CDISC Therapeutic Area Standard User Guide Highlights

on

  • 97 views

The Coalition For Accelerating Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute (C‐Path), was launched to accelerate clinical research and medical product ...

The Coalition For Accelerating Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute (C‐Path), was launched to accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas (TA) important to public health (cf CDISC webpage). The CFAST Program Steering Committee has released a prioritized list of TA data standards projects. As of today final versions have been released for Alzheimer, Asthma, Multiple Sclerosis, Polycystic Kidney Disease, Parkinson, Virology, Pain, Tuberculosis, while draft for other TA are available for public review such as Cardiovascular Disease. The aim of this poster is to introduce the CDISC‐TA UG project and new concepts introduced.

Statistics

Views

Total Views
97
Views on SlideShare
96
Embed Views
1

Actions

Likes
0
Downloads
1
Comments
0

1 Embed 1

http://www.slideee.com 1

Accessibility

Categories

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

CDISC Therapeutic Area Standard User Guide Highlights CDISC Therapeutic Area Standard User Guide Highlights Document Transcript

  • Program Overview – May 2014 CDISC Therapeutic Area Standard User Guide Highlights Angelo Tinazzi Cytel Inc, Geneva (Switzerland) The Coalition For Accelerating Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute (C Path), was launched to accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas (TA) important to public health (cf CDISC webpage). The CFAST Program Steering Committee has released a prioritized list of TA data standards projects. As of today final versions have been released for Alzheimer, Asthma, Multiple Sclerosis, Polycystic Kidney Disease, Parkinson, Virology, Pain, Tuberculosis, while draft for other TA are available for public review such as Cardiovascular Disease. The aim of this poster is to introduce the CDISC TA UG project and new concepts introduced. ABSTRACT SDTM mapping of key TA concepts e.g. endpoints Provides additional examples of situations not covered by current IG Re use of existing CDISC standards e.g. Oncology TU/TR from Oncologic to map cardiac lesions, and/or development of other existing non CDISC standards New Controlled Terminology New Domains Identification of Regulatory and Medical References Developed in collaboration with TA opinion leaders / organizations e.g. Cardiology: American College of Cardiology and Duke Clinical Research Institute Multiple Sclerosis: National Institute for Neurological Disorder and Stroke Creation of User Guides CDASH with SDTM annotations and ADaM (in future releases) The Coalition For Accelerating Standards and Therapies PhUSE SDE; Basel, Switzerland; July 3, 2014 Cytel, Inc. Shaping the Future of Drug Development Route de Pré Bois 20 C.P. 1839 1215 Geneva 15, Switzerland – angelo.tinazzi@cytel.com http://www.cytel.com | Blog: http://cytel.hs sites.com/blog STATUS OF APPROVED TA STANDARD PROJECTS AND MAJOR AREAS COVERED Therepeutic Area Status / Planned Date Major Area Covered Alzheimer V2.0 Clinical Scales (cognition and Function), biomarkers Asthma V1.0 Medical history, Pulmunary Functions Tests, Exacerbations of Asthma, QoL and composite outcomes, symptoms assessment Breast Cancer Q215 Diagnosis, Key Biomarkers, Medical/Family History, Treatment History, TEAE using CTCAE/MedDRA, Treatment/Study Disposition Chronic Obstructive Pulmonary Disease Planned Medical history, pulmonary function Tests, PRO, AESI and Cm of special interest, health care resource utilization Cardiovascular Endpoint Cardiovascular Imaging Draft Cardiovascular and stroke endpoints, additional data elements relevant to acute coronary care that can be collected during Cardiovascular Trials, Imaging Diabetes Q214 Diabetes history, PRO, key lab assessments Hepatatis C Q314 Medical history, health care resource utilization, PRO, cirrhosis, progression of liver disease, AE and CM of special interest, HCV Viral load testing Influenza Q414 Diagnosis and confirmation of influenza virus infection, exposure, symptoms, medical history, AE and CM of special interest Dyslipidemia Planned Diagnosis, treatment history, PRO, AE and CM of special interest, dietary, imaging Multiple Sclerosis V1.0 Disease Course, Disease Assessment, Questionnaires Pain V1.0* Initial focus on Pain conditions areas of interest within Acute and Chronic Pain, Questionnaires Parkinson V1.0* General guidance on how to map the SDTM standard domains. ad hoc SUPP, ad hoc terminology Polycystic Kidney Disease V1.0* General guidance on how to map the SDTM standard domains. ad hoc SUPP, ad hoc terminology QT Studies Q314 ECG related variables, dosing, PK and relevant pharmacogenomics data Schizophrenia Q414/Q115 Diagnosis, course of illness, family psychiatric history, psychiatric hospitalizations, rating scales Traumatic Brain Injury Q215 Medical history, biomarkers, Physical and neurological assessment, imaging, PRO, scaling Tuberculosis V1.0 General guidance on how to map the SDTM standard domains, ad hoc SUPP, ad hoc terminology Virology V1.0* Handling measurements of viral concentration from in vitro resistance testing. Propose ad hoc domains CONCEPT MAP: EXAMPLE FROM CARDIOVASCULAR TRANSIENT ISCHEMIC ATTACK (TIA): From Concept Map to Standards Development Joint initiative of CDISC and the Critical Path Institute (C Path) Partners: TransCelerate BioPharmaInc. (TCB), the U.S. FDA, and the NCI–Enterprise Vocabulary Service (NCI EVS), with participation and input from many other organizations Accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health. Identify a core set of clinical TA concepts and endpoints to target TA and translate them into CDISC standards The Therapeutic Area Standards Illustrates relationships among concepts and attributes Things that happen commonly in clinical research and therefore rise to common patterns of data * Provisional: Subject to change Other candidates/proposed TA: Rheumatoid Arthritis, Solid Organ Transplant, Osteoporosis, Oncology , Psoriasis, Major Depressive Disorder, Duchenne Muscular Dystrophy, Irritable Bowel Syndrome, Skin and Skin Structure Infections, Complicated UTI,s HIV POTENTIAL IMPACT ON EXISTING SDTM MAPPING – MULTIPLE SCLERORISIS STUDY – A CASE Clinical Data / Information Our Mapping prior to MG UG Applying MS UG Additional Notes Diagnosis MH MHCAT=‘HISTORY OF MS’ / MHTERM=‘MULTIPLE SCLEROSIS’ MH MHCAT=‘PRIMARY DIAGNOSIS’ / MHTERM=‘RRMS’ MH differentiates between ‘ONSET COURSE’ AND ‘CURRENT COURSE’ (MHSCAT); it also have details of INITIAL SYMPTOMS Diagnosis (Localization) e.g. Spinal Cord Y/N SUPPMH e.g. QNAM=‘CNSSPINL’ / QVAL=‘Y’ FAMH FALOC=‘SPINAL CORD’ / FAORRES=Y/N / FAMETHOD Relapses MH MHCAT=‘HISTORY OF MS CLINICAL RELAPSES’ / MHSEV CE CETERM=‘Multiple Sclerosis Relapse’ / CESEV=‘Moderate’ RELREC