V. Bertele'

Most-cited papers

Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration
L. Moja, E. Lucenteforte, K. Kwag, V. Bertele' +17 more
2014Cochrane Database of Systematic Reviews213 citations Open access
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Non-inferiority trials are unethical because they disregard patients' interests.
S. Garattini, V. Bertele'
2007The Lancet177 citations
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Barriers to the conduct of randomised clinical trials within all disease areas
S. Djurisic, A. Rath, Sabrina Gaber, S. Garattini +10 more
2017Trials133 citations Open access
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Efficacy, safety, and cost of new anticancer drugs
S. Garattini, V. Bertele'
2002British medical journal120 citations Open access
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Orphan drugs, orphan diseases. The first decade of orphan drug legislation in the EU
R. Joppi, V. Bertele', S. Garattini
2012European Journal of Clinical Pharmacology110 citations
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Evidence-based clinical practice: Overview of threats to the validity of evidence and how to minimise them.
S. Garattini, J. Jakobsen, J. Wetterslev, V. Bertele' +14 more
2016European journal of internal medicine103 citations Open access
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Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures
Giovanni Apolone, R. Joppi, V. Bertele', S. Garattini
2005British Journal of Cancer98 citations Open access
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Approvals of drugs with uncertain benefit-risk profiles in Europe.
R. Banzi, C. Gerardi, V. Bertele', S. Garattini
2015European journal of internal medicine96 citations Open access
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A systematic literature review of evidence-based clinical practice for rare diseases: what are the perceived and real barriers for improving the evidence and how can they be overcome?
A. Rath, V. Salamon, S. Peixoto, V. Hivert +13 more
2017Trials88 citations Open access
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Specific barriers to the conduct of randomised clinical trials on medical devices
E. Neugebauer, A. Rath, Sunya-Lee Antoine, M. Eikermann +14 more
2017Trials80 citations Open access
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Recent National and Regional Drug Reforms in Sweden
B. Wettermark, B. Godman, K. Andersson, L. Gustafsson +2 more
2012PharmacoEconomics (Auckland)79 citations
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Enhancing the rational use of new medicines across European health care systems
S. Garattini, V. Bertele', B. Godman, A. Haycox +2 more
2008European Journal of Clinical Pharmacology75 citations Open access
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Adjusting Europe's drug regulation to public health needs.
S. Garattini, V. Bertele'
2001The Lancet73 citations
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Orphan drug development is progressing too slowly.
R. Joppi, V. Bertele', S. Garattini
2006British Journal of Clinical Pharmacology71 citations Open access
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Older patients are still under-represented in clinical trials of Alzheimer’s disease
R. Banzi, Paolo Camaioni, M. Tettamanti, V. Bertele' +1 more
2016Alzheimer's Research & Therapy69 citations Open access
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How can we regulate medicines better?
S. Garattini, V. Bertele'
2007British medical journal62 citations Open access
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Orphan drug development is not taking off.
R. Joppi, V. Bertele', S. Garattini
2009British Journal of Clinical Pharmacology59 citations Open access
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How can research ethics committees protect patients better?
S. Garattini, V. Bertele', Luca Li Bassi
2003British medical journal49 citations Open access
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New Direct-Acting Antivirals for the Treatment of Patients With Hepatitis C Virus Infection: A Systematic Review of Randomized Controlled Trials.
V. Pecoraro, R. Banzi, E. Cariani, J. Chester +4 more
2019Journal of Clinical and Experimental Hepatology43 citations Open access
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FDA vs EMA: review times and clinical evidence on novel drugs at the time of approval.
R. Joppi, V. Bertele', T. Vannini, S. Garattini +1 more
2019British Journal of Clinical Pharmacology43 citations Open access
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Letting post-marketing bridge the evidence gap: the case of orphan drugs
R. Joppi, C. Gerardi, V. Bertele', S. Garattini
2016British medical journal34 citations
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Conditional approval of medicines by the EMA
R. Banzi, C. Gerardi, V. Bertele', S. Garattini
2017British medical journal29 citations
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Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?
M. Laville, B. Segrestin, M. Alligier, C. Ruano-Rodríguez +14 more
2017Trials29 citations Open access
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Peripheral arterial disease: Changes in clinical outcomes and therapeutic strategies in two cohorts, from 2002 to 2008 and from 2008 to 2014. A population-based study
M. Baviera, V. Bertele', F. Avanzini, T. Vannini +5 more
2018European Journal of Preventive Cardiology20 citations
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Europe’s opportunity to open up drug regulation
S. Garattini, V. Bertele'
2010British medical journal20 citations
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Placebo? no thanks, it might be bad for me!
S. Garattini, V. Bertele', R. Banzi
2013European Journal of Clinical Pharmacology19 citations
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Haematological anticancer drugs in Europe: any added value at the time of approval?
V. Bertele', R. Banzi, F. Capasso, G. Tafuri +3 more
2007European Journal of Clinical Pharmacology19 citations
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Ethics in clinical research.
S. Garattini, V. Bertele'
2009Journal of Hepatology18 citations Open access
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Provision of information on regulatory authorities’ websites
Agnes Vitry, J. Lexchin, L. Sasich, T. Dupin-Spriet +5 more
2008Internal medicine journal (Print)17 citations
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New antirheumatic drugs: any real added value? A critical overview of regulatory criteria for their marketing approval
V. Bertele', A. Assisi, V. Muzio, Danila Renzo +1 more
2007European Journal of Clinical Pharmacology17 citations
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Preapproval and postapproval evidence on drugs for multiple sclerosis
C. Gerardi, V. Bertele', S. Rossi, S. Garattini +1 more
2018Neurology16 citations
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Discontinuation of Vioxx. Authors' reply
Peter S. Kim, A. Reicin, M. Lièvre, E. Abadie +12 more
200515 citations
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Efficacy, safety and cost of new drugs acting on the central nervous system
S. Garattini, V. Bertele'
2003European Journal of Clinical Pharmacology15 citations
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Efficacy, safety and cost of new cardiovascular drugs: a survey
S. Garattini, V. Bertele'
2003European Journal of Clinical Pharmacology15 citations
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Clinical evidence supporting the marketing authorization of biosimilars in Europe
Eleonora Allocati, V. Bertele', C. Gerardi, S. Garattini +1 more
2020European Journal of Clinical Pharmacology14 citations
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Light and shade in proposed revision of EU drug-regulatory legislation.
S. Garattini, V. Bertele', L. Bassi
2003The Lancet14 citations
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European regulatory policies on medicines and public health needs.
Luca Li Bassi, V. Bertele', S. Garattini
2003European Journal of Public Health14 citations Open access
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Anything new in EU pharmacovigilance?
S. Garattini, V. Bertele'
2011European Journal of Clinical Pharmacology12 citations
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Homoeopathy: not a matter for drug-regulatory authorities.
S. Garattini, V. Bertele'
2009The Lancet12 citations
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Discontinuation of Vioxx.
S. Garattini, V. Bertele'
2005The Lancet11 citations Open access
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EMA’s reflection on placebo does not reflect patients’ interests
V. Bertele', R. Banzi, C. Gluud, S. Garattini
2011European Journal of Clinical Pharmacology10 citations
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Rosiglitazone and the need for a new drug safety agency
S. Garattini, V. Bertele'
2010British medical journal10 citations
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CNS drugs approved by the centralised European procedure: true innovation or dangerous stagnation?
C. Barbui, A. Cipriani, Camilla Lintas, V. Bertele' +1 more
2006Psychopharmacology9 citations
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PGE 1 Treatment of Severe Intermittent Claudication (Short-Term Versus Long-Term, Associated with Exercise)
G. Belcaro, A. Nicolaides, G. Agus, M. Cesarone +30 more
2000Angiology9 citations
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Fostering EMA's transparency policy.
R. Banzi, V. Bertele', J. Demotes-Mainard, S. Garattini +3 more
2014European journal of internal medicine8 citations
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Regulatory response to contaminated valsartan
R. Banzi, V. Bertele'
2018British medical journal7 citations
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EMA's transparency seems to be opaque.
R. Banzi, V. Bertele', S. Garattini
2014The Lancet7 citations Open access
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Limits of add-on trials: antirheumatic drugs
L. Ottolenghi, V. Bertele', S. Garattini
2008European Journal of Clinical Pharmacology7 citations Open access
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A matter of public interest
S. Garattini, V. Bertele'
2010British medical journal6 citations
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The impact of European regulatory policies on psychotropic drug prescribing patterns
S. Garattini, V. Bertele'
2005International Review of Psychiatry6 citations
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