Browsing by Subject "Clinical Trials as Topic"
Now showing items 1-20 of 60
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10 Years with ICH E10: Choice of Control Groups.
(Pharm Stat, 2011-09) -
A model for harmonizing flow cytometry in clinical trials.
(Nat Immunol, 2010-11)Complexities in sample handling, instrument setup and data analysis are barriers to the effective use of flow cytometry to monitor immunological parameters in clinical trials. The novel use of a central laboratory may help ... -
Accelerating stem cell trials for Alzheimer's disease.
(The Lancet. Neurology, 2016-02)At present, no effective cure or prophylaxis exists for Alzheimer's disease. Symptomatic treatments are modestly effective and offer only temporary benefit. Advances in induced pluripotent stem cell (iPSC) technology have ... -
Access to patient-level data from GlaxoSmithKline clinical trials.
(N Engl J Med, 2013-08-01) -
American Association of Physicists in Medicine Task Group 263: Standardizing Nomenclatures in Radiation Oncology.
(International journal of radiation oncology, biology, physics, 2018-03)A substantial barrier to the single- and multi-institutional aggregation of data to supporting clinical trials, practice quality improvement efforts, and development of big data analytics resource systems is the lack of ... -
Bumps and bridges on the road to responsible sharing of clinical trial data.
(Clin Trials, 2014-02)BACKGROUND: Sharing data from clinical trials could assist with the advancement of science and medicine, potentially providing a better understanding of both the benefits and risks of medicines and other treatments. Sharing ... -
Cell therapy for diverse central nervous system disorders: inherited metabolic diseases and autism.
(Pediatric research, 2018-01)The concept of utilizing human cells for the treatment of medical conditions is not new. In its simplest form, blood product transfusion as treatment of severe hemorrhage has been practiced since the 1800s. The advent of ... -
Complexity of Delivering Precision Medicine: Opportunities and Challenges.
(American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting, 2018-05)Precision medicine has emerged as a tool to match patients with the appropriate treatment based on the precise molecular features of an individual patient's tumor. Although examples of targeted therapies exist resulting ... -
Compliance with results reporting at ClinicalTrials.gov.
(N Engl J Med, 2015-03-12)BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials ... -
Conducting research with racial/ethnic minorities: methodological lessons from the NIDA Clinical Trials Network.
(The American journal of drug and alcohol abuse, 2011-09)Multiple studies in the National Institute on Drug Abuse Clinical Trials Network (CTN) demonstrate strategies for conducting effective substance abuse treatment research with racial/ethnic minorities (REMs).The objectives ... -
Conflicts of Interest and Outcomes of Cardiovascular Trials.
(Am J Cardiol, 2016-03-01)Conflicts of interests have long been recognized as potential sources of influence in the conduct and reporting of clinical trials. This controversy was again rekindled after the publication of the latest statin guidelines ... -
Cord blood for brain injury.
(Cytotherapy, 2015-06)Recovery from neurological injuries is typically incomplete and often results in significant and permanent disabilities. Currently, most available therapies are limited to supportive or palliative measures, aimed at managing ... -
Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.
(Stat Med, 1993-03)The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring ... -
Data Sharing at a Crossroads.
(N Engl J Med, 2016-09-22) -
Economic return of clinical trials performed under the pediatric exclusivity program.
(JAMA, 2007-02-07)CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric ... -
Effect of socioeconomic status as measured by education level on survival in breast cancer clinical trials.
(Psychooncology, 2013-02)OBJECTIVES: This paper aims to investigate the effect of socioeconomic status, as measured by education, on the survival of breast cancer patients treated on 10 studies conducted by the Cancer and Leukemia Group B. METHODS: ... -
Feasibility of Cancer Clinical Trial Enrollment Goals Based on Cancer Incidence.
(JCO clinical cancer informatics, 2020-01)<h4>Purpose</h4>More than 20% of US clinical trials fail to accrue sufficiently. Our purpose was to provide a benchmark for better understanding clinical trial enrollment feasibility and to assess relative levels of competition ... -
Frequency and Acceptability of Adverse Events After Anterior Cervical Discectomy and Fusion: A Survey Study From the Cervical Spine Research Society.
(Clinical spine surgery, 2018-06)PURPOSE:Anterior cervical discectomy and fusion has a low but well-established profile of adverse events. The goal of this study was to gauge surgeon opinion regarding the frequency and acceptability of these events. METHODS:A ... -
Gene therapy for glycogen storage diseases.
(Human molecular genetics, 2019-10)The focus of this review is the development of gene therapy for glycogen storage diseases (GSDs). GSD results from the deficiency of specific enzymes involved in the storage and retrieval of glucose in the body. Broadly, ...
