The Execution and Management of a Complex Clinical Trial

Elizabeth K. Walsh, RN

ECTSS 2013

Conflicts of InterestAdvisory Board for TAVR AdministratorsStudy Operations Steering Committee

January 2007 Planning Meeting for TAVR: The Heart Team

November 2007 1st TAVR Implant

November 2011 FDA approval for Inoperable

October 2012 FDA approval for High Risk

October 2013 Completion of Intermediate Risk enrollment

Future TAVR devices and Trials to start in the US

Introduction

Utilization of a Best Practice Model: Crucial for the execution of

a Successful Landmark Trial

A Single Site Timeline

Methods

2007 – 2011 238 Enrolled Partner 1

2011 – Present 203 Enrolled Partner 2 (continuing)

2011 – Present 275 Commercial Implants

Over 2000 Patients Screened for TAVR

Data Capture

Screening

Baseline

Index Procedure

Discharge

Follow up

Study Exit

Protocol Deviation

Adverse Events

• Hospitalization

• Hemorrhage/Vascular Injury

• Neurological

• Myocardial Infarction

• Infection

• Thromboembolic

• Average Data Points per patient Screening to

5 Year Follow = 1840

• CRF Pages = 92 (excluding AE Capture)

• Average Queries per Subject = 47

• Tracking the Data

• Audit and Monitoring of the Data

Results Complex Patient Population

1840 Data Points collected per patient

Multiple Adverse Events requiring 24 hour PI Review

Resource Intense

Continuing Education

• New Protocols and multiple Protocol Modifications

• Patient and Family Education

• Staff members throughout the hospital and outpatient

• Training New Research Staff

– Regulatory

– Safety

– Meeting Trial Endpoints

– Data Management

– Consenting

– Follow up

– Inspection Readiness

– Collaboration with clinical staff

FDA Trials are Serious BusinessFollow the Rules

Growth of Staff over time

Conclusion

Since 2007 over 2000 patients screened for TAVR

Heart Team Model: Strong Coordinator, Weekly Team Meetings

TAVR Clinic: Key to Patient Flow

Keeping up with the Volume

Patient Protocols Evolved from Best Practices in Clinical Trial

TAVR Model Excellent Example of Complex Clinical Trial

TAVR Trial a template for transition to a commercial Program

• Challenging Patient Population• Multiple Data Points• Multiple Sub-studies • Multiple protocol versions• Large Volume of AEs• High Profile Trial• Cost• Resources Intense• Multiple Data locks/Deadlines

Running a Complex Trial can be a heavy load

What is a Complex Clinical Trial