Clinical Trials and YOU
|
|
- Erick Lester
- 8 years ago
- Views:
Transcription
1 Clinical Trials and YOU
2 What are clinical trials? Controlled studies to determine how a particular anti-cancer strategy ( i.e. treatment ) affects the people who receive it Involve rigorous scientific testing May be randomized
3 Phases of Clinical Trials Phase I ( ): find a safe dosage, build a toxicity profile, determine pharmacokinetics and determine how the agent is to be given Phase 2 ( ~100 ): to determine if the agent has an effect on certain tumor types and to further build toxicity profiles Phase 3 (100s-1000s): Compares an investigational agent against a current standard treatment Phase 4 (1000s): to further evaluate long-term safety and effectiveness ( look for side effects that were not seen in earlier trials ). Also called post-marketing surveillance trial.
4 Types of Trials Treatment: new agents are investigated for their effects on cancer Prevention: interventions (such as drugs, lifestyle changes or diet) are investigated to see if they may prevent cancer from occurring Screening: investigates what sorts of tests may be predictive for a disease as early as possible Diagnostic: investigates new tests to identify a suspected cancer earlier and more accurately Quality of Life: investigates the sorts of interventions that can improve comfort and quality of life of people with cancer
5 Why you may want to consider participating in a clinical trial If a new treatment is proven to work and you are receiving it, you may be among the first to benefit. By looking at all your treatment choices, including clinical trials, you are taking an active role in a decision that affects your life. You have the chance to help others and improve cancer treatment.
6 What to Expect in a Phase I Clinical Trial Informed Consent a document that is signed by a patient/subject, to the degree he/she is capable, to be given the opportunity to choose what shall or shall not happen to them mandated by federal law lays out the course of the study, potential risks and benefits, and purpose of the study even after you sign the consent form, you can leave the study at any time.
7 What to Expect in a Phase I Clinical Trial A lot of information presented to you during your screening/informed consent process! ASK QUESTIONS Added assessments above and beyond what you would normally encounter with an approved therapy Extra blood draws for pharmacokinetics and standard hematological and metabolic labs More frequent visits with your provider than usual, at least until your first scan CT or PET/CT scans every 6-8 weeks to track your disease Side effects: these can be mild or severe but are presented in the informed consent document
8 Costs related to Phase I Clinical Trial Most assessments ARE paid by the sponsor/drug company but you will be responsible for co-pays or other financial obligations that are associated with standard of care assessments ( weekly CBCs, scans, monthly doctor visits ) What is standard of care? A SOC assessment is something which would occur during the course of your treatment irrespective of which treatment you are on.
9 Efficacy in Phase I Clinical Trials Efficacy is not a primary endpoint but definitely a hopeful one Phase I trials are about establishing dosing regimens, building toxicity profiles and looking for any potential efficacy Efficacy MAY be less at lower doses but this is never really known as these agents are first in man. Efficacy is hypothesized from all of the pre-clinical animal data and molecular research
10 Efficacy in Phase I Clinical Trials Newer targeted agents used against patients who possess the target have a much better chance for response Example: ALK mutation in NSCLC Only 5% of all NSCLC patients have this mutation Anyone who has this mutation and is placed on a targeted therapy to it will respond, often dramatically As research uncovers more of these targets, patients will be able to be pre-screened for a battery of targets to determine which treatment will work best for them
11 When is entry into a Clinical Trial appropriate? No further curative options are available or the cancer has developed resistance to standard therapy Patient has a relatively good performance status Patient has relatively good organ function ( kidney, liver and heart ) When patients believe the potential benefits to outweigh the potential risks
12 Things to think about when selecting a clinical trial Costs Will I have to pay for any of the treatments or tests? What costs will my health insurance cover? Daily life How could the trial affect my daily life? How often will I have to come to the hospital or clinic? Will I have to travel long distances to take part? Efficacy What are the possible side effects or risks of the new treatment? What are the possible benefits?
13 How to find and choose the right clinical trial Referral from primary oncologist to a research center
Not All Clinical Trials Are Created Equal Understanding the Different Phases
Not All Clinical Trials Are Created Equal Understanding the Different Phases This chapter will help you understand the differences between the various clinical trial phases and how these differences impact
More informationThe Clinical Trials Process an educated patient s guide
The Clinical Trials Process an educated patient s guide Gwen L. Nichols, MD Site Head, Oncology Roche TCRC, Translational and Clinical Research Center New York DISCLAIMER I am an employee of Hoffmann-
More informationCLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD
CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD Gwen L. Nichols, M.D., is currently the Oncology Site Head of the Roche Translational Clinical Research Center at Hoffman- LaRoche. In this
More informationCancer Clinical Trials: The Basics
Cancer Clinical Trials: The Basics What Are Cancer Clinical Trials? Research studies involving people Try to answer scientific questions and find better ways to prevent, diagnose, or treat cancer 2 Why
More informationWhat Cancer Patients Need To Know
Taking Part in Clinical Trials What Cancer Patients Need To Know NATIONAL INSTITUTES OF HEALTH National Cancer Institute Generous support for this publication was provided by Novartis Oncology. Taking
More informationTAKING PART IN CANCER TREATMENT RESEARCH STUDIES
For more infomation about Cancer Clinical Trials at Upstate Cancer Center please call Upstate Connect 1.800.464.8668 TAKING PART IN CANCER TREATMENT RESEARCH STUDIES Information provided by: National Cancer
More informationNational Cancer Institute
National Cancer Institute Taking Part in Cancer Treatment Research Studies U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Taking Part in Cancer Treatment Research Studies If
More informationCancer Clinical Trials
Cancer Clinical Trials The In-Depth Program National Institutes of Health National Cancer Institute The National Cancer Institute Clinical Trials Education Series Cancer Clinical Trials Books Cancer Clinical
More informationClinical Trial Design. Sponsored by Center for Cancer Research National Cancer Institute
Clinical Trial Design Sponsored by Center for Cancer Research National Cancer Institute Overview Clinical research is research conducted on human beings (or on material of human origin such as tissues,
More informationClinical Trials: Improving the Care of People Living With Cancer
CLINICAL TRIALS Clinical Trials: Improving the Care of People Living With Cancer Presented by Mary McCabe, RN, MA Memorial Sloan-Kettering Cancer Center Carolyn Messner, DSW CancerCare Learn about: Stages
More informationCancer Clinical Trials & You:
Cancer Clinical Trials & You: Source: National Cancer Institute What Are Cancer Clinical Trials? Research studies involving people Try to answer scientific questions and find better ways to prevent, diagnose,
More informationclinical trials patient-assisted research studies
LUNG CANCER TREATMENTS What you need to know about... clinical trials patient-assisted research studies foreword About LUNGevity LUNGevity is the largest national lung cancer-focused nonprofit, changing
More informationCancer Clinical Trials: In-Depth Information
Cancer Clinical Trials: In-Depth Information The Drug Development and Approval Process 1. Early research and preclinical testing 2. IND application filed with FDA 3. Clinical trials (phases 1, 2, and 3)
More informationParticipating in Alzheimer s Disease Clinical Trials and Studies
Participating in Alzheimer s Disease Clinical Trials and Studies FACT SHEET When Margaret was diagnosed with earlystage Alzheimer s disease at age 68, she wanted to do everything possible to combat the
More informationAsk Us About Clinical Trials
Ask Us About Clinical Trials Clinical Trials and You. Our specialists and researchers are at the forefront of their fields and are leading the way in developing new therapies and procedures for diagnosing
More informationIF AT FIRST YOU DON T SUCCEED: TRIAL, TRIAL AGAIN
+ IF AT FIRST YOU DON T SUCCEED: TRIAL, TRIAL AGAIN Rena Buckstein MD FRCPC Head Hematology Site Group Sunnybrook Odette Cancer Center (OCC) Head of Hematology Clinical Trials Group at OCC + Outline Start
More informationResearch on Research: Learning about Phase 1 Trials
CLINICAL CASE STUDY SERIES Research on Research: Learning about Phase 1 Trials Phases of clinical trial investigation are described in some detail in the Code of Federal Regulations. Phase 1 is described
More information4.1 Objectives of Clinical Trial Assessment
L1 4.1 Objectives of Clinical Trial Assessment Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office of Clinical
More informationGlossary of Clinical Trial Terms
Glossary of Clinical Trial Terms ADVERSE REACTION: (Adverse Event): Also known as side effects, adverse reactions include any undesired actions or effects of the experimental drug or treatment. Experimental
More informationFuture Directions in Clinical Research. Karen Kelly, MD Associate Director for Clinical Research UC Davis Cancer Center
Future Directions in Clinical Research Karen Kelly, MD Associate Director for Clinical Research UC Davis Cancer Center Outline 1. Status of Cancer Treatment 2. Overview of Clinical Research at UCDCC 3.
More informationA guide to prostate cancer clinical trials
1 A guide to prostate cancer clinical trials In this fact sheet: What is a clinical trial? Why are trials done? What are trials looking into at the moment? How are clinical trials done? Should I take part
More informationMedicine Safety Glossary
The following definitions are provided as a resource to supplement the information provided in the Medicine Safety Education section of the Pfizer.com Web site; they are not intended as a comprehensive
More informationLUNG CANCER CLINICAL TRIALS
UNDERSTANDING LUNG CANCER CLINICAL TRIALS 1-800-298-2436 LungCancerAlliance.org A GUIDE FOR THE PATIENT 1 TABLE OF CONTENTS INTRODUCTION TO CLINICAL TRIALS What Is a Clinical Trial?...4 Types of Clinical
More informationCancer Clinical Trials
Cancer Clinical Trials The Basic Workbook National Institutes of Health National Cancer Institute The National Cancer Institute Clinical Trials Education Series Cancer Clinical Trials Books Cancer Clinical
More information19. Drug Treatment Trials
1 9. D R U G T R E A T M E N T T R I A L S 19. Drug Treatment Trials The science behind the Progeria clinical drug trials Trial medications at a glance Progeria clinical drug trials The science behind
More informationGuidance for Industry
Guidance for Industry IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer U.S. Department of Health and Human Services Food and Drug Administration Center
More informationGuidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products
Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationNewsletter. WntResearch AB, Medeon Science Park, Per Albin Hanssons väg 41, 205 12 Malmö, Sweden. Primary Objective:
Newsletter This resume of the results from the phase 1 study with Foxy-5 is based on clinical and laboratory data from the study, and these data have now been locked into the database. The full report
More informationRegulatory Pathways for Licensure and Use of Ebola Virus Vaccines During the Current Outbreak FDA Perspective
Regulatory Pathways for Licensure and Use of Ebola Virus Vaccines During the Current Outbreak FDA Perspective Office of Vaccines Research and Review Center for Biologics Evaluation and Research U.S. Food
More informationAn EMR-Driven Approach to Survivorship Care Plans
BY SIGRUN HALLMEYER, MD, AND NAVEED CHEEMA, DO An EMR-Driven Approach to Survivorship Care Plans In order to minimize the challenges of time and resource allocation, Oncology Specialists, SC, set out to
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL EVALUATION OF ANTICANCER MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit London, 23 July 1998 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL
More informationThe Center for Prostate Cancer. Personalized Treatment. Clinical Excellence.
The Center for Prostate Cancer Personalized Treatment. Clinical Excellence. The Center for Prostate Cancer Leaders in Prostate Cancer Treatment and Research The Center for Prostate Cancer at the North
More informationEthics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015
Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient
More informationClinical Trials: What You Need to Know
Clinical Trials: What You Need to Know Clinical trials are studies in which people volunteer to test new drugs or devices. Doctors use clinical trials to learn whether a new treatment works and is safe
More informationVision for the Cohort and the Precision Medicine Initiative Francis S. Collins, M.D., Ph.D. Director, National Institutes of Health Precision
Vision for the Cohort and the Precision Medicine Initiative Francis S. Collins, M.D., Ph.D. Director, National Institutes of Health Precision Medicine Initiative: Building a Large U.S. Research Cohort
More informationBench to Bedside Clinical Decision Support:
Bench to Bedside Clinical Decision Support: The Role of Semantic Web Technologies in Clinical and Translational Medicine Tonya Hongsermeier, MD, MBA Corporate Manager, Clinical Knowledge Management and
More informationClinical research trials and insurance
Clinical research trials and insurance Information for people who are planning to take part in a clinical research trial January 2011 This information is subject to change depending on medical advances
More informationLauren Berger: Why is it so important for patients to get an accurate diagnosis of their blood cancer subtype?
Hello, I m Lauren Berger and I m the Senior Director of Patient Services Programs at The Leukemia & Lymphoma Society. I m pleased to welcome Dr. Rebecca Elstrom. Dr. Elstrom is an Assistant Professor in
More informationMEDICAL BREAKTHROUGHS RESEARCH SUMMARY TOPIC: MAMMOGRAM FOR THE HEART: CORONARY CALCIUM SCORE REPORT: MB #4014
MEDICAL BREAKTHROUGHS RESEARCH SUMMARY TOPIC: MAMMOGRAM FOR THE HEART: CORONARY CALCIUM SCORE REPORT: MB #4014 BACKGROUND: Heart disease is a term that can refer to several types of heart conditions. Coronary
More informationGuidance for Industry
Guidance for Industry Cancer Drug and Biological Products Clinical Data in Marketing Applications U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and
More informationGuidance for Industry
Guidance for Industry Codevelopment of Two or More New Investigational Drugs for Use in Combination U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationClinical Trials: The Crux of Cancer Innovation
Clinical Trials: The Crux of Cancer Innovation Even as medical science is transforming cancer care, major deficiencies in the way cancer clinical trials are designed, carried out, regulated and funded
More informationPhasel clinical trials:
Phasel clinical trials: what are they all about? Information for people wanting to know more about early clinical trials in cancer, Belfast City Hospital NORTHERN IRELAND CANCER TRIALS CENTRE Introduction
More informationPharmacology skills for drug discovery. Why is pharmacology important?
skills for drug discovery Why is pharmacology important?, the science underlying the interaction between chemicals and living systems, emerged as a distinct discipline allied to medicine in the mid-19th
More informationBreakthrough Lung Cancer Treatment Approved Webcast September 9, 2011 Renato Martins, M.D., M.P.H. Introduction
Breakthrough Lung Cancer Treatment Approved Webcast September 9, 2011 Renato Martins, M.D., M.P.H. Please remember the opinions expressed on Patient Power are not necessarily the views of Seattle Cancer
More informationWhat If I Have a Spot on My Lung? Do I Have Cancer? Patient Education Guide
What If I Have a Spot on My Lung? Do I Have Cancer? Patient Education Guide A M E R I C A N C O L L E G E O F C H E S T P H Y S I C I A N S Lung cancer is one of the most common cancers. About 170,000
More informationThe Promise and Challenge of Adaptive Design in Oncology Trials
THE POWER OFx Experts. Experience. Execution. The Promise and Challenge of Adaptive Design in Oncology Trials Clinical oncology trials are more complex and time consuming than those in any other therapeutic
More informationtargeted therapy a guide for the patient
targeted therapy FOR LUNG CANCER a guide for the patient TABLE OF CONTENTS lung cancer basics... 2-3 Gene changes... 4-5 Testing... 7-8 Targeted therapy... 9-11 Drugs Targeting EGFR... 12 Drugs Targeting
More informationClinical Trials: Questions and Answers
Clinical Trials: Questions and Answers Key Points Clinical trials are research studies that test how well new medical approaches work in people (see Question 1). Every clinical trial has a protocol, which
More informationWhen the diagnosis is cancer, many people
Hard decisions about cancer 5 tests and treatments to question When the diagnosis is cancer, many people understandably want to pull out all the stops to treat it. But some tests, treatments, and procedures
More informationClinical Trials at PMH
Clinical Trials at PMH What You Need To Know UHN Patient Education Improving Health Through Education A Guide for Patients, Their Families and Friends in the PMH Cancer Program This information is to be
More informationNEW HYBRID IMAGING TECHNOLOGY MAY HAVE BIG POTENTIAL FOR IMPROVING DIAGNOSIS OF PROSTATE CANCER
Media Release April 7, 2009 For Immediate Release NEW HYBRID IMAGING TECHNOLOGY MAY HAVE BIG POTENTIAL FOR IMPROVING DIAGNOSIS OF PROSTATE CANCER London, Ontario Improved hybrid imaging techniques developed
More informationProtein kinase C alpha expression and resistance to neo-adjuvant gemcitabine-containing chemotherapy in non-small cell lung cancer
Protein kinase C alpha expression and resistance to neo-adjuvant gemcitabine-containing chemotherapy in non-small cell lung cancer Dan Vogl Lay Abstract Early stage non-small cell lung cancer can be cured
More informationTricia Cox on 7/18/2012 at Oncology Center. Sarah Randolf. Female
SAMPLE This Survivorship Care Plan will facilitate cancer care following active treatment. It may include important contact information, a treatment summary, recommendations for follow-up care testing,
More informationPATIENT INFORMATION ABOUT ADJUVANT THERAPY AFTER THE WHIPPLE OPERATION FOR ADENOCARCINOMA ( CANCER ) OF THE PANCREAS AND RELATED SITES.
PATIENT INFORMATION ABOUT ADJUVANT THERAPY AFTER THE WHIPPLE OPERATION FOR ADENOCARCINOMA ( CANCER ) OF THE PANCREAS AND RELATED SITES. Radiation Oncology Sidney Kimmel Cancer Center at Johns Hopkins Last
More informationSession 6 Clinical Trial Assessment Phase I Clinical Trial
L1 Session 6 Clinical Trial Assessment Phase I Clinical Trial Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office
More informationGuidance for Industry Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations
Guidance for Industry Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations DRAFT GUIDANCE This guidance document is being distributed
More informationInformation Exchange and Data Transformation (INFORMED) Initiative
Information Exchange and Data Transformation (INFORMED) Initiative Sean Khozin, MD, MPH Senior Medical Officer Office of Hematology and Oncology Products (OHOP) Food and Drug Administration (FDA) The opinions
More information1. Overview of Clinical Trials
1. Overview of Clinical Trials 1.1. What are clinical trials? Definition A clinical trial is a planned experiment which involves patients and is designed to elucidate the most appropriate treatment of
More informationManagement of stage III A-B of NSCLC. Hamed ALHusaini Medical Oncologist
Management of stage III A-B of NSCLC Hamed ALHusaini Medical Oncologist Global incidence, CA cancer J Clin 2011;61:69-90 Stage III NSCLC Includes heterogeneous group of patients with differences in the
More informationA guide for the patient
Understanding series LUNG CANCER CLINICAL TRIALS 1-800-298-2436 LungCancerAlliance.org A guide for the patient TABLE OF CONTENTS The Basics What is a Clinical Trial?...3 Types of Clinical Trials... 3 Phases
More informationProstate Cancer Screening. A Decision Guide for African Americans
Prostate Cancer Screening A Decision Guide for African Americans This booklet was developed by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC). Published
More informationAnticancer Drug Clinical Trial Guideline. (version 2.0)
Anticancer Drug Clinical Trial Guideline (version 2.0) May, 2007 1 Table of Contents 1. Introduction... 4 2. The Overall Consideration of Clinical Trial... 4 2.1 The Selection of Patients... 4 2.2 Dose
More informationGuidelines for Cancer Prevention, Early detection & Screening. Prostate Cancer
Guidelines for Cancer Prevention, Early detection & Screening Prostate Cancer Intervention Comments & Recommendations For primary prevention, it has been suggested that diets low in meat & other fatty
More informationSheffield Kidney Institute. Planning a Clinical Trial
Planning a Clinical Trial Clinical Trials Testing a new drug Ethical Issues Liability and Indemnity Trial Design Trial Protocol Statistical analysis Clinical Trials Phase I: Phase II: Phase III: Phase
More informationProstate Cancer Screening. A Decision Guide
Prostate Cancer Screening A Decision Guide This booklet was developed by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC). Is screening right for you?
More informationClinical trials in haemophilia
Clinical trials in haemophilia Dr. Paul Giangrande Oxford Haemophilia and Thrombosis Centre & Nuffield Department of Clinical Medicine University of Oxford paul.giangrande@ndm.ox.ac.uk Why do clinical
More informationASCO Initiatives in Personalized Medicine. Richard L. Schilsky, MD, FACP, FASCO Chief Medical Officer American Society of Clinical Oncology
ASCO Initiatives in Personalized Medicine Richard L. Schilsky, MD, FACP, FASCO Chief Medical Officer American Society of Clinical Oncology Financial Disclosures No financial relationships to disclose.
More informationPersonalised Healthcare Frequently Asked Questions
Personalised Healthcare Frequently Asked Questions Foreword In one sense, personalised healthcare is nothing new. It is what doctors have aimed to provide for their patients through the exercise of their
More informationOvarian Cancer and Modern Immunotherapy: Regulatory Strategies for Drug Development
Ovarian Cancer and Modern Immunotherapy: Regulatory Strategies for Drug Development Sanjeeve Bala, MD, MPH Ovarian Cancer Endpoints Workshop FDA White Oak September 3, 2015 Overview Immune agents from
More informationFSH Society s 2014 Biennial FSHD Connect Meeting: Natural History Studies
FSH Society s 2014 Biennial FSHD Connect Meeting: Natural History Studies Raymond A. Huml, MS, DVM, RAC Executive Director, Head, Global Biosimilars Business Development and Strategic Planning, Quintiles
More informationA Career in Pediatric Hematology-Oncology? Think About It...
A Career in Pediatric Hematology-Oncology? Think About It... What does a pediatric hematologist-oncologist do? What kind of training is necessary? Is there a future need for specialists in this area? T
More informationFrequently Asked Questions (FAQs)
Frequently Asked Questions (FAQs) Research Rationale 1. What does PrEP stand for? There is scientific evidence that antiretroviral (anti-hiv) medications may be able to play an important role in reducing
More informationPERIPHERAL STEM CELL TRANSPLANT INTRODUCTION
PERIPHERAL STEM CELL TRANSPLANT INTRODUCTION This booklet was designed to help you and the important people in your life understand the treatment of high dose chemotherapy with stem cell support: a procedure
More informationCANCER TREATMENT: Chemotherapy
CANCER TREATMENT: Chemotherapy Chemotherapy, often called chemo, is the use of drugs to treat a disease. The term chemotherapy is now most often used to describe a type of cancer treatment. Dr. Khuri:
More informationAccelerating Development and Approval of Targeted Cancer Therapies
Accelerating Development and Approval of Targeted Cancer Therapies Anna Barker, NCI David Epstein, Novartis Oncology Stephen Friend, Sage Bionetworks Cindy Geoghegan, Patient and Partners David Kessler,
More informationThinking About Complementary & Alternative Medicine
Thinking About Complementary & Alternative Medicine A guide for people with cancer PATIENT & family EDUCATION U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer
More informationClinical Trial Designs for Incorporating Multiple Biomarkers in Combination Studies with Targeted Agents
Clinical Trial Designs for Incorporating Multiple Biomarkers in Combination Studies with Targeted Agents J. Jack Lee, Ph.D. Department of Biostatistics 3 Primary Goals for Clinical Trials Test safety and
More informationAnaplastic Thyroid Cancer:
1 Anaplastic Thyroid Cancer: A Doctor s Perspective for Patients and Families Living with the Disease By Maria E. Cabanillas, M.D., F.A.C.E. Associate Professor and Faculty Director of Clinical Research
More informationAdvancing research: a physician s guide to clinical trials
Advancing research: a physician s guide to clinical trials Recruiting and retaining trial participants is one of the greatest obstacles to developing the next generation of Alzheimer s treatments Alzheimer
More informationNew Advances in Cancer Treatments. March 2015
New Advances in Cancer Treatments March 2015 Safe Harbour Statement This presentation document contains certain forward-looking statements and information (collectively, forward-looking statements ) within
More informationCourse Curriculum for Master Degree in Clinical Pharmacy
Course Curriculum for Master Degree in Clinical Pharmacy The Master Degree in Clinical Pharmacy is awarded by the Faculty of Graduate studies at Jordan University of Science and Technology (JUST) upon
More informationTrastuzumab (Herceptin ) for patients with metastatic breast cancer
JULY 2007 Incorporates published evidence to November 2006 INFORMATION ABOUT Trastuzumab (Herceptin ) for patients with metastatic breast cancer This information has been developed to help you understand
More informationTREATING LUNG CANCER AT VA PITTSBURGH HEALTHCARE SYSTEM A HERO S GUIDE
Providing the best in cancer care for Veterans TREATING LUNG CANCER AT VA PITTSBURGH HEALTHCARE SYSTEM A HERO S GUIDE VA Pittsburgh s state-of-the-art TomoTherapy machine, which delivers radiation to patients.
More informationClinical Trial Results Database Page 1
Clinical Trial Results Database Page Sponsor Novartis Generic Drug Name BGT6 Therapeutic Area of Trial Advanced solid malignancies Approved Indication Investigational Study Number CBGT6A0 Title A phase
More informationMedicals c i e n t i f i c study
Medicals c i e n t i f i c study design risks medical-ethics review board 2 Table of contents M e d i c a l - s c i e n t i f i c study Preface 2 Introduction 4 Medical-scientific study 5 Why participate?
More informationSummary of the risk management plan (RMP) for Sirturo (bedaquiline)
EMA/16634/2014 Summary of the risk management plan (RMP) for Sirturo (bedaquiline) This is a summary of the risk management plan (RMP) for Sirturo, which details the measures to be taken in order to ensure
More informationEntering a Clinical Trial
Entering a Clinical Trial Is It Right for You? Paula Chandoha, Chandoha Productions About This Program THIS AUDIOVISUAL PROGRAM AND BOOKLET WERE produced by Dana-Farber Cancer Institute in collaboration
More informationA Guide to Clinical Trials
A Guide to Clinical Trials For young people with cancer and their parents Children s Cancer and Leukaemia Group www.cclg.org.uk Original booklet produced in conjunction with the CCLG Patient Advocacy Committee.
More informationProstate Cancer. Treatments as unique as you are
Prostate Cancer Treatments as unique as you are UCLA Prostate Cancer Program Prostate cancer is the second most common cancer among men. The UCLA Prostate Cancer Program brings together the elements essential
More informationINTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. Current Step 4 version
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL
More informationTargeted Therapies in Lung Cancer
Targeted Therapies in Lung Cancer I Edited by: Simona Carnio Thoracic Oncology Division - St Luigi Hospital Orbassano (TO) - Italy Silvia Novello Department of Oncology - University of Torino - Italy Why
More informationModel of Intelligence
CASE STUDY Chris Penland, Novatis Senior Expert Modeller Model of Intelligence SUMMARY The high quality data found in PharmaPendium is used in modeling dose exposure and mechanism of drug action. How Elsevier
More informationMedication Utilization. Understanding Potential Medication Problems of the Elderly
Medication Utilization Understanding Potential Medication Problems of the Elderly NICE - National Initiative for the Care of the Elderly WHAT ARE MEDICATION UTILIZATION PROBLEMS AMONG THE ELDERLY? A useful
More informationMesothelioma. Information for Patients and Families. identifying and evaluating experimental
Mesothelioma CLINICAL TRIALS Information for Patients and Families identifying and evaluating experimental treatments table of contents Pg. 2... Phases of a Clinical Trial Pg. 3... Mesothelioma and Clinical
More informationUnderstanding series. new. directions. 1-800-298-2436 LungCancerAlliance.org. A guide for the patient
Understanding series LUNG CANCER: new treatment directions 1-800-298-2436 LungCancerAlliance.org A guide for the patient TABLE OF CONTENTS What s New in lung cancer? Advancements...4 Changes in genes that
More informationCME Test for AMDA Clinical Practice Guideline. Diabetes Mellitus
CME Test for AMDA Clinical Practice Guideline Diabetes Mellitus Part I: 1. Which one of the following statements about type 2 diabetes is not accurate? a. Diabetics are at increased risk of experiencing
More informationIncreasing Patient Access through Oral Parity Legislation
Increasing Patient Access through Oral Parity Legislation The Leukemia & Lymphoma Society A powerhouse among nonprofits searching for cancer cures Our Mission; Cure leukemia, lymphoma, Hodgkin s disease
More informationMetastatic Breast Cancer...
DIAGNOSIS: Metastatic Breast Cancer... What Does It Mean For You? A diagnosis of metastatic breast cancer can be frightening. It raises many questions and reminds us of days past when cancer was such a
More information