AMIA - Clinical Research Informatics Working Group (CRI-WG)

Powerpoint Slides from CTWG Business Meeting and Panel Discussion:
"Clinical Research Inititatives and Opportunities for AMIA and the CTWG" (ppt)

CTWG Business Meeting and Panel Overview - Charlie Barr, MD, MPH (CTWG Chair)
Global Trial Bank, WHO International Clinical Trials Registry Platform - Ida Sim, MD, PhD (UCSF and WHO)
The BRIDG Project: A Model to Improve Clinical Trials Research - Douglas B. Fridsma, MD, PhD (Univ. of Pittsburgh)
NIH Roadmap and CTSA - Stephen Johnson, PhD (Columbia Univ.)
caBIG and Related Initiatives - Joyce C. Niland, PhD (City of Hope)
IT Industry Perspective - Amar Chahal, MD, MBA (Velos)
CDISC and AMIA CTWG - Becky Kush, PhD (President, CDISC)
IT Industry Perspective - Ed Sequine, MBA (CEO, FastTrack)
Group Discussion - Peter Embi, MD (Univ. Cinncinnati) and Philip Payne, PhD (Columbia Univ.)

AMIA 2005 -
Biomedical & Health Informatics: From Foundations to Applications to Policy

Clinical Trials and Clinical Research Expo 2005 Posters and Demonstrations (pdf)

Medinfo 2004

Clinical Research Informatics Working Group Expo at MedInfo 2004 (pdf file, 2 MB)
Abstracts And Supplemental Materials

PowerPoint slides from the CTWG Business Meeting at Medinfo 2004

AMIA 2002 -
Bio*Medical Informatics: One Discipline

Session 47
Authors: Joyce C. Niland, PhD City of Hope National Medical Center City of Hope National Medical Center R. Altman, MD,PhD, Stanford University, Palo Alto, CA J. Gennari, PhD, University of Washington, Seattle, WA P. Tarczy-Hornoch, MD, University of Washington, Seattle, WA.

Panel: The Relationship of Human Genome Data to the Future of Clinical Trials
Clinical trials are critical to the discovery, testing, and confirmation of new treatment discoveries in all areas of medicine. The growing pressure for higher quality, lower-cost medical treatments demands an increase in evidence-based medicine and more efficiently conducted clinical trials. Electronic systems can greatly facilitate these efforts, particularly if standardized shareable approaches are developed across the myriad stakeholders involved in such trials. Currently many independent groups and institutions are engaged in developing models, adopting specific terminologies, and creating software systems to support all phases of clinical trials, including: protocol authoring, eligibility screening, patient registration/randomization, database management, study management, adverse event tracking/reporting and customized analytic software programs.

We are on the verge of a new era of medicine, where treatment may be tailored to individual genetic profiles, and such profiles may hold the key to the creation of new interventions for testing within clinical trials. Research has led us to fundamental understanding of the genetic, molecular, and cellular progression of malignant tumors. To exploit this knowledge, the efficient management and analysis of vast data in a secure fashion will be key, requiring a closer coupling of bioinformatics and clinical informatics. The future of clinical trials will in all likelihood include genetic information as a critical aspect in many cases. There are several anticipated roles of genetic information in future trials, including: risk stratification for trial participants; genotyping for pharmacognetics; molecular targets for therapy; and eligibility based on personalized medicine. Already we are seeing novel therapies with molecular targets being tested in clinical trials, such as STI571 for CML. This panel will discuss the envisioned impact of the availability of the human genome on future clinical trials. Panelists will discuss the requirements for a clinical trials informatics infrastructure to support the integration of genomics into clinical trials. In addition the theme of the increased emphasis on patient confidentiality and safety in genomic-based trials will be considered. Each panelists will present a particular vantage point regarding the impact of the human gemone on the conduct of clinical trials, and the merging of genotype/phenotype data. Designs for high-throughput allele stratification data merged with biological correlates, and issues regarding the extensive safeguards for patients in genomic trials will be discussed.

AMIA 2001 -
A Medical Informatics Odyssey: Visions of the Future and Lessons from the Past

Workshop 2
Clinical Trials Expo and Workshop
Clinical trials are critical to the discovery, testing, and confirmation of new treatment discoveries in all areas of medicine. The growing pressure for higher quality, lower-cost medical treatments demands an increase in evidence-based medicine and more efficiently conducted clinical trials. Electronic systems can greatly facilitate these efforts, particularly if standardized shareable approaches are developed across the myriad stakeholders involved in such trials. Currently many independent groups and institutions are engaged in developing models, adopting specific terminologies, and creating software systems to support all phases of clinical trials, including: protocol authoring, eligibility screening, patient registration/randomization, database management, study management, adverse event tracking/reporting and customized analytic software programs.

To foster cooperation among groups, promote knowledge of available systems, and encourage continual movement towards standards, the AMIA Clinical Research Informatics Working Group is sponsoring this workshop to demonstrate the electronic systems they've developed in support of clinical trials.

AMIA 1999 -
Cornerstones for a New Information Management Paradigm

Session 47
Panel: Towards an Open Infrastructure for Clinical Trial Development and Interpretation
Session Chair: I. Sim, MD, PhD, University if California-San Francisco, San Francisco, CA.
Participants: I. Sim, MD, PhD, University if California-San Francisco, San Francisco, CA, M. Musen, MD, PhD, Stanford University, Stanford, CA, J. Wyatt, DM, University College, London, United Kingdom, and J. Niland, PhD, City of Hope Medical Center, Duarte, CA.

Billions of dollars are spent annually on clinical trials. As the clinical trial industry grows and as medical practice turns increasingly to clinical trial evidence, there is a need for information systems that can be used to help design, conduct, report, and interpret clinical trials more efficiently and correctly. Large savings in time, expense, and labor could result if these systems are integrated into an open infrastructure for clinical trial development and interpretation. At present, however, the clinical trials computing infrastructure is fragmented. Systems for trial design are not integrated with data management systems for trial execution. In turn, these trial management systems have either nonexistent or nonstandard links to clinical systems such as the electronic medical record. Furthermore, reports of even multimillion dollar clinical trials are limited to text articles of 5,000 or fewer words, resulting in a severe loss of information to the scientific and clinical communities. This panel will examine the wide spectrum of clinical trial activity from four complementary perspectives. The objective will be to find a common ground among clinical trial systems and to discuss potential approaches for building a shared informatics platform that spans all phases of clinical trial activity.