The NIH’s All of Us Research Program is a historic effort to create an unprecedented research resource that will speed biomedical breakthroughs, transform medicine and advance health equity. To create this resource, the program is enrolling at least 1 million people who reflect the diversity of the United States.
How do drug prices compare across Europe? A new analysis published by Sweden’s Tandvårds-och läkemedelsförmånsverket (TLV; Dental and Medical Benefits Agency) compared the list prices of widely prescribed patent-protected outpatient drugs in 20 leading European markets.
The study found that Switzerland had the highest prices in Europe—123% of the European average. Ireland ranked second (119%), followed by Denmark and Germany (114%), Italy (110%) and the United Kingdom (110%). At the other end of the pricing spectrum, Poland had the lowest prices (82% of the European average), followed by Slovakia (87%), Sweden (89%), Finland (90%) and France and Greece (91%).
The U.S. Food and Drug Administration (FDA), Office of Clinical Pharmacology (OCP) announces the availability of the 2022 OCP Annual Report. OCP is a dynamic, purpose-driven organization dedicated to promoting and protecting global public health through the application of clinical pharmacology and translational medicine principles.
The EMA is pleased to inform of the launch of a public consultation concerning the development of a multi-stakeholder platform to promote collaboration for improving clinical trials in the EU as foreseen by Accelerating Clinical Trials in the EU (ACT EU) priority action 3.
This platform will enable regular dialogue between all EU stakeholders on clinical trials and facilitate the evolution of the clinical trials environment by helping to identify key advances in clinical trial methodologies, technology and science. The platform will serve as a neutral space for the discussion of challenges and the development of practical solutions to enable and drive change. It is envisaged that there will be several phases of development before reaching its final design.
Cell and gene therapies (CGT) are the new frontier of medicine, offering life extension and sometimes cures for previously untreatable conditions. These revolutionary therapies are expensive and follow non-traditional routes to approval. There are different approaches to the requirements and how they are established including an additional reimbursement approval step required in the European Economic Area (EEA). When comparing requirements to obtain approval for cell and gene therapies between the FDA and the European Medicines Agency (EMA), you may be struck by large variations in terminology. However, a closer look quickly indicates that sponsors face similar challenges in both markets.
The EMA is pleased to inform that the European Commission has launched a call for evidence for cancer prevention – action to promote vaccination against cancer-causing viruses.
Europe’s Beating Cancer Plan (the ‘Cancer Plan’) is a key priority of the Commission in the area of public health and a cornerstone of the European Health Union. Together with the Horizon Europe Cancer Mission, it is the EU’s response to the increasing number of cancer cases and deaths across the EU population.
Large language models such as ChatGPT can produce increasingly realistic text, with unknown information on the accuracy and integrity of using these models in scientific writing. In order to test the ability to detect artificially generated texts, the authors gathered ten research abstracts from five high impact factor medical journals (n=50) and asked ChatGPT to generate research abstracts based on their titles and journals. Then they evaluated the abstracts using an artificial intelligence (AI) output detector, plagiarism detector, and had blinded human reviewers try to distinguish whether abstracts were original or generated.
It is our pleasure to provide our readers with an interesting publication from Academy Board member Dr. Eddie G.M. Power, entitled ‘Considerations for Effective Communication of Medical Information.’
As we know, medical terminology can be difficult for the general public to understand, a conclusion supported by surveys within the arena of clinical trials. Several surveys have shown that information required to be provided to patients to participate in clinical trials (Informed Consent form and Clinical Trial information sheet) are difficult to comprehend and may even detract from their ultimate goal of providing simple, concise information to informed patients. The use of digital media to deliver medical information may further exacerbate the challenges of communicating medical information.
The EMA is pleased to announce the distribution of the January 2023 issue of the monthly newsletter. It contains news on new drug approvals in the areas of Covid-19 vaccines, cancer, cardiovascular medicine, hematology, hepatology, HIV, hormones, immune system, metabolism, nephrology, CNS, ophthalmology, respiratory, rheumatology, and vaccines.
It also includes several updates on clinical guidelines and a list of reports of scientific events, most of them devoted to clarifications about the new CTIS (Clinical Trials Information System), in place in all EU countries from January 2022, and which is now mandatory for all sponsors planning to activate a new clinical trial.
The US FDA approved lecanemab, the second-ever treatment for Alzheimer’s disease that is intended to tackle the root of the condition and the slow cognitive decline that results. Clinicians welcome the decision, but their excitement is clouded by reports of patient deaths and that the FDA acted improperly last year when approving the first drug of this kind.