Research Topics
| investigational therapiesSummaryAlias: investigational treatments, innovative therapies, experimental therapies Summary: Treatments which are undergoing clinical trials or for which there is insufficient evidence to determine their effects on health outcomes; coverage for such treatments is often denied by health insurers. Webpages
neurosurgery.medschool.ucsf.edu/faculty_staff/index.html slybiochemweb.slu.edu/faculty/sly.html experimental therapiescourses.washington.edu/bonephys/opexp.html department of functional genomics - tokyo medical and dental universitywww.tmd.ac.jp/mri/mri-end/en/research_pg2.html keck : department of obstetrics & gynecology : education & trainingwww.usc.edu/schools/medicine/departments/obstetrics_gynecolo ... pcos treatment - university of chicago medical centerwww.uchospitals.edu/specialties/pcos/treatment.html department of internal medicine: the university of iowawww.int-med.uiowa.edu/Divisions/HemOnc/Directory/C.PatrickBu ... annual report of unité des cytokines et développement lymphoide for year 2000www.pasteur.fr/recherche/RAR/RAR2000/Cytobnk-en.html slu researchers receive grants | saint louis universitywww.slu.edu/readstory/more/22 nektar | r&d pipeline | products in development |clinical trials informationwww.nektar.com/product_pipeline/clinical_trials.html ol>Research Grants Analysis of Human B Cell Tolerance in Humanized MiceRoberta Pelanda; Fiscal Year: 2008 Asthma and Allergic Diseases Cooperative Research CenterYong-Jun Liu; Fiscal Year: 2008 Asthma and Allergic Diseases Cooperative Research CenterYong-Jun Liu; Fiscal Year: 2007 Asthma and Allergic Diseases Cooperative Research CenterYong-Jun Liu; Fiscal Year: 2006 UNIVERSITY OF NEW MEXICO CANCER CENTER PLANNING GRANTCheryl L Willman; Fiscal Year: 2004 Angiogenic tissue engineering to limit post-infarction ventricular remodelingY Joseph Woo; Fiscal Year: 2008 Equipoise and the research integrity of clinical trialsBenjamin Djulbegovic; Fiscal Year: 2003 AIDS ASSOCIATED MALIGNANCIES CLINICAL TRIALS CONSORTIUMAlexandra M Levine; Fiscal Year: 2005 MICROVASCULAR ABNORMALITIES IN SEPSISSteven M Hollenberg; Fiscal Year: 2002 UCLA SPOTRIAS CENTER APPLICATION RENEWAL-PROGRAM PROJECTJeffrey L Saver; Fiscal Year: 2008 ol>Publications Rethinking research ethicsRosamond Rhodes Mount Sinai School of Medicine Am J Bioeth 5:7-28 Ethical framework for the use of sham procedures in clinical trialsSam Horng Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892-1156, USA Crit Care Med 31:S126-30 Ethical issues in fetal surgery researchFrank A Chervenak Department of Obstetrics and Eynecology, The New York Presbyterian Hospital, Weill Medical College of Cornell University, 525 East 68th Street, J 130, New York, NY 10021, USA Best Pract Res Clin Anaesthesiol 18:221-30 Research versus innovation: real differencesHaavi Morreim University of Tennessee Health Science Center, USA Am J Bioeth 5:42-3; author reply W15-8 Third-party payers and the cost of biomedical researchAna S Iltis Center for Health Care Ethics, Saint Louis University, St. Louis, MO, USA Kennedy Inst Ethics J 15:135-60 Congressmen say military should have the right to informed consentDennis M Maloney The Deem Corporation, P.O. Box 44069, Omaha, NE 68144, USA Hum Res Rep 20:9 When is surgery research? Towards an operational definition of human researchC E Margo Watson Clinic, Lakeland, Florida, USA J Med Ethics 27:40-3 Ethics of innovative surgery: US surgeons' definitions, knowledge, and attitudesAngelique M Reitsma Center for Biomedical Ethics, University of Virginia, PO Box 800758, Charlottesville, VA 22908-0758, USA J Am Coll Surg 200:103-10 The critical path to medical innovationDavid Williams University of Liverpool, UK Med Device Technol 15:8-10 Innovation to research: some transitional obstacles in critical care unitsCynthiane J Morgenweck ol>Center for the Study of Bioethics, Medical College of Wisconsin, Milwaukee 53226, USA Crit Care Med 31:S172-7 | Scientific Experts
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Detail Information
Webpages
- faculty and staff - ucsf department of neurosurgery
neurosurgery.medschool.ucsf.edu/faculty_staff/index.html
slybiochemweb.slu.edu/faculty/sly.html
experimental therapiescourses.washington.edu/bonephys/opexp.html
department of functional genomics - tokyo medical and dental universitywww.tmd.ac.jp/mri/mri-end/en/research_pg2.html
keck : department of obstetrics & gynecology : education & trainingwww.usc.edu/schools/medicine/departments/obstetrics_gynecolo ...
pcos treatment - university of chicago medical centerwww.uchospitals.edu/specialties/pcos/treatment.html
department of internal medicine: the university of iowawww.int-med.uiowa.edu/Divisions/HemOnc/Directory/C.PatrickBu ...
annual report of unité des cytokines et développement lymphoide for year 2000www.pasteur.fr/recherche/RAR/RAR2000/Cytobnk-en.html
slu researchers receive grants | saint louis universitywww.slu.edu/readstory/more/22
nektar | r&d pipeline | products in development |clinical trials informationwww.nektar.com/product_pipeline/clinical_trials.html
infectious disease - statistics collaborative, inc. - design & analysis for biomedical researchwww.statcollab.com/therapeutic-areas/infectious-disease.html
research | nyu langone medical center department of surgerysurgery.med.nyu.edu/plastic/research
clinical trials | ochsner health system | new orleans, lawww.ochsner.org/services/cancer/cancer_services_clinical_tri ...
toxocariasiswww.peacehealth.org/kbase/nord/nord538.htm
sleep associateswww.sleepmed.com/research.htm
thomas jefferson university hospital - liver transplantation & surgerywww.jeffersonhospital.org/transplant/liver/
calgary health region - division of thoracic surgery - mesotheliomawww.calgaryhealthregion.ca/tsd/diagnoses/mesothelioma.htm
forest laboratories divisions & subsidiarieswww.frx.com/about/divisions.aspx
truncus arteriosuswww.peacehealth.org/kbase/nord/nord180.htm
print-friendly version of "ucsb makes important advances in studies of retinal detachment "www.ia.ucsb.edu/pa/print.aspx?pkey=1224
central pontine myelinolysis information page: national institute of neurological disorders and stroke (nindswww.ninds.nih.gov/disorders/central_pontine/central_pontine_ ...
cigna - nelson syndromewww.cigna.com/healthinfo/nord484.html
university of michigan hematology and oncology: our researchwww.med.umich.edu/intmed/hemonc/edu/research.htm
oncology - statistics collaborative, inc. - design & analysis for biomedical researchwww.statcollab.com/therapeutic-areas/oncology.html
systemic treatment for breast cancerwww.fccc.edu/cancer/types/breast/treatment/systemic.html
usc research center for alcoholic liver and pancreatic diseases | homewww.usc.edu/schools/medicine/research/alcohol_center/cirrhos ...
alpha-1-antitrypsin deficiencywww.ncbi.nih.gov/books/bv.fcgi?call=bv.View..ShowSection&rid ...
medimmune, inc. company profile - yahoo! financebiz.yahoo.com/ic/10/10176.html
ol>Research Grants
Analysis of Human B Cell Tolerance in Humanized MiceRoberta Pelanda; Fiscal Year: 2008
..Novel experimental therapies that aim at depleting B cells with specific antibodies have emphasized the important role that B ..
Asthma and Allergic Diseases Cooperative Research CenterYong-Jun Liu; Fiscal Year: 2008
..provide insight into the pathogenic mechanisms of allergic inflammation and define novel targets for developing innovative therapies for allergic asthma and atopy.
Public Health Relevance: This Public Health Relevance is not available.
Asthma and Allergic Diseases Cooperative Research CenterYong-Jun Liu; Fiscal Year: 2007
..The proposed studies will provide insight into the pathogenic mechanisms of allergic inflammation and define novel targets for developing innovative therapies for allergic asthma and atopy.
Asthma and Allergic Diseases Cooperative Research CenterYong-Jun Liu; Fiscal Year: 2006
..The proposed studies will provide insight into the pathogenic mechanisms of allergic inflammation and define novel targets for developing innovative therapies for allergic asthma and atopy.
UNIVERSITY OF NEW MEXICO CANCER CENTER PLANNING GRANTCheryl L Willman; Fiscal Year: 2004
..Increase the quality of cancer care in our region by providing access to innovative therapies and clinical trials, facilitated by a formal university-community oncology alliance developing between the ..
Angiogenic tissue engineering to limit post-infarction ventricular remodelingY Joseph Woo; Fiscal Year: 2008
..b>Innovative therapies are greatly needed...
Equipoise and the research integrity of clinical trialsBenjamin Djulbegovic; Fiscal Year: 2003
..what they are going to discover, and if the uncertainty principle is observed and the literature on experimental therapies is fairly complete, we would expect, over time, to find no significant difference between the proportion ..
AIDS ASSOCIATED MALIGNANCIES CLINICAL TRIALS CONSORTIUMAlexandra M Levine; Fiscal Year: 2005
..We have been instrumental in developing innovative therapies, such as anti-angiogenesis compounds, liposomal drugs, monoclonal antibodies and conjugates, and anti-sense ..
MICROVASCULAR ABNORMALITIES IN SEPSISSteven M Hollenberg; Fiscal Year: 2002
..responsiveness will aid in our understanding of important pathogenetic pathways and in the development of innovative therapies for septic shock. Specific aims: 1...
UCLA SPOTRIAS CENTER APPLICATION RENEWAL-PROGRAM PROJECTJeffrey L Saver; Fiscal Year: 2008
..Translational Research in Acute Stroke Center proposes an integrated research/training program to develop innovative therapies for acute ischemic and hemorrhagic stroke. Five research projects are proposed...
Quorum sensing-dependent interactions with biofilms and innate immunity defensesAlexander R Horswill; Fiscal Year: 2008
..Knowledge of these transition mechanisms could lead to innovative therapies that block the spread of this virulent, invasive pathogen...
Redox Determinants of Severe AsthmaSerpil C Erzurum; Fiscal Year: 2008
..The overarching goals of our studies are 1) development of improved asthma monitoring; and 2) design of innovative therapies tailored to specific biochemical abnormalities in severe asthma patients for whom therapeutic options are ..
Redox Determinants of Severe AsthmaSerpil C Erzurum; Fiscal Year: 2007
..The overarching goals of our studies are 1) development of improved asthma monitoring; and 2) design of innovative therapies tailored to specific biochemical abnormalities in severe asthma patients for whom therapeutic options are ..
Innovative Therapies and Clinical Studies for Classic GalactosemiaKent Lai; Fiscal Year: 2008
..Public Health Relevance: This Public Health Relevance is not available...
Innovative Therapies and Clinical Studies for Classic GalactosemiaKent Lai; Fiscal Year: 2007
....
Genomics of Primary Biliary CirrhosisKonstantinos N Lazaridis; Fiscal Year: 2008
..If successful, this study will pave the road to improved prevention and innovative therapies for this devastating disease.
Public Health Relevance: This Public Health Relevance is not available.
Targeted antigen receptor treatment of cancerAlan N Houghton; Fiscal Year: 2007
..in the laboratory through preclinical models into early stage clinical trials with the goal of selecting experimental therapies for late stage clinical testing...
Targeted antigen receptor treatment of cancerDavid A Scheinberg; Fiscal Year: 2008
..in the laboratory through preclinical models into early stage clinical trials with the goal of selecting experimental therapies for late stage clinical testing...
PEDIATRIC BRAIN TUMOR CONSORTIUM--CHOP MEMBERSHIPPeter C Phillips; Fiscal Year: 2003
..to develop new experimental therapies for CNS tumors in children and propose these strategies for phase I/II clinical trials by the PTBC; Aim 3...
Society for Inherited Metabolic Disorders Annual MeetingGerard Vockley; Fiscal Year: 2005
..This increase in knowledge is essential to maintain progress in innovative therapies for these severe disorders...
Southwest Oncology GroupSaul E Rivkin; Fiscal Year: 2004
..improvement in techniques of screening, early detection and prevention of cancer and the rapid transfer of innovative therapies from the laboratory to the clinic...
Southwest Oncology GroupSaul E Rivkin; Fiscal Year: 2007
..improvement in techniques of screening, early detection and prevention of cancer and the rapid transfer of innovative therapies from the laboratory to the clinic...
Southwest Oncology GroupSaul E Rivkin; Fiscal Year: 2008
..improvement in techniques of screening, early detection and prevention of cancer and the rapid transfer of innovative therapies from the laboratory to the clinic...
CLINICAL GENE THERAPY PROGRAM FOR THE TREATMENT OF AIDSRafael G Amado; Fiscal Year: 2002
..Consistent with the UCLA AIDS Institute's goal of developing innovative therapies for the treatment of AIDS, the applicant has led the effort to develop a gene therapy program within the ..
Mesenchymal Stem Cells for Treatment of Acute Lung InjuryJae Woo Lee; Fiscal Year: 2008
..Current treatment options remain primarily supportive with lung protective ventilation and fluid conservative strategy. Innovative therapies are needed.
Public Health Relevance: This Public Health Relevance is not available.
Examination Of Natural History And Therapy Of Multiple SHenry F McFarland; Fiscal Year: 2006
..Further, MRI has become an important and powerful tool for the assessment of the effect of new experimental therapies in MS...
Real-time Minimal Residual Disease assay of Pediatric B-Cell Non-Hodgkin LymphomaBruce T Shiramizu; Fiscal Year: 2007
..The assay developed by this exploratory proposal could be incorporated into pediatric B-cell NHL studies to assess MRD on therapy or to assess the efficacy of innovative therapies.
Heme Oxygenase Regulation of Eicosanoid BiosynthesisNader G Abraham; Fiscal Year: 2008
..vascular actions of the HO system are correct, then these findings may be applied to the development of innovative therapies based on gene targeting for the treatment of hypertension and cardiovascular disease.
..
Cleveland Clinic Cardiothoracic Collaborative Clinical Center - C6Eugene Blackstone; Fiscal Year: 2008
..new surgeon-investigators to take a leadership role in devising ways to build an evidence basis for use of innovative therapies in patients with life-threatening heart disease. (End of Abstract)
..
Aging and ARM: Dark Adaptation ImpairmentCynthia Owsley; Fiscal Year: 2008
..Scientists are already working to translate basic research discoveries in these areas to experimental therapies for ARM prevention, whose efficacy must be demonstrated in clinical trials...
Impact of intermittent hypoxia on ventilatory drive and apnea severityJASON HAROLD MATEIKA; Fiscal Year: 2008
..could be particularly useful in individuals who suffer from mild or moderate forms of OSA when used in conjunction with other potential innovative therapies.
Public Health Relevance: This Public Health Relevance is not available.
Cleveland Clinic Cardiothoracic Collaborative Clinical Center - C6Eugene Blackstone; Fiscal Year: 2007
..We also propose to educate and mentor new surgeon-investigators to take a leadership role in devising ways to build an evidence basis for use of innovative therapies in patients with life-threatening heart disease. (End of Abstract)
Impact of intermittent hypoxia on ventilatory drive and apnea severityJASON HAROLD MATEIKA; Fiscal Year: 2007
..This treatment could be particularly useful in individuals who suffer from mild or moderate forms of OSA when used in conjunction with other potential innovative therapies.
HSV VECTORS FOR THE DESTRUCTION OF BRAIN TUMORSNIGEL WILLIAM FRASER; Fiscal Year: 2005
..This project will allow us to use insights gained from molecular virology and cancer biology to develop viable innovative therapies for patients with brain (and other) tumors.
Somatic genetic predictors of response to therapy in metastatic melanomaKatherine L Nathanson; Fiscal Year: 2007
..In order to identify patient subsets that are most likely to respond and those for which other investigational therapies may be of higher priority, biomarker analyses in the context of large-scale clinical trials are ..
Mechanisms of Muscle WastingYi-Ping Li; Fiscal Year: 2008
..ligases via TNF-alpha- represented catabolic cytokines in inflammatory conditions and 2) evaluate experimental therapies through targeting the pathological signaling pathways in the animal models of muscle catabolism induced by ..
Mechanisms of Muscle WastingYi-Ping Li; Fiscal Year: 2007
..ligases via TNF-alpha- represented catabolic cytokines in inflammatory conditions and 2) evaluate experimental therapies through targeting the pathological signaling pathways in the animal models of muscle catabolism induced by ..
A COVERTIBLE PET CAMERA FOR ONCOLOGYWAI-HOI WONG; Fiscal Year: 2002
..The high-sensitivity, high-resolution, small-animal mode is for evaluating new experimental therapies and new diagnostic ligands and for extending our understanding of cancer through studies of animal tumor ..
Heme Oxygenase Regulation of Eicosanoid BiosynthesisNader G Abraham; Fiscal Year: 2007
..the anticipated beneficial vascular actions of the HO system are correct, then these findings may be applied to the development of innovative therapies based on gene targeting for the treatment of hypertension and cardiovascular disease.
Minimally Invasive Approaches for Craniofacial SurgeryMaria J Troulis; Fiscal Year: 2005
The importance of patient-oriented research (POR) in guiding therapy, applying innovative therapies and in evaluating outcomes is well documented...
GLOBE CONSERVATION IN TRANSGENIC RETINOBLASTOMATimothy G Murray; Fiscal Year: 2006
..improve treatment of children with intraocular retinoblastoma by utilizing animal modeling of current and experimental therapies to enhance tumor control while decreasing treatment related morbidity...
CCR5 and CXCR4 Binding Chemokines and Oral HIV InfectionGrace C John-Stewart; Fiscal Year: 2005
..collaboration and expertise of scientists in Nairobi, Oxford, and Seattle, the proposed study will provide insight into how chemokines and chemokine analogs may be used to develop innovative therapies to prevent infant HIV-1 infection.
From Bench to Bedside to CurbsideArthur S Slutsky; Fiscal Year: 2008
..of scientists, paramedics, administrators, ethicists, and physicians who will develop and test innovative therapies. The specific aims of this proposal are: 1) To develop a multidisciplinary team of scientists with ..
TERMIS-NA 2008 Annual Conference & ExpositionRobert L Sah; Fiscal Year: 2008
..TO PUBLIC HEALTH Tissue engineering and regenerative medicine have enormous potential for development of innovative therapies for the repair, regeneration, and treatment of diseased and damaged tissues and organs...
FASEB Conference -PKD Mechanisms and Clinical ImpactLisa M Guay-Woodford; Fiscal Year: 2005
..a translational focus - exploring biomarkers for disease progression and discussing targets for new and innovative therapies. The small size of the meeting (100-150 participants) with participants drawn from diverse disciplines ..
Phase II Study of 44Gy from 131I-81C6 for CNS TumorsDavid Reardon; Fiscal Year: 2004
..In response to the dire need for effective, innovative therapies for patients with malignant brain tumors, our center has developed radiolabeled monoclonal antibodies (mAB) ..
Host-mediated targets in glioma invasionBRIAN PATRICK (Contact) ELICEIRI; Fiscal Year: 2008
..lead to a better understanding of the mechanisms regulating brain tumor dispersal and the future design of innovative therapies that target the host rather than tumor cells themselves.
..
Translational Clinical Trials in Neuro-OncologyDavid Reardon; Fiscal Year: 2008
..In response to the dire need for effective, innovative therapies for patients for malignant brain tumors, our center has developed novel therapeutics aimed at tumor-..
DETECTION OF IMMUNOGENIC OVARIAN CANCER ANTIGENSMarcus O Butler; Fiscal Year: 2005
..medical and surgical treatment can induce clinical remissions in most patients, the time is now to attempt innovative therapies for the treatment and eradication of minimal residual disease. Dr...
A NEW PARADIGM FOR FIBROSIS: MONOCYTE ACTIVATION OF TGFClay B Marsh; Fiscal Year: 2004
..is to better define the pathological events regulating the genesis of pulmonary fibrosis and to define novel targets to direct innovative therapies to suppress lung destruction and fibrosis associated with this devastating lung disease.
Blood Flow MRI for Monitoring Glioma AngiogenesisDavid C Alsop; Fiscal Year: 2007
..and developments to enable the use of arterial spin labeling (ASL) blood flow MRI in clinical trials of experimental therapies for glioma...
Blood Flow MRI for Monitoring Glioma AngiogenesisDavid C Alsop; Fiscal Year: 2008
..and developments to enable the use of arterial spin labeling (ASL) blood flow MRI in clinical trials of experimental therapies for glioma...
SERUM GAD65 AS A BIOMARKER OF ISLET INJURY, INSULITIS AND TRANSPLANT REJECTIONSteven D Chessler; Fiscal Year: 2007
..including helping identify candidates for preventative therapies, monitoring the response to investigational therapies, assessing drugs for islet toxicity, monitoring transplanted islets for rejection, and investigating the ..
From Bench to Bedside to CurbsideArthur S Slutsky; Fiscal Year: 2007
..of scientists, paramedics, administrators, ethicists, and physicians who will develop and test innovative therapies. The specific aims of this proposal are: 1) To develop a multidisciplinary team of scientists with ..
Emergency Prehospital Investigative Consortium (EPIC)Jerris Hedges; Fiscal Year: 2007
..Given the extensive morbidity and mortality associated with injury and sudden cardiac death, evaluation of innovative therapies is warranted...
Emergency Prehospital Investigative Consortium (EPIC)Terri Schmidt; Fiscal Year: 2008
..Given the extensive morbidity and mortality associated with injury and sudden cardiac death, evaluation of innovative therapies is warranted...
Lysosomal Disease Network-4th Annual WORLD SymposiumChester B Whitley; Fiscal Year: 2008
..Session IV: Clinical Trials, Experimental Therapies Currently Being Tested. Session V: Natural History, Treatment Outcomes, and Quality of Life Issues...
ol>Publications
Rethinking research ethicsRosamond Rhodes
Mount Sinai School of Medicine
Am J Bioeth 5:7-28
Mount Sinai School of Medicine
Am J Bioeth 5:7-28
..These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research...
Ethical framework for the use of sham procedures in clinical trialsSam Horng
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892-1156, USA
Crit Care Med 31:S126-30
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892-1156, USA
Crit Care Med 31:S126-30
....
Ethical issues in fetal surgery researchFrank A Chervenak
Department of Obstetrics and Eynecology, The New York Presbyterian Hospital, Weill Medical College of Cornell University, 525 East 68th Street, J 130, New York, NY 10021, USA
Best Pract Res Clin Anaesthesiol 18:221-30
Department of Obstetrics and Eynecology, The New York Presbyterian Hospital, Weill Medical College of Cornell University, 525 East 68th Street, J 130, New York, NY 10021, USA
Best Pract Res Clin Anaesthesiol 18:221-30
..We demonstrate the applicability of this framework to fetal surgery research for spina bifida, a common fetal anomaly...
Research versus innovation: real differencesHaavi Morreim
University of Tennessee Health Science Center, USA
Am J Bioeth 5:42-3; author reply W15-8
University of Tennessee Health Science Center, USA
Am J Bioeth 5:42-3; author reply W15-8
Third-party payers and the cost of biomedical researchAna S Iltis
Center for Health Care Ethics, Saint Louis University, St. Louis, MO, USA
Kennedy Inst Ethics J 15:135-60
Center for Health Care Ethics, Saint Louis University, St. Louis, MO, USA
Kennedy Inst Ethics J 15:135-60
....
Congressmen say military should have the right to informed consentDennis M Maloney
The Deem Corporation, P.O. Box 44069, Omaha, NE 68144, USA
Hum Res Rep 20:9
The Deem Corporation, P.O. Box 44069, Omaha, NE 68144, USA
Hum Res Rep 20:9
When is surgery research? Towards an operational definition of human researchC E Margo
Watson Clinic, Lakeland, Florida, USA
J Med Ethics 27:40-3
Watson Clinic, Lakeland, Florida, USA
J Med Ethics 27:40-3
..Enforcing more rigid and less ambiguous guidelines of human research may curtail enrolment into some studies, but it will also protect patients from being used as subjects without their knowledge...
Ethics of innovative surgery: US surgeons' definitions, knowledge, and attitudesAngelique M Reitsma
Center for Biomedical Ethics, University of Virginia, PO Box 800758, Charlottesville, VA 22908-0758, USA
J Am Coll Surg 200:103-10
Center for Biomedical Ethics, University of Virginia, PO Box 800758, Charlottesville, VA 22908-0758, USA
J Am Coll Surg 200:103-10
..Some forms of innovation clearly fall under the current regulations for human subject research; others might not fully meet the definition but could still require some additional oversight...
The critical path to medical innovationDavid Williams
University of Liverpool, UK
Med Device Technol 15:8-10
University of Liverpool, UK
Med Device Technol 15:8-10
..A recent FDA report proposes some solutions to this problem...
Innovation to research: some transitional obstacles in critical care unitsCynthiane J Morgenweck
Center for the Study of Bioethics, Medical College of Wisconsin, Milwaukee 53226, USA
Crit Care Med 31:S172-7
Center for the Study of Bioethics, Medical College of Wisconsin, Milwaukee 53226, USA
Crit Care Med 31:S172-7
The real problem with equipoiseWinston Chiong
Stanford University Division of General Internal Medicine, USA
Am J Bioeth 6:37-47
Stanford University Division of General Internal Medicine, USA
Am J Bioeth 6:37-47
..In place of this traditional view, I propose a Kantian test for the reasonable partiality that physicians should show their patients, focusing on its application in clinical research and medical education...
Compliance. What's around the corner?J Stuart Showalter
Orlando Regional Healthcare System, College of Health and Public Affairs, University of Central Florida, Orlando, USA
Healthc Financ Manage 57:56-62
Orlando Regional Healthcare System, College of Health and Public Affairs, University of Central Florida, Orlando, USA
Healthc Financ Manage 57:56-62
..The charge description master should receive detailed attention to improve efficiency and net revenues. Violations of protected health information can have serious financial implications...
Bioterrorism, biodefense, and biotechnology in the military: a comparative analysis of legal and ethical issues in the research, development, and use of biotechnological products on American and British soldiersAshley R Melson
The Berkeley Law Firm, PC, USA
Albany Law J Sci Technol 14:E1-E44
The Berkeley Law Firm, PC, USA
Albany Law J Sci Technol 14:E1-E44
RNA interference: a critical analysis of the regulatory and ethical issues encountered in the development of a novel therapyReese McKnight
University of Texas School of Law, USA
Albany Law J Sci Technol 15:73-108
University of Texas School of Law, USA
Albany Law J Sci Technol 15:73-108
Is it time to rethink the expanded-access programs for HIV infection?Valerianna Amorosa
University of Pennsylvania, Philadelphia, PA 19104, USA
J Infect Dis 196:974-7
University of Pennsylvania, Philadelphia, PA 19104, USA
J Infect Dis 196:974-7
....
Trauma nursingLinda Lapointe
Directorate of Combat and Doctrine Development, USA
J Trauma 62:S77
Directorate of Combat and Doctrine Development, USA
J Trauma 62:S77
Investigational test protocols must include informed consentBarbara Harty-Golder
MLO Med Lab Obs 36:32
MLO Med Lab Obs 36:32
Smallpox revisited?Michael J Selgelid
University of the Witwatersrand, South Africa
Am J Bioeth 3:W-IF 1
University of the Witwatersrand, South Africa
Am J Bioeth 3:W-IF 1
..e. secret). I conclude by recommending numerous future areas for ethics research related to the weaponization of smallpox...
A traditional jewish approach to risky medical treatmentDaniel Eisenberg
Department of Radiology, Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, USA
Cancer Invest 25:209-15
Department of Radiology, Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, USA
Cancer Invest 25:209-15
..The approach of Jewish law is valuable in formulating a generic approach to the area of risky medical treatments and is beneficial in understanding the choices that Jewish patients might make regarding their care...
Multiple dietary antioxidants enhance the efficacy of standard and experimental cancer therapies and decrease their toxicityKedar N Prasad
Center for Vitamin and Cancer Research, Department of Radiology, University of Colorado Health Sciences Center, Denver 80262 0278, USA
Integr Cancer Ther 3:310-22
Center for Vitamin and Cancer Research, Department of Radiology, University of Colorado Health Sciences Center, Denver 80262 0278, USA
Integr Cancer Ther 3:310-22
..Patients unresponsive to standard or experimental therapies have little option except for poor quality of life for the remainder of life...
Factors affecting innovation in pediatric surgery: hospital type and appendectomiesDeena J Chisolm
Department of Pediatrics, The Ohio State University, College of Medicine and Columbus Children s Research Institute, Columbus, OH 43205, USA
J Pediatr Surg 41:1809-13
Department of Pediatrics, The Ohio State University, College of Medicine and Columbus Children s Research Institute, Columbus, OH 43205, USA
J Pediatr Surg 41:1809-13
..Children's hospitals appear more likely to adopt innovative surgical procedures, such as LA, even when clear benefit over standard treatment has not yet emerged...
Top 10 health-care trends for 2003: rising demand, increasing revenues and innovative technologiesRussell C Coile
Russ Coiles Health Trends 15:1, 3-10
Russ Coiles Health Trends 15:1, 3-10
The value of antihypertensive drugs: a perspective on medical innovationDavid M Cutler
Department of Economics, Harvard University, Cambridge, Massachusetts, USA
Health Aff (Millwood) 26:97-110
Department of Economics, Harvard University, Cambridge, Massachusetts, USA
Health Aff (Millwood) 26:97-110
..More effective use of antihypertensive medication would have an impact on mortality akin to eliminating all deaths from medical errors or accidents...
Use of off-label drugs in cancer care again under reviewEdward Braud
Springfield Clinic, Springfield, IL, USA
ONS News 20:8
Springfield Clinic, Springfield, IL, USA
ONS News 20:8
Access for the terminally ill to experimental medical innovations: a three-pronged threatShira Bender
University of Pennsylvania, USA
Am J Bioeth 7:3-6
University of Pennsylvania, USA
Am J Bioeth 7:3-6
Difficulties in performing clinical trials of antithrombotic therapy in neonates and childrenM Patricia Massicotte
Paediatric Thrombosis, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada
Thromb Res 118:153-63
Paediatric Thrombosis, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada
Thromb Res 118:153-63
..Means for overcoming these challenges are also addressed...
Research-related injury: problems and solutionsLarry D Scott
University of Texas Medical School at Houston, USA
J Law Med Ethics 31:419-28
University of Texas Medical School at Houston, USA
J Law Med Ethics 31:419-28
The scientific establishment of a new therapeutic intervention for developmental conditions: practical and ethical principlesShinji Ijichi
Institute for EGT, Nagahama Shinryojyo, 8 3 Nagahama, Shimokoshiki mura, Satsuma gun, 896 1411 Kagoshima, Japan
Childs Nerv Syst 19:711-5
Institute for EGT, Nagahama Shinryojyo, 8 3 Nagahama, Shimokoshiki mura, Satsuma gun, 896 1411 Kagoshima, Japan
Childs Nerv Syst 19:711-5
..In a clinical setting, where neither epidemiological studies nor animal experimentation can be introduced, if necessary the researcher should collaborate with experts to obtain multidisciplinary justification for clinical testing...
Ethical issues in fertility preservation for adolescent cancer survivors: oocyte and ovarian tissue cryopreservationDenise M Dudzinski
Department of Medical History and Ethics, University of Washington School of Medicine, Seattle, Washington 98195 7120, USA
J Pediatr Adolesc Gynecol 17:97-102
Department of Medical History and Ethics, University of Washington School of Medicine, Seattle, Washington 98195 7120, USA
J Pediatr Adolesc Gynecol 17:97-102
..developing policies addressing the disposition of gametes if the patient dies; and (7). respecting the patient by protecting her from harm while also honoring her right to self-determination...
Testing and estimation in flexible group sequential designs with adaptive treatment selectionMartin Posch
Section of Medical Statistics, Core Unit for Medical Statistics and Informatics, Medical University of Vienna, Spitalgasse 23, A 1090 Wien, Austria
Stat Med 24:3697-714
Section of Medical Statistics, Core Unit for Medical Statistics and Informatics, Medical University of Vienna, Spitalgasse 23, A 1090 Wien, Austria
Stat Med 24:3697-714
..Also point estimation in adaptive trials is considered. The methodology is illustrated in a detailed example based on an actual planned study...
An innovative approach to the care of patients on phase I and phase II clinical trials: the role of the experimental therapeutics nurseClaire Carlson
The Children s Hospital of Philadelphia, USA
J Pediatr Oncol Nurs 22:353-64
The Children s Hospital of Philadelphia, USA
J Pediatr Oncol Nurs 22:353-64
..The broader role of nursing in clinical trials, the multidisciplinary challenges of experimental therapies, and the development of an innovative approach to caring for patients on phase I/II studies are discussed.
Should patients undergoing chemotherapy and radiotherapy be prescribed antioxidants?Ralph W Moss
Cancer Communications, Lemont, Pennsylvania 16851, USA
Integr Cancer Ther 5:63-82
Cancer Communications, Lemont, Pennsylvania 16851, USA
Integr Cancer Ther 5:63-82
..A blanket rejection of the concurrent use of antioxidants with chemotherapy is not justified by the preponderance of evidence at this time and serves neither the scientific community nor cancer patients...
New investigational therapies for gastroesophageal reflux diseaseJoel E Richter
Department of Medicine, Temple University School of Medicine, 3401 North Broad Street, 8th Floor, Parkinson Pavilion, Philadelphia, PA, 19140, USA
Thorac Surg Clin 15:377-84
Department of Medicine, Temple University School of Medicine, 3401 North Broad Street, 8th Floor, Parkinson Pavilion, Philadelphia, PA, 19140, USA
Thorac Surg Clin 15:377-84
..Which of these drugs, if any, will be the new GERD drug for the millennium is unknown. There is no question, however, that improved drug treatments will parallel a better understanding of the complicated pathophysiology of GERD...
An innovative paradigm for clinical researchRosamond Rhodes
Mount Sinai School of Medicine
Am J Bioeth 3:59-61
Mount Sinai School of Medicine
Am J Bioeth 3:59-61
The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trialsBenjamin Djulbegovic
Department of Interdisciplinary Oncology, H Lee Moffitt Cancer Center and Research Institute, University of South Florida, 12902 Magnolia Dr, Tampa, FL 33612, USA
Account Res 10:301-15
Department of Interdisciplinary Oncology, H Lee Moffitt Cancer Center and Research Institute, University of South Florida, 12902 Magnolia Dr, Tampa, FL 33612, USA
Account Res 10:301-15
..We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."..
Compassionate approval process for experimental gene-based productsGladice Wallraven
J Clin Oncol 26:1899-900
J Clin Oncol 26:1899-900
Advances in the treatment of breast cancerS Moulder
Department of Breast Medical Oncology and Phase I Program, The University of Texas M D Anderson Cancer Center, Houston, Texas, USA
Clin Pharmacol Ther 83:26-36
Department of Breast Medical Oncology and Phase I Program, The University of Texas M D Anderson Cancer Center, Houston, Texas, USA
Clin Pharmacol Ther 83:26-36
....
Ophtec iris reconstruction lens United States clinical trial phase IMarianne O Price
Cornea Research Foundation of America, Indianapolis, Indiana, USA
Ophthalmology 111:1847-52
Cornea Research Foundation of America, Indianapolis, Indiana, USA
Ophthalmology 111:1847-52
..CONCLUSIONS: Preliminary results suggest that the Ophtec model 311 iris reconstruction lens can improve UCVA and reduce glare and photophobia in patients with partial or total absence of the iris or iris pigmentation...
Potential role of new therapies in modifying cardiovascular risk in overweight patients with metabolic risk factorsMichael D Jensen
Endocrine Research Unit, Division of Endocrinology, Mayo Clinic College of Medicine, Rochester, MN 55905, USA
Obesity (Silver Spring) 14:143S-149S
Endocrine Research Unit, Division of Endocrinology, Mayo Clinic College of Medicine, Rochester, MN 55905, USA
Obesity (Silver Spring) 14:143S-149S
..g., acipimox, pioglitazone). Surgically implanted gastric pacemaker systems that modulate vagus nerve activity and delay gastric emptying are under study...
FDA perspective on antivirals against biothreats: communicate early and oftenRosemary Roberts
US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Counter Terrorism and Emergency Coordination, 10903 New Hampshire Avenue, White Oak Campus, Silver Spring, MD 20993, United States
Antiviral Res 78:60-3
US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Counter Terrorism and Emergency Coordination, 10903 New Hampshire Avenue, White Oak Campus, Silver Spring, MD 20993, United States
Antiviral Res 78:60-3
..Efficient development of therapeutics against these agents requires collaborative efforts among industry, academia and federal agencies...
The risk-benefit balance in the United States: who decides?John Graham
Frederick S Pardee RAND Graduate School, Santa Monica, California, USA
Health Aff (Millwood) 26:625-35
Frederick S Pardee RAND Graduate School, Santa Monica, California, USA
Health Aff (Millwood) 26:625-35
..Our ultimate purpose is to urge the U.S. health policy community to develop a more consistent way of thinking about how risk-benefit decisions could be guided by general principles...
Medicines for Malaria Venture: sustaining antimalarial drug developmentIan Bathurst
Medicines for Malaria Venture MMV, International Center Cointrin ICC Building, 20 rte de Pré Bois, 1215 Geneva 15, Switzerland
Trends Parasitol 22:301-7
Medicines for Malaria Venture MMV, International Center Cointrin ICC Building, 20 rte de Pré Bois, 1215 Geneva 15, Switzerland
Trends Parasitol 22:301-7
..Together with its many partners, MMV manages the world's largest malaria research and development portfolio, covering the innovation spectrum from basic drug discovery to late-stage development...
The value of coronary heart disease care for the elderly: 1987-2002Allison B Rosen
University of Michigan and Ann Arbor Veterans Affairs, USA
Health Aff (Millwood) 26:111-23
University of Michigan and Ann Arbor Veterans Affairs, USA
Health Aff (Millwood) 26:111-23
..Overall, the value of our CHD spending is quite good. Despite this wise investment of resources to date, considerable opportunities remain for additional investment to improve the adoption of valuable but underused health services...
The arthroscopic surgeon: cowboy and scientist. Presidential addressStephen S Burkhart
Arthroscopy 19:678-83
Arthroscopy 19:678-83
Controversies in sepsis clinical trials: proceedings of a meeting of the International Sepsis Forum, Lausanne, Switzerland, September 29, 2001R Phillip Dellinger
Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ 08854, USA
J Crit Care 21:38-47
Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ 08854, USA
J Crit Care 21:38-47
Despite some recent success with clinical trials studying innovative therapies in sepsis, the field remains predominantly one of failure despite compounds with significant preclinical activity...
Medical self-defense, prohibited experimental therapies, and payment for organsEugene Volokh
UCLA School of Law, USA
Harv Law Rev 120:1813-46
UCLA School of Law, USA
Harv Law Rev 120:1813-46
ImperativesMichael P Aronson
Department of Obstetrics and Gynecology, University of Massachusetts Medical School, Worcester 01605-2982, USA
Am J Obstet Gynecol 192:1483-7
Department of Obstetrics and Gynecology, University of Massachusetts Medical School, Worcester 01605-2982, USA
Am J Obstet Gynecol 192:1483-7
The thin line between malpractice and benefit determinationJack A Rovner
Manag Care 12:31-2
Manag Care 12:31-2
Investigational therapies for metastatic thyroid carcinomaR Michael Tuttle
Joan and Sanford I Weill Medical College of Cornell University, Memorial Sloan Kettering Cancer Center, New York, New York 10021, USA
J Natl Compr Canc Netw 5:641-6
Joan and Sanford I Weill Medical College of Cornell University, Memorial Sloan Kettering Cancer Center, New York, New York 10021, USA
J Natl Compr Canc Netw 5:641-6
..Given the dramatic increase in availability of thyroid cancer clinical trials, all patients with radioactive iodine-refractory, progressive metastatic thyroid cancer should be considered for inclusion in a novel therapy trial...
Current drug development portfolio for antimalarial therapiesGiancarlo A Biagini
Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK
Curr Opin Pharmacol 5:473-8
Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK
Curr Opin Pharmacol 5:473-8
..The management of this portfolio is being driven by MMV (Medicines for Malaria Venture), with a number of projects recently reaching the clinical end of this drug development pipeline...
Australian pharmaceutical policy: price control, equity, and drug innovation in AustraliaEvan Doran
Clinical Pharmacology, University of Newcastle, Mater Hospital, Waratah, NSW, Australia
J Public Health Policy 29:106-20
Clinical Pharmacology, University of Newcastle, Mater Hospital, Waratah, NSW, Australia
J Public Health Policy 29:106-20
..The manner in which trade policy has effectively undermined a publicly funded pharmaceutical benefits scheme has clear implications for many countries that maintain such programmes...
Access to clinical devices through nontraditional routesRobert J Klepinski
Fredrikson and Byron, P.A, Minneapolis, MN, USA
Food Drug Law J 62:849-63
Fredrikson and Byron, P.A, Minneapolis, MN, USA
Food Drug Law J 62:849-63
Listen to all the voices: an advocate's perspective on early access to investigational therapiesMusa Mayer
Clin Trials 3:149-53
Clin Trials 3:149-53
..The essay that follows is inspired by the need for other voices from the patient and advocacy communities to be heard in this debate...
Can we afford innovation?Leon Morgenstern
Cedars-Sinai Medical Center, Los Angeles, California 90048, USA. morgenstern@ cshs.org
Surg Innov 14:138-9
Cedars-Sinai Medical Center, Los Angeles, California 90048, USA. morgenstern@ cshs.org
Surg Innov 14:138-9
Preservation of effect and the regulatory approval of new treatments on the basis of non-inferiority trialsSteven Snapinn
Amgen Inc, One Amgen Center Drive, 24 2 C, Thousand Oaks, CA 91320, USA
Stat Med 27:382-91
Amgen Inc, One Amgen Center Drive, 24 2 C, Thousand Oaks, CA 91320, USA
Stat Med 27:382-91
....
Don't avoid experimental treatmentsEric E Shore
Med Econ 84:30
Med Econ 84:30
Ethical issues in limb transplantsD Dickenson
University of Birmingham, England
Bioethics 15:110-24
University of Birmingham, England
Bioethics 15:110-24
..However, their legitimacy is not proven by appeals to the interests of scientific research, cost-benefit, or patient autonomy...
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