Featuring the FDA’s Project Patient Voice, certification for ORCID service providers, a call for responsible reporting of COVID-19 mathematical models, an analysis of open peer review journals, how the ABPI will navigate Brexit and the changing landscape of research communication.

Introducing Project Patient Voice via Bloomberg Law

Project Patient Voice is a pilot initiative from the US Food and Drug Administration (FDA) that will act as a public repository of patient-reported outcome (PRO) results from clinical trials. PROs have typically not been assessed by the FDA as part of product labelling; however, as clinical trial design becomes more patient centric, PROs are an increasingly relevant means of stakeholder engagement. AstraZeneca is the first company to participate in Project Patient Voice, reporting on its AURA3 trial on the use of osimertinib in individuals with lung cancer.

ORCID Service Provider Certification via ORCID

The Open Researcher and Contributor ID (ORCID) system relies on service providers such as journals and publishers to authenticate and update ORCID records. The new Service Provider Certification programme, which will be launched in summer 2020, will enable these providers to integrate into the ORCID workflow more effectively; it will also help to drive interoperability and communication between the different systems.

Mind the mathematical models via Research Professional News

An open letter published in Nature calls for mathematical modellers to be more cautious in reporting their COVID-19 models. The letter states that there are too many variables, both known and unknown, to justify the precision with which modellers make statistical claims that could be misinterpreted by policy makers and the public. The 22 signatories of the letter outline five ways in which modellers can ensure that the uncertainty and complexity of mathematical modelling is reported in a responsible manner.

  • Mind the assumptions.
  • Mind the hubris.
  • Mind the framing.
  • Mind the consequences.
  • Mind the unknowns.

Open peer review by discipline via Nature Index

Publishing peer review reports is an increasingly popular practice, but the uptake of open peer review varies by discipline. An analysis of 617 open peer review journals, published in Scientometrics, found that the process is largely dominated by the medical and health sciences and the natural sciences. While these disciplines account for approximately 80% of open peer review journals, the humanities make up only 1% of journals that share their peer review reports.

How will the ABPI navigate Brexit? via Faculty of Pharmaceutical Medicine

The UK leaving the EU does not mean that The Association of the British Pharmaceutical Industry (ABPI) is ending its collaboration with The European Federation of Pharmaceutical Industries and Associations. However, pharma companies, patients and payers in the UK are calling for changes to the ABPI Code of practice to better balance the needs of all stakeholders. The ABPI and Prescription Medicines Code of Practice Authority are currently working on changes to the Code, with a consultation to be held in the second half of 2020.

The dawning of a new era for research communication via Elephant in The Lab

For the past 300 years, science has been communicated through research articles published in peer-reviewed journals. In the wake of the 2019 novel coronavirus pandemic, researchers are embracing  new approaches to scientific communication that they may had, in the past, been reluctant to try. The article by Rebecca Lawrence, Managing Director of F1000 Research, discusses how the use of preprints and preprint review servers has increased dramatically during the pandemic and how the speed of scientific communication must not come at a cost to quality.

We at Open Pharma would like to continue to encourage all our readers to look after themselves and their community and continue to follow advice from their country’s government and health organizations.

Coronavirus mental health and wellbeing resources:

Mind UK

Mental Health Foundation UK

Centre for Disease Control and Prevention

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