Summary of the 2008 National Institute of Allergy and Infectious Diseases–US Food and Drug Administration Workshop on Food Allergy Clinical Trial Design
The Delta variant is currently the highly contagious predominant variant of the SARSCoV-2 virus worldwide that causes severe illness more than the previous variants in unvaccinated people (CDC, 2021). At a White House briefing, the National Institute of Allergy and Infectious Diseases director, Anthony Fauci, predicted that there would be an increase in the number of child hospitalisation proportionate to the increased number of children getting infected with the Delta variant (Press briefing White House, 2021). In response to this situation, the FDA (U.S. Food and Drug Administration) approved Pfizer-BioNTech and Moderna vaccines for children aged 12 – 17 years. Vaccines in children aged 5 – 11 years are currently under clinical trial (Sick-Samuels & Messina, 2021).
AbstractFuture radiation oncology encompasses a broad spectrum of topics ranging from modern clinical trial design to treatment and imaging technology and biology. In more detail, the application of hybrid MRI devices in modern image-guided radiotherapy; the emerging field of radiomics; the role of molecular imaging using positron emission tomography and its integration into clinical routine; radiation biology with its future perspectives, the role of molecular signatures in prognostic modelling; as well as special treatment modalities such as brachytherapy or proton beam therapy are areas of rapid development. More clinically, radiation oncology will certainly find an important role in the management of oligometastasis. The treatment spectrum will also be widened by the rational integration of modern systemic targeted or immune therapies into multimodal treatment strategies. All these developments will require a concise rethinking of clinical trial design. This article reviews the current status and the potential developments in the field of radiation oncology as discussed by a panel of European and international experts sharing their vision during the “X-Change” symposium, held in July 2019 in Munich (Germany).
Osteoarthritis clinical trial design and food and drug administration accelerated approval: lessons learned from the osteoporosis and liver fibrosis fields
