Stages and tasks of a clinical trial Evaluating and choosing partners/vendors

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2 Stages and tasks of a clinical trial Evaluating and choosing partners/vendors

3 Global (ICH-GCP) Federal (CFR) or other country regs IRB State/local laws and requirements Protocol SOPs Site Sponsor/CRO Others (OSHA, NIH, HIPAA etc.)

4 Pre-Study Preparation Study Start-Up Study Conduct Study Close-out THIS IS AN OVERVIEW ONLY. WHEN YOU GET READY TO START YOUR CLINICAL TRIAL, BE CERTAIN TO FIND GOOD ADVISORS TO MAKE SURE YOU GET ALL OF THE DETAILS.

5 What trial do you want to do Goals Audience Synopsis/Straw man Feasibility Cost Get help Advisory Committee or informal advisors (clinical, regulatory, and business) Clinical Contract Research Organization (CRO) or Independent Contractor

6 Develop Protocol (and other related study documents) Investigator Identification and Qualification Contract with sites IRB Submission(s) Create Trial Master File (TMF) Select additional vendors (e.g., central lab) Build database Conduct Investigator Meeting and/or Site Initiation Visits Register trial:

7 Evaluations: Staffing Enrollment IRB/Contracting Facility Location Common issues: Key Opinion Leader (KOL) conundrum The 1/3 rule for enrollment The study team you meet vs. the study team you get

8 Manage vendors Monitor sites (on-site monitoring visits and remote monitoring) Medical/Safety oversight IDE annual updates Monitor enrollment (mitigate as needed) Finalize Statistical Analysis Plan (SAP)

9 Plan for failure Back up sites/countries Advertising Site specific recruitment/mitigation plans Mid-study Study Coordinator Meeting

10 Close-out visits at sites Clean data Close and lock database Analyze data Write Clinical Study Report

11 Clinical Contract Research Organization (CRO) Independent Contractors Regulatory Consultation/Support Central Lab Packaging/labeling Manufacturing And more

12 In-house expertise What do you already have and what do you need In-house Project Manager to manage vendor(s) Vendor expertise Size Stability Cost Location 12

13 Medical and Scientific Writing (e.g., Protocols, IBs, Clinical Study Reports, Study Operations Manuals, peer-reviewed manuscripts and publications) Site contracting and payment Biostatistics and Data Management Project Management Site Monitoring (ensuring compliance) IRB submissions and communication Pharmacovigilance Vendor and Investigative Site Audits Subject Recruitment

14 Meet the team you will work with (not just the leadership team and BD) Audit the CRO (SOPs) Out of scope conversation (get examples) Mitigation and Conflict Resolution (get examples) Check financial stability (consider what will happen if they are bought out during your trial) Ask for and check references 14

15 Team environment Communication Priorities (Time, Cost, Quality) Frequent meetings Project reports Escalation process Co-Visits (talk to site staff 1:1) Mid-study Audit (if possible)

16 Intellectual Property protection Anything that is developed as a result of your product is yours Sponsor approval of team changes Scope Realistic Well understood by all parties Well documented

17 Termination clause and plan Indemnification and Insurance CRO, sites, committee members, vendors, etc. Budget negotiation

18 Do it yourself: Hire, pay, supervise: Medical Monitor Project Manager CRA Auditor Accountant Site Contract Negotiator Medical Writer, etc. Create team cohesion Benefits commitment CRO or Contractor: Use and pay for only what you need, when you need it Access to the right expertise CRO = Cohesive, centralized teams ideally (not just one individual that you hire)

19 Study fully enrolled Timelines met Compliance ensured Issues were mitigated, escalated as appropriate, and resolved Data answered the question You got what you needed when you needed it

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