professional engineering license — something he never needed during his career. Engineers at manufacturing firms such as DuPont have an exemption to the requirement….”

Elsevier’s OA Win — and Florida’s Fail – by Kent Anderson – The Geyser — Hot Takes & Deep Thinking on the Info Economy

“Two quick notes about predictable consequences this Monday morning. The first involves Elsevier’s well-known-by-now success in the OA market, emphasized in their earnings call on June 30, 2021, and captured in a transcript released late last week. In it, Elsevier executives claim they are growing faster in OA articles and revenues than the overall market, suggesting they are stealing share from others. What’s also striking is that the battle has become — in Elsevier’s mind, and probably in actual fact — between Elsevier and “other major providers.” That is, the era of a diverse publishing ecosystem continues to wind down as the consolidation so many predicted decades ago — including yours truly — has now become the norm.

The irony of all this is that OA — which has always been willing to move the goalposts and has held out a litany of diverse goals, not all of which made sense or have ever been measured — once included the goal of gutting the large commercial publishers like Elsevier. Instead, the middle of the market has been gutted — just as in nearly every other media space since the introduction of broadband. Entirely predictable, often predicted, entirely avoidable, but here we are — a few major providers dominating the scholarly and scientific publishing landscape, with Elsevier taking pole position….”

 

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

Abstract:  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.

Clinical trial results for FDA-approved drugs often remain hidden, new study finds

“A team of American researchers examined 62 products by 42 pharma companies that gained FDA approval in 2016 and 2017. Collectively, these drugs and biologics were approved based on 1,017 clinical trials involving more than 187,000 participants….

Around a quarter of these trials were subject to the FDA Amendments Act, a transparency law that requires drug makers to register applicable trials on a public registry within 21 days of their start date, and to make their results public on the registry within 30 days of initial FDA approval of a product.

 

 

 

 

 

The study team found that 55 of the 62 FDA approvals included at least one clinical trial that was subject to the transparency law. However, in the case of 13 products, these trials did not consistently meet legal registration or reporting requirements.

Large pharma companies were far more likely to comply with the law. For example, Merck Sharp & Dohme was legally responsible for registering and reporting 27 trials, and fully complied in every single case. However, several other major players – Gilead, Johnson & Johnson / Janssen, Novo Nordisk, Sanofi, and Shire – fell short of legal requirements.

 

 

Nonetheless, the study – which also covered companies’ data sharing policies – found that overall, there had been “sustained improvement” in pharma industry disclosure practices compared to previous years….”

 

European law could improve ‘scandalous’ lack of clinical trial data reporting | Science | AAAS

“The global pandemic has turned a spotlight on clinical trials, which test thousands of drugs and therapies each year. In Europe, however, the enthusiasm for trials is not matched with a zeal for reporting the results to the public. A total of 3846 European trials—nearly 28% of 13,874 completed trials in the EU Clinical Trials Register (EUCTR) on 1 July—had not posted their results on the register, according to the latest data from the EU Trials Tracker, set up by U.K. researchers in 2018 to expose lax reporting. Public research hospitals and universities, not drugmakers, are responsible for the vast majority of the lapses, which appear to violate European rules that require sponsors to post their results within 1 year of a trial’s conclusion….”

The burden of article processing charges on Canadian universities

Abstract:  The question about the cost of access to scholarly resources is usually answered by focusing on subscription cost. This study highlights the article processing charges (APCs) paid by Canada’s research institution as an additional scholarly resource. Unpaywall database was queried with the DOIs of CARL member universities’ publication indexed in the Web of Science. We find that while Open Access should in principle reduce the cost of access to scholarly literature, we are rather in a situation where both the cost of access and the cost of publishing are increasing simultaneously.

Supporting Impactful Publications (SIP) Program | provost

“The Tulane Supporting Impactful Publications (SIP) assists in covering fees to support open access options for high impact peer-reviewed publications for Tulane scholars serving as corresponding authors who do not have grant or other funds available to cover them. This program is funded and coordinated by the Office of Academic Affairs and Provost and co-funded by the Office of Academic Affairs and Tulane Libraries and Academic Information Resources. …

Eligible applicants may apply for funds once a peer reviewed journal article has been accepted for publication in a journal with impact factor of 8 or above. Applications for journals with impact factors <8 will also be considered for funding when the corresponding author provides a compelling case to do so. One application may be submitted per eligible publication….”

Owens | Scholarly Communication Outside the R1: Measuring Faculty and Graduate Student Knowledge and Interest at a Doctoral/Professional University | Journal of Librarianship and Scholarly Communication

Abstract:  INTRODUCTION This study explores the baseline knowledge and interest of faculty and graduate students at a Carnegie-classified Doctoral/Professional University regarding different components of scholarly communication. METHODS A survey was developed to inquire about such topics as scholarly research, scholarly publishing, access to research, copyright, measuring impact, promoting research, and open-educational resources. Responses more significantly represented the humanities and social sciences versus the natural and applied sciences. RESULTS & DISCUSSION Results showed some hesitancy in embracing the open access (OA) publishing model, especially the use of article processing charges (APCs). Faculty largely collect original data and believe public access to original data is important, but this varies by college and includes almost one-fourth of faculty who do not feel that sharing data is important. The areas in which respondents expressed the highest level of knowledge correlate directly with the areas in which respondents expressed the most interest in professional development. Preferences in professional development modality were split between virtual and in-person sessions. With virtual sessions specifically, graduate students prefer synchronous sessions while faculty prefer pre-recorded sessions. CONCLUSION Respondents were generally aware of the library’s current scholarly communications services, but additional promotion and marketing is still needed, especially for colleges with the lowest areas of engagement.

 

MIT and Harvard Have Sold Higher Education’s Future

“Last week Harvard University and the Massachusetts Institute of Technology sold their edX platform to a for-profit company for $800 million. Founded by the two institutions nearly a decade ago, edX was higher education’s answer to the venture-backed start-ups jostling for an online-course windfall. With the sale to one of those firms, Maryland-based 2U, Harvard and MIT have surrendered. Their decision to fold is a major, and potentially fateful, act of betrayal.

Alan Garber, Harvard’s provost, adopted the language of edX’s profit-maximizing rivals in conceding defeat. “Taking full advantage of [online learning’s] potential,” he told The Harvard Gazette, “will require capital investments at greater scale than is readily attainable for a nonprofit entity like edX.” The decision to sell comes as investor interest in higher education has swelled during the pandemic. Coursera, the Silicon Valley online-course provider, went public in March, and Instructure — the maker of the popular learning-management software Canvas — filed for an IPO last week. The Covid Zoom boom has brought the inevitable wave of start-ups hoping to cash in on the virtual college classroom. So it’s no surprise that the market value of 2U, after the edX announcement, surged past $3 billion.

Before the sale, edX was academe’s public option — a mission-aligned satellite of the brick-and-mortar campus. Now all the major players in the sector are profiteers, legally obligated to maximize shareholder return….

By the turn of the millennium, most societies had handed over their journals to be published by the big commercial players, in exchange for a share of profit. Now most scholarship is published by an oligopolist quintet of information conglomerates that, in turn, charge their college customers usurious fees.

That industry is among the most profitable in the world, in part because academics write and review for free. As the historian Aileen Fyfe has shown, there was nothing inevitable about the joint custody — nonprofit colleges and for-profit publishers — we’ve ended up with. We owe our current predicament, in part, to the decisions of learned societies who chose short-term cash over their scholar-members’ long-term interests. Harvard and MIT have just made the same disastrous miscalculation….

2U’s mission is fundamentally misaligned with the university tradition. 2U, Coursera, and their venture-funded competitors are built to squeeze profit from our students, using our faculty and course offerings. Harvard and MIT had no right, in the meaningful sense, to sell us off. None of us — not faculty members, not students — signed up for edX to increase Silicon Valley’s wallet share. We will look back on this careless abrogation of stewardship as the tragic squandering that it is.”

Clinical trials: regulators’ inaction has left EU registry “riddled with inaccurate and missing data” | The BMJ

“Nearly 6000 clinical trial results are currently missing from the European trial registry, despite transparency rules requiring countries to upload results within 12 months of trial completion, a report has found.1

Researchers from the University of Oxford said the findings show that medicines regulators in the 14 European countries included in the report have failed to ensure that important data on new drugs and vaccines are rapidly and consistently made public….”

An analysis of scientometric data and publication policies of rheumatology journals | SpringerLink

“We show that OA publication does not affect citations or scientometric indexes of rheumatology journals….When choosing a rheumatology journal to publish OA, rheumatologists should consider individual OA citation patterns and APC charges together.”

Public access to protocols of contemporary cancer randomized clinical trials | Trials | Full Text

Abstract:  Access to randomized clinical trial (RCT) protocols is necessary for the interpretation and reproducibility of the study results, but protocol availability has been lacking. We determined the prevalence of protocol availability for all published cancer RCTs in January 2020. We found that only 36.1% (48/133) of RCTs had an accessible protocol and only 11.3% of RCTs (15/133) had a publicly accessible protocol that was not behind a paywall. Only 18.0% (24/133) of RCTs were published in conjunction with the protocol on the journal website. In conclusion, few cancer RCTs have an accessible research protocol. Journals should require publication of RCT protocols along with manuscripts to improve research transparency.