Drug Industry

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  Subject Areas on Research

  • "Take your pill": the role and fantasy of pills in modern medicine. 
  • 10 x '20 Progress--development of new drugs active against gram-negative bacilli: an update from the Infectious Diseases Society of America. 
  • A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding? 
  • A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. 
  • A population-based study of the prevalence and influence of gifts to radiation oncologists from pharmaceutical companies and medical equipment manufacturers. 
  • A rationale for conducting parallel mechanistic studies in clinical trials of pharmacotherapy. 
  • Access to patient-level data from GlaxoSmithKline clinical trials. 
  • Advertisement breached code of practice 
  • Aerosolized ribavirin: the most expensive drug for pneumonia. 
  • Albumin industry launches global promotion. 
  • American Society of Clinical Oncology guidance statement: the cost of cancer care. 
  • An interview with Professor Robert J. Lefkowitz, M.D. Interview by Vicki Glaser. 
  • An overview of the pharmaceutical industry. 
  • Antibiotic Development Incentives That Reflect Societal Value of Antibiotics. 
  • Assessing distributions of estimated drug shelf lives in stability analysis. 
  • Assessing sensitivity and similarity in bridging studies. 
  • Assessing the consistency of traditional Chinese medicine with multiple correlative active components. 
  • Availability and use of essential medicines in China: manufacturing, supply, and prescribing in Shandong and Gansu provinces. 
  • Benefits, challenges and obstacles of adaptive clinical trial designs. 
  • Biomarkers and personalised medicine in rheumatoid arthritis: a proposal for interactions between academia, industry and regulatory bodies. 
  • Bridging studies in clinical development. 
  • Bringing new therapies to patients--what is the proper physician-industry relationship? 
  • Can Innovation in Regulatory Science Address Health Care Cost Burdens? 
  • Canadian Association for Immunization Research and Evaluation (CAIRE) guidelines for industry-sponsored clinical trial and epidemiology contract research. 
  • Cardiovascular drug development: is it dead or just hibernating? 
  • Cardiovascular research in India: a perspective. 
  • Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. 
  • Collaborations in the development and validation of imaging biomarkers. 
  • Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options 
  • Comparison of Industry Payments to Physicians and Advanced Practice Clinicians. 
  • Compliance with results reporting at ClinicalTrials.gov. 
  • Conflict of interest-- an issue for every psychiatrist. 
  • Congress, the FDA, and the fair development of new medications for children. 
  • Correction of misleading information in prescription drug television advertising: The roles of advertisement similarity and time delay. 
  • Cost of innovation in the pharmaceutical industry. 
  • Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations. 
  • Developing drugs for developing countries. 
  • Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry. 
  • Differential pricing of pharmaceuticals in the internet age. 
  • Discovery and development of lamotrigine for bipolar disorder: a story of serendipity, clinical observations, risk taking, and persistence. 
  • Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier. 
  • Drug Development. Are trade secrets delaying biosimilars? 
  • Drug companies cut HIV drug prices in the developing world. 
  • Drug companies seek MS patients to lobby for new products. 
  • Drug shortages in the United States: a critical evaluation of root causes and the need for action. 
  • Drug-company sponsorship and the Declaration of Helsinki. 
  • Economic return of clinical trials performed under the pediatric exclusivity program. 
  • Economics of new oncology drug development. 
  • Effective Partnering in Conducting Benefit-Risk Patient Preference Studies: Perspectives From a Patient Advocacy Organization, a Pharmaceutical Company, and Academic Stated-Preference Researchers. 
  • Effects of medical research on health care and economy. 
  • Efficacy of the Priority Review Voucher Program. 
  • Ensuring global access to COVID-19 vaccines. 
  • Expanding Access and Reducing Prices for Drugs to Prevent HIV: Should Government Enforce Its Patent Rights Against the Pharmaceutical Industry? 
  • Extraordinary claims require extraordinary evidence. 
  • FDA review vouchers. 
  • Factors influencing the participation of gastroenterologists and hepatologists in clinical research. 
  • Free-riding and the prisoner's dilemma: problems in funding economic analyses of phase III cancer clinical trials. 
  • Frequency, nature, effects, and correlates of conflicts of interest in published clinical cancer research. 
  • GRADE guidelines: 5. Rating the quality of evidence--publication bias. 
  • Genomics-enabled drug repositioning and repurposing: insights from an IOM Roundtable activity. 
  • Grassroots marketing in a global era: more lessons from BiDil. 
  • How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation. 
  • How direct-to-consumer television advertising for osteoarthritis drugs affects physicians' prescribing behavior. 
  • How does PLoS medicine manage competing interests? 
  • How informatics can potentiate precompetitive open-source collaboration to jump-start drug discovery and development. 
  • Hurry up and slow down: lessons in drug development from the COX-2 inhibitors. 
  • Impact of Economic, Regulatory and Patent Policies on Innovation in Cancer Chemoprevention 
  • Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy. 
  • Implications of pharmacogenomics for drug development and clinical practice. 
  • Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team. 
  • Improving pharmaceutical innovation by building a more comprehensive database on drug development and use. 
  • Incentivising wealthy nations to participate in the COVID-19 Vaccine Global Access Facility (COVAX): a game theory perspective. 
  • Industrial collaboration. 
  • Industry perspectives on ICH guidelines. 
  • Initial sequencing and analysis of the human genome. 
  • Innovation in the pharmaceutical industry: New estimates of R&D costs. 
  • Interactions between pharmaceutical representatives and doctors in training. A thematic review. 
  • Introduction of European priority review vouchers to encourage development of new medicines for neglected diseases. 
  • Is conflict of interest becoming a challenge for institution-based institutional review boards? 
  • Laboratory Animal Bite Anaphylaxis: A National Survey: Part 2: Treatment Protocols. 
  • Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs. 
  • Market watch: Forecasting market share in the US pharmaceutical market. 
  • Mechanisms to provide safe and effective drugs for children. 
  • Medicine. A portfolio model of drug development for tuberculosis. 
  • Medicine. The need for a global HIV vaccine enterprise. 
  • Mercury, vaccines, and autism: one controversy, three histories. 
  • Methodological issues in negative symptom trials. 
  • Misleading congress about drug development: Reply. 
  • Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry. 
  • Moving from the Trial to the Real World: Improving Medication Adherence Using Insights of Implementation Science. 
  • Navigating the Future of Cardiovascular Drug Development-Leveraging Novel Approaches to Drive Innovation and Drug Discovery: Summary of Findings from the Novel Cardiovascular Therapeutics Conference. 
  • New drugs for children and adolescents with cancer: the need for novel development pathways. 
  • No Shot: US Vaccine Prices And Shortages. 
  • Olanzapine on trial. 
  • Omission of bupropion as a recommended treatment for PTSD. 
  • Opening up to precompetitive collaboration. 
  • Panel discussion 1. 
  • Pathways Across the Valley of Death: Novel Intellectual Property Strategies for Accelerated Drug Discovery 
  • Patient Financial Assistance Programs: A Path to Affordability or a Barrier to Accessible Cancer Care? 
  • Patients, physicians, and clinical trials: the other side of the coins. 
  • Payments, promotion, and the purple pill 
  • Pediatric Antibacterial and Antifungal Trials From 2007 to 2017. 
  • Pfizer to sponsor European impotence awareness campaign. 
  • Pharmacogenetic challenges for the health care system. 
  • Pharmacogenetics: Ethical Issues and Policy Options 
  • Pipeline pharmacogenetics: a novel approach to integrating pharmaco-genetics into drug development. 
  • Potential impact of pharmaceutical industry rebates on medication adherence. 
  • Prevalence and impact of correlative science in breast cancer phase II trials. 
  • Prevention of laboratory animal allergy in the United States: a national survey. 
  • Price differentiation and transparency in the global pharmaceutical marketplace. 
  • Profiteering from vaccine inequity: a crime against humanity? 
  • Proposed 'grant-and-access' program with price caps could stimulate development of drugs for very rare diseases. 
  • Public sector must develop drugs for neglected diseases. 
  • Quantifiable impact of the contract for health and wellness: health behaviors, health care costs, disability, and workers' compensation. 
  • Reasons for optimism not disillusionment. 
  • Reflections on early stopping of a clinical trial. 
  • Relationship of pharmaceutical promotion to antidepressant switching and adherence: a retrospective cohort study. 
  • Renal Pre-Competitive Consortium (RPC2): discovering therapeutic targets together. 
  • Repairing the broken market for antibiotic innovation. 
  • Reply to Solnick. 
  • Representation of women in randomized clinical trials of cardiovascular disease prevention. 
  • Requiring 'independent' statistical analyses for industry sponsored trials? 
  • Responsibility for global health. 
  • Returns to R&D on new drug introductions in the 1980s. 
  • Science and the law. Working through the patent problem. 
  • Should the patent system for new medicines be abolished? 
  • Small Payments, Large Consequences. 
  • Social science and price transparency in direct-to-consumer prescription drug advertisements. 
  • Specialty Pharmaceuticals for Hyperlipidemia--Impact on Insurance Premiums. 
  • Spending on postapproval drug safety. 
  • Statistical analysis methods for QT/QTc prolongation. 
  • Strategic use of statistical thinking in drug development. 
  • Surfactant Administration in Preterm Infants: Drug Development Opportunities. 
  • Task force 5: Expert testimony and opinions. 
  • Technology evaluation: ipilimumab, Medarex/Bristol-Myers Squibb. 
  • Test for batch-to-batch variation in stability analysis. 
  • The AIDS epidemic: lessons learned? 
  • The Biomarkers Consortium: practice and pitfalls of open-source precompetitive collaboration. 
  • The Changing Life Science Patent Landscape 
  • The Commercial Market For Priority Review Vouchers. 
  • The Glaxo Wellcome health promotion program: the contract for health and wellness. 
  • The Personalized Medicine Coalition: goals and strategies. 
  • The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials. 
  • The Society for Clinical Trials opposes US legislation to permit marketing of unproven medical therapies for seriously ill patients. 
  • The Society for Clinical Trials supports United States legislation mandating trials registration. 
  • The changing relationship between health care professionals and the pharmaceutical industry. 
  • The clinical utility index as a practical multiattribute approach to drug development decisions. 
  • The cost of drug development. 
  • The cost to global health of drug company profits. 
  • The distribution of sales revenues from pharmaceutical innovation. 
  • The economic returns of pediatric clinical trials of antihypertensive drugs. 
  • The fragility of the U.S. vaccine supply. 
  • The hidden persuaders: subtle advertising in radiation oncology. 
  • The impact of manufacturer coupon use in the statin market. 
  • The impact of the international guideline entitled Statistical Principles for Clinical Trials (ICH E9). 
  • The importance of transparency in industry-sponsored multicenter clinical studies. 
  • The integration of molecular diagnostics with therapeutics. Implications for drug development and pathology practice. 
  • The need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Respect of Ethics and Excellence in Science (GREES). 
  • 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. 
  • The price of innovation: new estimates of drug development costs. 
  • The quantity and quality of worldwide new drug introductions, 1982-2003. 
  • The roles of patents and research and development incentives in biopharmaceutical innovation. 
  • The uncertainty principle and industry-sponsored research. 
  • The world's most neglected diseases. 
  • Trial registration: ignored to irresistible. 
  • Trial summaries on results databases and journal publication. 
  • Two-stage sampling in pharmaceutical applications. 
  • US web site will publish list of "drug-free practitioners". 
  • University of Pennsylvania 11th annual conference on statistical issues in clinical trials: Estimands, missing data and sensitivity analysis (morning panel session). 
  • Urge overkill: protecting deidentified human subjects at what price? 
  • Use Patents Can Be Useful: The Case of Rescued Drugs 
  • Use of Open Access Platforms for Clinical Trial Data. 
  • Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs. 
  • Value-based arrangements may be more prevalent than assumed. 
  • Welcome to ordinary? Marketing better boys. 
  • What are the obligations of pharmaceutical companies in a global health emergency? 
  • What's next in the pipeline. 
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  Keywords of People

  • Reed, Shelby Derene, Professor in Population Health Sciences, Duke Science & Society
  • Ridley, David Blaine, Professor of the Practice of Business Administration, Duke Science & Society
  • Zipkin, Daniella Ann, Professor of Medicine, Medicine, General Internal Medicine