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Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.

Clinical trials. --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Research

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Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite these opportunities, only a small fraction of investigational products are successfully developed into cures and therapies that can be accessed by patients. One response to the ever-widening gap between the number and promise of basic scientific discoveries and the translation of those discoveries into therapies is a renewed emphasis on collaborative approaches among federal agencies, academia, and industry, all directed at the advancement of the drug development enterprise. The newly developed Cures Acceleration Network (CAN)-a part of the National Center for Advancing Translational Sciences (NCATS) within the National Institutes of Health (NIH)-has the potential to catalyze widespread changes in NCATS, NIH, and the drug development ecosystem in general. On June 4-5, 2012, the IOM Forum on Drug Discovery, Development, and Translation held, at the request of NCATS, a workshop-bringing together members of federal government agencies, the private sector, academia, and advocacy groups-to explore options and opportunities in the implementation of CAN. Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary summarizes the workshop."--Publisher's description.

Drugs - United States - Design. --- Chemistry, Pharmaceutical --- Investigative Techniques --- Diagnosis --- Pharmacology --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Chemistry --- Natural Science Disciplines --- Biological Science Disciplines --- Disciplines and Occupations --- Diagnostic Techniques and Procedures --- Drug Discovery --- Drug monitoring. --- Drug development --- Drugs --- Pharmaceutical industry --- Design. --- Quality control. --- United States.

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"Tuberculosis (TB) kills approximately 4,500 people worldwide every day. While most cases of TB can be treated with antibiotics, some strains have developed drug resistance that makes their treatment more expensive, more toxic and less effective for the patient. The IOM Forum on Drug Discovery, Development, and Translation and the Academy of Science of South Africa held a workshop to discuss ways to fight the growing threat of drug-resistant TB."--Publisher's website.

Multidrug-resistant tuberculosis --- Tuberculosis --- Drug resistance --- Prevention --- Resistance to drugs --- Consumption (Disease) --- Lungs --- Phthisis --- Pulmonary tuberculosis --- TB (Disease) --- MDR-TB (Multidrug-resistant tuberculosis) --- MDR tuberculosis --- Polydrug-resistant tuberculosis --- Pharmacology --- Chest --- Mycobacterial diseases --- Mycobacterium tuberculosis --- Drug resistance in microorganisms --- Multidrug resistance --- Diseases

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An estimated 2 billion people, one third of the global population, are infected with Mycobacterium tuberculosis, the bacterium that causes tuberculosis. Spread through the air, this infectious disease killed 1.7 million in 2009, and is the leading killer of people with HIV. Tuberculosis (TB) is also a disease of poverty--the vast majority of tuberculosis deaths occur in the developing world. Exacerbating the devastation caused by TB is the growing threat of drug-resistant forms of the disease in many parts of the world. Drug-resistant tuberculosis presents a number of significant challenges in terms of controlling its spread, diagnosing patients quickly and accurately, and using drugs to treat patients effectively. In Russia in recent decades, the rise of these strains of TB, resistant to standard antibiotic treatment, has been exacerbated by the occurrence of social, political, and economic upheavals. The Institute of Medicine (IOM) Forum on Drug Discovery, Development, and Translation, in conjunction with the Russian Academy of Medical Sciences held a workshop to discuss ways to fight the growing threat of drug-resistant TB. This book presents information from experts on the nature of this threat and how it can be addressed by exploring various treatment and diagnostic options.

Multidrug-resistant tuberculosis - Russia. --- Multidrug-resistant tuberculosis --- Mycobacterium tuberculosis --- Antitubercular agents --- Anti-Bacterial Agents --- Mycobacterium Infections --- Actinomycetales Infections --- Anti-Infective Agents --- Therapeutic Uses --- Gram-Positive Bacterial Infections --- Pharmacologic Actions --- Bacterial Infections --- Bacterial Infections and Mycoses --- Chemical Actions and Uses --- Diseases --- Chemicals and Drugs --- Tuberculosis, Multidrug-Resistant --- Tuberculosis --- Antitubercular Agents --- Public Health --- Health & Biological Sciences --- Communicable Diseases --- Consumption (Disease) --- Lungs --- Phthisis --- Pulmonary tuberculosis --- TB (Disease) --- Chest --- Mycobacterial diseases

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"Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle"--

Communication -- Congresses. --- Risk assessment -- Congresses. --- Pharmaceutical policy --- Drugs --- Industry --- Risk --- Risk Management --- Chemicals and Drugs --- Publication Formats --- Information Science --- Behavior --- Epidemiologic Measurements --- Publication Characteristics --- Organization and Administration --- Probability --- Behavior and Behavior Mechanisms --- Public Health --- Technology, Industry, and Agriculture --- Health Services Administration --- Environment and Public Health --- Statistics as Topic --- Technology, Industry, Agriculture --- Psychiatry and Psychology --- Health Care Evaluation Mechanisms --- Epidemiologic Methods --- Health Care --- Quality of Health Care --- Investigative Techniques --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Health Care Quality, Access, and Evaluation --- Congresses --- Pharmaceutical Preparations --- Risk Assessment --- Communication --- Drug Industry --- Engineering & Applied Sciences --- Technology - General --- Decision making --- Law and legislation --- Risk assessment --- Government policy --- Testing