Innovative Hospital Partnership Model for High Quality Patient Clinical Trials

INNOVATIVE HOSPITAL PARTNERSHIP MODEL

FOR HIGH QUALITY PATIENT CLINICAL TRIALS

– CENTRAL & EASTERN EUROPE ONCOLOGY

TRIAL CASE STUDY

Istvan Udvaros Bela E Toth

Medical Director and CEE Expert

Project Director Oncology Senior Consultant for SGS

SGS

2 SGS BIOPHARMA DAY – OCTOBER 25, 2016

SGS CONCEPT FOR PATIENT TRIALS –

THE SGS ADDED VALUE

SGS has the know-how in Early Phase as a

major player in the Phase I ground

SGS targets Phase I/b (-II/a) on patients as well

to cover all EP clinical services

To increase access to patients, satellite project

was initiated in cooperation with selected

hospitals

Functional ownership on operations via

SGS clinical teams present for trial execution

excellence

SGS quality documents are used for full

transparency

SGS inspected sites (by independent auditors)


AZSM – THE BELGIAN EXAMPLE

8 bed patient unit

Dedicated to Phase I trial requirements

Full access to CPU know-how, expertise, services

Dedicated CRC for AZSM projects

SGS CPU Investigator available for trial

SGS CPU SN/Lab techs could be available

All trainings will be done in /by CPU staff

CPU Pharmacy support

Large public hospital with good access to patients

Oncology (solid and hematology)

Respiratory

Neurology

Orthopedics

Organ impairment (hepatic and renal), etc.

Strong motivation to work with us

due to hospital development strategy


OUR SATELLITE PROJECT FOR CEE/HUNGARY

CEE as targeted region

In proximity

EU member countries

EU guidelines, customs, IMP imports, etc..

Centralized health care systems

Motivated investigators

Some limitations to new therapy access

Hungary as selected pilot country

10 million population

High morbidity rates (oncology)

Government initiative to support clinical trials

Improving regulatory conditions (45 days for

2017, targeting 28 days for 2018)


THE SGS PATIENT UNIT IN THE HEALTH

CENTER OF HUNGARIAN DEFENSE FORCES

Medical Center HDF is one of the largest

hospital complex in Hungary

Number of beds: • 1200 active

• 600 rehabilitation/chronic care

Access up to 2 million people • army, police , fire brigades, government

• northeastern districts of Budapest

• counties north of the capital

Oncology Department

44 standard plus 20 day-care beds

12 medical doctors (8 board certified, 4 residents),

45 clinical trials with 369 enrolled patients 2011-16

3 study nurses, 3 coordinators (part time)

supporting LP trials


SGS UNIT CHARACTERISTICS

5 bed / 2 patient room unit separated from

standard of care hospital area

Attached to oncology department

SGS office within department for permanent staff

Research physician, study nurse, CRC

ICU, pharmacy within same building

Access to other indications

Rheumatology

Dermatology

Neurology

Gastrointestinal diseases

Cardiology

Etc…

Suppose photo will be added


ACCESS TO OTHER SATELLITES / PHASE I UNITS

ON COUNTRY LEVEL

18 licensed Phase I Units in Hungary (including SGS) –

9 are pre-qualified as potential partners

Additional sites might be supported to fulfill Phase I /

EP requirements

SGS can use country team and their expertise to

Site selection / qualification

Investigator relations – feasibility accuracy

Start up support

Identifying all gaps and go for solutions with the site

Provide resources, equipment, tech training, etc…

Hospitalier Order of St John hospital – case study

Hospital: Phase I Unit, biologicals expert PI, pharmacy, hospital

services

SGS: clinical team for execution, SGS work docs and templates,

study coordination, spec equipment


TRENDS IN CLINICAL RESEARCH

Globalization of Industry-Sponsored Trials

The balance to Pharmamerging markets

• Trends of movement away from traditional destinations (NA, W-

Eu)

• CEE countries continues to dominate highest market share gain

over the last years

• The Industry-sponsored product development growth rate of

trials in trends does not necessarily follow product sales growth

More complex Regulatory/EC procedures

• Country specific, needs local knowledge

Highly integrated systems (EDC, CTMS, IT, DM, eCRF, QA)

• Need for on-site /data entry by assigned study personnel

• Site access for global remote / and RBM monitoring

• Access to patient data by Safety and Adaptive Design reasons

• High demand for qualified/trained professional staff at site-level


CEE: POTENTIALS AND THE PRACTICE

Patient access

National Healthcare and

Insurance system

Feasibility by epidemiology

related indicators

Access to patient data in

regional clinics/hospitals

Information and education

for patients: trial access

Investigators’ networking

Support patients access

Regulatory environment

Competent Regulatory

<60days

Improved efficiencies with

ethics review process (<45

days)

Reasonable Costs and

Benefits

„Ready to” EMA/FDA

Short, predictable timelines


CEE - PROVEN QUALITY IN CLINICAL RESEARCH

Countries where the Clinical Quality is properly defined

and maintained throughout clinical conduct

Transparency and regulatory compliance

The „oral and written culture” of clinical reseearch

Adherence to FDA Access to Risk Based Quality

Management

Compliance to EU-regulations/FDA -guidelines

Centralised supportive procedurals to remain competitive

Experiences accumulated in the CEE/ Hungary „… along with the outstanding scientific quality may enable the

country to maintain the current quality of clinical trials, moreover, …

is considered a major value in Europe…”

“CEE was also the region with the lowest percentage of inspections

that required official or voluntary action… quality standards that are

not inferior to those in Western regions.” FDA inspections data referred by Longtaal Oct 2008 – Sep 2015)

AIPM (2015); Calderon (2012); Dutton, G. (2015)


THE CONCEPT

Smart-transitioning into Late-Phase trial environment

Expanded coverage

Durable and do-able

Achievable

Consequent

the proven

concept of

satellite-

site

Late

Phase

Trials • trial-methodology

• trained staff

• systems/ QC

• tailored start-up


THE CONCEPT:

TRANSITION FOR LATE PHASE TRIALS 1/3

What is needed for success in Late-Phase clinical trials?

Considering the research trends and technology • Study design and advanced tools in use

Site selection methodology • Experience, proven track record of a therapeutic field

• Relationship, trust and providing trained staff

Scientific collaboration b/w partners • Scientifc values throughout in trial development

Startup timelines: included Regulatory and Contract • Manage complexity and provide ready-made resolution intergrated to systems

Patient access

Site and staff readiness

Clinical quality

fail to meet

enrolment targets*

to be terminated or

recruit for rescue*

fail to enroll a

single patient*

Li G. Site Activation: The Key to More Efficient Clinical Trials. PharmExec. 2008.

http://www.pharmexec.com/site-activation-key-more-efficient-clinical-trials?pageID=2. Accessed September 10, 2015.


THE CONCEPT: CONTINUED SCIENTIFIC SUPPORT

IN TRANSITION FOR LATE PHASE 2/3

Managing the scientific challenges in drug development

Scientific contributions during the early phase programs

• Adequate data prior the decision to move to Phase 3

• Impact of study design, endpoints

• Potential issues on patient recruitment: clinical benefits, timelines

The specific challenges vary with the therapeutic area

• The estimated success rate is fairly low (in oncology and some

other therapeutic areas)

• Problems resulting in inaccurate information from the Phase 1/2

• Potential issues with the design and implementation of the

Phase 3 programs

Anastassios D. Retzios,: Why Do So Many Phase 3 Clinical Trials Fail?. 2010 - Pavlou AK and Reichert JM: 2010. Nat Biotechnol 22: 1513-1519 - Kola I and Landis J: Nat Rev

3: 711-715, 2004 - Industry Success Rates 2004, Centre for Medicines Research International Ltd. CMR04-234R, May 2004


THE CONCEPT:

TRANSITION FOR LATE PHASE TRIALS 3/3

The patient enrollment is determined by Sponsor (internal

business planning process),

varies by Sponsor’s plan and therapeutic area/disease state

site activation accounts for about 70% of enrollment time

NOT driven by individual investigator sites

Duration of site activation process can be reduced

Site activation is the driver in patient enrollment

Site selection

Site activation

Patient recruitment


SITE ACTIVATION IS THE DRIVER

What is needed to add value for Late-Phase clinical trials?

Pre-selected sites

• Past experiences in specific indications

• Enhance staff readiness

• SGS-certified training modules

• The site’s potential for performance

Other conditions

• Investigator relationship

• Budget, scientific value, novelty etc..


Site selection

Site activation (start-up)

Patient recruitment

1.


STARTUP

What is needed to add value for Late-Phase clinical trial?

Site-tailored business model

Enhanced study start-up

• Contracting and legal terms

• Budget and parties

• Procedural elements for LEC/ MEC Ethics Boards (EC)

• Essential documents

• Clinical supplies


Site selection


Patient recruitment

2.


PATIENT ACCESS

What is needed to add value for Late-Phase clinical trials?

Pre-selected sites

• The smart reserach planning (SRT) tool for enrolment

• Staffing support (SC / SN level)

• Qualified local research staff

Advanced track record of high enrolment in the CEE-region

Centralised health-care system/ access to patients in specific

indications


Site selection


Patient recruitment 3.


TRANSITION FOR LATE PHASE TRIALS

Satellite site Phase I unit

SGS research methodology

and culture:

Site level SOP

Research staff

• Study coordinator/

study nurse

SGS training modules

Clinical Quality

Ongoing relationship

Oncology sites for Phase

II/III. trials

Site with a lack of proper:

Management and

methodology

Site level SOP

Research staff

• CRC, data entry, SN

Trainings /TNA plan

Quality Assurance

Build relationship


TRANSITION FOR LATE PHASE TRIALS

Staffing of Satellite site

Phase I. unit

Supporting the Oncology

Phase II/III. sites

SGS-certified Pre-selected sites

SGS staff support (SC/SN level)

SGS-Startup methodology

Scientific management by SGS

SGS Clinical Quality

SGS Clinical Training Modules


CASE STUDY ONCOLOGY

Phase 2 breast cc immunotherapy trial with

experimental PK profiling part within trial

Hungary (and Poland) involved from CEE region

4 Hungarian sites, 2 with Phase I capabilities

(including SGS) – approved to participate PK part of

trial

SGS clinical team has full control above its own site

and supports other site with training and logistics

SGS teams (clinical and clin ops plus quality) are

working together for excellent site management and

overall trial success


Life Sciences Istvan Udvaros MD MSc

Medical Director Clinical Research

Project Director Oncology

SGS Belgium NV Phone: + 32 (0)15 28 30 46

Generaal De Wittelaan 19A, Fax: + 32 (0)15 27 32 50

B-2800 E-mail : [email protected]

Mechelen

Belgium Web : www.sgs.com/lifescience

THANK YOU FOR YOUR ATTENTION

+ 41 22 739 9548

+ 1 866 SGS 5003

+ 65 637 90 111

+ 33 1 53 78 18 79

+ 1 877 677 2667

+ 33 1 41 24 87 87

https://www.linkedin.com/company/sgs-life-sciences


QUESTIONS ?


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Innovative Hospital Partnership Model for High Quality Patient Clinical Trials