Clinical Trial Infrastructure in Centres

Lillian L. SiuPrincess Margaret Hospital

Key elements for success

Building a research team Engaging others in your research Be engaged in the work of others

who collaborate with your research Know some basic accounting Learn how to navigate the system Publish your work Make sure your staff are well trained

Personnel Your research program’s success depend

on the “buy-in” from your team: Other investigators:

Oncologists, laboratory scientists, pathologists, radiologists, etc.

Trial nurses, clinical research associates Pharmacists Biostatisticians

Meet with them regularly and tell them what’s happening!

Resources - institutional

Grants and contracts services Research financial services Technology development and

commercialization Institutional review board/research

ethics board/ethics committee (IRB/REB/EC)

Protocol review committee

Step-by-step guide to activating a clinical trial - 1

Concept --- protocol development Pharmaceutical-sponsored Investigator-initiated research (IIR) Academic agency-sponsored (e.g. NCIC, NCI,

RTOG, etc) Once confidential non-disclosure is

established, review the protocol in detail, and asks key individuals in your research team for input

Protocol review committee (if any)

Step-by-step guide to activating a clinical trial - 2

Key questions you need to ask before deciding to take part: Do you have enough patients to put on the

trial? Do you have any competing trials? Do you have the personnel to run the trial? Do you have the resources and

infrastructure to run the trial (e.g. electronic data capture; IV pumps; treatment space, etc)?

Step-by-step guide to activating a clinical trial - 3 Once you decide to participate in a

study, the following processes should be activated: Grants and contracts office – existent

templates would expedite contract review Budget – you (or someone familiar with the

costs of procedures and tests in your institution) need to review this carefully

IRB/REB/EC submission

Example of budget items – don’t forget the overhead (indirect costs)!

Procedure

Administrative Cost per Patient Visit (Includings Nursing)

Adverse Event / Toxicity Assessment (Average)

BIOCHEM-HCG (PREGNANCY) QUANT - S

Biomarkers

Biopsy - Procurement

Biopsy - Processing

Blood Sample Collection - Pharmacokinetic (PK)

Blood Sample Processing - Pharmacokinetic (PK)

Blood Sample Processing / Shipping

Blood test-Other

Concomitant Medication Assessment

Coordinator Activity - Pt Visit (Unit 0.25 Hour)

CT scans

Documentation (Source) - Follow-Up

Documentation (Source)-Eligibility/Entry (Average)

Documentation (Source)-Treatment Visit (Average)

Drug Administration (Oral)

eCase Report Form Completion Treatment, (Average)

eCase Report Form Completion, Baseline (Simple)

ECG / EKG / Electrocardiogram

Eligibility or Inclusion/Exclusion Assessment

History (Medical)

Informed Consent (ICF) - Other (See Note)

NUCLEAR-MUGA SCAN NUC MED

Patient Teaching / Patient Education (Average)

Performance Status (ECOG)

Pharmacy Activity

Physical, Weight & BSA

Routine Study Screening

Telephone Contact

Archival Tissue Sample Collection Coordination

Tumour Response Assessment (RECIST)

TOTAL

Total Plus 30% Overhead

Cumulative visit totals

Total cost per patient over study (all sites):

 

 

One Time Financial Events (All Sites)

OCREB (Ontario REB) Initial Local Submission and Annual Renewal

Document Archiving

Pharmacy Fees (Start-Up)

Pharmacy Fees (Annual) x 5

Study Start-Up (Average)

Study Close-Out

Step-by-step guide to activating a clinical trial - 3 Health Canada submission for a Clinical

Trials Application (CTA): Pharmaceutical-sponsored – done by

company or by a Clinical/Contract Research Organization (CRO)

Investigator-initiated research (IIR) – you may have to do this yourself!

Academic agency-sponsored (e.g. NCIC, NCI, RTOG, etc) – done by the sponsor ususally the academic agency itself. Typically done prior to IRB submission

Step-by-step guide to activating a clinical trial - 4

Protocol submission: IRB/REB/EC

Format consent forms to meet your institutional format and IRB preferred language

Other institutional committees that need to approve of protocol before activation

Step-by-step guide to activating a clinical trial - 5

Collecting documents prior to trial activation: PI and investigator CVs, GCP

certificates Lab licenses/certificates, normal ranges Financial disclosure agreements

Regulatory binder index1. Protocol Study Protocol

Study Protocol Amendments Protocol or Amendment Signature Pages Non-Disclosure Agreement Investigator Drug Brochure

2. 1572/Regulatory Forms/CV Form FDA 1572 (If applicable) Curricula Vitae Medical Licenses (US only, if applicable) Financial Disclosure Agreement

3. Approved Consent Form(s) Informed Consent(s)

4. IRB Approvals and Correspondence IRB/IBC/RAC Approvals for Protocol Amendments, Advertisements, Renewals IRB Correspondence (Progress reports, letters of submission for

approval, IRB notification, responses to SAE reports, and Safety Reports, Etc.

5. Laboratory Lab Certifications (CAP & CLIA) CV pathologist, if applicable

6. Study Logs Investigator Personnel Team Signature Page Site Visit Logs Site Signature Logs Master Subject Logs Screening Logs Training Logs (Site initiation Visit attendance log & training

certificates)

7. Correspondence Study related correspondence between the site, sponsor, CRO,etc.

8. Serious Adverse Events (SAE) Master SAE Reporting Form and Instructions Blank SAE Forms Safety Letters Completed SAE Reports (or note where they are located)

9. Drug Accountability Study Drug Receipt/packing invoices Study Drug Accountability Form Study Drug Supply Forms

10. Miscellaneous Miscellaneous (CRF transmittal logs), etc.

Step-by-step guide to activating a clinical trial - 6 Site initiation visit (SIV)

Personnel/signature log Drug and protocol review Investigator responsibilties Patient enrollment procedures Serious adverse event reporting Handling and shipment of biological

samples Drug shipment, storage, dispense CRF completion

Copyright © American Society of Clinical Oncology

McJoynt, T. A. et al. J Clin Oncol; 27:3855-3860 2009

Future state value stream map for the protocol development process