Baltimore’s community lab puts the scientific method in the people’s hands – The Washington Post

“Huon de Kermadec, originally from France, has been collaborating with a group of other “biohackers” for about two years to develop an alternative. The Open Insulin Project springs from the idea that people with diabetes should have access to affordable treatment methods outside the traditional pharmacologic brands, which can cost hundreds of dollars per vial.

If successful, the project could enable diabetics to set up their own low-cost insulin production systems at home.

A 30-something biochemist with a doctorate, Huon de Kermadec started working on open-source insulin in Oakland, Calif. But when his wife accepted a job at Johns Hopkins University, Huon de Kermadec relocated his workspace to the Baltimore Under Ground Science Space (BUGSS), a community lab designed with such purposes in mind.

BUGSS operates under the ethos that people other than university faculty members and students should have access to research lab space. Do-it-yourself biologists, hobbyists, and high school and home-schooled students have made BUGSS their official headquarters and classroom as they pursue advanced projects without much red tape involved….”

Proposing minimum requirements for announcing clinical trial results during the COVID-19 pandemic | Clinical Infectious Diseases | Oxford Academic

Abstract:  Recently, results from at least three major randomized clinical trials studying management of COVID-19 have been announced via press release without accompanying information. Given the unique nature of the pandemic, results of such trials often have immediate and worldwide relevance. Yet, while press releases serve the important purpose of disseminating top-level results quickly, they are inherently limited in scope, and rarely include sufficient data to inform practice. Herein, we propose a minimum set of trial characteristics and results to be released simultaneously with clinical trial announcements. This practice will ensure data related to management of COVID-19 can be used to appropriately impact care, while responding to the needs of diverse stakeholders in the scientific and publishing communities, as well as the public at large.

 

Can open, collaborative tactics help us crack COVID-19? | Opensource.com

“At least 109 organizations are currently working on treatment for COVID-19. But many researchers believe an approved, effective vaccine against the coronavirus will not be available in 2020.

But what would happen if these organizations collaborated on a global scale? What if they adopted open organization principles to accelerate the work of finding a treatment and cure?

In this article, I’ll examine how that might be possible. And I’ll explain one initiative that seems to be doing it….”

“Pharma are doing ok in terms of open access, but they could be doing more” – insights from the Open Pharma June roundtable meeting – Open Pharma

“Open Pharma Members, Supporters and key Advisers came together to discuss the ways in which the scientific publishing community can make research accessible, discoverable and transparent for patients and the public.

Many organizations are working towards the same goals in terms of transparency, discoverability, accessibility and accountability in scientific publishing, but wouldn’t it be better if these goals were aligned? On 15 June 2020, Open Pharma brought together the different stakeholders in academic publishing for a virtual roundtable meeting with the aim of coordinating their approach to open access models and enhanced content for scientific publications. Following a recap of the January roundtable meeting, attendees discussed the benefits of open access mandates for pharma. A clear definition of what open access is, with regards to Creative Commons licences and publishing embargoes, and a strong communications plan were both shown to be key to the successful implementation of a mandatory open access policy….”

Against pandemic research exceptionalism | Science

“The global outbreak of coronavirus disease 2019 (COVID-19) has seen a deluge of clinical studies, with hundreds registered on clinicaltrials.gov. But a palpable sense of urgency and a lingering concern that “in critical situations, large randomized controlled trials are not always feasible or ethical” (1) perpetuate the perception that, when it comes to the rigors of science, crisis situations demand exceptions to high standards for quality. Early phase studies have been launched before completion of investigations that would normally be required to warrant further development of the intervention (2), and treatment trials have used research strategies that are easy to implement but unlikely to yield unbiased effect estimates. Numerous trials investigating similar hypotheses risk duplication of effort, and droves of research papers have been rushed to preprint servers, essentially outsourcing peer review to practicing physicians and journalists. Although crises present major logistical and practical challenges, the moral mission of research remains the same: to reduce uncertainty and enable caregivers, health systems, and policy-makers to better address individual and public health. Rather than generating permission to carry out low-quality investigations, the urgency and scarcity of pandemics heighten the responsibility of key actors in the research enterprise to coordinate their activities to uphold the standards necessary to advance this mission….”

Big Pharma Attacks Coronavirus Price Controls

“On April 15, Rep. Jan Schakowsky, D-Ill., along with Reps. Peter DeFazio, D-Ore., Rosa DeLauro, D-Conn., and Lloyd Doggett, D-Texas, laid out basic principles for the development and pricing of coronavirus therapies and vaccines. Their demands were simple: Pharmaceutical companies should have to set reasonable prices for their drugs and vaccines used to treat or prevent Covid-19. They should be required to make the costs of research and manufacturing of these products public. During the pandemic, the legislators said, companies should not be able to profit exclusively from these potentially lifesaving drugs.

“Exclusivity determines who has access, who can manufacture, and how we scale up production to meet the need,” the members of Congress noted in a press release at the time….

Few have spoken out against the protections that were designed to ensure equitable access to lifesaving medicines — at least publicly. But privately, a coalition of conservative groups attacked the proposed patient protections as “dangerous, disruptive, and unacceptable.” In a May 7 letter, representatives of 31 groups, including Hudson Institute, the Council for Citizens Against Government Waste, and Consumer Action for a Strong Economy, called on Congress to reject the drug pricing guidelines and defended patents and the exclusive right to profit from drugs as “America’s great assets.” …

Perhaps most galling to the Democratic lawmakers is the fact that the vast majority (if not all) of the drugs they seek to protect from exorbitant pricing have been developed at least in part with taxpayer dollars. Between 2010 and 2016, every drug approved by the Food and Drug Administration benefited from science funded with federal research through the National Institutes of Health, according to the advocacy group Patients for Affordable Drugs. During that time, taxpayers spent more than $100 billion on that research.

Although American taxpayers are the “angel investors” of pharmaceuticals, as Doggett put it, many cannot afford the treatments they’ve bankrolled….

On Friday, the World Health Organization unveiled a global effort to pool intellectual property, data, and research related to Covid-19. While 36 countries have already announced their support for the project, the U.S. was not among them. Just as WHO was detailing its plan to broadly share the benefits of scientific advancement, President Donald Trump was announcing his plan to withdraw from the global organization.”

New Report – How COVID-19 is Changing Research Culture – Digital Science

“The report key findings include: 

As of 1 June 2020, there have been upwards of 42,700 scholarly articles on COVID-19 published, 3,100 clinical trials, 420 datasets, 270 patents, 750 policy documents, and 150 grants.

Preprints have rapidly established as a mainstream research output and a key part of COVID-19 research efforts. They started at relatively low levels in early January 2020 and accounted for around one quarter of research output by the beginning of May 2020.

To date, more than 8,300 organisations have been involved in supporting COVID-19 research, with over 71,800 individual researchers identified as working on COVID-19 research.

The highest intensity of research into COVID-19 began in China and gradually migrated west mirroring the movement of the virus itself.

While the US and EU have both now published more than China in journals such as The Lancet, New England Journal of Medicine and JAMA, China continues to benefit from an early mover advantage and continues to enjoy the lionshare of the citations. While research in the field is clearly moving quickly, it currently remains anchored to China’s early publications.

A density map of global COVID-19 paper production shows there are three to four major centres of research: an extended area in China composed of several cities—Wuhan, where the virus is alleged to have started, Beijing and Shanghai; Europe, specifically Italy and the UK, two of the harder hit countries; the US’s east coast research corridor including Boston and New York; and finally, a lighter focus from the Californian institutions on the West coast.

The top producing institution of COVID-19 research (since the beginning of 2020) is in China, Huazhong University of Science and Technology, followed by Harvard University and the University of Oxford.

The top healthcare producers of COVID-19 research (since the beginning of 2020) are Zhongnan Hospital of Wuhan University, then Renmin Hospital of Wuhan University, and Massachusetts General Hospital.

While the proportion of internationally co-authored work is steady, the vast majority of research on COVID to date has been unusually authored within countries.

At the time of writing, 156 grants totalling at least 20.8m USD have been awarded to COVID-themed researchers in public institutions.

Much of the clinical trial initiation activity in January and February is sponsored by China and this then begins to fall off in March, April and May. We see a similar wave for Europe and the US, but shifted back by two months, beginning in March….”

Missing clinical trial data: the knowledge gap in the safety of potential COVID-19 drugs | medRxiv

Abstract:  Abstract Objectives: Several drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosages, it is important to enable synthesis of existing safety data from clinical trials. However, availability of safety information is limited by a lack of timely reporting of clinical trial results on public registries or through academic publication. We aimed to analyse the knowledge gap in safety data by quantifying the number of missing clinical trial results for drugs potentially being repurposed for COVID-19. Design: ClinicalTrials.gov was searched for 19 drugs that have been identified as potential treatments for COVID-19. Relevant clinical trials for any prior indication were listed by identifier (NCT number) and checked for timely result reporting (within 395 days of the primary completion date). Additionally, PubMed and Google Scholar were searched using the NCT number to identify publications of results not listed on the registry. A second, blinded search of 10% of trials was conducted to assess reviewer concordance. Results: Of 3754 completed trials, 1516 (40.4%) did not post results on ClinicalTrials.gov or in the academic literature. 1172 (31.2%) completed trials had tabular results on ClinicalTrials.gov. A further 1066 (28.4%) completed trials had results from the literature search, but did not report results on ClinicalTrials.gov. Key drugs missing clinical trial results include hydroxychloroquine (37.0% completed trials unreported), favipiravir (77.8%) and lopinavir (40.5%). Conclusion: There is an important evidence gap for the safety of drugs being repurposed for COVID-19. This uncertainty could cause a large burden of additional morbidity and mortality during the pandemic. We recommend caution in experimental drug use for non-severe disease and urge clinical trial sponsors to report missing results retrospectively.

 

Database launched to share early-stage UK Covid-19 research – Research Professional News

“The Academy of Medical Sciences has launched a database for tracking early-stage UK Covid-19 research.

Announced on 1 June, the Covid-19 preclinical drug development database aims to help researchers identify collaborations, share expertise, materials and methods, as well as prioritise research and avoid duplicating effort.

The academy is calling on researchers from across academia and industry to submit projects to the database through an optional survey….”

Open letter from the European Medicines Agency

“Our activities in relation to COVID-19 deserve the highest possible level of transparency and, in keeping with our commitment, the Agency will take appropriate action to share information publicly. We are currently discussing how to enhance the level of transparency for COVID-19 procedures, including the possibility of rapidly publishing clinical data for these products. The need for rapid evaluation during the current emergency will require us to depart from our usual procedures. In some cases, we will be evaluating evidence as it emerges (i.e. ‘rolling review’) and putting information in the public domain in these circumstances will be subject to additional challenges which we are currently looking to address….

Inevitably, this disruption [Brexit] required the Agency to shift all its focus to core activities that are essential for public health. Regrettably, our efforts to publish clinical data had to be put on hold in these very trying circumstances. 

In view of this and the extra effort needed to deal with COVID-19 related activities, I can’t yet commit

to reinitiate all activities related to clinical data publishing for medicines evaluated by the Agency.

However, as stated above, COVID-19 related medicines deserve special consideration because of the

overriding public interest and the need to support the international research community and foster the

collaborative effort. Further information on the concrete proposals to increase transparency of COVID19 related activities will be communicated once agreed within EMA and the EU Regulatory Network….”