3. Evolution of Randomized Clinical Trials in Retina 1950s: Single center trial – Patz et al 1970s: Multicenter clinical trials at university-based centers (e.g., DRS) 1980s: Multicenter clinical trials at university-based and community-based centers (e.g., ETDRS) 1990s: Industry sponsors randomized clinical trials (e.g., PDT trials) as other government-sponsored trials continue (e.g., AREDS, SST, CAPT) 21 st Century: Networks for Randomized Clinical Trials in Retina
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5. What Is the Diabetic Retinopathy Clinical Research Network (DRCR.net)? Dedicated to multicenter clinical research of diabetic retinopathy, macular edema and associated disorders.
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10. 128 Laser Response Protocol (K) 198 Laser-Ranibizumab-Triamcinolone for PDR + DME (J) – Goal 325 618 Laser-Ranibizumab-Triamcinolone for DME (I) – Goal 701 121 Phase 2 Randomized Trial of Bevacizumab for DME (H) 82 Subclinical Diabetic Macular Edema Study (G) 155 Observational Study: Development of DME After PRP (F) 113 A Pilot Study of Peribulbar Triamcinolone Acetonide for DME (E) 2,715 DRCR Network Study Subject Total 237 Evaluation of Vitrectomy for DME (D) 107 Temporal Variation in OCT Measurements in DME (C) 693 Randomized Trial: Intravitreal Steroids vs Focal Laser for DME (B) 263 Pilot Study of Laser Photocoagulation for DME (A) # of Subjects DRCR Network Protocols (as of October 6, 2008)
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12. Browning Laser Response Protocol (K) Googe* Laser-Ranibizumab-Triamcinolone for PDR + DME (J) Elman Laser-Ranibizumab-Triamcinolone for DME (I) Scott Phase 2 Randomized Trial of Bevacizumab for DME (H) Bressler Subclinical Diabetic Macular Edema Study (G) Brucker Observational Study: Development of DME After PRP (F) Chew A Pilot Study of Peribulbar Triamcinolone Acetonide for DME (E) 11 DRCR Network Protocol Chair Totals Haller Evaluation of Vitrectomy for DME (D) Danis Temporal Variation in OCT Measurements in DME (C) Ip Randomized Trial: Intravitreal Steroids vs Focal Laser for DME (B) Fong Pilot Study of Laser Photocoagulation for DME (A) Protocol Chairs DRCR Network Protocols (as of October 6, 2008)
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15. DRCR Network Organization and Governance Executive Committee (“Board of Directors”): provides oversight; sets policy; approves protocols “ Officers” Run Operations of Network Coordinating Center Principal Investigator (“CEO”); Network Chair (“President”); Assistant Director (“COO”) Investigators/staff (“Shareholders”) NEI DSMC
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17. DRCR.net: From Idea to Protocol (Example of Bevacizumab for DME) Idea Tabled: Reviewed Periodically Idea Declined Anyone may submit idea on DRCR.net Idea Form – Nov 2005 Idea Accepted: Protocol Development Committee Created Executive Committee Reviews PRCR Reviews Monthly – Jan 2006 Disposition Protocol Concept Review Committee (PRCR) Reviews Ideas Monthly – Dec 2005
18. DRCR.net: From Idea to Protocol (Example of Bevacizumab for DME) Idea Tabled: Reviewed Periodically Idea Declined Anyone may submit idea on DRCR.net Idea Form – Nov 2005 Idea Accepted: Protocol Development Committee Created Executive Committee Reviews PRCR Reviews Monthly – Jan 2006 Disposition Protocol Concept Review Committee (PRCR) Reviews Ideas Monthly – Dec 2005
19. DRCR.net: From Idea to Protocol (Example of Bevacizumab for DME) IRBs/clinical sites need to approve Any industry collaboration may need approval Protocol Development Committee Creates Protocol – Feb 2006 FDA or other regulatory agencies may need to approve NIH External Protocol Review Committee Must Approve Protocol – Apr 2006 DSMC Must Approve Protocol – Apr 2006 Executive Committee Must Approve Protocol – Protocol Steering Committee Developed – Mar 2006
20. DRCR.net: From Idea to Protocol (Example of Bevacizumab for DME) Primary outcome complete October 2006 Follow-up completed November 2006 Data finalized December 2006 Writing Committee completes draft February 2007 Submitted March 2007, revised and accepted May 2007 Results published August 2007 Enrollment begins June 2006 Enrollment complete August 2006
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24. Randomized Clinical Trials in Retina: From Single Center Studies in 1950 to Networks in the 21 st Century New challenges in next 5 years for the DRCR Network: more protocols, international sites, even more streamlined operations
Editor's Notes
Neil- 29 years and I love you to death- but haven’t you forgotten something…….Honestly, though both Neil and I are very touched to receive this award– and to be recognized jointly for our efforts is much appreciated. But we both feel that it takes a village, or at least a large dedicated community of retina physicians to promote the development and careers of clinical trialists, and although we are the 2 individuals who stand before you receiving this honor– we do so because of the hard work, great minds and collaborative effort of the audience here.
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