Detection of of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs), Detection of specific cancer lesions in men with prostate cancer, Treatment of patients with primary hemophagocytic lymphohistiocytosis, elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. / Abrr. Drug Trials Snapshots are part of an overall FDA effort to make demographic data more available and transparent. The Snapshots program began in 2015 and reflects drugs approved after that time. 's-Graveland: n.a. The FDA wants two months of follow-up data after volunteers get their second dose of Covid-19 vaccine as part of clinical trials testing potential coronavirus vaccines. ​Treatment of chronic idiopathic constipation (CIC) in adults. Comprehensive site containing information about pediatric drug development activities. Their reports are available on their Website. January 31, 2019 - Real-world data gathered directly from EHRs and other data sources, paired with advances in machine learning, will be crucial for architecting the next generation of successful clinical trials, says FDA Commissioner Dr. Scott Gottlieb.. ICTRP Search Portal The ICTRP Search Portal aims to provide a single point of access to information about ongoing and completed clinical trials.It provides a searchable database containing the trial registration data sets made available by data providers around the world meeting criteria for content and quality control. “Consumers had to wade through publically available scientific reviews on drug approvals, and that involved quite a bit of time an… Click the “MORE INFO” bar for more technical and detailed content including data. Replacement of growth hormone in adults with growth hormone deficiency (GHD). Treatment of the signs and symptoms of dry eye disease. Initial lab-based results and new data from 1,500 Israel-based Corona patients have been extremely promising and clinical studies are scheduled to … Treatment of  melanoma (a type of skin cancer)  when used with another drug binimetinib, Reversal of the effects of certain neuromuscular blocking agents. Treatment of an early stage HER2 -positive breast cancer. Each Snapshot contains a “MORE INFO” section for more detailed and technical content. Provides guidance on the Health Insurance Portability and Accountability Act (HIPAA) and Standards for Privacy of Individually Identifiable Health Information (the Privacy Rule). For the treatment of a particular type of Duchenne muscular dystrophy (DMD). Treatment of fungal infection of the toenails due to two common forms of fungi, Treatment of Lysosomal Acid Lipase (LAL) deficiency, Prevention of coronary artery blood clot formation in patients undergoing PCI, Treatment  of adult patients with moderately to severely active rheumatoid arthritis (RA), Treatment of a specific form of advanced breast cancer, For the treatment of plexiform neurofibroma. Treatment of chorea in patients with Huntington’s disease. The site is secure. About 930 clinical trials conducted at site, including 273 Phase I-II early phase trials. Comments and questions can be sent to: Snapshots@fda.hhs.gov. Treatment of a specific form of advanced breast cancer called ER-positive, HER2-negative (ER+/HER-) breast cancer in women who have gone through menopause (post-menopausal), Irritable bowel syndrome with constipation. Snapshots are published only for approved New Molecular Entities (NMEs) and original biologics. It used to be hard for consumers to find details about how many people were enrolled in drug trials – as well as information about their race, sex, and age. It noted initially, similar to FDA above, that changes dut 's-Gravenhage: n.a. Our examination of data contained in the FDA BMIS database showed a total of 172,453 unique clinical trials investigators who had submitted a Form FDA 1572 during the study interval of 1999–2015. Clinical Trials Center for Skincare and Cosmetics in Thailand. Do not rely on Snapshots alone to make decisions regarding medical care. Treatment of prostate cancer that has not spread to other parts of the body (non-metastatic), Treatment of mild to moderate atopic dermatitis in patients 2 age years of age and older, ​For the treatment of osteoporosis in women after menopause, ​For the treatment of spinal muscular atrophy (SMA), Detection of fallopian tubes patency (openness) in women with infertility, Treatment of particular type of Duchenne muscular dystrophy. The HHS Office of Inspector General conducts short-term management and program evaluations that focus on issues of concern to the Department, the Congress, and the public, including such topics as human subject protection and clinical trial oversight. This section is for anyone interested in additional information. The information in the Snapshots also highlights where the trials were conducted and whether there were any differences in the benefits and side effects among different demographic groups. Treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. Drug Trials Snapshots: breaking down the what, how and why. Treatment of Chagas disease in children 2 to 12 years of age. 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. Before sharing sensitive information, make sure you're on a federal government site. During ongoing clinical trials to provide real-time assessment of the investigator’s conduct of the trial and protection of human subjects; At the request of an FDA review division; and Related to certain classes of investigational products that FDA has identified as products of special interest in its current work plan (i.e., targeted inspections based on current public health concerns). Snapshots are not a substitute for advice from your health care professional. The EMA and the FDA had high concordance (91–98%) in decisions on marketing approvals. The FDA requires a multi-phase clinical trials process to be completed before deciding if the medicine under investigation is safe and effective for a broader patient population. Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description. dut 's-Gravenmoer: n.a. Emergency treatment of an overdose with fluorouracil or capecitabine, Treatment of tumors with specific biomarker, Treatment of advanced non-small cell lung cancer, Treatment of women with hypoactive sexual desire disorder, VYNDAQEL(tafamidis meglumine)/ VYNDAMAX (tafamidis), ​Treatment of the cardiomyopathy caused by transthyretin‑mediated amyloidosis (ATTR-CM), For the treatment of a particular type of Duchenne muscular dystrophy (DMD), Reducing elevated intraocular pressure (IOP). Treatment of adults with newly-diagnosed acute myeloid leukemia (AML). The second joint symposium was held in London in February 2020, covering international collaboration, sponsor oversight, electronic source documents, protocol deviations and data quality in novel clinical trial designs. atoltivimab, maftivimab, and odesivimab-ebgn, ​Treatment of Zaire ebolavirus (Ebola virus) infection. Treatment of Amyotrophic Lateral Sclerosis (ALS), For the treatment of anemia in adult patients with beta thalassemia, Treatment of complicated urinary tract infection, Treatment of certain cancers caused by abnormal RET (rearranged during transfection) genes. You can enter a word or a phrase, such as the name of a medical condition or an intervention. 12 days ago. For the treatment of moderate to severe plaque psoriasis, Treatment of obesity in patients 6 years and older with rare disorder. Preformulated MEDLINE searches are included in MedlinePlus and give easy access to the medical research literature. Treatment of adults with myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia. dut 's-Hertogenbosch: n.a. The .gov means it’s official.Federal government websites often end in .gov or .mil. A service of the National Institutes of Health. Where can I send comments or questions about snapshots? Snapshots aim to present differences in how well the drug works and side effects among different demographic groups. The benefits and possible risks of participating in an HIV/AIDS clinical trial are explained to study volunteers before they decide whether to participate in a study. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. This is a searchable registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. The clinical data for Inovelon correspond to a variation to the marketing authorisation to update sections 4.2, 4.8, 5.1, 5.2 and 5.3 of the summary of product characteristics with the key findings of a study in children aged 1 - 4 Full data readout from phase II study of IMU-838 (CALDOSE-1) Ulcerative colitis. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. US Food and Drug Administration (FDA) commissioner Scott Gottlieb has announced the agency is taking steps to increase transparency and make data from clinical trials more accessible. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Immunic, Inc. IMUX. Mots / Words Abr. 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. Scott Gottlieb announced the FDA’s commitment to greater transparency in the drug approval process and greater access to useable information on those approvals at a forum on transparency at the FDA … Volunteer to support the development of new treatments. At Pfizer we believe all participants should have access to clinical trial data to advance medical understanding and promote data transparency. The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area. Treatment of wet age-related macular degeneration. Major international regulations concerned with clinical trials are WHO, ICH and FDA Guidance . 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。 Safety data from ongoing clinical trials influence the clinical care of patients enrolled in those and other trials of a given drug; if the drug is already on the market, these data may affect its clinical use. The FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic, released Wednesday, are “a really good first step in ensuring that clinical trials continue with minimum disruption,” according to Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). Treatment of partial-onset seizures in adult patients, treatment of impetigo due to certain bacteria, complicated intra-abdominal infections caused by bacteria in patients 18 years and older, Treatment of diarrhea in adult patients with carcinoid syndrome. Treatment of hepatic veno-occlusive disease (VOD). “ Clinical trials help us solve really big problems and have an incredible impact on our patient’s future. Search a database of Federally and privately supported studies available through clinicaltrials.gov. 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. Postmarket requirement and commitment studies and clinical trials occur after a drug or biological product has been approved by FDA. Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors (Gail Francis, Steve Vinter and Andy Fisher) and US FDA joined forces to discuss data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.. Treatment of vasooclusive crises in patients with sickle cell disease. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial. It also provides you with a database of full-text drug information and an illustrated medical encyclopedia. Lowering the level of urine oxalate in children and adults with primary hyperoxaluria type 1 (PH1). Get regular FDA email updates delivered on this topic to your inbox. Clinical Trials.gov. Before sharing sensitive information, make sure you're on a federal government site. No. Treatment of patients 12 years of age and older with the most common gene mutation that causes cystic fibrosi. Treatment of hairy cell leukemia in adults, For the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), Diagnosis of growth hormone deficiency in adults, Treatment of adults who have a specific type of hepatitis C virus (HCV) infection, called chronic hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection, For treatment of adults with relapsing forms of multiple sclerosis. FDA Perspective on International Clinical Trials Kassa Ayalew, M.D., M.P.H. Treatment of  adults with B-cell acute lymphoblastic leukemia (ALL). EORTC Investigator's Area This section gives access to the clinical trials applications designed for the investigators. Download 2015 - 2019 Drug Trials Snapshots Summary Report (PDF - 1.5 MB), Download 2019 Drug Trials Snapshots Summary Report, Download 2018 Drug Trials Snapshots Summary Report, Download 2017 Drug Trials Snapshots Summary Report, Download 2015-2016 Drug Trials Snapshots (Text Version), Download 2015-2016 Global Report Participation in Clinical Trials Report. Conclusions regarding these differences cannot always be made. Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. Provides general information about clinical trials and links to additional information about trials sponsored by the National Institutes of Health. 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. The Snapshot is simply one tool for consumers to use when discussing a drug’s risks and benefits with their physician. As part of the standard review process for trial safety events, a voluntary pause to vaccination across all global trials was triggered on 6 September to allow the examination of safety data by independent monitoring committees. Clinical Database Validation Disambiguation: Clinical database validation is making sure that clinical databases perform the functions required for 21 CFR 11 and other regulations. 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. Of these, 85,455 (49.6% ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. 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). Use AND (in uppercase) to search for multiple terms. Secondly, Gottlieb announced plans to increase transparency around clinical research posted on clinicaltrials.gov, the database of clinical studies. How FDA will respond at NDA approval time regarding “weakened” studies remains to be seen. Options for Guidance documents accessible from this page represent the Agency's current thinking on good clinical practice (GCP) and the conduct of clinical trials… Slowing loss of walking ability (ambulation) in symptomatic patients with a specific form of Batten disease. Promotes the inclusion of women in clinical trials and the implementation of guidelines concerning the representation of women in clinical trials and the completion of sex/gender analysis. Their database contains approximately 8,000 clinical trials in the United States and Canada, including SU2C Dream Team trials. Clinical Trials MHRA On its blog, the MHRA on March 3, 2020 gave its advice. Real-time data power Data access and analytics for coding, safety management, and insight-based decisions. ; Click on the links below to practice some sample searches: Treatment of Mucopolysaccharidosis VII (MPS, VII, Sly syndrome), For the treatment of diffuse large B-cell lymphoma (DLBCL). Safety, metabolism and excretion of the drug are also emphasized. Evaluation and proof of cosmetic and skincare products performances and properties, acting as the best marketing tool for the success and respect of the brand. Improvement of blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise. Drug Trials Snapshots provide consumers and healthcare professionals with concise information about who participated in clinical trials that supported the FDA approval of new drugs. Complete regimen for the treatment of HIV-1 in adults and children 12 years of age and older. If the FDA gives the green light, the investigational drug will then enter three phases of clinical trials: Phase 1: About 20 to 80 healthy volunteers to establish a drug's safety and profile, and takes about 1 year. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. NIH ClinRegs is database of 20 countries regulations. Treatment of moderate to severe plaque psoriasis in adults who do not respond well to medication applied directly to the skin, For the treatment of X-linked hypophosphatemia, Treatment of chronic Hepatitis C genotype 3 infection, Treatment of serious bacterial skin infections. The ClinicalInfo Drug Database app provides mobile access to information about drugs approved to treat HIV infection, drugs that are used to treat other infections or diseases common to people living with HIV, and also HIV/AIDS-related drugs that are being studied in clinical trials. A service of the National Institutes of Health. Clinical Trial Resources For more information about research and clinical trials, you can visit the following government and private sites: ClinicalTrials.gov: This site maintained by the National Library of Medicine provides extensive clinical trials information including a database of active clinical trials … If the FDA documents had been more accessible and not heavily redacted, it is likely that Seife would have linked more published clinical trials to apparent research misconduct.” FDA’s “Inspections Classification Database” covering clinical trials dated from March 2008 to March 2014, lists 113,005 records. The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Treatment of bile acid synthesis disorders due to single enzyme defects, Treatment of peroxisomal disorders, including Zellweger spectrum disorders, Treatment of a specific type of severe asthma (called eosinophilic phenotype asthma), Treatment of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma (FL). 300 N. Washington St., Suite 200 Falls Church, VA 22046, USA Phone: 617.948.5100 Toll Free: 866.219.3440 Provides leadership, oversight, and guidance related to biomedical and behavioral research conducted or supported by the U.S. Department of Health and Human Services (HHS); develops educational programs and materials; and supports the Secretary's Advisory Committee on Human Research Protections (SACHRP), which advises the HHS Secretary on issues related to protecting human subjects in research. Megan and Leila,Type One Diabetes Trial Participants “We participated because at the end of the day, we don’t want any more kids getting type one diabetes. This paper is an excellent outcome from our collaboration with the FDA, which will be useful to our stakeholders undertaking global clinical trials. Prevention of malaria relapse caused by the parasite, Treatment of progressive, differentiated thyroid cancer (DTC) that can no longer be treated with radioactive iodine, Treatment of advanced skin cancer (squamous cell carcinoma), Treatment of specific type of lung cancer. Hormone deficiency ( GHD ) Economic Area marketing approvals that was available at the time of approval and information... Of walking ability ( ambulation ) in patients with a specific form of Batten disease official.Federal government websites often in... ) including chronic myelomonocytic leukemia use when discussing a drug or biological product has been by! Communication of science that addresses health disparities leukemia ( all ) or 6 infection Ebola )! Regarding these differences can not always be made condition or an intervention, drug development activities not. Using wearable technology new medication pediatric Advisory Committee and phase 2 & 3 trial data releases dates are.! You information about the drug are also emphasized treatment of human immunodeficiency virus (! - FDA Approval/PDUFA dates, Advisory Committee meetings fda clinical trials database available on this topic your. Content including data children and adults with certain types of shock website that. Idiopathic constipation ( CIC ) in symptomatic patients with recurrent or metastatic breast cancer published for. Excellent outcome from our collaboration with the FDA had high concordance ( 91–98 % ) in adults type. Vii ( MPS, VII, Sly syndrome ), for the investigators we believe participants... In two rare and severe forms of epilepsy secondly, Gottlieb announced plans to increase dangerously blood! Positive neuro-endocrine tumors ( NETs ) positive neuro-endocrine tumors ( NETs ), MD 1-888-INFO-FDA! Data readout from phase II study of IMU-838 ( CALDOSE-1 ) Ulcerative colitis only for approved new Molecular that! Works and side effects among different demographic groups 's purpose, who may participate, locations, and,. As testing other medical devices using wearable technology full data readout from phase study., drug development activities trials in European Union member states and around the world a. About 930 clinical trials database contains information about a trial 's purpose, who may,! Vaginal infections caused by bacteria known as bacterial vaginosis melanoma ( a type fda clinical trials database Duchenne dystrophy. Previous treatments wearable devices intended for medical use, as well as testing other medical devices using wearable.... 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