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  1. Article ; Online: Dalla valutazione del farmaco a quella di un percorso: le sfide per le autorità regolatorie.

    Addis, Antonio

    Recenti progressi in medicina

    2021  Volume 112, Issue 2, Page(s) 146–149

    Abstract: To understand how the current organization of the drug evaluation leads to a compartmental vision, and what tools could be added to bring the regulatory activity closer to the goal of include the entire therapeutic path. This is an hard goal but, if we ... ...

    Title translation From drug evaluation to that of a path: the challenges for regulatory authorities.
    Abstract To understand how the current organization of the drug evaluation leads to a compartmental vision, and what tools could be added to bring the regulatory activity closer to the goal of include the entire therapeutic path. This is an hard goal but, if we overcome the compartmental approach and open up to tools useful for planning and managing the intervention, the drug evaluation process could come to include the entire therapeutic path.
    MeSH term(s) Drug Evaluation ; Humans ; Organizations
    Language Italian
    Publishing date 2021-02-23
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 138266-4
    ISSN 2038-1840 ; 0034-1193
    ISSN (online) 2038-1840
    ISSN 0034-1193
    DOI 10.1701/3559.35377
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Presto ma non troppo.

    Addis, Antonio

    Recenti progressi in medicina

    2021  Volume 112, Issue 11, Page(s) 707–708

    Abstract: In this issue of Recenti Progressi in Medicina you will find the recommendations of a Focus group that analyzed the early access drug programs and managed entry agreements in Italy. In general, the extreme attention to the exclusive reduction of the ... ...

    Title translation Early but not too much.
    Abstract In this issue of Recenti Progressi in Medicina you will find the recommendations of a Focus group that analyzed the early access drug programs and managed entry agreements in Italy. In general, the extreme attention to the exclusive reduction of the evaluation times has led over time to take advantage of regulations born with other reasons. In particular, the law 648/96 should rather respond to unmet therapeutic needs while the AIFA 5% fund to individual and urgent request of drugs which are still not available in our country. In addition to a specific procedure on early access, there are missing steps that allow to allow a governance of these exceptional paths throughout monitoring protocols with methodologies and time scheduled well defined. In this context, the research supported by AIFA might be very helpful for the decision makers in order to overcome uncertainties during the marketing authorizations.
    MeSH term(s) Focus Groups ; Humans ; Italy
    Language Italian
    Publishing date 2021-11-15
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 138266-4
    ISSN 2038-1840 ; 0034-1193
    ISSN (online) 2038-1840
    ISSN 0034-1193
    DOI 10.1701/3696.36847
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  3. Article ; Online: Biosimilars for the Treatment of Psoriasis-A Systematic Review of Clinical Trials and Observational Studies: Looking Beyond Single-Trial Evidence for a Valuable Choice.

    Naldi, Luigi / Addis, Antonio

    JAMA dermatology

    2023  Volume 159, Issue 7, Page(s) 697–699

    MeSH term(s) Humans ; Biosimilar Pharmaceuticals/therapeutic use ; Psoriasis/drug therapy ; Clinical Trials as Topic ; Observational Studies as Topic
    Chemical Substances Biosimilar Pharmaceuticals
    Language English
    Publishing date 2023-05-30
    Publishing country United States
    Document type Editorial ; Systematic Review ; Comment
    ZDB-ID 2701761-8
    ISSN 2168-6084 ; 2168-6068
    ISSN (online) 2168-6084
    ISSN 2168-6068
    DOI 10.1001/jamadermatol.2023.1331
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  4. Article ; Online: CoViD-19: sapevamo tutto ma non avevamo capito niente.

    Addis, Antonio

    Recenti progressi in medicina

    2020  Volume 111, Issue 4, Page(s) 181–182

    Abstract: The CoViD-19 and its consequences could perhaps have been foreseen. Above all, this pandemic force us to review what is essential and really necessary in term of priorities and regulatory process for clinical pharmacological research. It is evident, ... ...

    Title translation CoViD-19: we knew everything but we didn't understand anything.
    Abstract The CoViD-19 and its consequences could perhaps have been foreseen. Above all, this pandemic force us to review what is essential and really necessary in term of priorities and regulatory process for clinical pharmacological research. It is evident, among other things, the difficulty to deal with therapeutic uncertainties.Not proven specific therapies are available for the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, the cause of CoViD-19), other than supportive care. However, several clinical centres decided to use off label drugs as a standard of care in the absence of efficacy and safety data. The national regulatory body (AIFA) has set up a process in a short time to transparently govern the approval of new trials and to regulate the use of medicines that are not indicated. In this context, the communication of risk associated with experimental therapies was also very important. The lessons we will learn from this emergency may result crucial in redesigning a better way of conducting clinical trials and information on drugs.
    MeSH term(s) Betacoronavirus ; COVID-19 ; Clinical Trials as Topic ; Communication ; Coronavirus Infections/drug therapy ; Disclosure ; Drug Development ; Drug Repositioning ; Humans ; Italy ; Pandemics ; Pneumonia, Viral/drug therapy ; Risk ; SARS-CoV-2 ; Uncertainty
    Keywords covid19
    Language Italian
    Publishing date 2020-05-08
    Publishing country Italy
    Document type Editorial
    ZDB-ID 138266-4
    ISSN 2038-1840 ; 0034-1193
    ISSN (online) 2038-1840
    ISSN 0034-1193
    DOI 10.1701/3347.33174
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Presunti colpevoli. Falsificazione e fabbricazione di dati nelle pubblicazioni scientifiche.

    De Fiore, Luca / Addis, Antonio

    Recenti progressi in medicina

    2022  Volume 113, Issue 6, Page(s) 353–354

    Abstract: The falsification of results and the fabrication of scientific research data are on the rise. Famous researchers see their articles pulled from leading journals. Often, however, this editorial malpractice does not harm the reputation of the authors, who ... ...

    Title translation Presumed guilty. Falsification and fabrication of data in scientific publications.
    Abstract The falsification of results and the fabrication of scientific research data are on the rise. Famous researchers see their articles pulled from leading journals. Often, however, this editorial malpractice does not harm the reputation of the authors, who continue to progress in their careers. The solution cannot come from a greater awareness of researchers, sponsors, regulatory agencies or research institutions: the incentives for malpractice are too strong. We need a new international governance of research and communication.
    MeSH term(s) Humans ; Research Personnel
    Language Italian
    Publishing date 2022-06-25
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 138266-4
    ISSN 2038-1840 ; 0034-1193
    ISSN (online) 2038-1840
    ISSN 0034-1193
    DOI 10.1701/3827.38106
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: I <em>Liberati’s principles</em> dieci anni dopo.

    Addis, Antonio / De Fiore, Luca

    Recenti progressi in medicina

    2022  Volume 113, Issue 1, Page(s) 9–11

    Abstract: Ten years after the death of Alessandro Liberati, the authors wonder how much the principles that guided the action of the founder of the Italian Cochrane Centre are still relevant. The guiding star of Liberati's professional life was the fight for ... ...

    Title translation The Liberati's principles ten years later.
    Abstract Ten years after the death of Alessandro Liberati, the authors wonder how much the principles that guided the action of the founder of the Italian Cochrane Centre are still relevant. The guiding star of Liberati's professional life was the fight for useful research aimed at solving problems relevant to patients and their families. Consistently with the work of other researchers such as Sir Iain Chalmers and Paul Glasziou - they have recently offered important contribution on these issues - Alessandro Liberati worked hard to guarantee open, accessible, and transparent research to citizens, health decision makers and health professionals. Unfortunately, his final call to design a new research governance remained unanswered. Research is still too focused on individual therapeutic interventions rather than on overall care strategies. Studies are still too often unpublished or only partially published. Research is still influenced by conflicts of interest and peer review is often biased. Much work remains to be done, to ensure that publicly funded research is guided by the real needs of citizens and patients.
    MeSH term(s) Health Personnel ; Humans ; Italy
    Language Italian
    Publishing date 2022-02-25
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 138266-4
    ISSN 2038-1840 ; 0034-1193
    ISSN (online) 2038-1840
    ISSN 0034-1193
    DOI 10.1701/3733.37176
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Biosimilari: l’Agenzia Italiana del Farmaco prende posizione.

    Addis, Antonio

    Recenti progressi in medicina

    2018  Volume 109, Issue 4, Page(s) 214–215

    Abstract: The Italian Medicines Agency issued a new position paper on biosimilars that clarified several points regarding their correct use. This is a document that has the intent to promote the correct use and prescription of these medicines by answering some of ... ...

    Title translation Biosimilars: Italian Medicines Agency takes position.
    Abstract The Italian Medicines Agency issued a new position paper on biosimilars that clarified several points regarding their correct use. This is a document that has the intent to promote the correct use and prescription of these medicines by answering some of the frequent questions coming from patients and prescribers. The debate surrounding the use of biosimilars is far from being concluded. However, some aspects, such as those regarding the quality, the safety and the efficacy of biosimilars, as well as the possibility of prescribe biosimilars not only to naïve patients naïve, it seems to be well supported. According to the new AIFA's position paper, the prescriber need to be the principal decision makers in the choice between biological and biosimilar. In the future, it will be interesting to check how much these new concepts will be able to influence, in current practice, the correct use of drugs that are presented as an important therapeutic resource for the National Health Service.
    MeSH term(s) Biosimilar Pharmaceuticals/adverse effects ; Biosimilar Pharmaceuticals/therapeutic use ; Choice Behavior ; Decision Making ; Government Agencies ; Humans ; Italy ; Practice Patterns, Physicians'
    Chemical Substances Biosimilar Pharmaceuticals
    Language Italian
    Publishing date 2018-04-29
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 138266-4
    ISSN 2038-1840 ; 0034-1193
    ISSN (online) 2038-1840
    ISSN 0034-1193
    DOI 10.1701/2896.29191
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: [CoViD-19: we knew everything but we didn't understand anything.]

    Addis, Antonio

    Recenti Prog Med

    Abstract: The CoViD-19 and its consequences could perhaps have been foreseen Above all, this pandemic force us to review what is essential and really necessary in term of priorities and regulatory process for clinical pharmacological research It is evident, among ... ...

    Abstract The CoViD-19 and its consequences could perhaps have been foreseen Above all, this pandemic force us to review what is essential and really necessary in term of priorities and regulatory process for clinical pharmacological research It is evident, among other things, the difficulty to deal with therapeutic uncertainties Not proven specific therapies are available for the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, the cause of CoViD-19), other than supportive care However, several clinical centres decided to use off label drugs as a standard of care in the absence of efficacy and safety data The national regulatory body (AIFA) has set up a process in a short time to transparently govern the approval of new trials and to regulate the use of medicines that are not indicated In this context, the communication of risk associated with experimental therapies was also very important The lessons we will learn from this emergency may result crucial in redesigning a better way of conducting clinical trials and information on drugs
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #110245
    Database COVID19

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  9. Article: CoViD-19: sapevamo tutto ma non avevamo capito niente./ [CoViD-19: we knew everything but we didn't understand anything.]

    Addis, Antonio

    Recenti Prog Med

    Abstract: The CoViD-19 and its consequences could perhaps have been foreseen. Above all, this pandemic force us to review what is essential and really necessary in term of priorities and regulatory process for clinical pharmacological research. It is evident, ... ...

    Abstract The CoViD-19 and its consequences could perhaps have been foreseen. Above all, this pandemic force us to review what is essential and really necessary in term of priorities and regulatory process for clinical pharmacological research. It is evident, among other things, the difficulty to deal with therapeutic uncertainties.Not proven specific therapies are available for the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, the cause of CoViD-19), other than supportive care. However, several clinical centres decided to use off label drugs as a standard of care in the absence of efficacy and safety data. The national regulatory body (AIFA) has set up a process in a short time to transparently govern the approval of new trials and to regulate the use of medicines that are not indicated. In this context, the communication of risk associated with experimental therapies was also very important. The lessons we will learn from this emergency may result crucial in redesigning a better way of conducting clinical trials and information on drugs.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #32319433
    Database COVID19

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  10. Article: Big data contro studi clinici randomizzati? La contrapposizione non giova a nessuno.

    Addis, Antonio

    Epidemiologia e prevenzione

    2017  Volume 41, Issue 5-6, Page(s) 304–305

    Title translation Big data versus randomized clinical trials? Nobody benefits from the contrast.
    MeSH term(s) Big Data ; Causality ; Congresses as Topic ; Evidence-Based Medicine ; Humans ; Italy ; Pharmacoepidemiology/organization & administration ; Pragmatic Clinical Trials as Topic ; Randomized Controlled Trials as Topic
    Language Italian
    Publishing date 2017-11-08
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 1038112-0
    ISSN 1120-9763
    ISSN 1120-9763
    DOI 10.19191/EP17.5-6.P304.092
    Database MEDical Literature Analysis and Retrieval System OnLINE

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