From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA: Sponsors established in the United Kingdom prior to 31 Dec 2020, must as of 1 January 2021 be legally established in the EU/EEA or have a Legal representative who is legally established in the EU/EEA. Treatment of seizures in two rare and severe forms of epilepsy. Treatment of excessive sleepiness due to narcolepsy. Options for The clinical trial data collection at Pharma Intelligence includes clinical trial data sets, clinical research information, data from the FDA clinical trial database, and much more information related to drug trials… A service of the National Institutes of Health. An official website of the United States government, : Treatment of the signs and symptoms of dry eye disease. checking clinical data for problems, is on another page. Treatment of Mucopolysaccharidosis VII (MPS, VII, Sly syndrome), For the treatment of diffuse large B-cell lymphoma (DLBCL). Treatment of seizures in patients with Dravet syndrome, Source of calories and fatty acids for patients with long-chain fatty acid oxidation disorders, Treatment of adults with low platelet count, Treatment of moderate to severe atopic dermatitis in adults, Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN, Treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older, Metastatic HER2-positive breast cancer in adults, Treatment ofnneuromyelitis optica spectrum disorder (NMOSD). Click the “MORE INFO” bar for more technical and detailed content including data. Improvement of blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise. Search a database of Federally and privately supported studies available through clinicaltrials.gov. Treatment of chorea in patients with Huntington’s disease. dut 's-Gravenhage: n.a. Divergence in approval decisions, type of approval, and approved indication were primarily due to differences in agencies’ conclusions about efficacy based on review of the same data or differing clinical data submitted to support the application. “ Clinical trials help us solve really big problems and have an incredible impact on our patient’s future. For the treatment of moderate to severe plaque psoriasis, Treatment of obesity in patients 6 years and older with rare disorder. Mots / Words Abr. For the detection of estrogen receptor (ER)-positive lesions in patients with recurrent or metastatic breast cancer. This section is for anyone interested in additional information. FDA's roles in the Critical Path Initiative include identifying the scientific hurdles hindering medical product development, and serving as catalyst in bringing together stakeholders who are interested in combining their efforts to create new tools for medical product development. Assists and encourages the identification, development, and availability of safe and effective products for people with rare diseases and disorders. Treatment of adults with acute myeloid leukemia (AML) that has a mutation in a gene called FLT3, in combination with chemotherapy, Treatment of adults with advanced systemic mastocytosis (SM), insulin degludec and insulin aspart injection, Improves blood sugar control in adults with diabetes mellitus (DM), Prevention of stroke in patients with atrial fibrillation, Increasing pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria, For the treatment of certain types of acne vulgaris in patients 9 years and older, SILIQ is used for treatment of moderate to severe plaque psoriasis in adults, Treatment of serious bacterial skin infections known as acute bacterial skin and skin structure infections, Treatment of moderate to severe plaque psoriasis. Lowering the level of urine oxalate in children and adults with primary hyperoxaluria type 1 (PH1). The site is secure. Improvement of blood sugar control in adults with type 2 diabetes mellitus (DM) when used in addition to diet and exercise. Treatment of adults with mantle cell lymphoma. Clinical Trials and Human Subject Protection, Recalls, Market Withdrawals and Safety Alerts, Clinical Trials and Human Subject Protection, Regulations: Good Clinical Practice and Clinical Trials, Clinical Investigations Compliance & Enforcement, FDA's Role: ClinicalTrials.gov Information, Good Clinical Practice Educational Materials, Guidance Documents (Including Information Sheets) and Notices, Replies to Inquiries to FDA on Good Clinical Practice, Reporting Complaints Related to FDA-Regulated Clinical Trials, Websites with Information About Clinical Trials, FDA’s Office of Minority Health and Health Equity, FDA's Office of Orphan Products Development, HHS Office for Human Research Protections. Reduce hospitalization from worsening heart failure. Division of Clinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) 2 Outline 1.Global Distribution of Clinical Trial Data in FDA Wiley database on Gene Therapy Trials WorldwideThe Journal of Gene Medicine clinical trial site presenting charts and tables showing the number of approved, ongoing or completed clinical trials worldwide. For the treatment of a complicated urinary tract infection. Treatment of adults with myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia. Treatment of adult patients with bacterial skin infections. Search Tips and Examples. Their database contains approximately 8,000 clinical trials in the United States and Canada, including SU2C Dream Team trials. Use AND (in uppercase) to search for multiple terms. Find Studies The Find Studies section of this site describes the options for finding studies on ClinicalTrials.gov, how to use those options to find the studies you are looking for, and how to read study records. Consequences from Data Integrity Issues in Clinical Trials Can Be Costly. The clinical trial data collection at Pharma Intelligence includes clinical trial data sets, clinical research information, data from the FDA clinical trial database, and much more information related to drug trials. To maximise use of the database and available information, users are advised to link to external resources, including publicly available registries, to obtain further information such as trial objectives and patient eligibility. 臨床試験は、医薬品、医療機器等の有効性や安全性の評価を目的に行われる試験です。臨床試験のうち、医薬品、医療機器等の承認申請に使用することを目的とした臨床試験が治験であり、それ以外の臨床試験が非治験です。 Tract cancer called non-small cell lung cancer called non-small cell lung cancer called urothelial carcinoma Hepatitis virus. 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