Community Based Community Based Clinical Trials Clinical Trials - PDF document

Community Based Community Based Clinical Trials Clinical Trials Sponsored by: Abraxis Sponsored by: Abraxis Oncology Oncology Peter D. Eisenberg, M.D., FACP LaDale K. George California Cancer Care, Inc. Partner, Foley & Lardner LLP Brian Cornblatt, Ph.D. Director, Translational Research, St. Joseph Medical Center of Towson, Maryland Clinical Research: Clinical Research: Making the Right Decision for Making the Right Decision for Your Practice Your Practice LaDale K. George Partner, Foley & Lardner LLP 1

Acknowledgements Acknowledgements • Michael Blau • Gregg Britt, CEO of INNOVIS, LLC • Melissa Roth • Donna, Avery & Quincy 3 Agenda Agenda • Overview of the research and clinical innovation industry • Evaluating clinical research program options • Designing and implementing the right program 4 2

Industry Overview Industry Overview 5 Industry Overview (cont Industry Overview (cont’ ’d) d) 6 3

The Drug Approval Process The Drug Approval Process Phase I Phase I- -III III Phase IV Phase IV Product Product Preclinical Preclinical File File File File Clinical Clinical Clinical Clinical Creation Creation Testing NDA Testing NDA IND IND Trials Trials Trials Trials • • Safety and Safety and • Preclinical results • Preclinical results • Selects sites from pool • Selects sites from pool • • Regulatory affairs Regulatory affairs • Must comply with • Must comply with biological activity biological activity of thousands where of thousands where quality assurance quality assurance • • Study/protocol Study/protocol • • Pharmacoeconomics Pharmacoeconomics enrollment and enrollment and • • Toxicology Toxicology design design • • Continue chemical Continue chemical monitoring of 1,000- - monitoring of 1,000 analytical and analytical and • Case report form • Case report form 10,000 patients takes 10,000 patients takes stability studies stability studies development development place place • • Data entry and Data entry and verification verification Early Research/ Early Research/ Preclinical Testing Preclinical Testing Phase I Phase I Phase II Phase II Phase III Phase III FDA FDA Phase IV Phase IV Years Years Years 6.5 1 2 3 1- -3 3 6.5 6.5 1 1 2 2 3 3 1 1-3 File NDA at FDA File NDA at FDA Laboratory Laboratory 20- 20 -80 80 100- 100 -300 300 Test Test Test Laboratory File IND at FDA File IND at FDA 20-80 100-300 1,000- -3,000 patient 3,000 patient 1,000-3,000 patient 1,000 and animal healthy patient and animal and animal healthy healthy patient patient Population Population volunteers Population volunteers volunteers Additional Additional Additional studies volunteers volunteers studies studies volunteers volunteers volunteers volunteers Review Review Review post- post- post - process/ process/ process/ marketing marketing marketing Evaluate Evaluate Evaluate Verify effectiveness, Verify effectiveness, Verify effectiveness, approval approval approval testing testing Assess safety Assess safety Assess safety Determine Determine Determine testing effectiveness, effectiveness, effectiveness, monitor adverse monitor adverse monitor adverse Purpose Purpose Purpose required and biological and biological and biological safety and safety and safety and required required look for side look for side look for side reactions from long- reactions from long- reactions from long - by FDA activity activity activity dosage dosage dosage by FDA by FDA effects effects term use term use effects term use 5,000 Success Success Success 5,000 5,000 5 1 5 5 1 1 compounds compounds compounds Rate Rate Rate enter trials enter trials enter trials approved approved approved evaluated evaluated evaluated 7 Industry Overview (cont Industry Overview (cont’ ’d) d) • 8,386 clinical trial conducted in the U.S. in 2005. ( BCC Research ) • Spending for clinical trials in the U.S. $25.6 billion in 2006, projected to rise to $32.1 billion in 2011, an average annual growth rate (AAGR) of 4.6%. (BCC Research). • $1.2 billion is the average cost of developing a new biotechnology product. (Tufts Center for the Study of Drug Development) 8 4

Clinical Research Program Options Clinical Research Program Options Our Philosophy “Research and clinical innovation should be integrated into the operations and should support the advancement of the organization’s strategic goals” “The best defense is a good offense” 9 Clinical Research Program Options (cont Clinical Research Program Options (cont’ ’d) d) • Clinical Research is a strategic decision – Articulate the “why” – Articulate the “what” – Articulate the “how” 10 5

Clinical Research Program Options (cont Clinical Research Program Options (cont’ ’d) d) • Articulate the “why” – Scientific value – Reputation enhancement – Recruitment and retention of clinical talent – Expanded therapeutic options – Quality enhancement – Revenue diversification and enhancement • Articulate the “what” 11 Clinical Research Program Options (cont Clinical Research Program Options (cont’ ’d) d) Translational Spectrum of Health Innovation Development/ Clinical Clinical Discovery Validation Innovation Integration • Ground Breaking Health • Pre-Clinical Therapeutic • Early Adoption Process • Broad Adoption of Knowledge/Advancements Development Innovation into • Validated New • Basic Science • Non-Therapeutic Research Standard Practice Therapies/Approaches • Bench Research • Phases I, II, and III Clinical Trials • Bed Side Treatments • In-House Validation/Outcome • Animal Studies • New Device Trials • Clinical Protocol Studies • Epidemiological Study • Diagnostic Validation Studies Development • Phase IV Clinical Trials Development • Clinical Procedure Refinement/ • Quality Care • Impact Analysis • New Molecules Validation Initiatives • Epidemiological/Community • New Drug Therapies • In-House Validation Studies • Outcomes Improve- Health Impact Studies • New Devices ment initiatives • Technology Assessment • New Diagnostics • Health Services/ • Novel Nursing Cost Benefit Research Intervention • Surgical Techniques 12 6

Clinical Research Program Options (cont Clinical Research Program Options (cont’ ’d) d) Areas of Innovation and Research Research a l B m Clinical i o - s p n i e c i m A e n & c Subject Nursing Education / Academic s i B a Trials & D a t a h r c Q e a Research u s Protection a l R e i t R e p y o s i t o Affiliation r i e s . O u Public & Technology Program t c o m e s Assessment Population Health r a u l / c e s r a a v C o d i r a l a Oncology C c y / h i r s s t i t a e s c l r c c i a C n n i t r e o d a H m e e i p d i l c e s u s o n ’ P o h P r t e u r m O e o N W Key Therapeutic Service Lines 13 Designing and Implementing the Designing and Implementing the Right Program Right Program • Articulate the “How” – Designing and implementing a clinical research program • Step 1: Obtain meaningful understanding of research activities • Step 2: Design and implement effective research infrastructure • Step 3: Evaluate and adjust control systems 14 7

Clinical Research Flow Chart Clinical Research Flow Chart “Follow the Trial “ Follow the Trial” ” Budget and New Contracts Study Feasibility Study Human Subject Subject Recruitment/ Regulatory Enrollment/Retention Clinical Operations Protections Monitoring and IRB Study Closeout QA (Clinical) Reporting 15 Designing and Implementing the Designing and Implementing the Right Program Right Program • Step 2: Design and implement effective research infrastructure – Accessibility – Accountability – Reliability 16 8

Designing and Implementing the Right Designing and Implementing the Right Program Program (cont’ (cont ’d) d) Government Sponsors CRO Principal Hospital Investigators Commercial Hospital IRB IRB 17 Designing and Implementing the Right Designing and Implementing the Right Program Program (cont’ (cont ’d) d) CRO Sponsors Government Centralized Research Principal Hospital Program Investigators Hospital Commercial IRB IRB 18 9

Designing and Implementing the Designing and Implementing the Right Program Right Program (cont’ ’d) d) (cont • Step 3: Evaluate and adjust control systems – Establish compliance baseline – Periodic operation audits 19 Clinical Research Flow Chart “Follow the Patient” Research and Non- Randomization Site Research Service Sites Health System Health System Patient Physician Clinic Ancillary Service Health System Non-Health System Emergency Depart. Physician Clinic Service Health System Inpatient Service Health System Inpatient Health System Outpatient Service Non-Health System Inpatient Non-Health System Service 20 10