How to Start An Industry Sponsored Clinical Trial

1
How to Start An Industry Sponsored Clinical Trial

• Lynda Lane, MS, RN
• Administrative Director, GCRC

2
Starting A Clinical Trial

• Confidentiality Agreement
• Study Synopsis
• Protocol Evaluation and Feasibility
• Site Selection Visit

3
Confidentiality Agreement

• The clinical agreement is between Vanderbilt
  University, by and through its Medical Center and
  the Sponsor

4
Key Points in a Confidentiality Agreement

• The sponsor wants to assure you will not share
  their protocol with others.
• You need to avoid agreeing to terms you cannot
  satisfy.

5
Study SynopsisAn overview of the study that
includes the following

• Inclusion Criteria
• Exclusion Criteria
• Duration of Subject Involvement
• Duration of Study
• Statistical Methods

• Protocol Number
• Title
• Study Phase
• Objectives
• Study Design
• Subject Population

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Protocol Evaluation Feasibility

• The protocol is evaluated to determine if the
  study center and/or principle investigator have
  the resources to complete the proposed study,
  including
• Qualified Personnel
• Equipment
• Facilities
• Access to the required subject population
• Is the project of benefit to the Principle
  Investigator and institution

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Protocol Evaluation Protocol Contents

• Title page
• Table of contents
• Introduction
• Study Design
• Objective
• Experimental Design
• Patient Selection
• Statistical Analysis
• Adverse Events
• Subject Withdrawal
• Drug Accountability

• Discontinuation of Study
• Data Disclosure/Publication
• Documentation
• Project Timetable/Flowchart
• References
• Appendices

8
Site Selection Visit

• The site selection visit allows the sponsor to
• Evaluate the ability of a study site to
  successfully conduct the proposed clinical trial
• Evaluate the credentials of study personnel
• Evaluate the adequacy of clinic facilities.

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Site Selection VisitIssues Reviewed

• Investigator Brochure.
• Protocol.
• IRB issues.
• Laboratory issues.
• Drug storage and accountability.
• Source document requirements.

10
Site Selection Visit

• Discuss monitoring visits.
• General clinic operations.
• Responsibilities of study personnel.
• Available regulatory documents provided.
• Tour clinic facility.
• Tour investigational drug pharmacy

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You are ready to start enrolling when

• The sponsor gives you the go ahead
• You have all IRB and regulatory documents
  completed and approved.
• You have all supplies and meds.
• You have all case report forms.