Scientific Supports for Clinical Trials UCD Clinical Research

Scientific Supports for Clinical Trials UCD Clinical Research

Scientific Supports for Clinical Trials UCD Clinical Research Centre Dr Eoin J Cotter UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Enabling Translational Research UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Drivers of translation

Culture Creativity People Infrastructure & Processes UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Role of CRC Research Support Grants, nurses, databases etc Research Oversight Sponsorship of Clinical Trials Research Infrastructure Biomarker Laboratory

Partnerships Industry and academic networks Education and Training UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD UCD CRC| Footprint In addition to MMUH and SVUH sites The UCD CRC has active research investigators and protocols at : Our Ladys Childrens Hospital, Crumlin James Connolly Memorial Hospital, Blanchardstown Childrens University Hospital, Temple St Coombe Womens and Infants University Hospital

St Columcilles Hospital, Loughlinstown National Maternity Hospital, Holles St Rotunda Maternity Hospital Clearly demonstrates how wider network can leverage the core CRC investment and capacity UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD UCD CRC| 2006-2014 36,000+ Patient Contacts 91 Active Projects

190 Users 82 Principal Investigators 27M+ leveraged Funding Activity at 9 hospital sites

First to routinely build and deploy clinical research databases First IMB audited CRC First University Sponsor of Investigator Initiated Clinical Trial First compliant biobank facility First compliant IMP storage and monitoring systems

First Irish non-commercial core lab for clinical trial First Graduate taught programme in Clinical research UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Clinical Trials Key activity domain for UCD Early access to novel treatment for our patients Rare diseases Development of strategic partnerships

Clinical Trial Types Industry initiated Investigator initiated UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Investigator Initiated Clinical Trials Importance Investigative culture of academic medicine Novel indications for established medicines Rare disease clinical trials Combinations of treatments from different manufacturers Translation of basic lab findings

UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Sponsorship EU Clinical Trials Directive 2004 Simplify & harmonize the regulation of clinical trials across the EU, thereby facilitating the internal market in medicinal products and protect participants & public health Every clinical trial, whether commercial or non-commercial must have a sponsor, under the clinical trials directive UCD School of Medicine & Medical Science

Scoil an Leighis agus Eolaocht an Leighis UCD Responsibilities of the Sponsor Authorisation & Regulatory Clinical Trial Authorisation (Ethics Committee and Competent Authority) Insurance Subcontracts & Delegation Good Clinical Practice GCP compliance Safety Measures Pharmacovigilance Adverse events monitoring SUSAR reporting UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD

Impact of Clinical Trial Directive on Academic Medicine Study must have named sponsor Sponsor responsibilities are significant However. Still need to support Investigator initiated research UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD UCD as Sponsor UCD can act as sponsor for investigator initiated studies

Bank of SOPs developed (and growing) as part of QMS Master CT insurance policy Core template agreements developed and used Currently Sponsor for 12 Trials (3 complete, 9 ongoing) (Nephrology, Obstetrics, paediatrics, endocrinology, dermatology )

Critical step in funding success Developed specific scientific supports for Investigator Initiated Clinical Trials UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD CRC Scientific support services

Advice and expertise in study planning Sample processing and management Sample Storage Sample Analysis UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD CRC Scientific Services Activity Laboratory support Over 70 ongoing clinical trials and studies Analytical testing/core biomarker lab 7 International Studies 2 Multicentre clinical studies 3 Local research programmes

Biorepository 11 Major ongoing collections and registries 40+ Historical/archive collections Indirectly support studies at other sites UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Sample Management Activities in the Clinical Study/trial context Sample plan Sample shipping Sample collection

Sample analysis CRC SCIENTIFC SERVICES UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Sample storage Study Design - Sample plan Synergise Study activities across disciplines and physical locations Concept of sample utility maximising sample value

Sample integrity Data protection/ethical concerns Appropriate collection, processing and storage Logging and documentation UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Samples to be taken Processing

required Location, Materials, Transport, Tracking Facilities, Expertise Sample storage Access policy Facilities, systems +supports, Ethics application, Study SOP, Patient kit design etc

UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Cardiac Biobanking Studies - Initial Meetings Collection of LV/RV tissue samples from explanted hearts with associated plasma samples for future molecular and histological analysis. Samples for Molecular post mortem in cases of suspected SADS (national scope) Potentially expand to collect cardiac biopsies and blood Studies involve coordination of efforts between histopathology, biochemistry, cardiology, surgery and CRC. UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD

CRC Supports Contribution to drafting of protocol and ethics applications Design of sampling plan/collection logistics Design and provision of patient kits, sample tracking, labelling and logging Provision of space in monitored biobank UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Sample collection and processing Appropriate facilities Expertise and training Clear, well planned protocols

UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD DIP Study Currently ongoing at SVUH (PI Brian Kirby) Examining effect of (Dipeptidyl peptidase-4) DPP4 inhibition on psoriasis Primary endpoint clinical improvement Secondary endpoints include examination of PBMC cytokine expression, inflammation biomarkers, cardiovascular risk factors etc. UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Timepoint Blood tube

Process Aliquots Storage Visit 2 Purple Gold Grey Green DNA Serum Plasma (Dpp4) PMBC

Red blood cell lysis 8 aliquots 3 aliquots 5 aliquots -20C ERC -80C ERC -80C ERC LN2 CRC Visit 3 Gold Serum 8 aliquots

-80C ERC Visit 4 Gold Serum 8 aliquots -80C ERC Visit 5 Gold Grey Green

Serum Plasma (Dpp4) PMBC 8 aliquots 3 aliquots 5 aliquots -80C ERC -80C ERC LN2 CRC Visit 6 Gold Serum

8 aliquots -80C ERC Visit 7 Gold Serum 8 aliquots -80C ERC Visit 8 Gold

Grey Green Serum Plasma (Dpp4) PMBC 8 aliquots 3 aliquots 5 aliquots -80C ERC -80C ERC LN2 CRC UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD

DIP Study CRC Supports Patient Kits Laboratory and study protocol Labelling and logging Lab technician support for sample processing UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD DIP Study CRC supports Research clinical

facilities Samples to be taken Patient kits Order of draw info etc laboratory Processing required biobank Sample

storage Access policy Clear labelling, processing protocols Technical support UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Precise storage and logging instructions Sample shipping Paperwork

Processes Training, health and safety UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Sample shipping Sample receipt Sample receipt logs Package temperature records

Sample transfer to long term storage Reconciliation with shipment manifest Safe handling of dry ice UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Sample shipping Health and safety considerations with dry ice handling Appropriate packaging and labelling (IATA requirement) Creation of shipping manifest

Liaising with recipients, couriers etc Cold chain management UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Akinesis Study Co-funded by Abbott and Alere, this study recruited some 930 patients across 15 sites worldwide between spring 2011 and autumn 2013. CRC SVUH acted as core lab for the Abbott portion of this study, received 76 shipments over 3 years, as well as shipping samples to Alere and other and other sites. UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD

We drafted a series of forms and protocols to capture all essential elements of the shipping process Package sign in log Sample receipt and storage logs Package temperature reporting Shipping manifest forms UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Biomarker Analysis at CRC Biomarker core lab analysis facility at CRC SVUH Abbott architect ci4100, clinical analyser both standard clin chem panels, and novel biomarker immunoassays (ie NGAL, TnI)

In discussions with other vendors to expand capability of core lab UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD CRC Core Biomarker Lab Activity 30000 tests completed 25000 20000 15000 10000 5000

0 UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Key considerations Sample shipping, handling and storage Sample integrity quality control, chain of custody Instrument accuracy and precision familiarisation testing and daily QC UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD AKINESIS study

Testing of region 4000 urine samples in 5 batches over 3 years. Working closely with study sponsors to report progress, instrument performance/QC etc Working with both sponsors to report final study data UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Core lab workflow AKINESIS study Sample receipt Testing list Daily testing

FAM Reagents etc FAM report Daily testing log Reagent accountability Core lab study file UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Data compilation + validation

Testing report Data spread sheet UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Sample Storage - Biorepositories Infrastructure Procedures Systems UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Physical Biobank Infrastructure

Air con -20 -80 ventilation ln2 Secure power supply (15A breaker) Secure Access, monitoring etc UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD - The CRC has significant biobank facilities across both sites - LN2 crystorage facilities

- over 20 freezers hosted -collections from a wide variety of disease groups UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Monitoring system tscan Covers both biobank and IMP storage 2 hospital sites, 3 networks, 58 individual sensors, 60+ users UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD

Emergency response planning Redundant space is a key element of response to freezer breakdown. UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Recent developments New 2D barcode labelling system in place Improved, standardised soft and hard copy logs SOPs updated in line with best practise Biocollections handbook for investigators UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD

Biobanking national developments ISO TC 276 biotechnology Development of standards around a number of related areas, including biorepositories Consultative committee formed under the chair of Suzanne Bracken (MMI) UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Irish biobank association Development team formed, actively seeking feedback from stakeholders involved or interested in clinical biobanking. To develop of a corpus of support materials and to disseminate new material to members. To develop of a directory of biobanking activity in Ireland. To act as a focal point for interactions between the biobanking

community other agencies To increase awareness and understanding of the importance of biobanking. UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Sample plan Sample shipping Sample collection Sample analysis

CRC SCIENTIFC SERVICES [email protected] UCD School of Medicine & Medical Science Scoil an Leighis agus Eolaocht an Leighis UCD Sample storage

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