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. 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 … A service of the National Institutes of Health. This paper is an excellent outcome from our collaboration with the FDA, which will be useful to our stakeholders undertaking global clinical trials. 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 … 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. Visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS). Explore 361,962 research studies … Snapshots aim to present differences in how well the drug works and side effects among different demographic groups. The EMA and the FDA had high concordance (91–98%) in decisions on marketing approvals. 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. 2 Note: Standardized drug names automatically assigned by the National Library of Medicine based on drug names provided by the Responsible Party. 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. For the treatment of a particular type of Duchenne muscular dystrophy (DMD). Treatment of adults with an episode of acquired thrombotic thrombocytopenic purpura (aTTP). For the treatment of symptoms associated with opioid withdrawal during abrupt opioid discontinuation. 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.. Temporary improvement of the appearance of glabellar lines (wrinkles between the eyebrows). EORTC Investigator's Area This section gives access to the clinical trials applications designed for the investigators. Slowing loss of walking ability (ambulation) in symptomatic patients with a specific form of Batten disease. For the treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. MedlinePlus will direct you to information to help answer health questions. 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. 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. 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. Each Snapshot contains a “MORE INFO” section for more detailed and technical content. This is a searchable registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. You can check out information on the LSD Trials and what stage they're at. 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. Treatment of  melanoma (a type of skin cancer)  when used with another drug binimetinib, Reversal of the effects of certain neuromuscular blocking agents. And here is an excellent overview entitled 'Navigating Clinical Trials… 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. 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. Treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. At Pfizer we believe all participants should have access to clinical trial data to advance medical understanding and promote data transparency. This section is for anyone interested in additional information. 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, 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. Drug Trials Snapshots are part of an overall FDA effort to make demographic data more available and transparent. The EORTC Clinical Trials Database contains information about EORTC clinical trials and clinical trials from other organisations with EORTC participation. About 930 clinical trials conducted at site, including 273 Phase I-II early phase trials. Use AND (in uppercase) to search for multiple terms. Search a database of Federally and privately supported studies available through clinicaltrials.gov. FDA Clinical Trials Search. Division of Clinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) 2 Outline 1.Global Distribution of Clinical Trial Data in FDA 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). Guidance documents accessible from this page represent the Agency's current thinking on good clinical practice (GCP) and the conduct of clinical trials… 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. Treatment of Chagas disease in children 2 to 12 years of age. Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description. Safety reports derived from ongoing clinical trials must be meaningful, relevant, and amenable to … News update 26-11-2020 EudraCT and EU CTR application Through Drug Trials Snapshots, FDA is addressing concerns raised by advocacy groups and the public, including important issues such as tracking information about how many women and minorities participate in drug trials. Search for clinical research studies on the CenterWatch Clinical Trials Listing Service. Prevent ion or reduction of bleeding episodes in adults and children with hemophilia A. 12 days ago. 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. 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. 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. Initial lab-based results and new data from 1,500 Israel-based Corona patients have been extremely promising and clinical studies are scheduled to … 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 Snapshot is simply one tool for consumers to use when discussing a drug’s risks and benefits with their physician. 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. Drug Approvals and Databases, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, CDER Conversations: Drug Trials Snapshots, FDA Basics Webinar - April 27, 2015: Drug Trials Snapshots, CDER’s New Molecular Entities and New Therapeutic Biological Products, Inside Clinical Trials: Testing Medical Products in People, The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective. Treatment of chorea in patients with Huntington’s disease. Assists and encourages the identification, development, and availability of safe and effective products for people with rare diseases and disorders. Major international regulations concerned with clinical trials are WHO, ICH and FDA Guidance . / Abrr. Before sharing sensitive information, make sure you're on a federal government site. 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. Click the “MORE INFO” bar for more technical and detailed content including data. Comments and questions can be sent to: Snapshots@fda.hhs.gov. The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial. For the detection of estrogen receptor (ER)-positive lesions in patients with recurrent or metastatic breast cancer. How FDA will respond at NDA approval time regarding “weakened” studies remains to be seen. 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 Conclusions regarding these differences cannot always be made. 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. 300 N. Washington St., Suite 200 Falls Church, VA 22046, USA Phone: 617.948.5100 Toll Free: 866.219.3440 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. ​Treatment of chronic idiopathic constipation (CIC) in adults. 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. Search a database of Federally and privately supported studies available through clinicaltrials.gov. 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. Detection of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs). For more information, please read: "Report to Congress: Reports on Postmarketing Studies [FDAMA 130]" and the Guidance for Industry (PDF - 456KB). Improvement of blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise. Safety, metabolism and excretion of the drug are also emphasized. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. 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. FDA Clinical Trials Search. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area. checking clinical data for problems, is on another page. dut 's-Heerenberg: n.a. Treatment of hepatic veno-occlusive disease (VOD). No. The .gov means it’s official.Federal government websites often end in .gov or .mil. The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial. Clinical trials are an important step in our being able to have new treatments for diabetes and other conditions. An official website of the United States government, : Of these, 85,455 (49.6% 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. 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. Regulations, guidances, drug development activities, and information about pediatric advisory committee meetings are available on this Web site. Real-time data power Data access and analytics for coding, safety management, and insight-based decisions. 's-Graveland: n.a. 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. Preformulated MEDLINE searches are included in MedlinePlus and give easy access to the medical research literature. At the end of each consumer section of the Snapshot, there is a shaded bar with the words “MORE INFO”. 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 wet age-related macular degeneration. 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. Options for 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. Clinical Trials Center for Skincare and Cosmetics in Thailand. Reduce hospitalization from worsening heart failure. 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 HIV infection in patients with limited treatment options. 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. dut -agōgē dut 's-Hertogenbosch: n.a. dut 's-Gravenhage: n.a. Mots / Words Abr. Treatment of gastrointestinal stromal tumors. The site is secure. 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. 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. Treatment of adults with mantle cell lymphoma. Each Snapshot contains information about the drug in a question and answer format. “ Clinical trials help us solve really big problems and have an incredible impact on our patient’s future. ＜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 The FDA usually requires a phase III clinical trial before approving a new medication. 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 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. 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). Clinical Database Validation Disambiguation: Clinical database validation is making sure that clinical databases perform the functions required for 21 CFR 11 and other regulations. Search Tips and Examples. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Treatment of chronic Hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection. 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. Q1 2021. Treatment of adult patients with bacterial skin infections. 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. Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. Treatment of the signs and symptoms of dry eye disease. Do not rely on Snapshots alone to make decisions regarding medical care. Treatment of excessive sleepiness due to narcolepsy. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Treatment of seizures in two rare and severe forms of epilepsy. The Snapshots program began in 2015 and reflects drugs approved after that time. NIH ClinRegs is database of 20 countries regulations. 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. Use our tools on your road to profit in the stock market. 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. Tap into Pharma Intelligence for the latest in clinical studies and clinical trials data. Treatment of adenosine deaminase severe combined immune deficiency. The .gov means it’s official.Federal government websites often end in .gov or .mil. “Consumers had to wade through publically available scientific reviews on drug approvals, and that involved quite a bit of time an… 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. 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… Clinical data validation, i.e. 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). Data is available Publication information concerning a variety of research-related topics can be found on this webpage. Replacement of growth hormone in adults with growth hormone deficiency (GHD). 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. 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. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm 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.. 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. Promotes and protects the health of diverse populations through research and communication of science that addresses health disparities. Treatment of a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced (metastatic). Used to increase dangerously low blood pressure in adults with certain types of shock. The FDA guidance on IND and BA/BE reporting summarizes the FDA’s requirements and thinking on SAE reporting in clinical trials. Treatment of starting and maintaining sedation in adults undergoing short (less than 30 minutes) procedures. Drug Trials … This includes wearable devices intended for medical use, as well as testing other medical devices using wearable technology. Get regular FDA email updates delivered on this topic to your inbox. An official website of the United States government, : atoltivimab, maftivimab, and odesivimab-ebgn, ​Treatment of Zaire ebolavirus (Ebola virus) infection. 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. Lang. Treatment of adults with newly-diagnosed acute myeloid leukemia (AML). Provides guidance on the Health Insurance Portability and Accountability Act (HIPAA) and Standards for Privacy of Individually Identifiable Health Information (the Privacy Rule). Secondly, Gottlieb announced plans to increase transparency around clinical research posted on clinicaltrials.gov, the database of clinical studies. The snapshots are published within 30 days of approval and contain information that was available at the time of approval. 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. Legally, FDA has the authority to accept foreign data as …
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