The contribution of patient associations in clinical trials

2022-10-05T11:20:42+00:00September 28th, 2022|Categories: Medical Research, Meditrial|

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 [...]

The importance of the Data Monitoring Committee in the trials of today and tomorrow

2022-09-28T11:02:03+00:00September 21st, 2022|Categories: Medical Research, Meditrial|

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

2022-09-28T11:03:04+00:00September 21st, 2022|Categories: AboutPharma|

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

2022-09-28T10:10:51+00:00September 15th, 2022|Categories: AboutPharma|

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

2022-09-28T10:21:58+00:00September 15th, 2022|Categories: Medical Research, Meditrial|

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

2022-09-16T16:01:49+00:00September 7th, 2022|Categories: Medical Research, Meditrial|

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

2022-09-16T19:54:37+00:00September 7th, 2022|Categories: AboutPharma|

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 [...]

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