Author: GMDP Academy Editorial Board

Clinical trials in stroke in 2022: new answers and questions

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In 2022, several clinical trials have answered important research questions about revascularisation, and about the indications for endovascular thrombectomy, but their answers have raised additional questions. For example, two multicentre, open-label, randomised trials (DIRECT-SAFE and SWIFT-DIRECT) compared endovascular thrombectomy alone with combined intravenous thrombolysis and endovascular thrombectomy to find out if intravenous alteplase could be withheld in patients with large vessel occlusion who present directly to a hospital at which endovascular thrombectomy can be done (referred to as mothership patients).

Are ChatGPT and AlphaCode Going to Replace Programmers?

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The future of AI is looking smarter and smarter! Artificial intelligence (AI) researchers have been impressed by the skills of AlphaCode, an AI system that can compete with humans in the solving of simple computer-science problems. can often compete with humans at solving simple computer-science problems. Google’s sister company DeepMind, an AI powerhouse based in London, released the tool in February and has now published its results in Science. Results indicate that AlphaCode beat about half of humans at code competitions. Additionally, social media users have been mesmerized by the ability of another chatbot, ChatGPT, to produce occasionally meaningful-sounding (and sometimes sublimely ridiculous) mini-essays on request — including short computer programs. But these state-of-the-art AIs can perform only rather limited tasks, and researchers say they are far from being able to replace human programmers.

News from Oncology: UK Awaits a New Cancer Plan

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Many surveys have indicated that current care for oncology patients in the UK is below European standards. Reasons for such include lack of reimbursement from the NHS for new and expensive therapies, among others. According to a recent editorial in the Lancet, “The UK Government was due to publish the next version of the 10-year cancer plan for England in the summer of 2022 with the aim of improving cancer outcomes to match the best in Europe. However, recent political turmoil has resulted in no clear date for when the plan will appear. Given the considerable challenges on health care in the UK, we call on the new Prime Minister, Rishi Sunak, to break this inaction and publish a fully detailed plan as a matter of urgency…”

News from the EMA: Public Consultation for the Evaluation of NAS

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The European Medicines Agency has published for public consultation a reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances.

This document describes the current scientific thinking applied to New Active Substance (NAS) assessment of biological active substances and provides guidance on the elements required to be submitted by applicants to substantiate a NAS claim. Advanced Therapy Medicinal Products (ATMPs) are within the scope of this document.

Why is Health Literacy Failing So Many?

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Health literacy is vital to good health and wellbeing. It is fundamental to achieving the Sustainable Development Goals by 2030 and is a crucial tool to deliver universal health coverage. People need to know how to prevent disease and navigate health-care systems to ensure good health outcomes. However, many are not able to make healthy choices, even in countries with the strongest health systems. Why is this? Traditionally, health literacy has focused on an individual’s ability to access, understand, appraise, and use information to maintain good health. Of course, such knowledge is important. But this approach neglects the societal and structural forces that shape our choices. In many parts of the world, health decisions occur within the family. The health of communities is often dictated by social and environmental factors outside the control of individuals. Research progress in these areas has been slow, and many health interventions still leave people behind. The result has been a health failure.

Sales of Antibiotics for Animal Use Have Almost Halved Between 2011-2021

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The pharmaceutical industry voluntarily agreed to eliminate animal uses of some classes of antibiotics to reduce the likelihood that resistant bacteria develop and threaten human health. There are several classes of antibiotics that are used in both humans and livestock production. There is some probability that the continued use of these antibiotics to improve performance of livestock would have sped up resistance in bacteria that infect people. Indeed, cases of individuals being colonized by antibiotic-resistant bacterial strains have been documented. These strains are believed to have originated in livestock and the colonized individuals often have been in contact with livestock. So, there are reasons to be concerned about the potential for impacting human health.

Altered Image in 1999 Paper Raises Peril for Stanford President

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New findings of altered images in research co-authored by Stanford University president Marc Tessier-Lavigne add to the weight of allegations against him, according to experts on research misconduct. Stanford announced an investigation into its president following allegations of altered images in four papers co-authored by Tessier-Lavigne over a seven-year period earlier in his research career. A subsequent analysis by Elisabeth Bik, a scientific integrity expert who specializes in identifying manipulated images, found an additional image that raises concern in a paper published in the journal Cell in 1999, two years earlier than the set of papers originally flagged to Stanford.

EMA Publishes Concept Paper on Platform Clinical Trials

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The methodology of clinical trials is continuously evolving, and there has been recent interest in platform clinical trials. Platform trials are a type of randomized clinical trial that allow simultaneous comparison of multiple intervention groups against a single control group that serves as a common control based on a prespecified interim analysis plan. Platform trials are an extension of adaptive multiarm, multistage trial designs that allow for the evaluation of multiple interventions using interim evaluations and the addition of new interventions during the trial.

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