Prospective Clinical Trial Registration: A Prerequisite for Publishing Your Results | Radiology

“The ICMJE requires that clinical trial results be published in the same clinical trial depository where the trial is registered. These results are in the form of a short (?500 words) abstract or table (6,7). Full disclosure of the existing results publication in a clinical trial registry should be explicitly stated when the manuscript is submitted for publication. The Food and Drug Administration (FDA) has indicated it will enforce trial results reporting related to ClinicalTrials.gov (8). The FDA is authorized to seek civil monetary penalties from responsible parties, including additional civil monetary penalties. In the United States, the sponsor of an applicable clinical trial is considered the responsible party, unless or until the sponsor designates a qualified principal investigator as the responsible party. The FDA issued its first Notice of Noncompliance in April 2021 for failure to report results in ClinicalTrials.gov based on a lack of reporting the safety and effectiveness results for the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (8).

Finally, as of July 1, 2018, manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement. Clinical trials that begin enrolling participants on or after January 1, 2019, must include a data sharing plan in the trial registration. (for further information, see www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html). Since most clinical trials take 2 or more years for results to be reported, the Radiology editorial board had expected such mandatory data sharing plans to be reported in the current year. However, because of the COVID-19 pandemic, many clinical trials were halted. Thus, journal publication requirements to include data sharing statements are more likely to impact authors beginning in 2023. Data sharing statements required for Radiological Society of North America (RSNA) journals may be found at https://pubs.rsna.org/page/policies#clinical.

In conclusion, prospective clinical trial registration is a mechanism allowing us to ensure transparency in clinical research conduct, honest and complete reporting of the clinical trial results, and minimization of selective result publications. Since its inception in 2004, this requirement has evolved into a policy that is practiced by major medical journals worldwide, is mandatory for publication of trial results, and, in some circumstances, is enforced by the FDA. Further, ICMJE journals, including RSNA journals, are expecting manuscripts that report trial results to include statements on data sharing. As each clinical trial design is unique, we encourage authors to refer to the full description of the current ICMJE policy at icmje.org for additional information pertaining to their specific circumstances.”

Risky business: COVAX and the financialization of global vaccine equity | Globalization and Health | Full Text

Abstract:  Background

During the first year and a half of the COVID-19 pandemic, COVAX has been the world’s most prominent effort to ensure equitable access to SARS-CoV-2 vaccines. Launched as part of the Access to COVID-19 Tools Accelerator (Act-A) in June 2020, COVAX suggested to serve as a vaccine buyers’ and distribution club for countries around the world. It also aimed to support the pharmaceutical industry in speeding up and broadening vaccine development. While COVAX has recently come under critique for failing to bring about global vaccine equity, influential politicians and public health advocates insist that future iterations of it will improve pandemic preparedness. So far COVAX’s role in the ongoing financialization of global health, i.e. in the rise of financial concepts, motives, practices and institutions has not been analyzed.

Methods

This article describes and critically assesses COVAX’s financial logics, i.e. the concepts, arguments and financing flows on which COVAX relies. It is based on a review of over 109 COVAX related reports, ten in-depth interviews with global health experts working either in or with COVAX, as well as participant observation in 18 webinars and online meetings concerned with global pandemic financing, between September 2020 and August 2021.

Results

The article finds that COVAX expands the scale and scope of financial instruments in global health governance, and that this is done by conflating different understandings of risk. Specifically, COVAX conflates public health risk and corporate financial risk, leading it to privilege concerns of pharmaceutical companies over those of most participating countries – especially low and lower-middle income countries (LICs and LMICs). COVAX thus drives the financialization of global health and ends up constituting a risk itself – that of perpetuating the downsides of financialization (e.g. heightened inequality, secrecy, complexity in governance, an ineffective and slow use of aid), whilst insufficiently realising its potential benefits (pandemic risk reduction, increased public access to emergency funding, indirect price control over essential goods and services).

Conclusion

Future iterations of vaccine buyers’ and distribution clubs as well as public vaccine development efforts should work towards reducing all aspects of public health risk rather than privileging its corporate financial aspects. This will include reassessing the interplay of aid and corporate subsidies in global health.

CORONA Project Demonstrates Value of Sharing Knowledge to Save Lives – SPARC

“On Friday, March 13, 2020, much of the United States shut down with COVID-19 restrictions. Three days later, Dr. David Fajgenbaum launched an effort to track and publicly share what drugs were being tried to combat the disease.

The CORONA (Covid-19 Registry of Off-label & New Agents) Project has been a valued resource ever since, keeping an inventory – in real time – of the now more than 500 treatments that have been administered to COVID-19 patients. Fajgenbaum led a team that has reviewed thousands of journal articles to identify the drugs, determine which are most promising at various stages, and make it all available through an open-source data repository.

 

In the past 18 months, more than 30,000 unique users have viewed the database, including members of the general public and officials from the National Institutes of Health and the U.S. Food and Drug Administration who have used the database to select drugs to test in clinical trials….”

Clinical trials and tribulations: lessons from spinal cord injury studies registered on ClinicalTrials.gov | Spinal Cord

Abstract:  Objective

ClinicalTrials.gov is an online trial registry that provides public access to information on past, present, and future clinical trials. While increasing transparency in research, the quality of the information provided in trial registrations is highly variable. The objective of this study is to assess key areas of information on ClinicalTrials.gov in interventional trials involving people with spinal cord injuries.

Setting

Interventional trials on ClinicalTrials.gov involving people with spinal cord injuries.

Methods

A subset of data on interventional spinal cord injury trials was downloaded from ClinicalTrials.gov. Reviewers extracted information pertaining to study type, injury etiology, spinal cord injury characteristics, timing, study status, and results.

Results

Of the interventional trial registrations reviewed, 62.5%, 58.6%, and 24.3% reported injury level, severity, and etiology, respectively. The timing of intervention relative to injury was reported in 72.8% of registrations. Most trials identified a valid study status (89.2%), but only 23.5% of those completed studies had posted results.

Conclusions

Our review provides a snapshot of interventional clinical trials conducted in the field of spinal cord injury and registered in ClinicalTrials.gov. Areas for improvement were identified with regards to reporting injury characteristics, as well as posting results.

Characteristics of available studies and dissemination of research using major clinical data sharing platforms – Enrique Vazquez, Henri Gouraud, Florian Naudet, Cary P Gross, Harlan M Krumholz, Joseph S Ross, Joshua D Wallach, 2021

Abstract:  Background/Aims:

Over the past decade, numerous data sharing platforms have been launched, providing access to de-identified individual patient-level data and supporting documentation. We evaluated the characteristics of prominent clinical data sharing platforms, including types of studies listed as available for request, data requests received, and rates of dissemination of research findings from data requests.

Methods:

We reviewed publicly available information listed on the websites of six prominent clinical data sharing platforms: Biological Specimen and Data Repository Information Coordinating Center, ClinicalStudyDataRequest.com, Project Data Sphere, Supporting Open Access to Researchers–Bristol Myers Squibb, Vivli, and the Yale Open Data Access Project. We recorded key platform characteristics, including listed studies and available supporting documentation, information on the number and status of data requests, and rates of dissemination of research findings from data requests (i.e. publications in a peer-reviewed journals, preprints, conference abstracts, or results reported on the platform’s website).

Results:

The number of clinical studies listed as available for request varied among five data sharing platforms: Biological Specimen and Data Repository Information Coordinating Center (n?=?219), ClinicalStudyDataRequest.com (n?=?2,897), Project Data Sphere (n?=?154), Vivli (n?=?5426), and the Yale Open Data Access Project (n?=?395); Supporting Open Access to Researchers did not provide a list of Bristol Myers Squibb studies available for request. Individual patient-level data were nearly always reported as being available for request, as opposed to only Clinical Study Reports (Biological Specimen and Data Repository Information Coordinating Center?=?211/219 (96.3%); ClinicalStudyDataRequest.com?=?2884/2897 (99.6%); Project Data Sphere?=?154/154 (100.0%); and the Yale Open Data Access Project?=?355/395 (89.9%)); Vivli did not provide downloadable study metadata. Of 1201 data requests listed on ClinicalStudyDataRequest.com, Supporting Open Access to Researchers–Bristol Myers Squibb, Vivli, and the Yale Open Data Access Project platforms, 586 requests (48.8%) were approved (i.e. data access granted). The majority were for secondary analyses and/or developing/validating methods (ClinicalStudyDataRequest.com?=?262/313 (83.7%); Supporting Open Access to Researchers–Bristol Myers Squibb?=?22/30 (73.3%); Vivli?=?63/84 (75.0%); the Yale Open Data Access Project?=?111/159 (69.8%)); four were for re-analyses or corroborations of previous research findings (ClinicalStudyDataRequest.com?=?3/313 (1.0%) and the Yale Open Data Access Project?=?1/159 (0.6%)). Ninety-five (16.1%) approved data requests had results disseminated via peer-reviewed publications (ClinicalStudyDataRequest.com?=?61/313 (19.5%); Supporting Open Access to Researchers–Bristol Myers Squibb?=?3/30 (10.0%); Vivli?=?4/84 (4.8%); the Yale Open Data Access Project?=?27/159 (17.0%)). Forty-two (6.8%) additional requests reported results through preprints, conference abstracts, or on the platform’s website (ClinicalStudyDataRequest.com?=?12/313 (3.8%); Supporting Open Access to Researchers–Bristol Myers Squibb?=?3/30 (10.0%); Vivli?=?2/84 (2.4%); Yale Open Data Access Project?=?25/159 (15.7%)).

Conclusion:

Across six prominent clinical data sharing platforms, information on studies and request metrics varied in availability and format. Most data requests focused on secondary analyses and approximately one-quarter of all approved requests publicly disseminated their results. To further promote the use of shared clinical data, platforms should increase transparency, consistently clarify the availability of the listed studies and supporting documentation, and ensure that research findings from data requests are disseminated.

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.

Drug discovery project shows potential of smart openness – Research Professional News

“Commitment to sharing doesn’t mean you can’t work with industry, say Hamish Evans and colleagues

There are several ways for scientific research and innovation to have an impact on society. Different routes to impact are, however, often seen as being in tension. In particular, commercialisation and open science can sometimes seem to be mutually exclusive….”

The National Institute of Pharmaceutical Education and Research partners with F1000 to launch OA publishing hub in India

“The National Institute of Pharmaceutical Education and Research (NIPER-Kolkata) launched its own open access publishing hub with F1000, Taylor & Francis Group’s open research publishing arm. This will be hosted on the F1000Research site, adopting its pioneering approach to open science publishing.

NIPER-Kolkata, founded in 2007 as a centre of excellence for higher education, research and development in Pharmaceutical Sciences, will be adopting F1000’s open science practices to increase the reproducibility and accessibility of their published research. This means the research is free for anyone to read and will use the innovative F1000Research publishing model that combines the benefits of rapid publication with mechanisms to assure quality and transparency, thereby accelerating research impact.

The NIPER-Kolkata gateway provides a home for their conference-linked outputs, enabling their scientific outcomes to be published open access. This gateway welcomes submissions from the fields of, drug discovery, process chemistry, pharmacological studies, natural products, pharmaceutical formulation, computational studies, and medical devices, published in all forms, from traditional research articles, to a protocols, registered report, data notes, case studies, and much more….”

NIH-Wide Strategic Plan: Fiscal Years 2021-2025

“NIH is committed to making findings from the research that it funds accessible and available in a timely manner, while also providing safeguards for privacy, intellectual property, security, and data management. For instance, NIH-funded investigators are expected to make the results and accomplishments of their activities freely available within 12 months of publication. NIH also encourages investigators to share results prior to peer review, such as through preprints, to speed the dissemination of their findings and enhance the rigor of their work through informal peer review. A robust culture of data sharing is critical to continued progress in science, maximizing NIH’s investment in research, and assurance of the highest levels of transparency and rigor. To this end, NIH will continue to promote opportunities for data management and sharing while allowing flexibility for various data types, sharing platforms, and strategies. Additionally, NIH is implementing a policy requiring that all applications include data sharing and management plans that consider input from stakeholders….”

?Clarivate?Acquires?Bioinfogate, Reinforcing Position as Premier Provider of End-to-End Research Intelligence Solutions for Life Sciences – Clarivate

“?Clarivate Plc?(NYSE:CLVT), a global leader in providing trusted information and insights to accelerate the pace of innovation, today announced that it has acquired Bioinfogate, a leading provider of analytics solutions in the life sciences and producer of the OFF-X™?portal.?Financial terms of the transaction were not disclosed.

The?Bioinfogate?OFF-X™?portal is a cutting-edge safety intelligence solution aimed at empowering pharmaceutical organizations to identify toxicology and safety signals, mitigate safety liabilities and de-risk early-stage assets. It is one of the largest?translational safety and toxicity?portals, featuring over 1,200,000 safety alerts corresponding to over 23,000 drugs and biologics and more than 15,000 targets of pharmacological interest….”

Editorial policy regarding the citation of preprints in the British Journal of Pharmacology (BJP) – George – – British Journal of Pharmacology – Wiley Online Library

“Because of the increasing number of articles submitted to BJP over the past year and that cite preprint material, the Editor-In-Chief and Senior Editors with the full Editorial Board of BJP have undertaken a review of the issues and our discipline-relevant data to set policy on the issue of preprint citation for the Journal….

The discussion so far has highlighted the negative aspects of preprints, but it is important to be balanced in our considerations and to note that, during the COVID-19 pandemic, the availability of preprints has been viewed as a key factor in the break-neck speed with which the biomedical research community has shared research on insights regarding the biology and clinical features of the infection, resulting in the rapid and timely delivery of much needed therapeutic options (Else, 2020)….

An excellent example is the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial which showed the benefit of the simple and low-cost utility of dexamethasone that has saved many lives globally. The RECOVERY trial was published as a preprint on 22 June 2020 (Horby et al., 2020) and as a peer-reviewed article published as an epub in the New England Journal of Medicine on July 17th 2020 (RECOVERY collaborative group, 2021). Whilst it is highly likely that the preprint publication and sharing of the results saved lives during the short time between preprint posting and full publication, the data were made available to regulatory authorities and clinicians prior to full publication….

CONCLUSION: THE BJP WILL NOT ALLOW THE FORMAL CITATION OF PREPRINTS

 

The Editorial Board of the BJP support the principles of preprinting. However, given the potential risks associated with allowing the citation of preprints, it is our collective view, supported by feedback received from the journal’s international Editorial Board, that BJP should take all reasonable steps to avoid perpetuating these risks….

We are aware that the issue of preprint citation is under discussion at COPE and that the British Pharmacological Society is establishing a working group to review this issue more broadly across its publications. Thus, the stated editorial position will be reviewed, and if solutions to the problems highlighted above emerge, we will revisit our policy….”

Does open access to academic research help small, science-based companies? | Emerald Insight

Abstract:  Purpose

This study investigates the extent to which a company’s usage of open access (OA) literature for R&D activities depends on its size. The authors’ assumption is that smaller pharmaceutical companies have less access to (usually expensive) journal subscriptions.

Design/methodology/approach

A fixed-effect Poisson model was used to study a panel dataset of USPTO pharmaceutical company patents. The dependent variable is the count of citations to OA resources in a given company patent.

Findings

Results support current anecdotal evidence that many SMEs suffer from high journal prices.

Originality/value

This result justifies the assumption made by policymakers about the potentially positive impact OA mandates have on national innovation activity. It was also shown that collaborating with universities can be a potential coping mechanism for companies that struggle to gain access to the journals they need. In addition to the novelty of its findings, this study introduces a new way to study the impact of OA in nonacademic contexts.

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….”