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    37 results match your criteria Clinical Investigation [Journal]

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    Androgen receptor and immune inflammation in benign prostatic hyperplasia and prostate cancer.
    Clin Investig (Lond) 2014 Oct;4(10):935-950
    George Whipple Lab for Cancer Research, Departments of Pathology, Urology, & Radiation Oncology, The Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY 14642, USA ; Sex Hormone Research Center, China Medical University & Hospital, Taichung, Taiwan.
    Both benign prostatic hyperplasia (BPH) and prostate cancer (PCa) are frequent diseases in middle-aged to elderly men worldwide. While both diseases are linked to abnormal growth of the prostate, the epidemiological and pathological features of these two prostate diseases are different. BPH nodules typically arise from the transitional zone, and, in contrast, PCa arises from the peripheral zone. Read More

    Cyclosporine ophthalmic emulsions for the treatment of dry eye: a review of the clinical evidence.
    Clin Investig (Lond) 2015;5(3):267-285
    Miami Veterans Administration Medical Center, 1201 NW 16th St, Miami, FL 33125, USA ; Bascom Palmer Eye Institute, University of Miami, 900 NW 17th Street, Miami, FL 33136, USA.
    Dry eye has gained recognition as a public health problem given its high prevalence, morbidity and cost implications. Although dry eye is common and affects patients' quality of life, only one medication, cyclosporine 0.05% emulsion, has been approved by the US FDA for its treatment. Read More

    Person-centric clinical trials: defining the N-of-1 clinical trial utilizing a practice-based translational network.
    Clin Investig (Lond) 2015;5(2):145-159
    PEARL New York University, 421 First Ave., New York, NY 10010, USA.
    A person-centric clinical trial is inclusive of both the investigator and the person and as such represents point-of-use data generated at the practice level and encompasses both health and disease. Raising the clinical encounter to a research encounter and providing an infrastructure to support a level of quality assurance creates a synergy for efficiency for healthcare delivery. The interface of translational studies and clinical research poses an opportunity, whereby person-centricity can support transparency, facilitate informed consent, improve safety, enhance recruitment and compliance, improve dissemination of results, implement change and help close the translational gap. Read More

    Data fraud in clinical trials.
    Clin Investig (Lond) 2015;5(2):161-173
    IDDI (International Drug Development Institute) Inc., San Francisco, CA 94109, USA.
    Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality. Read More

    Trials and tribulations of conducting medication trials: pediatric bipolar disorder as prototype.
    Clin Investig (Lond) 2014 Nov;4(11):993-996
    Pediatric Mood Disorders Program, University of Illinois at Chicago, M/C 747, Chicago, IL 60612, USA
    "In reality, it is the interpretation of symptomatology that leads to accurate diagnosis, rather than the short-term training and inter-rater reliability attained by conducting semi-structured research diagnostic interviews." Read More

    An evaluation of recruitment methods utilized for a clinical trial with periodontal and diabetes enrollment criteria: the Diabetes and Periodontal Therapy Trial.
    Clin Investig (Lond) 2014 Dec;4(12):1065-1081
    University of Minnesota, School of Dentistry, Moos Tower 7-364, 515 Delaware Street SE, Minneapolis, MN 55455-0357, USA.
    Background: Diabetes and its complications are a major United States public health concern.

    Methods: The Diabetes and Periodontal Therapy Trial (DPTT) evaluated whether non-surgical treatment of periodontal disease influenced diabetes management among persons with Type 2 diabetes and periodontitis. The aim of this study was to evaluate DPTT's many recruitment strategies in terms of enrollment success. Read More

    Efficacy and safety of a unique enteric-coated bicarbonate-buffered pancreatic enzyme replacement therapy in children and adults with cystic fibrosis.
    Clin Investig (Lond) 2013 Aug;3(8):723-729
    The Pennsylvania State Milton S Hershey Medical Center, Hershey, PA, USA.
    Background: Pancreatic enzyme replacement therapy (PERT) is used to treat exocrine pancreatic insufficiency in cystic fibrosis.

    Results/methods: Efficacy and safety of a unique enteric-coated (EC) bicarbonate-buffered PERT product (PERTZYE(®)/PANCRECARB(®); Digestive Care, Inc., Bethlehem, PA, USA) was studied in a randomized, double-blind, placebo-controlled cross-over design. Read More

    Study design considerations for evaluating the efficacy and safety of pancreatic enzyme replacement therapy in patients with cystic fibrosis.
    Clin Investig (Lond) 2013 Aug;3(8):731-741
    University of Washington, Seattle, WA, USA ; CF Therapeutics Development Network Coordinating Center, Seattle, WA, USA.
    In 2006, the US FDA issued a 'Guidance for Industry' regarding submission of New Drug Applications for pancreatic enzyme replacement therapy (PERT) products. Five oral delayed-release PERT products have been approved by the FDA, and several others are under development and/ or evaluation for New Drug Application submission. We present in this paper recommendations of the Cystic Fibrosis Foundation's Cystic Fibrosis (CF) Therapeutics Development Network and Data Safety Monitoring Board regarding study design considerations for evaluating PERT products in patients with CF. Read More

    Measuring symptoms as a critical component of drug development and evaluation in hematological diseases.
    Clin Investig (Lond) 2013 Dec;3(12):1127-1138
    Department of Symptom Research, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1450, Houston, TX 77030, USA.
    With the rapid development of new therapies for patients with hematological malignancies, there is an increasing need for patient report of symptom status during all phases of drug testing. The patient's perspective on new treatments reflects treatment tolerability as well as symptom benefit, and may assist patients and clinicians in choosing treatments. Inclusion of patient-reported outcomes, more common in solid-tumor than hematological trials, provides early information about symptoms to guide decisions about appropriate dosing and supportive care needs. Read More

    Novel treatment options for ulcerative colitis.
    Clin Investig (Lond) 2013 Nov;3(11):1057-1069
    Center for Inflammatory Bowel Disease, Rose, 1/East, 330 Brookline Avenue, Boston, MA, 02215, USA.
    The approved treatment options for patients with ulcerative colitis (UC) are currently limited to mesalamine or immunosuppressants. Patients who do not respond to mesalamine-based therapy can be treated with immunomodulators or anti-TNF antibody therapy. Failure or adverse reactions to these medications leaves the patient with little choice other than colectomy. Read More

    HIV PrEP Trials: The Road to Success.
    Clin Investig (Lond) 2013 Mar;3(3)
    Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Kerr Hall 3318, CB#7569, Chapel Hill, NC 27519-7569, (P) 919-966-9998, (F) 919-962-0644.
    The global HIV epidemic cannot be controlled by current treatment or prevention strategies. Pre-exposure prophylaxis (PrEP) using antiretrovirals is a promising approach to curbing the spread of HIV transmission. Recently, four clinical trials demonstrated favorable results when antiretroviral PrEP was administered topically or orally. Read More

    Outcome measures in amyotrophic lateral sclerosis clinical trials.
    Clin Investig (Lond) 2014 ;4(7):605-618
    Harvard Medical School, Department of Neurology, Neurological Clinical Research Institute (NCRI), Massachusetts Genera Hospital, MA, USA.
    Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with an average survival of 3-5 years. While therapies for ALS remain limited, basic and translational ALS research has been host to numerous influential discoveries in recent years. These discoveries have led to a large pipeline of potential therapies that await testing in clinical trials. Read More

    Considerations in the design of clinical trials for pediatric acute lymphoblastic leukemia.
    Clin Investig (Lond) 2013 Sep;3(9)
    Department of Biostatistics, Colleges of Medicine, Public Health & Health Professions, University of Florida, 6011 NW 1st Place, Gainesville, FL 32607, USA.
    Acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy. Although outcomes for children with ALL have improved dramatically over the last 50 years, ALL remains the leading cause of childhood cancer death. In addition, high-risk patient subsets can be identified with significantly inferior survival. Read More

    Novel oral taxane therapies: recent Phase I results.
    Clin Investig (Lond) 2013;3(4):333-341
    Section of GI Cancers & Experimental Therapeutics, Tufts University School of Medicine, Boston, MA 02111, USA.
    The oral taxanes are analogues of existing taxanes with a possible broad range of antitumor activity. They also have the potential advantages of ease of administration, better efficacy and lesser toxicity than currently available taxanes. These drugs have been used in several Phase I clinical trials, the methodology and results of which will be reviewed here. Read More

    Treatment of Clostridium difficile infection: recent trial results.
    Clin Investig (Lond) 2013 ;3(9):875-886
    Department of Medicine, Division of Infectious Diseases & International Health, Duke University Medical Center, Durham, NC, USA ; Duke Infection Control Outreach Network, Duke University Medical Center, Durham, NC, USA.
    Clostridium difficile is a major cause of infection worldwide and is associated with increasing morbidity and mortality in vulnerable patient populations. Metronidazole and oral vancomycin are the currently recommended therapies for the treatment of C. difficile infection (CDI) but are associated with unacceptably high rates of disease recurrence. Read More

    Rethinking Phase II Clinical Trial Design in Heart Failure.
    Clin Investig (Lond) 2013 Jan;3(1):57-68
    Center for Cardiovascular Research, Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri 63110.
    The incidence and economic burden of heart failure continue to rise worldwide, despite implementation of a number of effective heart failure therapies. Although there have been a number phase I-II studies of potential novel heart failure therapies over the past decade, none of these new compounds have been successful in phase III clinical trials. While there are likely a number of reasons for this failure, one of the problems that has become increasingly apparent is the inability of phase II trials to correctly identify novel therapies that will be successful in phase III clinical trials. Read More

    HIV Vaccine Trials Network: activities and achievements of the first decade and beyond.
    Clin Investig (Lond) 2012 Mar;2(3):245-254
    HIV Vaccine Trials Network, Vaccine & Infectious Disease Institute, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave North, Seattle, WA 98109, USA.
    The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and educators facilitating the development of HIV/AIDS preventive vaccines. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity, to testing vaccine efficacy. Over the past decade, the HVTN has aimed to improve the process of designing, implementing and analyzing vaccine trials. Read More

    Developing an international network for Alzheimer research: The Dominantly Inherited Alzheimer Network.
    Clin Investig (Lond) 2012 Oct;2(10):975-984
    Departments of Neurology and of Pathology and Immunology, and the Programs in Physical Therapy and Occupational Therapy, Washington University, St. Louis, MO (JCM). Other authors' affiliations are as follows: the Departments of Neurology (RB, AF, DH, VB, AO, KM, NS), Biostatistics (CX), Psychiatry (AG), Radiology (TB, DM), and Pathology and Immunology (NC), Washington University School of Medicine, St. Louis; University College London Institute of Neurology, London (MR); the Department of Neurosciences, University of California, San Diego, La Jolla (PA); the Department of Pathology and Laboratory Medicine (BG) and the Center for Bioethics (KQ), Indiana University School of Medicine, Indianapolis; the Departments of Psychiatry (WK) and Neurology (WK, EM), University of Pittsburgh School of Medicine, Pittsburgh; the Centre of Excellence for Alzheimer's Disease Research and Care, Edith Cowan University, Joondalup, WA (RM), the Mental Health Research Institute, University of Melbourne, Melbourne, VIC (CM), and Neuroscience Research Australia and the School of Medical Sciences, University of New South Wales, Sydney (PS) - all in Australia; the Taub Institute for Research on Alzheimer's Disease and the Aging Brain and the Department of Neurology, Columbia University College of Physicians and Surgeons, New York (RM); the Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles (JR); the Center for Alzheimer Research and Treatment and the Department of Neurology, Brigham and Women's Hospital, Massachusetts General Hospital, and Harvard Medical School (RS) - all in Boston; the Department of Neurology and the Memory and Aging Program, Butler Hospital, Warren Alpert Medical School of Brown University, Providence, RI (SS); and the Departments of Medicine, Radiology, and Psychiatry, University of California San Francisco (MW).
    The Dominantly Inherited Alzheimer Network (DIAN) is a collaborative effort of international Alzheimer disease (AD) centers that are conducting a multifaceted prospective biomarker study in individuals at-risk for autosomal dominant AD (ADAD). DIAN collects comprehensive information and tissue in accordance with standard protocols from asymptomatic and symptomatic ADAD mutation carriers and their non-carrier family members to determine the pathochronology of clinical, cognitive, neuroimaging, and fluid biomarkers of AD. This article describes the structure, implementation, and underlying principles of DIAN, as well as the demographic features of the initial DIAN cohort. Read More

    The unfolding treatment landscape for men with castration-resistant prostate cancer.
    Clin Investig (Lond) 2011 Nov;1(11):1533-1544
    Bunting-Blaustein Cancer Research Building-I, Room 1M45, 1650 Orleans St, Baltimore, MD 21231, USA.
    Castration-resistant prostate cancer (CRPC) is a fatal disease in virtually all patients. Docetaxel chemotherapy became the standard front-line agent based on the results of the TAX327 trial in 2004, with a survival advantage of 3 months achieved over mitoxantrone. Over the past few years, an improved understanding of the molecular biology of castration-resistance has resulted in expansion of the treatment armamentarium for advanced prostate cancer with the emergence of novel androgen receptor-directed therapies, cytotoxic chemotherapies, as well as immunotherapies. Read More

    Clinical outcome measures for trials in Duchenne muscular dystrophy: report from International Working Group meetings.
    Clin Investig (Lond) 2011 Sep;1(9):1217-1235
    Institute of Genetic Medicine, International Centre for Life, Newcastle University, Newcastle upon Tyne, UK.
    In June 2010, 25 representatives from Europe and the US met in Washington, DC, USA, to discuss clinical outcome measures in Duchenne muscular dystrophy (DMD) in the context of clinical trial design and analysis. The workshop was organized in response to a September 2009 European Medicines Agency meeting where a clear directive was given that an international consensus needs to be developed that provides a foundation for age-appropriate clinical outcome measures for use in clinical trials of emerging therapeutics for DMD. Data were presented from eight multicenter longitudinal datasets, representing nearly 1900 patients over a 20-year time period. Read More

    New considerations in the design of clinical trials for amyotrophic lateral sclerosis.
    Clin Investig (Lond) 2011 Oct;1(10):1375-1389
    Massachusetts General Hospital, Department of Neurology, Neurology Clinical Trials Unit, 149 Thirteenth Street, Suite 2274, Charlestown, MA 02129, USA.
    Amyotrophic lateral sclerosis is a devastating neurodegenerative disease caused by loss of motor neurons. Its pathophysiology remains unknown, but progress has been made in understanding its genetic and biochemical basis. Clinical trialists are working to translate basic science successes into human trials with more efficiency, in the hope of finding successful treatments. Read More

    New considerations in the design of clinical trials for traumatic brain injury.
    Clin Investig (Lond) 2012 Feb;2(2):153-162
    Department of Neurosurgery, Antwerp, University Hospital & University of Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium.
    Randomized controlled trials in traumatic brain injury (TBI) pose several complicated methodological challenges related to the heterogeneity of the population. Several strategies have been proposed to deal with these challenges. Recommendations presented by the International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) study group include the use of relatively broad enrollment criteria combined with covariate adjustment for strong predictors of outcome in the analysis phase, rather than the use of strict enrollment criteria. Read More

    miRNA-mediated immune regulation and immunotherapeutic potential in glioblastoma.
    Clin Investig (Lond) 2011 Dec;1(12):1637-1650
    Department of Neurosurgery, The University of Texas MD Anderson Cancer Center, Unit 442, 1515 Holcombe Boulevard, Houston, TX 77030-4009, USA.
    Glioblastoma (GB), the most common primary neoplasm of the CNS, remains universally fatal with standard therapies and has a mean overall survival time of only 14.6 months. Even in the most favorable situations most patients do not survive longer than 2 years. Read More

    Incentives and barriers to neurological clinical research participation.
    Clin Investig (Lond) 2011 Dec;1(12):1663-1668
    The EMMES Corporation, 401 N Washington St, Suite 700, Rockville, MD 20854, USA.
    BACKGROUND: Understanding barriers and incentives to neurological research participation may improve clinical trial enrollment. RESULTS: Telephone-based focus groups were conducted with four neurological disorder patient groups (n = 22) and one caregiver group (n = 6). A total of 14 neurologists and neurosurgeons participated in structured interviews. Read More

    Neoplastic meningitis resulting from hematological malignancies: pharmacokinetic considerations and maximizing outcome.
    Clin Investig (Lond) 2011 Oct;1(10):1391-1402
    Long Island Brain Tumor Center at NSPC, NY, USA.
    Neoplastic meningitis, also known as leptomeningeal metastases, is a complication of various types of cancer that occurs when tumor cells enter the cerebrospinal fluid (CSF), travel along CSF pathways and grow. Treatment options include drug delivery directly into the CNS or systemic administration for targeted action in the CNS. CNS drug delivery is limited by the blood-brain barrier and the blood-CSF barrier. Read More

    Design of clinical trials for biomarker research in oncology.
    Clin Investig (Lond) 2011 Dec;1(12):1629-1636
    Division of Biomedical Statistics & Informatics, Mayo Clinic, Rochester, MN 55905, USA.
    The developmental pathway from discovery to clinical practice for biomarkers and biomarker-directed therapies is complex. While several issues need careful consideration, two critical issues that surround the validation of biomarkers are the choice of clinical trial design (which is based on the strength of the preliminary evidence and marker prevalence) and the biomarker assay related issues surrounding the marker assessment methods such as the reliability and reproducibility of the assay. This review focuses on trial designs for marker validation, both in the setting of early phase trials for initial validation, as well as in the context of larger definitive trials. Read More

    Src inhibitors in the treatment of metastatic bone disease: rationale and clinical data.
    Clin Investig (Lond) 2011 Dec;1(12):1695-1706
    Department of Pathology & Laboratory Medicine, University of Rochester Medical Center, 601 Elmwood Avenue, Box 626, Rochester, NY 14642, USA.
    Src is a nonreceptor tyrosine kinase essential for the activation of osteoclasts, the cells that degrade bone. Src also regulates normal cell functions, cancer cell growth and metastasis to organs, including bone where tumor cells induce bone destruction by osteoclasts. Src inhibitors prevent bone destruction and tumor cell growth in animal models of metastatic bone disease, and some are being investigated in clinical trials, particularly in patients with prostate cancer, which has high bone metastatic potential. Read More

    Experience in international clinical research: the HIV Prevention Trials Network.
    Clin Investig (Lond) 2011 Dec;1(12):1609-1618
    FHI 360, Inc., Durham, NC, USA.
    The HIV Prevention Trials Network (HPTN) is supported by the NIH to conduct randomized clinical trials to assess the efficacy of HIV prevention strategies and technologies to reduce HIV transmission between adults. A special focus of attention is on the use of antiretroviral drugs to prevent HIV transmission, both by reducing infectiousness among HIV-infected persons taking combination antiretroviral therapy (cART) and also by reducing susceptibility among HIV-uninfected persons taking antiretrovirals for pre-exposure prophylaxis. Studies may be developmental in nature to assess novel ideas for interventions or for assessing trial feasibility. Read More

    Outcome measures for clinical trials assessing treatment of cystic fibrosis lung disease.
    Clin Investig (Lond) 2012;2(2):163-175
    Case Western Reserve University School of Medicine & Rainbow Babies & Children's Hospital, Cleveland, OH, USA.
    Cystic fibrosis (CF) is a complex genetic disease characterized by death from loss of lung function. Therapies target pathophysiologic changes associated with pulmonary disease progression. Although therapeutic mechanisms differ, efficacy demonstration is limited to a few accepted outcome measures, each with shortcomings that are becoming more pronounced as CF population health improves. Read More

    Novel agents in Waldenström macroglobulinemia.
    Clin Investig (Lond) 2011 ;1(6):815-824
    Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, 450 Brookline Avenue, Boston, MA 02115, USA.
    Waldenström macroglobulinemia (WM) is a B-cell disorder characterized by the infiltration of the bone marrow with lymphoplasmacytic cells and the detection of an IgM monoclonal gammopathy in the serum. WM is considered an incurable disease, with a median overall survival of 87 months. The success of targeted therapy in multiple myeloma has led to the development and investigation of more than 30 new compounds in this disease and in other plasma cell dyscrasias, including WM, both in the preclinical settings and as part of clinical trials. Read More

    Velaglucerase alfa in the treatment of Gaucher disease type 1.
    Clin Investig (Lond) 2011 Feb;1(2):285-293
    Cincinnati Children's Hospital Medical Center, Division of Human Genetics, 3333 Burnet Avenue, MLC 4006, Cincinnati, OH 45229-43039, USA.
    Gaucher disease is an autosomal recessively inherited lysosomal storage disease that results from the defective activity of the enzyme acid β-glucosidase (glucocerebrosidase). Velaglucerase alfa was recently developed and approved as an alternative form to imiglucerase enzyme therapy. Despite differences in primary structure and glycosylation patterns, recent preclinical and clinical trials of the preparation have shown similar efficacy and safety profiles to those of imiglucerase. Read More

    Design of clinical trials of antibacterial agents for community-acquired bacterial pneumonia.
    Clin Investig (Lond) 2011 Jan;1(1):19-32
    Division of General Internal Medicine, Los Angeles Biomedical Research Institute (LA BioMed) at Harbor-University of California Los Angeles (UCLA) Medical Center, CA, USA.
    Standards for the conduct of clinical trials of antibacterial agents for community-acquired bacterial pneumonia (CABP) have changed dramatically in recent years. A draft guidance from the US FDA on the conduct of such trials was issued in March 2009. However, the guidance has already faced substantial criticism during the open public comment period, resulting in uncertainty regarding the appropriate design of such studies from a regulatory perspective. Read More

    New considerations in the design of clinical trials for the treatment of acute leukemia.
    Clin Investig (Lond) 2011 Apr;1(4):509-517
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans Street, CRB 1, Room 2M44, Baltimore, MA 21231-21000, USA.
    There is great need for improved therapy for patients with acute leukemia. The current systems of clinical drug development and delivery of leukemia care are imperfectly adapted to the optimal identification and testing of future regimens. Novel clinical trial design with increased enrolment and appropriate end point selection would facilitate more efficient validation of candidate therapies. Read More

    Personalized therapy for urothelial cancer: review of the clinical evidence.
    Clin Investig (Lond) 2011 Apr;1(4):546-555
    Clinical Fellow in Hematology and Oncology, Dana Farber Cancer Institute, 450 Brookline Avenue, Smith 353, Boston, MA 02115, 617-632-3779 (telephone), 617-632-5822 (fax),
    Despite a detailed understanding of the molecular aberrations driving the development of urothelial cancers, this knowledge has not translated into advances for the treatment of this disease. Urothelial cancers are chemosensitive, and platinum-based combination chemotherapy remains the standard of care for advanced disease, as well as neoadjuvant and adjuvant therapy for locally advanced disease. However, nearly half of patients who undergo resection of locally advanced urothelial cancer will relapse and eventually develop platinum-resistant disease. Read More

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