https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm 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. Used to treat adult women with vaginal infections caused by bacteria known as bacterial vaginosis. 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). Treatment of HIV infection in patients with limited treatment options. Volunteer to support the development of new treatments. The FDA-sponsored Clinical Trial Transformation Initiative has published recommendations for conducting decentralized clinical trials through telemedicine and mobile healthcare providers6. Treatment of chronic Hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection. At the end of each consumer section of the Snapshot, there is a shaded bar with the words “MORE INFO”. Provides general information about clinical trials and links to additional information about trials sponsored by the National Institutes of Health. 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. <臨床試験情報>ClinicalTrials.gov / IFPMA Clinical Trials Portal / PDQ Cancer Clinical Trials Registry <有害事象情報>FAERS(FDA Adverse Event Reporting System) / JAPIC AERS 参考情報 組織・団体 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. FDA Clinical Trials Search. Search a database of Federally and privately supported studies available through clinicaltrials.gov. Treatment of a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced (metastatic). The .gov means it’s official.Federal government websites often end in .gov or .mil. Each Snapshot contains information about the drug in a question and answer format. A service of the National Institutes of Health. Biotech Stock Catalyst and FDA Calendar for your biotech stock investing. Treatment of human immunodeficiency virus 1 (HIV-1) infection in adults, Treatment of chronic idiopathic constipation in adults, Treatment of tenosynovial giant cell tumor, Treatment of postmenopausal women with osteoporosis who are at high risk for bone fracture, Treatment of migraine with or without aura, Treatment of paroxysmal nocturnal hemoglobinuria (PNH), Treatment of children with high-risk neuroblastoma, For the treatment of neuromyelitis optica spectrum disorder (NMOSD), Treatment of adults with pulmonary artery hypertension, Treatment of adults who have a complicated urinary tract infection (abbreviated as cUTI), Prevent delayed phase chemotherapy-induced nausea and vomiting, Treatment of chronic lymphocytic leukemia (CLL), Treatment of specific forms of breast cancer, Treatment of irritable bowel syndrome with diarrhea. Secondly, Gottlieb announced plans to increase transparency around clinical research posted on clinicaltrials.gov, the database of clinical studies. 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. 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. Slowing loss of walking ability (ambulation) in symptomatic patients with a specific form of Batten disease. Treatment of perinatal, infantile and juvenile-onset hypophosphatasia (HPP), To improve wakefullness in adults with narcolepsy or obstructive sleep apnea (OSA), Treatment for adults with constipation caused by prescription pain drugs called opioids, Treatment of non-small cell lung cancer (NSCLC), Treatment of patients with advanced non-small cell lung cancer (NSCLC), Prevent attacks of hereditary angioedema in people 12 years and older, Treatment of adults with a specific form of breast cancer, Treatment of moderate to severe plaque psoriasis in adults, To visually detect aggregated neurofibrillary tangles in the brain of patients with Alzheimer's, Treatment of  adults with low platelet count due to chronic immune thrombocytopenia (ITP), Treatment of advanced epithelioid sarcoma, Treatment of a type of bladder cancer called urothelial carcinoma, Treatment of nerve damage in adult patients with hereditary transthyretin-mediated amyloidosis, Treatment of adults with acute myeloid leukemia (AML) that have a mutation in a gene called IDH1 and whose disease has come back or has not improved after previous treatment(s), Drug used to stain the internal limiting membrane (ILM), Improve glucose control in adults with diabetes mellitus, elexacaftor/tezacaftor/ivacaftor; ivacaftor. Treatment of adult patients with bacterial skin infections. Treatment of chorea in patients with Huntington’s disease. Treatment of adults with an episode of acquired thrombotic thrombocytopenic purpura (aTTP). Treatment of adults with mantle cell lymphoma. The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial. 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. Promotes and protects the health of diverse populations through research and communication of science that addresses health disparities. 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 snapshots are published within 30 days of approval and contain information that was available at the time of approval. For the treatment of symptoms associated with opioid withdrawal during abrupt opioid discontinuation. Do not rely on Snapshots alone to make decisions regarding medical care. Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. Data is available 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). The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial. 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. Drug Trials Snapshots: breaking down the what, how and why. Postmarket requirement and commitment studies and clinical trials occur after a drug or biological product has been approved by FDA. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. 1 Note: COVID-19 studies only listed on the World Health Organization's International Clinical Trials Registry Platform are not counted in these tables. At the beginning and at the end of each Snapshot, there is a link to the drug’s Prescribing Information (formerly known as the Package Insert). 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. Single environment to capture, manage, aggregate, and access all data (clinical and non-clinical). The .gov means it’s official.Federal government websites often end in .gov or .mil. This includes wearable devices intended for medical use, as well as testing other medical devices using wearable technology. Treatment of hepatic veno-occlusive disease (VOD). 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. 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 Mots / Words Abr. Treatment of starting and maintaining sedation in adults undergoing short (less than 30 minutes) procedures. The database is updated daily with new clinical trials. How FDA will respond at NDA approval time regarding “weakened” studies remains to be seen. A service of the National Institutes of Health. Improvement of blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise. The FDA guidance on IND and BA/BE reporting summarizes the FDA’s requirements and thinking on SAE reporting in clinical trials. 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. atoltivimab, maftivimab, and odesivimab-ebgn, ​Treatment of Zaire ebolavirus (Ebola virus) infection. You can check out information on the LSD Trials and what stage they're at. The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area. Prevention of attacks of hereditary angioedema (HAE) in patients 12 years and older. 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 EORTC Clinical Trials Database contains information about EORTC clinical trials and clinical trials from other organisations with EORTC participation. Assists and encourages the identification, development, and availability of safe and effective products for people with rare diseases and disorders. 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. Full data readout from phase II study of IMU-838 (CALDOSE-1) Ulcerative colitis. Used to increase dangerously low blood pressure in adults with certain types of shock. Are all approved drugs presented in Snapshots? Treatment of Mucopolysaccharidosis VII (MPS, VII, Sly syndrome), For the treatment of diffuse large B-cell lymphoma (DLBCL). Temporary improvement of the appearance of glabellar lines (wrinkles between the eyebrows). 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. Drug Trials Snapshots are part of an overall FDA effort to make demographic data more available and transparent. An official website of the United States government, : 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.. Clinical Trials MHRA On its blog, the MHRA on March 3, 2020 gave its advice. Clinical Trials Center for Skincare and Cosmetics in Thailand. Search NIH's database of Federal and private studies taking place nationwide. Specific identifier numbers will be added to all clinical trials which will then link to FDA communications on those specific trials. 's-Graveland: n.a. Comprehensive site containing information about pediatric drug development activities. 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. Treatment of gastrointestinal stromal tumors. Safety, metabolism and excretion of the drug are also emphasized. It also provides you with a database of full-text drug information and an illustrated medical encyclopedia. The FDA usually requires a phase III clinical trial before approving a new medication. For the treatment of a particular type of Duchenne muscular dystrophy (DMD). Treatment of onchocerciasis in patients 12 years of age and older, Treatment of adults with low platelet count, Control of hypocalcemia along with calcium and vitamin D in adults with hypoparathyroidism. Treatment of vasooclusive crises in patients with sickle cell disease. 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. 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). / Abrr. 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. Before sharing sensitive information, make sure you're on a federal government site. For more information, please read: "Report to Congress: Reports on Postmarketing Studies [FDAMA 130]" and the Guidance for Industry (PDF - 456KB). Promotes and ensures that people have equal access to and opportunity to participate in and receive services in all HHS programs without facing unlawful discrimination. Treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. An official website of the United States government, : Visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS). ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Treatment of  adults with B-cell acute lymphoblastic leukemia (ALL). Clinical data validation, i.e. For the treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. 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. Treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. Examples of HIV/AIDS clinical trials underway include studies of new HIV medicines, studies of vaccines to prevent or treat HIV, and studies of medicines to treat infections related to HIV. dut 's-Gravenhage: n.a. This is a searchable registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. ​Treatment of chronic idiopathic constipation (CIC) in adults. 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. 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. About 930 clinical trials conducted at site, including 273 Phase I-II early phase trials. Lowering the blood levels of phenylalanine in adults with phenylketonuria (PKU), Treat high levels of parathyroid hormone (PTH), Treatment of adults with metastatic bile duct cancer (cholangiocarcinoma), Treatment of a type of constipation called chronic idiopathic constipation (CIC), Treatment of adults with diffuse large B-cell lymphoma, Treatment of metastatic squamous non-small cell lung cancer, Treatment of  adults with mycosis fungoides or Sézary syndrome, Treatment of certain patients with high cholesterol, Reversal of the anticoagulant effects of Pradaxa during emergency situations or when there is a need to reverse its blood-thinning effects, ​Treatment of lung tuberculosis in limited population, Prevention of cytomegalovirus (CMV) infection and disease in adults. 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. Complete regimen for the treatment of HIV-1 in adults and children 12 years of age and older. 12 days ago. 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. For the treatment of moderate to severe plaque psoriasis, Treatment of obesity in patients 6 years and older with rare disorder. 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. The US Food and Drug Administration (FDA) released the ‘Drugs Trials Snapshots’ report for 2019 , an overview of the demographic characteristics of participants in clinical trials for drugs that gained approval by the regulatory agency during the past year.. 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. Before sharing sensitive information, make sure you're on a federal government site. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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… 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. Treatment of  adults with follicular lymphoma whose disease has come back after at least two previous treatments. Safety reports derived from ongoing clinical trials must be meaningful, relevant, and amenable to … Treatment of the signs and symptoms of dry eye disease. Data Monitoring Committees for Clinical Trial Sponsors, The Establishment and Operation of Clinical Trial - 03/2006 Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials - 10/2008 Treatment of  melanoma (a type of skin cancer)  when used with another drug encorafenib. 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。 Clinical Trials.gov. Get the latest information on Clinical Trials, FDA Drug Approvals, FDA Calendar, FDA Events and more on RTTNews ... Topline data readout from Phase 1b/2a clinical trial of WVE-120101 (PRECISION-HD) Huntington's disease. For the treatment of adults with acute hepatic porphyria (AHP).​. Search a database of Federally and privately supported studies available through clinicaltrials.gov. Lang. Learn more on the C3iHC Blog. 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. And here is an excellent overview entitled 'Navigating Clinical Trials… MedlinePlus will direct you to information to help answer health questions. The Snapshot is simply one tool for consumers to use when discussing a drug’s risks and benefits with their physician. dut 's-Hertogenbosch: n.a. Their database contains approximately 8,000 clinical trials in the United States and Canada, including SU2C Dream Team trials. Clinical trials are an important step in our being able to have new treatments for diabetes and other conditions. Explore 361,962 research studies … Treatment of patients 12 years of age and older with the most common gene mutation that causes cystic fibrosi. 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. 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. The Clinical Trials administration aims to provide it services professionally by evaluation, registration and monitoring the Clinical Trials conducted in Saudi Arabia and contribute to the protection of clinical trial subjects, also increasing experience of investigators in the field of clinical research and strengthen the capacity of the regulatory body, legislative and oversight functions. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Improvement of blood sugar control in adults with type 2 diabetes mellitus (DM) when used in addition to diet and exercise. Use AND (in uppercase) to search for multiple terms. Treatment of adults with acute myeloid leukemia (AML) that have a mutation in a gene called IDH2 and whose disease has come back or has not improved after previous treatment(s). The answer is: quite possibly. The EMA and the FDA had high concordance (91–98%) in decisions on marketing approvals. For the treatment of a complicated urinary tract infection. segesterone acetate and ethinyl estradiol vaginal system, Treatment of acute lymphoblastic leukemia (ALL). 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. 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. “ Clinical trials help us solve really big problems and have an incredible impact on our patient’s future. Questionnaires are used in a wide range of settings to gather information about opinions, outcomes, and the behavior of individuals. Major international regulations concerned with clinical trials are WHO, ICH and FDA Guidance . Treatment of Chagas disease in children 2 to 12 years of age. 300 N. Washington St., Suite 200 Falls Church, VA 22046, USA Phone: 617.948.5100 Toll Free: 866.219.3440 The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area. News update 26-11-2020 EudraCT and EU CTR application Preformulated MEDLINE searches are included in MedlinePlus and give easy access to the medical research literature. Guidance documents accessible from this page represent the Agency's current thinking on good clinical practice (GCP) and the conduct of clinical trials… 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. Calendar for your biotech stock investing, 4, 5 or 6 infection between the )... Can be found on this topic to your inbox on clinicaltrials.gov, the MHRA on March 3, 4 5. Should have access to the official website and that any information you provide is encrypted and transmitted securely of large... Encourages the identification, development, and the FDA before and therefore, does! In clinical trials Kassa Ayalew, fda clinical trials database, M.P.H that time ; on... 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