{"title":"Clinical Trials for Pharmaceuticals: Design and Development","description":"\u003cp\u003e\u003cimg title=\"Course Description\" border=\"0\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseDescription.jpg?n=8101\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eThis course addresses the practical issues in the design of pharmaceutical trials and protocol development, as well as broader issues relating to the interface of clinical trial design with overall drug development.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Learning Objectives\" border=\"0\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/LearningObjectives.jpg?n=1786\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eAddress the ethical considerations involved in conducting clinical trials\u003c\/li\u003e\n\u003cli\u003eStrategically plan for successful clinical trials\u003c\/li\u003e\n\u003cli\u003eDevelop trial objectives and hypothesis testing\u003c\/li\u003e\n\u003cli\u003eDevelop protocols in accordance with regulations\u003c\/li\u003e\n\u003cli\u003eEvaluate basic statistical issues relating to sample size\u003c\/li\u003e\n\u003cli\u003eDistinguish and utilize assessment instruments\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" border=\"0\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/WhoShouldAttend.jpg?n=5464\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eStaff from Pharmaceutical Companies or Contract Research Organizations (CROs) who will be involved in the design of clinical trials and have responsibility for protocol development\u003c\/li\u003e\n\u003cli\u003eProject Managers who have little or no clinical trial experience\u003c\/li\u003e\n\u003cli\u003eProject Team Leaders who will be designing clinical trials\u003c\/li\u003e\n\u003cli\u003eClinical, Regulatory, and Development Staff who would like to learn how to design a clinical trial program\u003c\/li\u003e\n\u003cli\u003eInvestigators who would like to learn how to design a clinical trial and about protocol development\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" border=\"0\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/Instructor.jpg?n=4140\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eEdith A. Zang, Ph.D.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"\/pages\/instructor-biographies\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Interactive Activities\" border=\"0\" alt=\"Interactive Activities\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/InteractiveActivities.jpg?n=4477\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eEthical Issues\u003c\/li\u003e\n\u003cli\u003eCase Studies: Improving Clinical Trials\u003c\/li\u003e\n\u003cli\u003eControl Groups\u003c\/li\u003e\n\u003cli\u003eGroup Assignments\u003c\/li\u003e\n\u003cli\u003eRationale Evaluation\u003c\/li\u003e\n\u003cli\u003eProtocol Modifications\u003c\/li\u003e\n\u003cli\u003eSample Size\u003c\/li\u003e\n\u003cli\u003eStudy Objectives\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Course Outline\" border=\"0\" alt=\"Course Outline\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseOutline.jpg?n=2216\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eDay 1: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003e\n\u003cb\u003eHistorical Overview:\u003c\/b\u003e Overview of the regulatory process; general ethical considerations\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eClinical Investigational Plan:\u003c\/b\u003e Strategic planning; special clinical trial opportunities; clinical trial simulation\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003ePhases of Drug Development:\u003c\/b\u003e Phase I and II; Phase IIIa and IIIb; Phase I\u003cb\u003eV\u003c\/b\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eRegulations and Guidelines Pertaining to Clinical Trial Design:\u003c\/b\u003e USA; Europe; Japan; “Rest of the World”\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eImpact of the ICH on Clinical Trials:\u003c\/b\u003e Principles of ICH GCP; clinical trial protocol and protocol amendments; statistical principles; clinical trial reports; structure and content\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eDay 2: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003e\n\u003cb\u003eClinical Trial Design:\u003c\/b\u003e Definitions; types (controlled and ethical considerations uncontrolled); relative and absolute efficacy; placebo controversy; (ethical considerations)\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eProtocol Structure and Format:\u003c\/b\u003e Subdivisions of individual sections\u003c\/li\u003e\n\u003cli\u003ePatient Populations: Inclusion and exclusion criteria; sub-population choices\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eSample Size:\u003c\/b\u003e Qualitative endpoint; quantitative endpoint; establishing equivalence; rare events; single group\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eTrial Objectives and Hypothesis Testing:\u003c\/b\u003e Single versus multiple; a priori and posteriori hypothesis testing; assessment instruments (number and sensitivity; variations for centers in multicenter studies; pharmacoeconomic and quality of life considerations)\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Registration Fees\" border=\"0\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/RegistrationFees.jpg?n=6142\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eRegistration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eSpecial rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for our seminar cancellation policy\" href=\"https:\/\/stage.barnettinternational.com\/EducationalServices\/SeminarFAQs.aspx\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Accreditation Information\" border=\"0\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/AccreditationInformation.jpg?n=7031\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"ACPE Logo\" border=\"0\" alt=\"ACPE Logo\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services_-_Under_Construction\/ACPE%20Logo.JPG\"\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-10-005-L01-P. Released: 10\/10.\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eHold this course at your company!\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eFor more information, contact Naila Ganatra at (215) 413-2471.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/clinical-trials-for-pharmaceuticals-design-and-development.oembed","provider":"Barnett International ","version":"1.0","type":"link"}