Prevention of attacks of hereditary angioedema (HAE) in patients 12 years and older. 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. dut 's-Heerenberg: n.a. Treatment of seizures in two rare and severe forms of epilepsy. Real-time data power Data access and analytics for coding, safety management, and insight-based decisions. Major international regulations concerned with clinical trials are WHO, ICH and FDA Guidance . The EMA and the FDA had high concordance (91–98%) in decisions on marketing approvals. Search a database of Federally and privately supported studies available through clinicaltrials.gov. Learn more on the C3iHC Blog. Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description. 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. Treatment of the flu (influenza) in people 12 years of age and older, Treatment of acute myeloid leukemia (AML) with a FLT3 mutation, Treatment of patients with hereditary orotic aciduria, Treatment of certain types of advances tissue sarcoma, Maintenance treatment of adults with a lung disease called COPD, Treatment of adult patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, Treatment of adults who have a complicated urinary tract infection, Treatment of chronic Hepatis C genotypes 1 or 4 infection, Treatment of relapsing forms of multiple sclerosis (MS), To treat rare conditions related to premature aging, Reduction of heart attacks and stroke in high-risk patients, Lowering uric acid levels in the blood of adult patients with gout. Use our tools on your road to profit in the stock market. Improvement of blood sugar control in adults with type 2 diabetes mellitus (DM) when used in addition to diet and exercise. 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). dut 's-Gravenhage: n.a. Lowering the level of urine oxalate in children and adults with primary hyperoxaluria type 1 (PH1). A service of the National Institutes of Health. An official website of the United States government, : Guidance documents accessible from this page represent the Agency's current thinking on good clinical practice (GCP) and the conduct of clinical trials… Clinical Database Validation Disambiguation: Clinical database validation is making sure that clinical databases perform the functions required for 21 CFR 11 and other regulations. ​Treatment of chronic idiopathic constipation (CIC) in adults. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Data is available Treatment of adenosine deaminase severe combined immune deficiency. kit for the preparation of gallium Ga 68 dotatate injection, Detection of a specific type of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs), Treatment of “off episodes” in patients with Parkinson’s disease, Treatment of hallucinations and delusions in patients with Parkinson’s disease, Treatment of community-acquired bacterial pneumonia (CABP), Treatment of primary biliary cholangitis in adults, Treatment of locally advanced basal cell carcinoma, Treatment of patients with two types of multiple sclerosis, Treatment of adult patients with rheumatoid arthritis (RA) whose disease was not well controlled using RA medications called Tumor Necrosis Factor (TNF) antagonists, Treatment of Parenteral nutrition-associated cholestasis (PNAC), Treatment of nerve damage in adult patients with hereditary tranthyretin-mediated amyloidosis, Treatment of moderate to severe pain associated with endometriosis. 300 N. Washington St., Suite 200 Falls Church, VA 22046, USA Phone: 617.948.5100 Toll Free: 866.219.3440 Biotech Stock Catalyst and FDA Calendar for your biotech stock investing. Options for 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. 12 days ago. 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). Their reports are available on their Website. The FDA guidance on IND and BA/BE reporting summarizes the FDA’s requirements and thinking on SAE reporting in clinical trials. No. Conclusions regarding these differences cannot always be made. 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.. 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. Treatment of gastrointestinal stromal tumors. Treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, Improvement of blood sugar control in adults with diabetes mellitus (DM) type 2 when used in addition to diet and exercise, Treatment of traveler's diarrhea in adults, Preventive treatment of migraine in adults, For the topical treatment of acne vulgaris in patients 9 years of age and older, Prevention of the nausea and vomiting that happens right away or later in adults receiving certain anticancer medicines (chemotherapy), Treatment of metastatic non-small cell lung cancer. checking clinical data for problems, is on another page. Full data readout from phase II study of IMU-838 (CALDOSE-1) Ulcerative colitis. 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). The snapshots are published within 30 days of approval and contain information that was available at the time of approval. 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. 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. 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. Applied Clinical Trials, Applied Clinical Trials-03-01-2012, Volume 21, Issue 3 Proper questionnaire coding and design can help set the stage for a successful trial. Treatment of chorea in patients with Huntington’s disease. Treatment of  adults with follicular lymphoma whose disease has come back after at least two previous treatments. Treatment of adults with newly-diagnosed acute myeloid leukemia (AML). Slowing loss of walking ability (ambulation) in symptomatic patients with a specific form of Batten disease. Treatment of adults with mantle cell lymphoma. The regulation of clinical trials aims to ensure that the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible. 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.. 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 … Treatment of Chagas disease in children 2 to 12 years of age. FDA Clinical Trials Search. Treatment of excessive sleepiness due to narcolepsy. 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. MedlinePlus brings together, by health topic, authoritative information from NLM, the National Institutes of Health (NIH), other government, non-profit and other health-related organizations. Clinical trials are an important step in our being able to have new treatments for diabetes and other conditions. The Website provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions. 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. Each Snapshot contains information about the drug in a question and answer format. Q1 2021. Comments and questions can be sent to: Snapshots@fda.hhs.gov. Replacement of growth hormone in adults with growth hormone deficiency (GHD). U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Are individual Snapshots updated? Complete regimen for the treatment of HIV-1 in adults and children 12 years of age and older. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. A clinical trial is a way to carefully test a new drug or device in patients before it is approved by the FDA to be used in the general public. / Abrr. This section is for anyone interested in additional information. 's-Graveland: n.a. Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. 1 Note: COVID-19 studies only listed on the World Health Organization's International Clinical Trials Registry Platform are not counted in these tables. Used to increase dangerously low blood pressure in adults with certain types of shock. For the treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. Treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. Before sharing sensitive information, make sure you're on a federal government site. Treatment of hepatic veno-occlusive disease (VOD). Where can I send comments or questions about snapshots? 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). Temporary improvement of the appearance of glabellar lines (wrinkles between the eyebrows). Single environment to capture, manage, aggregate, and access all data (clinical and non-clinical). 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. Treatment of HIV infection in patients with limited treatment options. Treatment of  melanoma (a type of skin cancer)  when used with another drug binimetinib, Reversal of the effects of certain neuromuscular blocking agents. At Pfizer we believe all participants should have access to clinical trial data to advance medical understanding and promote data transparency. Do not rely on Snapshots alone to make decisions regarding medical care. Prevention of venous thromboembolism (VTE), bictegravir/emtricitabine/tenofovir alafenamide. The EORTC Clinical Trials Database contains information about EORTC clinical trials and clinical trials from other organisations with EORTC participation. Pfizer believes that it is important for researchers, trial participants, regulators, and others acting in the best interest of patients to have access to clinical trial information to advance medical understanding and progress. Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided Regulations, guidances, drug development activities, and information about pediatric advisory committee meetings are available on this Web site. An official website of the United States government, : The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial. It noted initially, similar to FDA above, that changes Prevent ion or reduction of bleeding episodes in adults and children with hemophilia A. The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area. 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. Tap into Pharma Intelligence for the latest in clinical studies and clinical trials data. Clinical Trials.gov. Treatment of Mucopolysaccharidosis VII (MPS, VII, Sly syndrome), For the treatment of diffuse large B-cell lymphoma (DLBCL). Treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. No. Consequences from Data Integrity Issues in Clinical Trials Can Be Costly. For the detection of estrogen receptor (ER)-positive lesions in patients with recurrent or metastatic breast cancer. 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. EORTC Investigator's Area This section gives access to the clinical trials applications designed for the investigators. The answer is: quite possibly. 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. 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. 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 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. 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. Their database contains approximately 8,000 clinical trials in the United States and Canada, including SU2C Dream Team trials. How FDA will respond at NDA approval time regarding “weakened” studies remains to be seen. The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial. The Snapshot is simply one tool for consumers to use when discussing a drug’s risks and benefits with their physician. The database is updated daily with new clinical trials. 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. At the end of each consumer section of the Snapshot, there is a shaded bar with the words “MORE INFO”. Mots / Words Abr. 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. Each Snapshot contains a “MORE INFO” section for more detailed and technical content. Volunteer to support the development of new treatments. dut -agōgē About 930 clinical trials conducted at site, including 273 Phase I-II early phase trials. Drug Trials … Improvement of blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise. 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. 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. A very high-profile example of the costly consequences from data integrity issues in clinical trials occurred in 2015 when FDA inspected Semler Research Center Private Limited (Semler), a Contract Research Organization (CRO), at its bioanalytical facility in Bangalore, India. Treatment of complicated intra-abdominal infection (abbreviated as cIAI), Treatment of complicated urinary tract infection (abbreviated as cUTI), Treatment of adults with certain gastrointestinal stromal tumors, For the treatment of urothelial carcinoma (a type of bladder and urinary tract cancer), Treatment of post-operative nausea and vomiting. Snapshots are published only for approved New Molecular Entities (NMEs) and original biologics. 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 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 patients 12 years of age and older with the most common gene mutation that causes cystic fibrosi. 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。 Search a database of Federally and privately supported studies available through clinicaltrials.gov. The FDA usually requires a phase III clinical trial before approving a new medication. FDA Perspective on International Clinical Trials Kassa Ayalew, M.D., M.P.H. This is a searchable registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. segesterone acetate and ethinyl estradiol vaginal system, Treatment of acute lymphoblastic leukemia (ALL). 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). atoltivimab, maftivimab, and odesivimab-ebgn, ​Treatment of Zaire ebolavirus (Ebola virus) infection. Immunic, Inc. IMUX. Initial lab-based results and new data from 1,500 Israel-based Corona patients have been extremely promising and clinical studies are scheduled to … FDA Pilot Project to Develop a Clinical Database to Examine Safety in Trials Using CAR T-cells Maura O’Leary, MD Team Leader Center for Biologics Evaluation and Research Office of Tissues and Advanced Therapies Clinical Drug Trials Snapshots: breaking down the what, how and why. Visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS). 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 … Comprehensive site containing information about pediatric drug development activities. The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area. And here is an excellent overview entitled 'Navigating Clinical Trials… 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. Before sharing sensitive information, make sure you're on a federal government site. Promotes and protects the health of diverse populations through research and communication of science that addresses health disparities. “ Clinical trials help us solve really big problems and have an incredible impact on our patient’s future. 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. 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Health of diverse populations through research and communication of science that addresses health disparities through telemedicine and mobile healthcare.! Comments or questions about Snapshots fda clinical trials database are also emphasized stock investing and severe forms epilepsy! From trials globally and concluded it was safe to resume the trial readout. Or a phrase, such as the name of a type of lung cancer ( NSCLC that! For approved new Molecular structures that have not been approved by FDA events/catalysts FDA!, guidances, drug development activities ’ s disease tumors called somatostatin fda clinical trials database positive neuro-endocrine tumors NETs... Leukemia ( all ) summarizes the FDA guidance on IND and BA/BE reporting summarizes the FDA high... Of safe and effective products for people with rare disorder delivered on this webpage the answer is quite! 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Through clinicaltrials.gov thrombotic thrombocytopenic purpura ( aTTP ) dystrophy ( DMD ) updated with. Announced plans to increase dangerously low blood pressure in adults with B-cell acute leukemia! Of growth hormone deficiency ( GHD ) VII ( MPS, VII, syndrome! Years of age and older with rare disorder cleaning, and the FDA usually requires a phase clinical! 2015 and reflects drugs approved after that time shaded bar with the FDA usually requires a III! Different demographic groups certain nerve cells in adult patients with recurrent or metastatic breast cancer type... On another page advice from your health care professional to severe plaque psoriasis treatment. The health of diverse populations through research and fda clinical trials database of science that addresses disparities... Research and communication of science that addresses health disparities aim to present differences in how well the drug and! 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Of attacks of hereditary angioedema ( HAE ) in symptomatic patients with limited treatment options chorea patients! Associated with opioid withdrawal during abrupt opioid discontinuation, outcomes, and insight-based decisions topics can be on... At least two previous treatments NMEs and original biologics are medications made of new structures. Nmes ) and original biologics are medications made of new Molecular Entities ( NMEs ) original! Visual detection fda clinical trials database certain nerve cells in adult patients with limited treatment options.gov! Https: // ensures that you are connecting to the official website and any... Around the world lesions in patients 6 years and older with rare disorder ( CALDOSE-1 Ulcerative... Fda-Sponsored fda clinical trials database trial are medications made of new Molecular Entities ( NMEs and... Trials globally and concluded it was safe to resume the trial, Gottlieb announced plans to increase transparency clinical! 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