Speed to Market Abbott Nutrition Experience in Streamlining the Pediatric Clinical Research Process

Transcription

1 Speed to Market Abbott Nutrition Experience in Streamlining the Pediatric Clinical Research Process Geraldine Baggs, Suzanne Monnin, Deborah Shye, Sue Zhang Abbott Nutrition Research & Development Abbott Laboratories, Columbus Ohio May 2010

2 Context / Background Institute of Medicine Forum on Drug Discovery, Development and Translation,10/2009 conference, Transforming Clinical Research in the U.S. Recognize growing indications that the current system of conducting clinical research in the US is not meeting the needs of the nation Therefore, a new effort to identify areas of strength and weakness in our current clinical trial enterprise, and consider transformative strategies for enhancing the ways in which clinical research is organized and conducted Strategies from practical, incremental improvements to broad, transformative change Aim: speed to market - Increase efficiency & productivity - Faster, better delivery & uncompromised quality - Build & sustain customer satisfaction & marketplace success 2

3 R&D approach: Productivity Committees Establish cross-functional Productivity Committees Nutrition Science Clinical Operations Clinical Data Management Project Management Statistics Programming Mission: Improve & track clinical trial productivity 3

4 Productivity Committees: Process Review & define by functional area: What works? What doesn t? - Defined burn rate (cost/duration), success rate (launch, termination) - Defined optimal time frame for clinical project requests - Defined clinical trial start & stop - Reviewed current metrics for typical studies - Reviewed proposed template for time reduction - Established areas of focus 4

5 Productivity Committees: Areas of focus 1. Development of templates & standards - apply to similar types of research - foster consistency & accuracy 2. innovative data summary & presentation - faster statistical analysis, reporting, & interpretation - faster clinical study report (CSR) writing, with required appendices 3. Managing sites effectively 5

6 Protocol template e.g., pediatric study template Goals: accuracy, consistency, speed Developed by cross-functional committee - Pediatric nutrition science - Clinical operations - Statistics - Medical safety - Regulatory affairs Permits standardization of - Eligibility criteria - Reasons for exit - Prior & concomitant therapy - AE reporting - Procedures for premature discontinuation of study product - Exclusion from evaluable analysis - Protocol deviations 6

7 Case report form (CRF) templates CRF templates for pediatric clinical studies Basis in R&D s historical compilation of CRFs Committee development & refinement of template Cross-functional committee approval Variations require approval of standardized CRF Change Form Outcome Since 4/2009, three pediatric studies have used template CRFs, resulting in significant time savings 7

8 Performance incentives Payments for on-time completion of Investigator agreements, certification of scales, similar documents IRB approval Executed clinical study contracts Staff training on protocol requirements Patient recruitment initiation tasks Submission of study data within one week of last subject s exit Outcome 7 week decrease, on average, for time to patient screening 8

9 Patient recruitment The biggest gain in reducing time comes from shortening study start up processes, and rapid enrollment and study execution Formal written recruitment plan Time line with metrics (e.g. X number of patients by Y date) Recruitment methods (e.g. invitations to moms in labor / delivery; flyers posted at well-baby visit sites, etc.) Backup plan for increasing enrollment (e.g., advertising in local media) 9

10 Site management Led by clinical study team (scientists, monitors, statistician, data management, programmer, medical safety, clinical support) Goals: To ensure Protocol is followed Data are accurately recorded & submitted on time Adequate enrollment & timely start-up Continuous proactive communication & monitoring Initial investigator meeting, pre-recruitment Weekly submission of screening & enrollment logs, with feedback & support as appropriate Site closure if enrollment is inadequate after 4 to 6 weeks Routine clinical meetings Monthly newsletters 10

11 Site Metrics: Value & Abbott approach Value of routine collection of site metrics Accurate estimates of number of study sites needed Projections of study timelines Selection of appropriate sites Abbott Nutrition R&D approach: collect data during Initial contact with potential new sites Formal site qualification visits Monitoring visits Close out visits End-of-study site evaluation 11

12 Site Metrics Initial site contact metrics Number of newborns/month Newborn diets Percent breastfed Percent formula-fed Percent combination-fed Routine well baby visit schedule Average length of time Site-sponsor study agreement Site IRB submission to approval Ongoing metrics Number of patients screened Number of patients enrolled Number of adverse events Number of deviations 12

13 Site Metrics Enrollment rate Ratio of screened to enrolled End of study metrics Percentage of subjects prematurely discontinued Percentage of subjects exited early Number of evaluable subjects Number of data queries Number of protocol deviations Time to execute confidential disclosure agreement, study agreement Time to prepare the IRB submission 13

14 Data management Standard CDM QA program (in process) Will permit automated QA checks on standardized CRFs Template Clinical Data Management Plan Corresponds to standardized CRFs 14

15 Programming & analysis Standard programming code Calculates parameters of safety, study formula intake, stool & anthropometric measurements Standard pediatric programming plan template (in process) Will contain variable calculations, treatment/visit information, evaluability criteria, file locations, details on output variables for the statistical analysis data sets, data listings, & summary tables Data / table review meeting during study Scientist, programmer, & statistician meet for data review, discussion of table layout, variables, additional requests, reducing preparation time for CSR 15

16 Clinical Study Report Writing Data / table review meeting during study Streamlined process of data summary Typical Abbott Nutrition study includes up to 100 tables Old ASCII output: manual typing, expensive, error-prone New RTF output replaces use of ASCII formatted data Benefits Permits transfer of tables directly to CSR, little or no manual editing Saves time & money, improves accuracy ASCII: American Standard Code for Information Interchange first published in 1963 RTF: Rich text format, a proprietary document file format marketed by Microsoft in

17 Productivity Committees: Outcomes to date Mission: Improve & track clinical trial productivity Outcomes 1. Development of templates for protocols & CRFs 2. Early closure of non-performing sites 3. Decreased use of US academic sites 4. Tracking - key performance indicators 1st site initiated, 25%,50%,75% enrolled, database release - project-related effort for estimating project time, expense 5. Preliminary 1:1 meetings with key protocol reviewers prior to committee review 17

18 Summary of the Abbott Nutrition experience Abbott Nutrition experience speaks to the challenge for organizations to deliver faster and better without compromise to quality. Our efforts have produced significant efficiencies and progress toward the shared goal of growing customer satisfaction & continued market success. Thank you for your attention. 18