Clinical Trial Performance Metrics

Transcription

1 Clinical Trial Performance Metrics

2 Clinical trial performance metrics? Data points that provide insight into operational and quality of performance.

3 Objectives of Clinical Trial Performance Metrics The sponsor retain the ultimate responsibility for the conduct of a clinical trial (GCP) Protection of subjects Credibility of data Business requirements Protect the sponsor interest Delivery of a successful trial/program

4 Which metrics should we track? Trial Metrics- overview of the study progress Vendor metrics- oversight of vendors Quality metrics

5 Cost/Performance Recruitment Timeliness Choosing the Right Metrics Business Development Document Management Quality Quality Deliverables Trial Management Utilization

6 Metrics Should Be Tailored to the Study Phase Start up Maintenance Close-out

7 Start Up Metrics Investigator recruitment and progress Protocol ready on time Vendor selection (labs and etc.) Cycle time to site qualification Cycle time to first site activated Cycle time to site activated Regulatory pack approval rate Percent planned sites activated Clinical supply readiness FPFV on time

8 Study Maintenance Metrics Execution per protocol Meet eligibility criteria Compliance with protocol procedures / evaluations Compliance with con meds restrictions Integrity of randomization and of blind Integrity of investigational product and administration Timelines for report delivery Site quality % planned sites activated % open sites not recruiting/ closed

9 Study Maintenance Metrics Cont. Integrity of data Data completion Missing data Open quires Trial data errors Discrepancy rates Discrepancy resolution rates Underreporting of AE

10 Study Maintenance Metrics Cont. Protection of subjects rights and welfare All subjects consented appropriately through out the study Notification of new safety information to the subject, investigator and IRB/EC Privacy Subjects removed from the study when appropriate Appropriate emergency un-blinding Compliance of documents TMF complete and accurate Regulatory submission done on time Safety reporting done Regulatory responses complete

11 Closeout Metrics LPLV on time Time from LPLV to database lock Database lock to final analysis Analysis plan answered the protocol questions? Analysis free of errors that matter Time to last site closure

12 Financial Metrics Recruitment duration projected vs. actual Study and/or project budget projected vs. actual Number of change orders Variance to budget Per site Per country

13 Vendor Performance Monitor the conduct of a study : As surrogate for vendor performance To manage the relationship Resource allocation Patients per CRA Staff contractor retention

14 Sponsor Metrics Responsiveness of sponsor to vendors Availability to discuss issues as they arise Appropriate level of decision making Invoice payment

15 Plan-Do-Act Develop a plan Implement, measure performance Plan Do Decide on changes needed and implement Act Check Study Assess performance, identify area of opportunity

16 Summary Clinical trial metrics is offering numerous benefits towards overseeing clinical trials, optimizing clinical operations, and mitigating study risks The sponsor should have a set of standard set of trial performance metrics The shorter the metric is the better the organization is and the sponsor is more happy Cost is always linked with the recruitment efficacy and method Planning and acting starting with the study planning and up to its end is needed At the study set-up define the study/ program metrics Create your vendor management plan Define the metrics and the goal related to each of them Define process for metrics assessments Project scale will help defining how extensive the metrics should be