Clinical Approvals - news, views, reports and blogs - Biotech, Pharma and Life Science Channel
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.
Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.
Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be a governmental organization, a pharmaceutical, or biotechnology company. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization or a clinical trials unit in the academic sector.
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.
Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.
Source: Wikipedia
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News Articles
Arena Pharmaceuticals to Present at Two Upcoming Investor Conferences
SAN DIEGO, May 24, 2013 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the company is scheduled to present a corporate overview at the following investor conferen...
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today provided an update on the clinical program for preladenant, Merck’s investigational adenosine A2A rec...
Japan had a population of 127,817,277 in 2011, making it the 10th most populated country in the world (The World Bank, 2012). However, since 2005, as the number of deaths exceeded that of births, th...
JERUSALEM, May 23, 2013 /PRNewswire/ -- Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY), a publicly traded portfolio of biotech companies, based on intellectual property developed and own...
Echo Therapeutics Announces Successful Unveiling of Symphony® CGM System
PHILADELPHIA, May 23, 2013 /PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony® CGM System as a non-invasive, wireless, transdermal continuo...
SAN DIEGO and SHANGHAI, May 23, 2013 /PRNewswire/ -- Zensun Sci & Tech, Ltd., a biopharmaceutical company based in Shanghai and San Diego, announced today positive results of four completed P...
BioTime Announces Results of Vote at Special Meeting of Shareholders
Shareholders approve proposals related to the planned acquisition of stem cell assets of Geron Corporation by BioTime subsidiary Asterias Biotherapeutics, Inc. BioTime,...
Verastem to Present at the 2013 ASCO Annual Meeting
Verastem, Inc., (NASDAQ: VSTM) focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced that members of the research and...
SAN DIEGO and SHANGHAI, May 23, 2013 /PRNewswire/ -- Zensun Sci & Tech, Ltd., a biopharmaceutical company based in Shanghai and San Diego, announced today positive results of four completed P...
Investigational New Drug Application Cleared by FDA for OMS824 in Huntington's Disease
SEATTLE, May 23, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has...
Events
Including an Update on the Proposed Changes to the EU Clinical Trial Directive
Point-of-Care Diagnostics World Congress 2013
The Point-of-Care Diagnostics World Congress will take place in San Diego.
Promoting Clinical Trials - Sao Paulo, Brazil
THIS CONFERENCE AIMS TO RAISE THE LATAM PROFILE AS A KEY REGION TO CONDUCT CLINICAL RESEARCH.
6TH ANNUAL RECOMBINANT ANTIBODIES Conference
An insight into novel therapeutics and future technologies
Companies
Founded in 1989 and with headquarters in Ann Arbor, Michigan, Aastrom Biosciences is dedicated to the development of stem cell treatments for critical cardiovascular diseases. Aastrom is currently e...
Ambry Genetics is a CAP-accredited, CLIA-certified commercial clinical laboratory headquartered in Aliso Viejo, California. Since the company's inception in 2000, it has become a leader in provi...
McKesson Corporation, currently ranked 14th on the FORTUNE 500, is a healthcare services and information technology company dedicated to making the business of healthcare run bett...
Algeta was founded in 1997 (as Anticancer Therapeutic Inventions) based upon a unique combination of radiation chemistry, nuclear medicine and clinical oncology expertise brought together by its two...
Acorda Therapeutics, Inc. was established in March 1995 to develop therapeutic products for spinal cord injury ("SCI") and other central nervous system disorders. Acorda is focusing its initial develo...
Loma Linda University Medical Center
Loma Linda University Medical Center (LLUMC), a Seventh-Day Adventist institution, is among the largest private medical educational centers in the United States and the only one in inland Southern...
Cancer Genetics, Inc. (CGI) is an emerging leader in the field of personalized medicine, offering products and services that enable cancer diagnostics as well as treatments that are tailored to the...
Certara is dedicated to improving human health through a broad spectrum of software products and services, from molecular discovery through clinical development, with special focu...
Alvine Pharmaceuticals, Inc. is a private, clinical-stage, specialty biopharmaceutical company located in San Carlos, CA, focused on the development of biologics targeting autoimm...
Izun Pharmaceuticals Corporation
Izun Pharmaceuticals is a US based pharmaceutical company with a wholly owned R&D center in Israel. Izunâs technology platform allows it to develop botanical drugs by optimiz...
Clinical Trials
Nephrotic Syndrome Study Network
Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for appr...
This prospective, multi-center, non-interventional study will evaluate the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in Chinese patients with gastric or g...
USG Nerve Blocks for ACL Reconstruction
Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional femoral/sciatic block combinations effectively reduce postoperative pain, but results in considerable...
The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastri...
"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery
Aims and Hypotheses: This randomised placebo controlled study will test the hypothesis that Recombinant Activated Factor VII (rVIIa) will improve haemostasis after an inadequate response...
Bipolar Disorder Research Study for Ages 12 and Older
The Bipolar Disorder Center for Pennsylvanians aims to reduce significant differences in treatment results among Pennsylvanians with bipolar disorder, especially among youth, the elderly,...
Influenza Vaccine in Lung Transplant Patients
Research Question: How do antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation and healthy individua...
The purpose of this study is to determine if treatment using a medication (Arimidex), which lowers estrogen levels in the blood is better than placebo, a tablet that does not contain any a...
PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation. The investigators postulate that erythropoietin reduc...
Adrenal Function in Critical Illness
An appropriate hypothalamic-pituitary-adrenal (HPA) axis response is required to survive critical illness. Primary adrenal insufficiency, relative adrenal insufficiency, tissue resistance...
PubMed Articles
Generic Drugs for Hypertension: Are They Really Equivalent?
Many antihypertensive drugs are now available in generic formulations at fractions of the cost of their branded counterparts. In the United States, marketing approval for generic medications is usuall...
Istradefylline: First Global Approval.
Kyowa Hakko Kirin is developing istradefylline, a selective adenosine A2A receptor antagonist, for the once-daily oral treatment of Parkinson's disease (PD). Adenosine A2A receptors are considered to...
Activity-Based Imaging Probes of the Proteasome.
Over the years, the proteasome has been extensively investigated due to its crucial roles in many important signaling pathways and its implications in diseases. Two proteasome inhibitors-bortezomib an...
Background: Dexmedetomidine is a highly selective α2 agonist with analgesic, anxiolytic, and antiinflammatory properties. We investigated the effect of a single dose of dexmedetomidine on patient-per...
OBJECTIVES: This study was conducted to provide information regarding prevalence of pain, type of provider managing pain, and use of Internet for information regarding pain, among patients coming for...
Cultivating a positive culture of compliance.
Melinda Bruns, BS, RVT, LATG, Research Compliance Analyst: Post-approval Monitoring, Office of Research Integrity, University of Cincinnati, OH.
ENTRY INTO MOTHERHOOD AMONG ADOLESCENT GIRLS IN TWO INFORMAL SETTLEMENTS IN NAIROBI, KENYA.
Summary The contribution of adolescents' childbearing to total fertility rates in many sub-Saharan African countries is higher than in other parts of the world. In this paper, data collected from 897...
Clinical Accuracy of Estimated Fetal Weight in Term Pregnancies in a Teaching Hospital.
Abstract Objective: To evaluate whether clinical characteristics alter the accuracy of clinical estimation of fetal weight (EFW) in term pregnancies in a teaching hospital. Methods: Secondary analysis...
Videos
Obtaining Regulatory Approvals for Medical Devices in a Global Market
Head of Regulatory Affairs, Medical Devices -- Medpace, Michael Winegar, addresses investment on clinical trials, outlining the phases necessary to obtain ap...
Medical and Biotech [MESH] Definitions
Ethics Consultation
Services provided by an individual ethicist (ETHICISTS) or an ethics team or committee (ETHICS COMMITTEES, CLINICAL) to address the ethical issues involved in a specific clinical case. The central purpose is to improve the process and outcomes of patients' care by helping to identify, analyze, and resolve ethical problems.
Nontherapeutic Human Experimentation
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
Computers, Handheld
MICROCOMPUTERS, sometimes called PDA, that are very small and portable, fitting in a hand, and that have much more function than a calculator. They are convenient to use in clinical and other field situations for quick data management. They usually require docking with MICROCOMPUTERS for updates.
Mastocytosis, Systemic
A group of disorders caused by the abnormal proliferation of MAST CELLS in a variety of extracutaneous tissues including bone marrow, liver, spleen, lymph nodes, and gastrointestinal tract. Systemic mastocytosis is commonly seen in adults. These diseases are categorized on the basis of clinical features, pathologic findings, and prognosis.
Animal Care Committees
Institutional committees established to protect the welfare of animals used in research and education. The 1971 NIH Guide for the Care and Use of Laboratory Animals introduced the policy that institutions using warm-blooded animals in projects supported by NIH grants either be accredited by a recognized professional laboratory animal accrediting body or establish its own committee to evaluate animal care; the Public Health Service adopted a policy in 1979 requiring such committees; and the 1985 amendments to the Animal Welfare Act mandate review and approval of federally funded research with animals by a formally designated Institutional Animal Care and Use Committee (IACUC).
