Clinical trials sponsored by industry and other private organizations

Abstract:  The present manuscript discussed some relevant aspects related to private sponsored clinical trials in dentistry. For decades, the academy has been the major responsible for research in Brazil. Distant from the trade sector, academic research has not always provided clear benefits to society. A key aspect of making benefits clearer is the process of scientific knowledge transference to decision-makers, which is, in fact, the ground of evidence-based dentistry. Although private sponsoring of clinical research seems to be part of the research progress of the business rates, investment in Brazil is lower than those observed in other countries. It is particularly important to understand that instead of creating its own rules, dentistry imported the high-quality standards originally designed for pharmaceutical studies. Therefore, it is critical to understand the original rules and how dental items are classified by regulatory agencies. In fact, knowledge about international and local regulation is a basic assumption in industry-sponsored research. Despite globalization, the identification of industry-sponsored studies through open access databases is still very hard and time-demanding. A common concern when conducting industry-sponsored trials is study biases. Fortunately, many relevant organizations, academic and industry groups, have been working seriously against that. Finally, for less experienced researchers, many aspects related to industry-sponsored studies – such as confidentiality, authorship, budget – are deeply discussed until a final version of the trial agreement can be written and signed, protecting all sides. In short, the scenario should be improved, but it already represents a nice opportunity for dental research.

 

Industry Report Reveals Challenges among Researchers and Research Office Leaders during COVID-19

“Ex Libris, a ProQuest company, is pleased to announce the publication of its annual study on the challenges that academic researchers face, the priorities of research office leaders, and key opportunities for research offices and libraries to support scholarship at institutions of higher education.

The study was commissioned by Ex Libris and conducted by Alterline, an independent research agency. The report presents findings from a survey of 314 researchers across a range of disciplines and 101 senior members of research offices in the United States, the United Kingdom, and Australia….

Senior members of research offices want to strengthen relationships with the library. The top areas of collaboration between the research office and the library consist of open-access compliance (noted by 64% of respondents), the tracking of publications by the institution’s researchers (46%), and the updating of researcher profiles (32%).
Researchers’ support for open access is growing. Before COVID-19, 72% of researchers viewed open access favorably, and 18% now report that they view open access more positively since the onset of COVID-19….”

Support Centre for Data Sharing

“The?“Support Centre for Data Sharing” (SCDS)?is a new initiative funded by the European Commission to further support the development of the?Digital Single Market. Our objective is to facilitate data sharing, i.e. transactions in which data held by public sector or private sector are made available to other organisations (public or private) for use and re-use. Data sharing can happen in exchange for payment (or other reward) or for free. Success of data sharing depends on practices, technology, cultural elements and legal frameworks that are relevant to sharing any kind of information digitally, between individuals or organisations. …”

Computational social science: Obstacles and opportunities | Science

“An alternative has been to use proprietary data collected for market research (e.g., Comscore, Nielsen), with methods that are sometimes opaque and a pricing structure that is prohibitive to most researchers.

We believe that this approach is no longer acceptable as the mainstay of CSS, as pragmatic as it might seem in light of the apparent abundance of such data and limited resources available to a research community in its infancy. We have two broad concerns about data availability and access.

First, many companies have been steadily cutting back data that can be pulled from their platforms (5). This is sometimes for good reasons—regulatory mandates (e.g., the European Union General Data Protection Regulation), corporate scandal (Cambridge Analytica and Facebook)—however, a side effect is often to shut down avenues of potentially valuable research. The susceptibility of data availability to arbitrary and unpredictable changes by private actors, whose cooperation with scientists is strictly voluntary, renders this system intrinsically unreliable and potentially biased in the science it produces.

Second, data generated by consumer products and platforms are imperfectly suited for research purposes (6). Users of online platforms and services may be unrepresentative of the general population, and their behavior may be biased in unknown ways. Because the platforms were never designed to answer research questions, the data of greatest relevance may not have been collected (e.g., researchers interested in information diffusion count retweets because that is what is recorded), or may be collected in a way that is confounded by other elements of the system (e.g., inferences about user preferences are confounded by the influence of the company’s ranking and recommendation algorithms). The design, features, data recording, and data access strategy of platforms may change at any time because platform owners are not incentivized to maintain instrumentation consistency for the benefit of research.

For these reasons, research derived from such “found” data is inevitably subject to concerns about its internal and external validity, and platform-based data, in particular, may suffer from rapid depreciation as those platforms change (7). Moreover, the raw data are often unavailable to the research community owing to privacy and intellectual property concerns, or may become unavailable in the future, thereby impeding the reproducibility and replication of results….

Despite the limitations noted above, data collected by private companies are too important, too expensive to collect by any other means, and too pervasive to remain inaccessible to the public and unavailable for publicly funded research (8). Rather than eschewing collaboration with industry, the research community should develop enforceable guidelines around research ethics, transparency, researcher autonomy, and replicability. We anticipate that many approaches will emerge in coming years that will be incentive compatible for involved stakeholders….

Privacy-preserving, shared data infrastructures, designed to support scientific research on societally important challenges, could collect scientifically motivated digital traces from diverse populations in their natural environments, as well as enroll massive panels of individuals to participate in designed experiments in large-scale virtual labs. These infrastructures could be driven by citizen contributions of their data and/or their time to support the public good, or in exchange for explicit compensation. These infrastructures should use state-of-the-art security, with an escalation checklist of security measures depending on the sensitivity of the data. These efforts need to occur at both the university and cross-university levels. Finally, these infrastructures should capture and document the metadata that describe the data collection process and incorporate sound ethical principles for data collection and use….”

Open Science Policy Platform: final report

The Open Science Policy Platform (OSPP, also EUOSPP) presented in April 2020 its final report “Progress on Open Science: Towards a Shared Research Knowledge System”.

What was the role of the OSPP?

The OSPP consisted of 25 representatives of the most important relevant European open science stakeholders (except business and industry community). This high-level advisory group was set up in 2016 by the European Commission’s Directorate-General for Research and Innovation. Its role was to advise the European Commission on how to develop its Open Science Policy. It also supported policy implementation by reviewing best practices, drawing policy guidelines, and encouraging their active uptake by stakeholders. In particular, the OSPP was in charge of working with other high-level expert groups on very specific topics and bringing the stakeholder’s perspective into their recommendations.

According to Europe Direct, there will be no third mandate for the OSPP. There are clear rules that regulate the maximum length of time during which an expert group can advise the commission, “which in this case means there will be no extension after the two mandates (12 months per mandate).”

OSPP final report

The final report provides a brief overview of the four-year work (two mandates) of the platform. It draws up recommendations for the Commission and analyses the status of implementation of open science practices. It also describes progress made and barriers imposed on Open Science implementation by each different stakeholder community1 over the past two years.

The report identifies three ambitions with high disparities between stakeholders (research integrity, skills&education, citizen science), which suggests a need for further discussion to develop common views on the challenges. Another urgent issue is the role of open science in public-private partnerships and “the dilemma faced by business and industry in adopting Open Science practices and principles whilst fulfilling requirements for Intellectual Property Rights (IPR) and commercial practices”. Here, the OSPP recognises that it is difficult to address the challenges faced by the business and industry community who are not represented among the OSPP stakeholders.

In conclusion, the OSPP experts call upon the EU Member States and all relevant actors in the private and public sectors to undertake broader systemic efforts and coordinate their strategies.

The report encourages them to move beyond Open Science to co-create a “research system based on shared knowledge by 2030”, identifying five priorities:

  1. An academic career structure that fosters outputs, practices and behaviours to maximise contributions to a shared research knowledge system.  
  2. A research system that is reliable, transparent and trustworthy.
  3. A research system that enables innovation.
  4. A research culture that facilitates diversity and equity of opportunity.
  5. A research system that is built on evidence- based policy and practice.

1 In this report, stakeholders are divided into the following groups: Universities & Research Organizations, Scientific Societies and Academies, Research Funding Organizations, Policy-Making Organizations, Citizen Science Organizations, Publishers, Open Science Platforms and Intermediaries, Research Libraries, Researchers.

Methodology:

The report does not strive to provide consensus view, but rather shows stakeholders’ opinions along the eight identified core areas (“ambitions”) identified by the EU Commission: 1) rewards and incentives, 2) indicators & next-generation metrics, 3) future of scholarly communications, 3) European Open Science Cloud (EOSC), 5) FAIR data, 6) research integrity, 7) skills &  education, 8) citizen science.

Each stakeholder community evaluated the level of progress for each ambition according to 5 categories (discussion, planning, implementation, adoption and common practice). For each ambition, 2 to 4 recommendations were made.

image: Photo by Guillaume Périgois on Unsplash

The post Open Science Policy Platform: final report appeared first on openscience.eu.

Pharmaceutical companies should publish more research open access – The BMJ

“Pharmaceutical companies fund around half of all biomedical research, but, in contrast to many public funders of research, only two companies (Takeda and Ipsen) mandate that all the research they fund must be published open access. Nevertheless, other pharmaceutical companies, including GlaxoSmithKline, are able to publish up to three quarters of the research they fund open access without a mandate. This is not bad when less than 50% of research overall is published open access….

Open Pharma has produced a position statement on open access that calls for journals to give authors who are publishing research funded by pharmaceutical companies the same rights as authors of research funded by public funders. In the 9 months since its launch, the position statement has gained over 150 endorsements, including eight publisher and 29 pharmaceutical company endorsements.

The liveliest part of the roundtable meeting was when patients called for full open access to research. Patients have not usually been included in debates about open access because they have not been considered to be “end users” of research. Nowadays, not only do patients participate at each stage of the research life cycle, from clinical trial design to establishing patient-reported outcome measurements, but they are also increasingly involved in the creation and curation of scientific studies. Yet patients can access no more than one-quarter of published clinical research. …”

As data-sharing becomes more crucial, agencies say industry can help with privacy issues

“Agencies like the Census Bureau want better commercial off-the-shelf (COTS) technologies for protecting data privacy and computation, so they can securely link datasets and make predictions about the coronavirus pandemic….

Agencies like the Census Bureau want better commercial off-the-shelf (COTS) technologies for protecting data privacy and computation, so they can securely link datasets and make predictions about the coronavirus pandemic….”

 

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….”

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.”