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  1. Article

    Open Access

    Bayesian interim analysis for prospective randomized studies: reanalysis of the acute myeloid leukemia HOVON 132 clinical trial

    Randomized controlled trials (RCTs) are the gold standard to establish the benefit-risk ratio of novel drugs. However, the evaluation of mature results often takes many years. We hypothesized that the addition...

    Niek G. van der Maas, Jurjen Versluis, Kazem Nasserinejad… in Blood Cancer Journal (2024)

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    Article

    A Review of Causal Inference for External Comparator Arm Studies

    Randomized controlled trials (RCTs) are the gold standard design to establish the efficacy of new drugs and to support regulatory decision making. However, a marked increase in the submission of single-arm tri...

    Gerd Rippin, Nicolás Ballarini, Héctor Sanz, Joan Largent, Chantal Quinten… in Drug Safety (2022)

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    Article

    The value of anticancer drugs — a regulatory view

    The high prices of new anticancer drugs and the marginal added benefit perceived by some stakeholders have fuelled a debate on the value of anticancer drugs in the European Union, even though an agreed definit...

    Francesco Pignatti, Ulla Wilking, Douwe Postmus… in Nature Reviews Clinical Oncology (2022)

  4. No Access

    Chapter

    Ethical Aspects of Regulating Oncology Products

    Medicines, including those intended for the treatment of cancer, are tightly regulated. Such regulation, historically linked to disasters due to unsafe medicines, evolved to cover all aspects of research aroun...

    Lorenzo Guizzaro, Spyridon Drosos… in Ethical Challenges in Cancer Diagnosis and… (2021)

  5. No Access

    Chapter

    Regulatory and Evidence Requirements and the Changing Landscape in Regulation for Marketing Authorisation

    In this chapter, we describe the changing landscape of the EU pharmaceutical legislation concerning regulation and evidence requirements for marketing authorisation. First, we describe the legal requirements f...

    Francesco Pignatti, Elias Péan in Regulatory and Economic Aspects in Oncology (2019)

  6. No Access

    Article

    The European Medicines Agency approval of ingenol mebutate (Picato) for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use (CHMP)

    The European Commission has recently issued a marketing authorisation valid throughout the European Union for ingenol mebutate (Picato) in the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actini...

    Kyriaki Tzogani, Nithyanandan Nagercoil… in European Journal of Dermatology (2014)

  7. No Access

    Article

    Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma

    Drug regulatory agencies face the challenge of striking the appropriate balance between the need for rapid access to new drugs and the need to obtain comprehensive data on their benefit/risk profiles. This art...

    Hans-Georg Eichler, Francesco Pignatti, Bruno Flamion… in Nature Reviews Drug Discovery (2008)

  8. No Access

    Article

    The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome

    Abstract

    Francesco Pignatti, Bo Aronsson, Nick Gate… in European Journal of Clinical Pharmacology (2002)