Genentech’s Perjeta Significantly Extends Survival In People With HER2-Positive Metastatic Breast Cancer
Genentech, a member of the Roche Group , today announced updated survival results from the Phase III CLEOPATRA study, which showed that the combination of Perjeta® , Herceptin® and docetaxel chemotherapy significantly extended the lives of people with previously untreated HER2-positive metastatic breast cancer , compared to Herceptin, chemotherapy and placebo. ... Read News
UIDELINES FOR THE CONDUCT OF EGISTRY BASED TUDIES USING THE ...
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Post-market/data registry studies Waivers of co-payments and deductibles Inducements for future purchases, nonclinical laboratory studies, and clinical studies in animals. Comments are due May 20, 2010. 1/13/2010: Guidance - IRB Continuing Review After Clinical Investigation Approval. ... Fetch Content
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Investigator's Brochure - Wikipedia, The Free Encyclopedia
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Food & Dru - Covington & Burling LLP
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Submissions To ClinicalTrials.gov At UCSF
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Air? Clinical Trial Registry IND Issues IND Issues Is it necessary for an IRB to review IND documentation? Form FDA 1571: Investigational New Drug and Trials of Devices Prospective clinical studies of health outcomes comparing an intervention with a device against a control in human ... Read More
EbXML Case Study: A Clinical Guideline Registry For The SAGE ...
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CDC Says Worker Who Caused Tyson Gas Leak Gas Leak Couldn't Read English
The Centers for Disease Control released a report today saying that a Tyson poultry plant worker who poured a solution into a 55-gallon drum, releasing chlorine gas, could not read the English label on the drum that would have alerted him to its contents, but Tyson disputes the findings. Six hundred workers were evacuated from the plant after the incident, on June 27, 2011, and of those 195 told ... Read News
Clinical Trials Reporting And Publication
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Standard 2.5: Quality Improvement Plan Sample
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Medicare Coverage ~ Clinical Trials - Home | Centers For ...
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Principles Of Medical Research Clinical Trial Registry
For studies that are under review by peer-reviewed journals that prohibit pre-publication results disclosure, the results will be posted will be provided in the clinical trial registry for study results disclosed in a peer-reviewed journal. ?? ... Read Content
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ClinicalTrials . gov is also a very valuable resource, as it is a registry of federally and privately supported clinical is a good resource for our latest studies available to patients. NationwideChildrens in We are also starting clinical trials for other ways of ... View Video
Registering & OW DO I REGISTER MY TRIAL Reporting Results AND ...
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Editorial - ICMJE: Uniform Requirements For Manuscripts ...
Ing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor’s product. Unfortunately, their trial in a registry that meets several criteria. The reg-istry must be accessible to the public at no charge. ... Read More
T1D Exchange Announces Appointment Of Dana Ball As Chief Executive Officer
BOSTON, Dec. 6, 2012 /PRNewswire/ -- The T1D Exchange, a not-for-profit organization accelerating the discovery of new approaches to type 1 diabetes research and treatment, announced today that Dana Ball ... Read News
REGISTERING STUDIES AT CLINICALTRIALS
Prospective clinical studies of health outcomes comparing an intervention with a device against a control in human subjects ClinicalTrials.gov has become the registry of choice and is now the registry required by the FDA Amendments Act of 2007. ClinicalTrials.gov is a service of the ... Read Content
Guidance For Industry And FDA Staff - U S Food And Drug ...
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Biopharmachannel - YouTube
0:38 Anand Tharmaratnam (Quintiles) & Malcolm Burgess (Icon Clinical Research) 31 views | 1 month ago; 0:51 Dr Paul Coleman 19:39 The NIH on infrastructure start-up for a global patient registry at World Orphan Drug Congress Planning Studies Biopharma Asia Convention ... View Video
Clinical Syndromes And Clinical Outcome In Patients With ...
Studies of Stein et al.1–3 This may be explained by the fact that only 19% of patients in the circulatory Embolism * : Findings From the RIETE Registry Clinical Syndromes and Clinical Outcome in Patients With Pulmonary ... Read Full Source
Parkinson's Disease Sitemap - Page 1 2012-12-05
Most studies of Parkinson's disease suggest that men are more likely to get PD than women. Clinical trials are by the Food and Drug Administration Support the Creation of a National Registry for Parkinson's Disease and Multiple Sclerosis ... Read Article
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