Resources
RadPharm is pleased to provide you with relevant resources designed to aid you in your search for information. Here you will find published papers, a glossary of imaging terms and links to relevant websites.
Please check this space often as we continue to improve and expand our resource library.
If you have any questions or ideas, please contact us.
Published Papers
Title |
Author / Date |
Publication |
Analysis of the Cause of Discordance Between Two Radiologists in the Assessment of Radiographic Response and Progression for Subjects Enrolled in Breast Cancer Clinical Trials Employing Blinded Independent Central Review
|
Kristin Borradaile MS,
et al
|
ASCO Poster 2010 |
| |
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Analysis of the Rate of Non-target Disease Progression in Patients with Stable or Responding Target Disease
by the Response Evaluation Criteria in Solid Tumors (RECIST)
|
Kristin Borradaile, et al
|
ASCO 2009 |
| |
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The Impact of the Inclusion of Clinical Data Review on Overall Radiographic Response and Progression in Oncology Clinical Trials as Assessed by Blinded Independent Central Review |
Nicolette Wangler, et al
|
ASCO 2009 |
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Computer-Assisted Photographic Evaluation in Rheumatology (CAPER gout tophi) |
A.N. Maroli et al.
|
ACR Presented Poster |
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Recommendations for the assessment of progression in randomised cancer treatment trials |
J.E. Dancy , et al.
|
EJC 45 (2009) |
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New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) |
E.A. Eisenhaur, et al.
|
EJC 45 (2009) |
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Lessons learned from independent central review |
Dr. Robert Ford, et al.
|
ECJ 45 (Jan 2009) |
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Individual patient data analysis to assess modifications to the RECIST criteria |
Jan Bogaerts , et al.
|
EJC 45 (2009) |
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Report of Task Force II: Best Practices in the Use of Medical Imaging Techniques in Clinical Trials |
Dr. Robert Ford, et al.
|
Task Force II |
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Analysis of the Rate of Missing Data, the Rate of Discordance between Readers, and the Rate of Site versus Central Discordance in Clinical Studies of Recently Approved Breast Cancer Agents that Have Used Blinded Independent Central Review |
Kristin Borradaile
|
SABCS presented poster |
| |
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Applying PMBOK Principles to Clinical Submission |
Lance Wolf
|
PMI Pharmaceutical |
| |
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A Retrospective Exploratory Study of the Variability of Radiologists Measurements in a Selected Subgroup of Subjects Enrolled in a Clinical Trial |
Dr. Robert Ford, et al.
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Inter-observer Variability in Radiographic Assessment of Response in Chemotherapy Trials for Pancreatic Cancer |
Brian C. Baumann, AB, et al.
June 2007 |
ASCO presented poster |
| |
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Evaluation of Number of Target Lesions to Analyze in
Time to Progression by RECIST |
Mithat Gönen, et al.
|
ASCO presented poster |
| |
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|
| DICOM Structured Reporting and Cancer Clinical Trials Results |
David A. Clunie
May 2007 |
Cancer Informatics |
| |
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| DICOM structured reporting: an object model as an implementation boundary (SPIE MI 2001) |
David A. Clunie
2001 |
SPIE MI |
Links
Organizations
Association of Clinical Research Organizations
www.acrohealth.org
Association of Clinical Research professionals
www.acrpnet.org
American Society of Clinical Oncology (ASCO)
www.asco.org
American Society of Hematology (ASH)
www.hematology.org
Biotechnology Industry Organization
www.bio.org
CDISC – clinical Data Interchange Standards Consortium
www.cdisc.org
CISCRP – Center for Information & Study on Clinical Research Participation
www.ciscrp.org
Drug Information Association
www.diahome.org
Regulatory Affairs Professionals Society
www.raps.org
Society for Clinical Data Management
www.scdm.org
Society of Clinical Research Associates
www.socra.org
FDA Sites
FDA Home page
www.fda.gov
FDA – European Union
www.fda.gov/oia/EC_EMEA.htm
The Center for Biologics Evaluation and Research (CBER)
http://www.fda.gov/cber/guidelines.htm
The Center for Drug Evaluation and Research (CDER)
http://www.fda.gov/cder
The Office of Regulatory Affairs (ORA)
http://www.fda.gov/ora
Government Sites
European Medicines Agency
http://www.emea.europa.eu
National Institutes of Health
http://www.nih.gov
Agency for Healthcare Research and Quality (AHRQ)
http://www.ahrq.gov
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