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Subject Areas on Research
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A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?
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A comparison of moment-based and probability-based criteria for assessment of follow-on biologics.
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A note on special articles on adaptive clinical trial designs.
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A pre-marketing ALT signal predicts post-marketing liver safety.
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Accountability in Patenting of Federally Funded Research
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An application of the revised CONSORT standards to FDA summary reports of recently approved antidepressants and antipsychotics.
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Anti-VEGF therapies in the clinic.
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Application of the parallel line assay to assessment of biosimilar products based on binary endpoints.
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Assessing biosimilarity and interchangeability of biosimilar products.
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Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.
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Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015.
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Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration.
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Balancing the benefits and risks of inhaled long-acting beta-agonists--the influence of values.
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Balancing the cyclooxygenase portfolio.
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Balancing the risks and benefits of long-term antiplatelet therapies for cardiovascular disease: clinical, research, and regulatory implications.
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Bevacizumab biosimilars: scientific justification for extrapolation of indications.
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Blinatumomab: A New Treatment for Adults With Relapsed Acute Lymphocytic Leukemia.
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Building a drug development database: challenges in reliable data availability.
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Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation.
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Cardiovascular drug development: is it dead or just hibernating?
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Ceftaroline applications for therapy in the United States.
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Ceftaroline: clinical and microbiology experience with focus on methicillin-resistant Staphylococcus aureus after regulatory approval in the USA.
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Certolizumab pegol.
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Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.
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Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration.
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Clinical and Technical Considerations for Brain PET Imaging for Dementia.
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Clinical research in the lay press: irresponsible journalism raises a huge dose of doubt.
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Clinical strategies for selecting oral anticoagulants in patients with atrial fibrillation.
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Clinical utility of the Food and Drug Administration Electrocardiogram Warehouse: a paradigm for the critical pathway initiative.
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Comments on the FDA draft guidance on biosimilar products.
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Congress, the FDA, and the fair development of new medications for children.
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Cryoprecipitate therapy.
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Current knowledge of the platelet glycoprotein IIb/IIIa receptor antagonists for the treatment of coronary artery disease.
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Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010-2020.
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Demonstrating effectiveness or demonstrating not ineffectiveness - A potential solution for rare disease drug product development?
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Developing Breakthrough Drugs for Heart Failure: Lessons Learned From the Cystic Fibrosis Experience.
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Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19.
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Developing drugs for developing countries.
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Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015.
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Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.
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Drug Development in Kidney Disease: Proceedings From a Multistakeholder Conference.
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Drug Development. Are trade secrets delaying biosimilars?
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Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.
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Early dissemination of bevacizumab for advanced colorectal cancer: a prospective cohort study.
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Economic return of clinical trials performed under the pediatric exclusivity program.
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Economics of new oncology drug development.
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Efficacy of the Priority Review Voucher Program.
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Emergency Use Authorization of Remdesivir: The Need for a Transparent Distribution Process.
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Endpoint surrogacy in oncology Phase 3 randomised controlled trials.
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Endpoints in Heart Failure Drug Development: History and Future.
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Evaluation of Flibanserin: Science and Advocacy at the FDA.
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Evaluation of Representation of Women as Authors in Pivotal Trials Supporting US Food and Drug Administration Approval of Novel Cardiovascular Drugs.
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Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors: A Systematic Review.
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Exploring options for improving healthcare.
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Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval.
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FDA approval of dapagliflozin for chronic kidney disease: a remarkable achievement?
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FDA review vouchers.
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Facial Filler Complications.
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Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.
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Food and Drug Administration: Cardiovascular and Renal Drugs Advisory Committee, 98th meeting, January 6th-7th, 2003.
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Gene Therapy 2017: Progress and Future Directions.
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Generating comparative evidence on new drugs and devices after approval.
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Generic clopidogrel: time to substitute?
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HIV pre-exposure prophylaxis.
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Haloperidol for postoperative nausea and vomiting: are we reinventing the wheel?
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Harmonising regulatory approval for antibiotics in children.
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Hurry up and slow down: lessons in drug development from the COX-2 inhibitors.
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Idarucizumab since FDA approval: Use in the real-world.
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Impact of Food and Drug Administration Approval of Vismodegib on Prevalence of Orbital Exenteration as a Necessary Surgical Treatment for Locally Advanced Periocular Basal Cell Carcinoma.
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Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.
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Improving Cardiovascular Drug and Device Development and Evidence Through Patient-Centered Research and Clinical Trials: A Call to Action From the Value in Healthcare Initiative's Partnering With Regulators Learning Collaborative.
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Improving pharmaceutical innovation by building a more comprehensive database on drug development and use.
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Improving the assessment of heart toxicity for all new drugs through translational regulatory science.
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Improving the tools of clinical pharmacology: Goals for 2017 and beyond.
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Individual bioequivalence testing under 2x3 designs.
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Industry perspectives on ICH guidelines.
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Information Transparency in the Drug Approval Process.
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Innovative design and analysis for rare disease drug development.
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Introducing CCR perspectives in drug approval.
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Introduction of European priority review vouchers to encourage development of new medicines for neglected diseases.
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Introduction: fusidic acid enters the United States.
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Is conflict of interest becoming a challenge for institution-based institutional review boards?
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Making genuine progress against metastatic breast cancer.
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Medical Marijuana Laws Reduce Prescription Medication Use In Medicare Part D.
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Medicine. A portfolio model of drug development for tuberculosis.
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NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives.
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Neuropsychiatric adverse effects of oseltamivir in the FDA Adverse Event Reporting System, 1999-2012.
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New FDA breakthrough-drug category--implications for patients.
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New rules for clinical trials of patients with acute bacterial skin and skin-structure infections: do not let the perfect be the enemy of the good.
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Noncollagen Dermal Fillers: A Summary of the Clinical Trials Used for Their FDA Approval.
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Off-label applications for SSRIs.
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Off-label uses for selective serotonin reuptake inhibitors.
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On flexibility of adaptive designs and criteria for choosing a good one--a discussion of FDA draft guidance.
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On safety margin for drug interchangeability.
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On sample size requirement for analytical similarity assessment.
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Patients, physicians, and clinical trials: the other side of the coins.
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Peripheral T-cell lymphoma, NOS, and anaplastic large cell lymphoma.
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Pharmacokinetics and safety of recently approved drugs used to treat methicillin-resistant Staphylococcus aureus infections in infants, children and adults.
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Premature release of data from clinical trials of ezetimibe.
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Prescribing BiDil: is it black and white?
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Prescribing rates and characteristics of recipients of tenofovir-containing regimens before and after market entry of tenofovir alafenamide.
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Priorities for the Priority Review Voucher.
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Pro: The Food and Drug Administration Black box warning on droperidol is not justified.
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Probability monitoring procedures for sample size determination.
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Proceedings of the 99th meeting of the Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee. May 29th and 30th, 2003.
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Proposals of statistical consideration to evaluation of results for a specific region in multi-regional trials--Asian perspective.
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Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs.
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Rationing in urologic oncology: lessons from sipuleucel-T for advanced prostate cancer.
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Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA.
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Recommendations for the registration of agents for prevention and treatment of glucocorticoid-induced osteoporosis: an update from the Group for the Respect of Ethics and Excellence in Science.
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Regulatory Review of New Therapeutic Agents - FDA versus EMA, 2011-2015.
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Regulatory Review of New Therapeutic Agents.
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Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.
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Repairing the broken market for antibiotic innovation.
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Report from the 94th Cardiovascular and Renal Drugs Advisory Committee Meeting, October 11, 2001.
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Reproducibility probability in clinical trials.
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Research design features and patient characteristics associated with the outcome of antidepressant clinical trials.
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Roundtable on postherpetic neuralgia--what, why, how long, and what's next?
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Scientific considerations for assessing biosimilar products.
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Scientific factors and current issues in biosimilar studies.
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Selection bias, phase II trials, and the FDA accelerated approval process.
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Sensible guidelines for the conduct of large randomized trials.
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Some thoughts on drug interchangeability.
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Some thoughts on the QR method for analytical similarity evaluation.
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Specialty Pharmaceuticals for Hyperlipidemia--Impact on Insurance Premiums.
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Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration.
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Spending on postapproval drug safety.
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Statistical and regulatory considerations in assessments of interchangeability of biological drug products.
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Statistical assessment of biosimilar products.
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Statistical considerations for rare diseases drug development.
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Strategic use of statistical thinking in drug development.
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Suicidality as a possible side effect of antidepressant treatment.
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Systematic review: reliability of compendia methods for off-label oncology indications.
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Systematic survey of therapeutic trials for metastatic colorectal cancer: room for improvement in the critical pathway.
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Telavancin.
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Ten-Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs.
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The 21st Century Cures Act.
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The Commercial Market For Priority Review Vouchers.
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The FDA in the 21st Century: How Is the FDA Responding to the New World? A Focus on Cardiovascular Drug Development.
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The Society for Clinical Trials opposes US legislation to permit marketing of unproven medical therapies for seriously ill patients.
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The balance of benefit and safety of rosiglitazone: important lessons for our system of drug development and postmarketing assessment.
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The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics.
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The price of innovation: new estimates of drug development costs.
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The roles of patents and research and development incentives in biopharmaceutical innovation.
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Trends in hepatitis C treatment uptake in the United States.
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Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3.
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U.S. Food and Drug Administration-Approved Poly (ADP-Ribose) Polymerase Inhibitor Maintenance Therapy for Recurrent Ovarian Cancer: A Cost-Effectiveness Analysis.
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US Food and Drug Administration Facilitated Pediatric Approval Programs: Application to Pediatric Neurological Disorders.
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US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.
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Understanding the sleep-wake cycle: sleep, insomnia, and the orexin system.
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Updating the 2003 European regulatory requirements for registering disease-modifying drugs to be used in the treatment of rheumatoid arthritis.
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Use Patents Can Be Useful: The Case of Rescued Drugs
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Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs.
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Using Medicare administrative data to conduct postmarketing surveillance of follow-on biologics: issues and opportunities.
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Vaccine Development: Steps to Approval of an Investigational Vaccine.
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Value in Healthcare Initiative: Summary and Key Recommendations.
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What should work, may not.
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Who should go first in trials with scarce agents? The views of potential participants.
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Will Precision Medicine Move Us beyond Race?
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Will a new tenofovir prodrug for the treatment of HIV reduce the risk of nephrotoxicity?
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Will biosimilars gain momentum?
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Keywords of People
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Cohen-Wolkowiez, Michael,
Professor of Pediatrics,
Pediatrics, Infectious Diseases
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Grambow, Steven C.,
Associate Professor of Biostatistics & Bioinformatics,
Biostatistics & Bioinformatics
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Reed, Shelby Derene,
Professor in Population Health Sciences,
Duke Science & Society
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Ridley, David Blaine,
Professor of the Practice of Business Administration,
Duke Science & Society
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Zafar, Syed Yousuf,
Adjunct Professor in the Department of Medicine,
Duke Science & Society