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Improving FDA/Industry Interactions by R. Bhore ; J. Derr

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1 Improving FDA/Industry Interactions by R. Bhore ; J. Derr
September 29, 2006 Improving FDA/Industry Interactions: Suggestions from FDA/CDER Statisticians Rafia Bhore, Ph.D. Janice Derr, Ph.D. FDA / CDER / Office of Biostatistics The views expressed in this presentation are those of the speakers and not necessarily of the U.S. Food and Drug Administration (FDA). 2006 FDA / Industry Statistics Workshop, Washington DC

2 CDER Office of Biostatistics
Improving FDA/Industry Interactions by R. Bhore ; J. Derr CDER Office of Biostatistics September 29, 2006 DB1 Cardiovascular & Renal; Neurological; Psychiatric DB2 Pulmonary & Allergy; Metabolism & Endocrine; Analgesics & Anesthetics DB3 Gastrointestinal; Reproductive & Urologic; Dermatologic & Dental DB4 Anti-Infective & Ophthalmology; Anti-Viral; Special Pathogen & Transplant DB5 Oncology Biologics; Oncology Drugs; Imaging & Hematology DB6 Generic; Pharmacology & Toxicology; Chemistry & Manufacturing; Safety; Special Projects & Clinical Pharmacology 2006 FDA / Industry Statistics Workshop, Washington DC

3 Communication Dynamics between FDA and Industry
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Communication Dynamics between FDA and Industry Industry Clinical Stats Micro Clin Pharm Chem Pharm/ Tox Project Team Project Manager Regulatory Affairs 2006 FDA / Industry Statistics Workshop, Washington DC

4 Interactions During Drug Development
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Interactions During Drug Development Clinical Start NDA/BLA Submission NDA Review Pre-clinical Research Phase I Phase II Phase III Pre-IND Meeting EOP II Meeting Pre-NDA Meeting Labeling Meeting 2006 FDA / Industry Statistics Workshop, Washington DC

5 Good Meeting Management Practices
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Good Meeting Management Practices GMMPs Facilitate input from review disciplines Prior to internal meeting (draft responses to industry questions) Internal meeting (preliminary comments to sponsor) Formal meeting (moderated discussion) Follow-up (meeting minutes, further discussion) 2006 FDA / Industry Statistics Workshop, Washington DC

6 Suggestions from CDER Statisticians (Good Meeting Practices)
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Suggestions from CDER Statisticians (Good Meeting Practices) Use a meeting with FDA as an opportunity to send in questions about statistical issues Ask good questions that will give you useful answers Provide sufficient detail to help us give useful statistical review comments Use the channels of communication to get a response from FDA statisticians about statistical issues 2006 FDA / Industry Statistics Workshop, Washington DC

7 Investigational New Drug Application (IND) Stage
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Investigational New Drug Application (IND) Stage Special Protocol Assessment Statistical Analysis Plans 2006 FDA / Industry Statistics Workshop, Washington DC

8 Special Protocol Assessment
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Special Protocol Assessment SPA Guidance 2002 Sponsors can submit certain types of protocols with specific questions prior to start of study (Guidance recommends 90 days). FDA determines if SPA process applies to the request, and if so, responds to questions within 45 days (PDUFA goal). Protocol agreements under SPA are part of the administrative record. Regulations describe the circumstances under which the agreements can be changed. 2006 FDA / Industry Statistics Workshop, Washington DC

9 Suggestions from CDER Statisticians (Special Protocol Assessment)
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Suggestions from CDER Statisticians (Special Protocol Assessment) Ask good questions that will give you useful answers Provide sufficient detail to help us give useful statistical review comments 2006 FDA / Industry Statistics Workshop, Washington DC

10 Statistical Analysis Plan (SAP)
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Statistical Analysis Plan (SAP) Prospective plan of statistical methods not detailed in the Protocol Protocol details design considerations vs. SAP details analysis considerations Design: Endpoints, type of control, planned comparisons, multiple testing, interim analyses Analysis: Statistical models, handling of missing data, nature of censoring, analysis populations, repeated measurements over time, study windows, etc. 2006 FDA / Industry Statistics Workshop, Washington DC

11 Suggestions from CDER Statisticians (Statistical Analysis Plan)
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Suggestions from CDER Statisticians (Statistical Analysis Plan) Statistical Analysis Plan (SAP) should be detailed and prospectively written Prospectively submit to FDA for Phase 3 studies and Phase 2 supportive studies Open-label studies submit before study begins Blinded studies submit prior to last patient enrolled or first interim analysis (whichever comes first) 2006 FDA / Industry Statistics Workshop, Washington DC

12 Suggestions from CDER Statisticians (Statistical Analysis Plan contd.)
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Suggestions from CDER Statisticians (Statistical Analysis Plan contd.) Identify critical issues at protocol design stage or at least Statistical Analysis Plan writing Examples: adjustment for multiplicity, interim analysis plan, non-inferiority evaluation, missing data, … Commercial Sponsors should encourage co-operative trialists to write a Statistical Analysis Plan 2006 FDA / Industry Statistics Workshop, Washington DC

13 New Drug Application (NDA) Stage
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 New Drug Application (NDA) Stage Integrated Summary of Efficacy Labeling 2006 FDA / Industry Statistics Workshop, Washington DC

14 Integrated Summary of Efficacy (Suggestions from CDER Statisticians)
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Integrated Summary of Efficacy (Suggestions from CDER Statisticians) Important component of New Drug Application Review Provide clinically meaningful and logically tight argument whether drug has necessary evidence for efficacy claim Provide side by side comparison of studies NOT necessarily pooled or meta-analysis of efficacy Discuss pooling study results with FDA 2006 FDA / Industry Statistics Workshop, Washington DC

15 Improving FDA/Industry Interactions by R. Bhore ; J. Derr
September 29, 2006 Integrated Summary of Efficacy Example: Can YoU PRove Efficacy and Safety of curevir (CURES) ? Let's discuss 2006 FDA / Industry Statistics Workshop, Washington DC

16 Statistical Input on Labeling Text
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Statistical Input on Labeling Text FDA Statisticians review labeling text: Statistical support for study conclusions, claims and indications Description of study results, summary statistics and inferential language Information in tables and figures 2006 FDA / Industry Statistics Workshop, Washington DC

17 Labeling Example #1: Statistical Input Provided
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Labeling Example #1: Statistical Input Provided CLINICAL STUDIES … The NAGLAZYME-treated group showed greater mean increases in the distance walked in 12 minutes (12-minute walk test, 12-MWT) and in the rate of stair climbing in a 3-minute stair climb, compared to the placebo group (Table 2). 2006 FDA / Industry Statistics Workshop, Washington DC

18 Labeling Example #2: Statistical Input Needed
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Labeling Example #2: Statistical Input Needed Proposed text: “The combination of A and B is effective in lowering LDL-C levels beyond that achieved by either agent alone.” Statistical issue: The study was not designed to support this conclusion. The study had two arms, (A+B) combination product, and A monotherapy. 2006 FDA / Industry Statistics Workshop, Washington DC

19 Labeling Example #3: Statistical Input Needed
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Labeling Example #3: Statistical Input Needed Proposed table: The symbol “*” was used for p<0.05, and “**” was used to indicate no statistically significant difference between the active treatment arm and the placebo arm. Statistical issue: This is not a typical way to depict this outcome and may be confusing to some readers. 2006 FDA / Industry Statistics Workshop, Washington DC

20 Suggestions from CDER Statisticians (Labeling)
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Suggestions from CDER Statisticians (Labeling) Provide your statistical perspective in the development of labeling text. Labeling Guidance, 2006: Clinical Studies Section Adverse Reactions Section 2006 FDA / Industry Statistics Workshop, Washington DC

21 Improving Statistical Communication
Improving FDA/Industry Interactions by R. Bhore ; J. Derr September 29, 2006 Improving Statistical Communication Provide statistical input at all stages Ask good questions Provide detailed, timely information Address critical statistical issues Industry Clinical Stats Micro Clin Pharm Chem Pharm/ Tox 2006 FDA / Industry Statistics Workshop, Washington DC

22 Improving FDA/Industry Interactions by R. Bhore ; J. Derr
September 29, 2006 Acknowledgments FDA Statisticians from Divisions of Biometrics 1, Biometrics 2, Biometrics 3, Biometrics 4, and Biometrics 5 Industry Statisticians /Programmers for their promptness in responding to FDA questions! 2006 FDA / Industry Statistics Workshop, Washington DC

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