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New drugs: where did we go wrong and what can we do better?
8 references·5 citing·38 second hop
New drugs: where did we go wrong and what can we do better? (2019)New drugs: where did we go wrong and what…Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval (2019)Assessment of the Clinical Be…Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13 (2017)Availability of evidence of b…Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study (2015)Trends in utilization of FDA …From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients (2015)From adaptive licensing to ad…American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options (2015)American Society of Clinical …A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) (2015)A standardised, generic, vali…Unintended Consequences of Expensive Cancer Therapeutics—The Pursuit of Marginal Indications and a Me-Too Mentality That Stifles Innovation and Creativity (2014)Unintended Consequences of Ex…Drugs for neglected diseases initiative (2005)Drugs for neglected diseases …Project Rebuild the Evidence Base (REB): a method to interpret randomised clinical trials and their meta-analysis to present solid benefit-risk assessments to patients. (2022)Project Rebuild the Evidence …Generating comparative evidence on new drugs and devices before approval (2020)Generating comparative eviden…Generating comparative evidence on new drugs and devices after approval (2020)Generating comparative eviden…Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study (2020)Association between FDA and E…Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States (2020)Approval of Cancer Drugs With…Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers (2007)Clinical development success rates for investigational drugs (2014)Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future (2017)Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions (2019)Limits on Medicare's Ability to Control Rising Spending on Cancer Drugs (2009)Delivering affordable cancer care in high-income countries (2011)The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts (2013)Financial toxicity and implications for cancer care in the era of molecular and immune therapies (2018)An Arm and a Leg: The Rising Cost of Cancer Drugs and Impact on Access (2021)Financial toxicity in cancer care: origins, impact, and solutions (2021)Accelerated Approval of Oncology Products: The Food and Drug Administration Experience (2011)Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer (2011)Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000–2015 (2017)Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017 (2020)Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs (2000)GRADE guidelines: 3. Rating the quality of evidence (2011)Economic burden of cancer across the European Union: a population-based cost analysis (2013)Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received (2016)The high price of anticancer drugs: origins, implications, barriers, solutions (2017)Net Health Benefits (1998)Projections of the Cost of Cancer Care in the United States: 2010-2020 (2011)The Financial Toxicity of Cancer Treatment: A Pilot Study Assessing Out-of-Pocket Expenses and the Insured Cancer Patient's Experience (2013)Essential medicines for universal health coverage (2016)Financial Hardships Experienced by Cancer Survivors: A Systematic Review (2016)A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics (2018)Population-health impact of new drugs recommended by the National Institute for Health and Care Excellence in England during 2000–20: a retrospective analysis (2024)Pricing in the Market for Anticancer Drugs (2015)Prices and clinical benefit of cancer drugs in the USA and Europe: a cost–benefit analysis (2020)Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe (2021)Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019 (2022)Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets (2018)The replicability crisis and public trust in psychological science (2018)Pricing of pharmaceuticals is becoming a major challenge for health systems (2020)Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy (2023)Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval (2024)A means of improving public health in low- and middle-income countries? Benefits and challenges of international public–private partnerships (2017)Why miltefosine—a life-saving drug for leishmaniasis—is unavailable to people who need it the most (2018)Are academia–pharma partnerships essential for novel drug discovery in the time of the COVID-19 pandemic? (2020)
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References

  • 2015American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options916 cited
  • 2015A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS)817 cited
  • 2017Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13600 cited
  • 2014Unintended Consequences of Expensive Cancer Therapeutics—The Pursuit of Marginal Indications and a Me-Too Mentality That Stifles Innovation and Creativity304 cited
  • 2019Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval302 cited
  • 2015From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients196 cited
  • 2015Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study189 cited
  • 2005Drugs for neglected diseases initiative165 cited

Cited by

  • 2020Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study111 cited
  • 2020Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States96 cited
  • 2020Generating comparative evidence on new drugs and devices after approval87 cited
  • 2020Generating comparative evidence on new drugs and devices before approval

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79 cited
  • 2022Project Rebuild the Evidence Base (REB): a method to interpret randomised clinical trials and their meta-analysis to present solid benefit-risk assessments to patients.15 cited