Report of task force II: Best practices in the use of medical imaging techniques in clinical trials

Drug Information Journal

Volumn 42, Issue 5, 2008, Pages 515-523

  Ford, Robert ^a   Mozley, P David ^b  

^a RadPharm Inc   (United States)

^b PhRMA Imaging Group

Author keywords

Central review; Clinical trials; Imaging core labs; Independent review; Medical imaging

Indexed keywords

NEW DRUG;

CLINICAL COMPETENCE; CLINICAL PROTOCOL; CLINICAL RESEARCH; COMPUTER ASSISTED TOMOGRAPHY; CONFERENCE PAPER; CONTROLLED STUDY; DIAGNOSTIC IMAGING; DOSE RESPONSE; GOOD CLINICAL PRACTICE; HUMAN; IMAGE ANALYSIS; IMAGE QUALITY; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REPRODUCIBILITY; STANDARDIZATION;

EID: 53849119894     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150804200512     Document Type: Conference Paper

References (11)

1. Pfizer. Highlights of prescribing information. Available at: http://www.pfizer.com/files/products/uspi_sutent.pdf.
2. Single-agent SUTENT prolonged progression-free survival across all advanced kidney cancer patient risk groups, including those with poorest prognoses, data show. June 3, 2007. Available at: http://findarticles.com/p/articles/mi_m0EIN/is_2007_June3/ai_n19188572.
3. Welt Online. Newsticker. http://newsticker.welt.de/ index.php?channel=fin&module=smarthouse&id=593480. (In German.)
4. Panitumumab significantly improved progression-free survival and disease control in metastatic colorectal cancer patients, phase III trial. April 9, 2006. Available at: http://www.medicalnewstoday.com/articles/ 41267.php.
5. Prud'homme A. Cell Game. New York: Harper Collins; 2004.
6. Timmerman L. Genentech's Avastin not recommended for breast cancer (Update4). Blooomberg.com. December 5, 2007. Available at: http://wwwbloomberg.com/apps/news?pid=newsarchive&sid=aoRSxqNgis58.
7. US Food and Drug Administration. Subchapter D - Drugs for Human Use, Part 312, Investigational New Drug Application. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=312.
8. Drug Information Association. Transcript of October 2007 meeting. Available at: http://www.diahome.org/DIAHome/.
9. FDA Guidance for Industry, Developing Medical Imaging Drugs and Biologic Products, Parts I-IV, June 2004. Available at: http://www.fda.gov/CBER/ gdlns/medimagesaf.pdf.
10. National Archives and Records Administration. 2000 CFR Title 21, Vol. 7. Available at: http://www.access.gpo.gov/nara/cfr/waisidx_00/ 21cfr54_00.html.
11. Metrics Champion Consortium. Available at: www.metricschampion.org.