The end of 2022 saw several initiatives in oncology in Europe that, if successfully implemented, could radically improve European cancer research and patient care.
The recently launched European Groundshot Commission, which includes new data on cancer research activity and outcomes across Europe during the past 12 years, proposes an evidence-based, patient-centered cancer research roadmap for Europe.
We continue with our Professional Identity and Medicines Development series. We are pleased to share a well-written essay from Academy alumni Matteo Bonetto Gambrosier. We extend our sincere gratitude to Matteo for his contributions to the IFAPP community.
Louis Pasteur was born in France on Dec 27, 1822. He was a young polymath when he embarked on a path of discovery with profound societal relevance. By the age of 40 years, he was a national hero and an international authority on microbiology, vaccines, and immunology. His germ theory of disease laid the foundation for hygiene and sanitation within public and global health. He developed the first vaccine against human rabies in 1885. Along with other great scientists of his time, Pasteur shaped scientific reasoning and communication for the better, creating a legacy that catalysed progress in human health that has been sustained for the past 150 years. Yet infectious diseases continue to cause millions of unnecessary deaths. Even before the COVID-19 pandemic, global burden of disease (GBD) data indicated that infections were involved in more than 20% of deaths globally. A GBD study indicates that 13.6% of deaths globally are associated with just 33 bacterial pathogens.
Last December, Anthony Fauci stepped down as director of the US National Institute of Allergy and Infectious Diseases (NIAID) after more than 38 years in the post and 54 years at its parent organization, the US National Institutes of Health (NIH). He has led the institute under seven US presidents and overseen its research and response to the HIV/AIDS epidemic, the Ebola outbreak that began in West Africa in 2014 and the COVID-19 pandemic. The 81-year-old physician-scientist became a household name during the pandemic, during which he was revered as a trusted source of some and disparaged by others, including former US president Donald Trump, who saw his advice as inconsistent and overbearing. On 11 December, he was attacked on Twitter by Elon Musk, who took over the social media platform in October 2022.
The European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralized clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected. This is an outcome of their joint initiative to Accelerate Clinical Trials in the European Union (ACT EU).
Clinicians and parents in Canada are watching with concern as paediatric hospitalizations for seasonal influenza climb — at present, they are at more than ten times the normal rate for this time of year. In late November, weekly admissions were 50% higher than at the record peak for at least the past seven flu seasons. “The younger age group is being hit unusually hard for this time of year,” says Alyson Kelvin, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Saskatoon, Canada. Unusually, flu-based hospitalizations are currently higher for children aged 0–4 years than for people aged over 65.
In collaboration with the EMA and the European Union, the Heads of Medicines Agencies (HMA) issued a guideline called ‘Recommendation Paper on Decentralised Elements in Clinical Trials’.
More and more, clinical trials on Investigational Medicinal Products (IMPs) are using procedures conducted outside the traditional ‘clinical trial site’, a concept usually referred to as decentralisation. In addition, there is increasing use of digital tools within clinical trials.
The Japanese Ministry of Health, Labour and Welfare has the responsibility of the National Agency for drugs. The messages offered to Japanese citizens are very clear and contain illustrations to better explain the key recommendations.
More and more, clinical trials on Investigational Medicinal Products (IMPs) are using procedures conducted outside the traditional ‘clinical trial site’, a concept usually referred to as decentralisation. In addition, there is increasing use of digital tools within clinical trials.
The CIOMS December 2022 Newsletter is now available. In the fourth quarter of 2022, three recent CIOMS publications were presented at various international events. Two webinars were announced for January. One occurred on 19 January on clinical trials in Africa. Another is available on 31 January: 2023 CoRE webinar series – The CIOMS consensus report on patient involvement. The registration link is in the newsletter, which you can access here.
The newsletter further includes information on global health issues and developments related to the CIOMS areas of work. The 2021 consensus report on Clinical research in resource-limited settings will be considered in future WHO guidance. The Chinese translation of another CIOMS pharmacovigilance report has been distributed, as well. This has immediately become one of the top ten downloads of CIOMS publications.
We are pleased to announce that the European Medicines Agency will be hosting a virtual Regulatory and scientific conference on RNA-based medicines on 2 February 2023.
The aim of the conference is to promote the development of RNA-based medicines by:
Identifying scientific and regulatory opportunities and challenges of RNA-based innovative medicines.
Facilitating dialogue between industry/academia and regulators and raising awareness on scientific and regulatory aspects.
Identifying gaps in regulatory science.