FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on in clinical research. The WHO [...]
Il contributo delle associazioni pazienti negli studi clinici
In collaborazione con Aboutpharma Storicamente, le organizzazioni dei pazienti hanno avuto lo scopo primario di supportare le comunità che rappresentavano. Oggi questa rimane una funzione cruciale ma le modalità sono cambiate, come anche il ruolo che le [...]
The importance of the Data Monitoring Committee in the trials of today and tomorrow
Dr. Paola Antonini, Meditrial Scientific Director All clinical trials benefit from oversight, which is currently provided by regulatory authorities, Ethics Committees or Institutional Review Boards, and Data Monitoring Committees (Dmc), also sometimes referred to as Data Safety Monitoring [...]
L’importanza del Data Monitoring Committee nei trial di oggi e domani
D.ssa Paola Antonini, direttore scientifico Meditrial - IN COLLABORAZIONE CON ABOUTPHARMA Tutti gli studi clinici beneficiano di supervisione, che attualmente è fornita dalle autorità regolatorie, dai Comitati Etici o dalle Institutional Review Board, e dalle Data [...]
Studi di fattibilità precoce sui devices: “fare prima” per evitare il fallimento dei trial
Paola Antonini, direttore scientifico Meditrial - IN COLLABORAZIONE CON MEDITRIAL Si stima che oltre il 90% degli studi clinici fallisca a causa di un limitato reclutamento dei pazienti, inefficienze dello sperimentatore, insufficiente comprensione degli aspetti etici e [...]
Early feasibility studies on devices: “doing it sooner” to avoid trial failure
Paola Antonini, Meditrial Scientific Director. It is estimated that more than 90% of clinical trials fail due to limited patient recruitment, investigator inefficiencies, insufficient understanding of local ethical and regulatory aspects, site and region selected for conducting the [...]
SaMD, artificial intelligence and machine learning: regulators’ first steps
Dr.ssa Paola Antonini, Meditrial scientific director The International medical device regulators forum (Imdrf), describes Software as a Medical Device (SaMD) as software that can run on generic (non-medical) computing platforms. They can be used in conjunction with other [...]
SaMD, intelligenza artificiale e machine learning: i primi passi degli enti regolatori
Dr.ssa Paola Antonini, direttore scientifico Meditrial - IN COLLABORAZIONE CON MEDITRIAL. L’International medical device regulators forum (Imdrf), descrive i SaMD (Software as a Medical Device (SaMD) come software che possono funzionare su piattaforme informatiche generiche (non [...]
Clinical trials, how biomarkers help research
Dr.ssa Paola Antonini, Meditrial scientific director In recent years, the field of biomarkers in research and clinical practice has shown remarkable progress. These tests can be used in the screening, diagnosis, characterization, and monitoring of diseases; as prognostic [...]
