Clinical Trials of New Drug Products: What Gets Compared to Whom
Charles Kowalski
American Journal of Clinical and Experimental Medicine, 2015
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Biased by design? Clinical trials and patient benefit in oncology
Pan Pantziarka
Future Oncology
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Shackling Innovation The Regulation of Industry Supported Clinical Trials
Alison Mathey, Sigrid Fry-Revere
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Clinical Trials: The Role of Regulatory Agencies, Pharmacovigilance Laws, Guidelines, Risk Management, Patenting, and Publicizing Results
Sabitha Kandi
Borneo Journal of Pharmacy, 2023
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Generating comparative evidence on new drugs and devices after approval
Lise Rochaix
The Lancet, 2020
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The positioning of economic principles under the changing conditions of the novel drug developmental process in cancer
Nils Wilking
Chinese clinical oncology, 2014
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Can adaptive clinical trials help to solve the productivity crisis of the pharmaceutical industry? - a scenario analysis
Jörg Mahlich
Health Economics Review
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Abandoning clinical trial safeguards won't boost local industry
Paul Komesaroff
2013
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At a glance: economic impact of industry-sponsored clinical trials of pharmaceutical products
Mehdi Varmaghani
Journal of Medical Economics
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The Research-Based Pharmaceutical Industry and Society: What Is at Stake in the Future?
KARL WÜNDISCH
2014
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Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009
Joseph DiMasi
Clinical pharmacology and therapeutics, 2011
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Facing the Challenges of the European Clinical Trials Directive – The European Organisation for Research and Treatment of Cancer Perspective
Diane van Vyve
European Oncology & Haematology, 2008
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Beyond Access vs. Protection in Trials of Innovative Therapies
Marina Emborg
Science, 2010
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Success in Meeting the Primary Endpoint in Phase III Trials: A Comparison of Industry and Cooperative Group Trials
Ben Djulbegovic
Blood
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Policy DEFINING INNOVATION WITH RESPECT TO NEW MEDICINES: A SYSTEMATIC REVIEW FROM A PAYER PERSPECTIVE
Stefano Capri
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Disease-mongering through clinical trials
Maria González Moreno
Studies in history and philosophy of biological and biomedical sciences, 2015
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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
S. Garattini
British Journal of Cancer, 2005
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Response to Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”
Faye Williamson
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Unintended Consequences of Expensive Cancer Therapeutics—The Pursuit of Marginal Indications and a Me-Too Mentality That Stifles Innovation and Creativity
Andrew Lo
JAMA Otolaryngology–Head & Neck Surgery, 2014
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Mitigating Deficiencies in Evidence during Regulatory Assessments of Advanced Therapies: A Comparative Study with Other Biologicals
Magdi Elsallab
Molecular Therapy - Methods & Clinical Development, 2020
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Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials
Iztok Hozo, Branko Miladinovic
PLoS ONE, 2013
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Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Jenerius Aminawung
JAMA, 2014
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Unveiling the Dark Side of Clinical Trials
Sumana Sen
PARIPEX INDIAN JOURNAL OF RESEARCH
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Clinical trials in the age of personalized medicine
Alberto Cambrosio
Journal of Medicine and the Person, 2011
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Relevance of randomised controlled trials in oncology
Saroj Niraula
The Lancet Oncology, 2016
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Randomized Clinical Trials — Removing Unnecessary Obstacles
Jackie Bosch
New England Journal of Medicine, 2013
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Additional consensus recommendations for conducting complex innovative trials of oncology agents: a post-pandemic perspective
Jonathan Fennelly-Barnwell
British Journal of Cancer
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Why New Drugs, Treatments, and Medical Devices Still Needs to be Tested Clinically Before Making it Available in the Market?
Naiya Patel
JOURNAL OF NEUROLOGICAL RESEARCH AND THERAPY , 2019
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Pharmaceutical clinical research and regulation: an impact evaluation of public policy
Greta Falavigna
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Assessing claims about the cost of new drug development: a critique of the public citizen and TB Alliance reports
Joseph DiMasi
Tufts Center for the Study of …, 2004
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Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency
Marisa Papaluca, Thorsten Vetter
Trials, 2014
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What is the probability of discovering breakthrough interventions in industry versus publicly sponsored randomized controlled trials
Branko Miladinovic
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