Search Results for: Nota AIFA 100: luci ed ombre

Modifiche alla prescrizione a partire dal 19 luglio 2025.

Dopo allarme lanciato da associazione talassemici

Dopo allarme lanciato da associazione talassemici

A 100 anni dalla nascita della storica figura della cardiologia

A 100 anni dalla nascita della storica figura della cardiologia

Messo a punto da Int per il glioma diffuso della linea mediana

Guarini (Lifc), ‘Estendere farmaco a 30% pazienti esclusi’

Medicinali a base di risperidone in formulazione soluzione orale da 1 mg/mL: errore terapeutico associato a sovradosaggio accidentale nei bambini e negli adolescenti.

L’Agenzia Italiana del Farmaco rende disponibile l’aggiornamento delle liste di trasparenza dei farmaci equivalenti con i relativi prezzi di riferimento aggiornati al 15 luglio 2025.

The RCOG World Congress 2025 took place at the London ExCeL Centre on June 23–25, hosting over 2500 delegates from around 100 countries and delivering over 70 sessions with more than 220 global speakers. Under the theme of “Equity in care, innovation in action”, the programme covered an impressive range of topics, relevant to both UK and global audiences, including women’s health (eg, menopause, sexual health, inequalities in access to care, cancer, endometriosis, vulval disease, human papillomavirus (HPV) vaccination, and imaging in gynaecology), fertility and reproduction (eg, developments in assisted reproduction, abortion, and contraception), and pregnancy and post-partum care (eg, preterm birth, obstetric fistula, foetal imaging, and postpartum complications), as well as the emerging role of artificial intelligence (AI) and digital health across these topics.

Una corsia preferenziale per chi fa ricerca sui preziosi antibiotici fondamentali per combattere i nuovi super batteri, ma anche priorità a chi decide di fare la ricerca clinica e preclinica…

L’indagine ha l’obiettivo di individuare istituzioni universitarie e istituti di ricerca, pubblici o privati, cui affidare corsi di formazione a beneficio degli esperti delle agenzie regolatorie nell’ambito di due tematiche innovative e sfidanti in ambito farmaceutico.

La Società Italiana di Medicina Generale e delle Cure Primarie esprime pieno apprezzamento per la decisione comunicata dall’Agenzia Italiana del Farmaco (Aifa) il 30 giugno con cui vengono riclassificate le gliflozine (SGLT2-i: inibitori del trasportatore sodio/glucosio di tipo 2) in fascia A e contestualmente abrogati, per l’intera classe, i Piani Terapeutici per il loro utilizzo nel trattamento del diabete di tipo 2, dello scompenso cardiaco e della malattia renale cronica.

Objective
During the COVID-19 pandemic, many clinical trials were conducted to identify effective COVID-19 therapeutics. However, while a large amount of resources was invested and significant numbers of patients participated, this did not necessarily have an impact on clinical practice. To face these issues, initiatives such as the 100 Days Mission have been set out globally. Yet, limited data exist on the context surrounding the implementation of clinical trials at a national level during a health emergency. The study explored experiences and perceptions of principal investigators in conducting clinical trials for COVID-19 therapeutics in Japan.

Design
A qualitative study was conducted using semistructured interviews. The obtained data were inductively analysed using thematic analysis.

Setting and participants
We interviewed 15 principal investigators between September and November 2022 who conducted investigator-initiated clinical trials on the development of COVID-19 therapeutics in Japan.

Results
Three themes were generated: structural barriers, fragmented efforts and limited evidence generation. Structural barriers and fragmented efforts comprised four subthemes: individual, institutional, interinstitutional and policy/regulatory levels. Structural barriers at all levels included (1) limitations of individual capabilities, (2) the double burden of clinical practice and research, (3) inefficient interinstitutional collaboration and (4) regulatory frameworks and available resources that interrupt stakeholders’ actions, leading to limited evidence generation despite the fragmented efforts of principal investigators and other stakeholders.

Conclusions
This study illustrated that the efforts of Japanese principal investigators did not necessarily pay off in identifying therapeutics. A strategic and systematic approach for an improved national clinical trial ecosystem must be sought during the interpandemic period to overcome structural barriers in harmonisation with the global stakeholders.