They Pledged to Donate Rights to Their COVID Vaccine, Then Sold Them to Pharma – Kaiser Health News

“Oxford University surprised and pleased advocates of overhauling the vaccine business in April by promising to donate the rights to its promising coronavirus vaccine to any drugmaker.

The idea was to provide medicines preventing or treating COVID-19 at a low cost or free of charge, the British university said. That made sense to people seeking change. The coronavirus was raging. Many agreed that traditional vaccine development, characterized by long lead times, manufacturing monopolies and weak investment, was broken….

A few weeks later, Oxford—urged on by the Bill & Melinda Gates Foundation—reversed course. It signed an exclusive vaccine deal with AstraZeneca that gave the pharmaceutical giant sole rights and no guarantee of low prices—with the less-publicized potential for Oxford to eventually make millions from the deal and win plenty of prestige….”

Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further | SpringerLink

“Over 1000 randomized clinical trials (RCTs) for the treatment and prevention of COVID-19 have been initiated. With access to the data from RCTs, researchers can integrate and summarize findings, evaluate new hypotheses, design future trials, and prioritize the next research questions to be addressed. This ensures that the value from the investment in the RCTs goes beyond the original intent of the trial protocols. None of this is possible without first having easy and responsible systems to allow access to data: the primary tenets of the open science FAIR principles dictate a proactive intent to share results and patient data from clinical trials [Wilkinson]. While much has been written and progress has been made, there is more to be done in this journey to true openness [Rockhold]. Reasons for this include (1) the well-known complexities of data access (patient privacy, content of the trial’s informed consent and the primary data holder’s decision rights as to sharing), (2) concerns about mis-interpretation of data in the context of secondary research (beyond the original intent of the trial), and (3) the use of platform trials where multiple intervention arms are studied relative to a single control arm.

The International COVID-19 Data Alliance (ICODA) is one of the groups initiating concerted data sharing as a powerful mechanism to address COVID-19. We focus our attention to RCTs recognizing that the Alliance will encompass many other data types….”

Transparency in Clinical Trials: adding value to Paediatric Dental Research – Cenci – – International Journal of Paediatric Dentistry – Wiley Online Library

Abstract:  Background

Even though considered as studies with high methodological power, many RCTs in paediatric dentistry do not have essential quality items in their design, development and report, making results’ reliability questionable, replication challenging to conduct, wasting time, money and efforts, and even exposing the participants to research for no benefit.

Aim

We addressed the main topics related to transparency in clinical research, with an emphasis in paediatric dentistry.

Design

We searched for all controlled clinical trials published from January 2019 up to July 2020 in the three paediatric dentistry journals with high journal Impact Factor, indexed on Medline. These papers were assessed for transparency according to Open Science practices and regarding reporting accuracy using some items required by CONSORT.

Results

53.6% of the studies declared registration, 75% had sample size calculation, 98.2% reported randomisation, and from those, 65.4% explained the randomisation method. Besides that, no study shared their data, and 6.8% were published in open access format.

Conclusions

Unfortunately, a large proportion of RCTs in paediatric dental research show a lack of transparency and reproducibility.

Opinion | Want Vaccines Fast? Suspend Intellectual Property Rights – The New York Times

“There aren’t enough vaccines to go around in the richest countries on earth, let alone the poorest ones.

That’s why it makes little sense that the United States, Britain and the European Union, among others, are blocking a proposal at the World Trade Organization that would allow them, and the rest of the world, to get more of the vaccines and treatments we all need.

The proposal, put forward by India and South Africa in October, calls on the W.T.O. to exempt member countries from enforcing some patents, trade secrets or pharmaceutical monopolies under the organization’s agreement on trade-related intellectual property rights, known as TRIPs….”

Full article: Pharmaceutical industry-authored preprints: scientific and social media impact

Abstract

Aim: Non–peer-reviewed manuscripts posted as preprints can be cited in peer-reviewed articles which has both merits and demerits. International Committee of Medical Journal Editors guidelines mandate authors to declare preprints at the time of manuscript submission. We evaluated the trends in pharma-authored research published as preprints and their scientific and social media impact by analyzing citation rates and altmetrics.

Research design and methods: We searched EuroPMC, PrePubMed bioRxiv and MedRxiv for preprints submitted by authors affiliated with the top 50 pharmaceutical companies from inception till June 15, 2020. Data were extracted and analyzed from the search results. The number of citations for the preprint and peer-reviewed versions (if available) were compiled using the Publish or Perish software (version 1.7). Altmetric score was calculated using the “Altmetric it” online tool. Statistical significance was analyzed by Wilcoxon rank-sum test.

Results: A total of 498 preprints were identified across bioRxiv (83%), PeerJ (5%), F1000Research (6%), Nature Proceedings (3%), Preprint.org (3%), Wellcome Open Research preprint (0.2%) and MedRxiv (0.2%) servers. Roche, Sanofi and Novartis contributed 56% of the retrieved preprints. The median number of citations for the included preprints was 0 (IQR =1, Min-Max =0-45). The median number of citations for the published preprints and unpublished preprints was 0 for both (IQR =1, Min-Max =0-25 and IQR =1, Min-Max =0-45, respectively; P?=?.091). The median Altmetric score of the preprints was 4 (IQR =10.5, Min-Max =0-160).

Conclusion: Pharma-authored research is being increasingly published as preprints and is also being cited in other peer-reviewed publications and discussed in social media.

Data could hold the key to stopping Alzheimer’s | Bill Gates

“Unfortunately, this siloed approach to research data hasn’t yielded great results. We have only made incremental progress in therapeutics since the late 1990s. There’s a lot that we still don’t know about Alzheimer’s, including what part of the brain breaks down first and how or when you should intervene. But I’m hopeful that will change soon thanks in part to the Alzheimer’s Disease Data Initiative, or ADDI….

I worked with a coalition of partners to create ADDI, because we believe that more data sharing will accelerate progress towards an Alzheimer’s breakthrough. To make this happen, ADDI created the Alzheimer’s Disease workbench.

 

This workbench hosts an open, global, and easy-to-use set of tools and resources. The goal is to simplify how researchers and data scientists around the world work together and share data, code, and knowledge in order to make advances in the field…..”

Ten principles for data sharing and commercialization | Journal of the American Medical Informatics Association | Oxford Academic

Abstract:  Digital medical records have enabled us to employ clinical data in many new and innovative ways. However, these advances have brought with them a complex set of demands for healthcare institutions regarding data sharing with topics such as data ownership, the loss of privacy, and the protection of the intellectual property. The lack of clear guidance from government entities often creates conflicting messages about data policy, leaving institutions to develop guidelines themselves. Through discussions with multiple stakeholders at various institutions, we have generated a set of guidelines with 10 key principles to guide the responsible and appropriate use and sharing of clinical data for the purposes of care and discovery. Industry, universities, and healthcare institutions can build upon these guidelines toward creating a responsible, ethical, and practical response to data sharing.

 

Why is uploading clinical trial results onto trial registries so important?

“Some university researchers still believe that if their clinical trial publishes its outcomes in a peer-reviewed journal, they do not also have to upload its summary results onto trial registries.

 

That is wrong. Here are the facts:

 

Both EU regulations and US law require the results of many (though not all) clinical trial results to be uploaded onto trial registries within 12 months of trial completion.

Best practices set out by the World Health Organization (WHO) require the results of all clinical trials to be uploaded onto a trial registry within that timeframe.

Posting results onto registries accelerates medical progress because the 12-month timeline permits far more rapid results sharing than the slow academic publication process allows.

Posting results onto registries minimises the risk of a trial never reporting its results and becoming research waste, which can happen when a principal investigator dies or leaves their post during the prolonged process of submitting an academic paper to a succession of medical journals.

Results posted on registries are easier to locate and are open access.

Research shows that trial results posted on registries typically give a more comprehensive and accurate picture of patient-relevant trial outcomes than corresponding journal articles do.

Registry reporting facilitates comparison of trial outcomes with a trial’s originally stated aims, and thus discourages harmful research malpractices such as the ‘silent’ suppression, addition, or switching of selected outcomes, HARKing, and p-hacking.

Results on trial registries enable the more rapid and reliable identification of potential safety risks posed by medicines already on the market. …”