Site Landscape Asia-Pac Site Solutions Summit 2016apsitesolutionssummit.com/wp-content/uploads/2016/07/1... · 2016-07-20 · Site Landscape Asia-Pac Site Solutions Summit 2016 Christine

Site Landscape

Asia-Pac Site Solutions Summit

2016

Christine Pierre

President

SCRS

[email protected]

#SCRS16 1

The Site Landscape

• Connecting patients to clinical trials through thousands of disease specific social media

patient communities.

• Over 1,000 research sites globally list their clinical trials on StudyKIK and are being

connected to qualified patients.

• Has built multiple tools for research sites to easily communicate with patients signing up

for the local clinical trials through StudyKIK.com including a instant patient text message

conversation tool & automatic appointment reminder system to name a few.

• StudyKIK's goal is to allow patients to easily find approved clinical trial information on a

local site level and give research sites the tools needed to easily streamline the

enrollment process.

Disclaimer • Any reference to companies is not an endorsement or statement of their

services.

• Check with your professional consultants (legal, financial, HR, etc.) to

obtain specific information pertaining to your company.

• This information is not meant to direct you on how to address any specific

issues.

• Antitrust–compliance policy adherence.

http://myscrs.org/24-revision-v1/policies/antitrust-compliance-policy/

4

A Visionary, Colleague, Friend & So Much More!

Katerina “Kat” Champion

2016 Asia-Pac Community Australia & New Zealand Ambassadors

Gina Kennedy - Chair Radhika Butala Radhika Butala Tam Nguyen

Tam Nguyen Megan Robertson Megan Robertson Jenny McGrath

Jenny McGrath Cheryl-Ann Hawkins Cheryl-Ann Hawkins April Josephsen

Anne Woollett Annette Corbitt April Josephsen Catherine May Elizabeth Wilson Katie Kennett

Katie Kennett Rachel Harris Carolyn Stewart Simon Carson

Todd Albin

Thank You!

• https://www.ted.com/talks/derek_sivers_how

_to_start_a_movement?language=en

6

Announcing & Celebrating a

New Collaborative Partnership

A Trade Organization Founded in 2012

Unify the Voice of the Global Clinical Research

Site Community for Greater Site Sustainability

2,800

42

Sites Strong

& Growing

Countries

SCRS Membership

50%

28%

14%

8% Practice

Freestanding

Hospital

Academic

11% Emerging Sites • 2% Developing Countries

5% Asia-Pac Region

82% 10+ yrs experience • All TA

• Drugs • Devices • Biologics

Sites Strong

& Growing

Scholarship

Thank you!

10

Member Benefits

Advocate Educate Connect Mentor

Advocate Educate Connect Mentor

• Members’ perspectives and voices

represented by SCRS to regulatory

agencies and industry stakeholders

• Promote your commitment to site

sustainability by proudly displaying the

SCRS logo

• Obtain TransCelerate GCP and EDC

recognized training for your site’s staff

• Gain critical insight from monthly and

featured webinars

Good Business Practices

Good Clinical Practices

Good Technology Practices

The Hidden Costs of

Conducting Clinical Research

at the Site

Inspection Readiness

• Receive critical information and stay

up-to-date with shifting trends and

practices through SCRS’ expert-driven

content

• Address site challenges through

exclusive thought leadership content

available in SCRS’ global journal,

InSite

• Access SCRS’ Study Opportunity

Platform, a hub where sponsors and

CROs provide study opportunities to

SCRS members

• Maximize your site’s exposure to

leading sponsors and CROs on

SCRS’ Member Site Directory

• Expand your membership

experience through participation in an

SCRS Community

Asia-Pac Summit

• Engage with industry stakeholders

and drive positive results through

participation in a Site Advocacy

Group (SAG)

• Access SCRS’ ListServ, a dynamic

and engaging platform for members

that facilitates positive change through

discussion and debate among your

peers

• Find solutions to business and

marketplace challenges through

SCRS’ mentorship program

• Join the Ambassador program and

bring more of SCRS to your region of

the world

Acurian

Australia Centralized Enrollment

& Retention

BMS

Protocol Review

EMD Serono

Protocol Review

Merge

Investigator Performance

Inventiv Health

INC Research

Scientific & Operational

Investigator Payments

TransCelerate

Shared Investigator Platform

E-Consent

E-Labels

Common Protocol Template

Patient Awareness and Access

Lilly

Innovation

SCRS Multi-Stakeholder Initiatives

13

Collaboration with TransCelerate Clinical Practice vs Clinical Research

Clinical Research Overview

Delegation and Training

Facilities and Equipment

Conducting a Study

IRB Ethics and Informed Consent

Essential Documents for a Clinical Study

Source Documentation

Investigational Product

Adverse Events and Safety

Monitoring and Auditing

Collaboration with CTTI

Corporate Partners

Your Summit Experience • No Whining, No Witching

• Focus on SOLUTIONS

• Have fun & meet lots of people!

Make the SCRS Connection THE PROTOCOL FOR SELFIES WITH FRIENDS

1 Experiment with angles

2 Stand in the light

3 Accessorize

4 Pose with someone new

5 Do something interesting – smile!

6 Adjust your shoulder placement

7 Show you’re having fun

8 Extend your neck forward

9 Hang out with cool/fun people: Summit People!

10 Post to social media

6 Site Solutions I Want to Share with You

1. Study Opportunities

2. Feasibility

3. Contracts

4. Site Study Dashboard

5. RBM

6. Site Payments

Impacting Your Site’s Sustainability

23%

37% 39%

51% 56%

77%

Source: SCRS Summit Survey 2015

Top 11 Pharma Companies by R&D Spend

Novartis Johnson & Johnson

Roche AstraZeneca

Pfizer GlaxoSmithKline

Merck & Co. Lilly

Sanofi Amgen

Bristol-Meyers Squibb

Source: EvaluatePharma 2015

Therapeutic Areas of Focus Therapy Area Count As a % Oncology & Immunomodulators 8,864 34%

Systemic Anti-infectivies 4,080 16%

Central Nervous System 3,572 14%

Various 1,497 6%

Musculoskeletal 1,211 5%

Cardiovascular 1,154 4%

Endocrine 1,064 4%

Respiratory 996 4%

Gastro-Intestinal 973 4%

Dermatology 831 3%

Sensory Organs 775 3%

Blood 596 2%

Genito-Urinary 557 2%

Total 26,171

Source: Evaluate Pharama 2015

Geographic R&D Spend

78.3%

15.2%

1.9% 1.1% 1.4% 0.5% 0.1% 0.1% 0.3% 0.0%

10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%

Source: Evaluate Pharama 2015

FDA (CDER) 2014 Inspections Africa 1% Asia/Pac

5% AUS 1% Canada

4%

Eastern EU 6%

Latin Amer 3%

Middle East/ Central Asia

1%

USA 74%

Western EU 5%

Source: PAREXEL Consulting May 2014

1. SCRS Study Platform Opportunities SCRS & have partnered to develop the Study Platform

It will provide:

Opportunities for companies to engage with SCRS member sites

Opportunities for SCRS members to proactively connect with companies and be evaluated

for potential participation in upcoming trials (access through secured member only portal) \

it does NOT guarantee site selection

SCRS invites other organizations to join the SCRS Study Opportunity Platform and engage

with committed sites

Pilot Includes:


Feasibility Realities

30 Minutes Average time sites spend

Feasibility: A Two Way Dialogue

Site Process

• 55% of sites provide a “Site CV” (info about their site)

– 59% - during feasibility

• 82% provide a Study Questionnaire (seeking study information)

• 52% require it returned prior to site selection

Source: SCRS Feasibility Survey 2015

How Was it Received? • 55% of sponsors/CROs report having received a Site CV

– 85% helpful in shortening the start up process

• 94% said they would be interested in receiving such a form

– 62% want it during feasibility

• 37% report having received a Study Questionnaire

– 95% would provided the information requested

– 48% said they can typically provide the information requested

Source: SCRS Feasibility Survey 2015

2. SCRS Feasibility Process & Tools

• White Paper & Tools

– Site CV template & Study Questionnaire

• Webinars

• Workshops

CHAIR

Vivienne van de Walle, MD, PhD, CPI

Medical Director & Owner

PT&R

Let us never negotiate out of fear.

But never let us fear to negotiate. John F Kennedy

Extremely or Very Burdensome

Source: DrugDev Investigator Survey 2015; 572 responses 9 countries

Study Start Up Realities

Source: goBalto 2014-2015 – 200 studies; 1000+ sites

REALLY 13 WEEKS

A Reminder of Our Responsibility

31

Meet TJ Sharp & His Family

“To you it’s a document.

To me it’s my life.”

TJ Sharp

32

3. Clinical Language Evaluation &

Reconciliation Charter (CLEAR)

• Addressing contract clauses “that matter”

Protocol Complexity

0

10

20

30

40

50

2000-2002 2003-2005 2006-2008 2009-2011 2012-2015

Pro

toco

l C

om

ple

xity (

Me

dia

)

Source: Medidata - N = 8275 studies, phase II & III, all TAs

Screen Failure Trends

0

10

20

30

40

50

2006 2007 2008 2009 2010 2011 2012 2013 2014

Scre

en

Fa

ilure

Ra

te

(Media

n)

Source: Medidata: studies > 10 sites N = 657 studies, phase II & III, all TAs

Screen Failure Rate

Source: Medidata Enrollment closed, studies > 10 sites, N = 657 studies, phase II & III, all TAs

Non Enrolling Sites By Country 1. South Korea

2. Japan

3. Bulgaria

4. Ukraine

5. Taiwan

6. Romania

7. Hungary

8. Czech Republic

9. Russia

10. Belgium

11. Spain

12. Poland

13. Canada

14. Sweden

15. Australia

16. United Kingdom

17. United States

18. Italy

19. Austria

20. France

21. Germany

22. Mexico

23. Netherlands

24. Argentina

25. Brazil

37 Source: Medidata *Phase 2 & 3 Only, 2010-2015 studies with closed enrollment ** where N > 150 studies

1. Brazil

2. South Korea

3. Japan

4. Sweden

5. Argentina

6. Austria

7. Bulgaria

8. Canada

9. Czech Republic

10. France

11. Germany

12. Hungary

13. Italy

14. Mexico

15. Netherlands

16. Romania

17. Spain

18. Ukraine

19. United Kingdom

20. Russia

21. Australia

22. Taiwan

23. United States

24. Poland

38

High Enrolling Sites By Country

Source: Medidata *Phase 2 & 3 Only, 2010-2015 studies with closed enrollment ** where N > 150 studies

Patient Reimbursement/Visit Worldwide 2012 – 2015 (Phase II & III)

$44

$49

$48

2012 2013 2014

Source: IMS Health May 2015

Patient Stipends

40

86

60

53

50

50

50

47

44

44

37

36

33

Ophthalmology

Devices & Diagnostics

Blood Disorders

Infection Disease

CNS

Pain

Musculoskeletal & Connective Tissue

Respiratory

Oncology

Genitourinary System

Dermatology

Cardiovascular US Dollars

Source: IMS Health May 2015

Do the Sponsors/CROs share…

24%

21%

61%

63%

15%

16%

0% 20% 40% 60% 80% 100%

...their performancemetrics for your site?

...any “benchmarking” information, so that

you can put your site’s performance …

Yes No Unsure


Give The Sites What They Need & Want

• 79% of sites report a desire to receive a Site Study

Dashboard

• 62% indicate receiving such feedback would

definitely allow them to improve the quality from

their site

Source: Site Solutions Summit 2013

Allergan Site Study Dashboard Project

• 71% found the metrics were helpful or extremely

helpful

• 100% indicated they use the data when received to

course correct and build a stronger site foundation

4. Site Study Dashboard Quintiles, Allergan, Apostle Site: Co-Chairs

• Identify metrics to be measured

• Format & frequency to provide sites feedback

nimblif y

Risk Based Monitoring – What Is It?

…strategies for monitoring activities that reflect a

modern, risk-based approach that focuses on critical

study parameters and relies on a combination of

monitoring activities to oversee a study effectively. For

example, the guidance specifically encourages greater

use of centralized monitoring methods where

appropriate.

FDA: Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring

RBM - At Least a Chuckle

Reasons for RBM

39

29

42 61 29

26

44

25

82

23 0

102030405060708090

Improve DateQuality

Hot Topic of theDay

Increase PtSafety

CostEfficiencies

Regulatoryrequirement

2013 2015Percent

Source: SCRS & Linking Leaders RBM Survey 2013, SCRS Summit Survey 2015

# 1 Reason for RBM

39

29

42 61 29

26

44

25

82

23 0

102030405060708090

Improve DateQuality

Hot Topic of theDay

Increase PtSafety

CostEfficiencies

Regulatoryrequirement

2013 2015Percent


Site’s Policy on Data Entry

0%

10%

20%

30%

40%

50%

60%

70%

Day of visit Within 3 days ofvisit

Within 4-10 daysof visit

When we havetime

20132014


Data Entry Reality

Source: Medidata Insights Metrics Warehouse 2014-Feb and Medidata analysis

RBM Impact on Quality & Resources

40%

11%

43%

59%

72%

54%

1%

17%

3%

Regulatory Obligations

Data Quality

Site's need for QA

Increase No Change Decreased


66%

57%

63%

6%

29%

37%

32%

72%

5%

6%

5%

22%

Work Load

Resource Needs

Costs

# of pts you can seeIncrease No Change Decreased

5. Sites are Impacting Change

• TransCelerate – Site Advocacy Group

• Intel Gathering & Collaboration

– Surveys

– White Papers

– Presentations

11% of sites fail to

enrol a single

patient;

37% under enroll1

Over the last 15

years, 86% of studies

failed to recruit on

time

Cost to maintain a site

is approximately

$1,500 per month3

2014, 65% of sites

surveyed have less

than

3 months operating

cash

Cost to initiate a site costs approximately $20,000-$30,0002

The ability to recruit and retain motivated, informed,

protocol-eligible patients starts with sites

Time, Resources, Cost

39% meet

enrolment

targets and

13% exceed1

Data and research from Society of Clinical Research Sites, 2014; 1. Tufts CSDD Impact report http://csdd.tufts.edu; 2.

Mishra E. Clinical Leader. Dec 19, 2013 http://www.clinicalleader.com/doc/; 3. Lamberti MJ, Brothers C, Getz, K.

Therapeutic Innovation and Regulatory Science. 2013;47(1):101-109

http://csdd.tufts.edu/

http://www.clinicalleader.com/doc/

Hours Spent Pre Study – SIV Average - 40 Hours

40 42 38

42

55

42

< 250K 251-500K 501-1M 1.1-1.6M 1.7-2.1 Over 2.2 M

By Annual Revenue


Non-Refundable Start Up Received

Sources: Site Solutions Summit Survey 2006, 2007, 2008, 2009, 2011, 2013, Drug Dev 2015

$2,376

$1,381

$2,550 $2,740

$3,205 $2,927 $3,429

2006 2007 2008 2009 2011 2013 2015

US Dollars

Average Reimbursement per Visit

Both exclude screen failures and discontinues

Source: CFS Clinical 2013, 2104, DrugDev 2015

$809

$847

$800

$880 $890

$772

$700

$750

$800

$850

$900

2013 2014 2015

w/vaccines w/out vaccines

Of Note

2000 sites were paid

~$500/visit

Protocol complexity

has increased ~50%

Overhead

0% 5% 10% 15% 20% 25% 30% 35% 40%

< 10%

11-15%

16-20%

26-30%

30% +


Withholding Trends

Source: Site Solutions Summit 2007, 2008, 2009 & 2010, 2013 CFS Clinical n= 11,427 studies,

2015 DrugDev n= 23,810 studies

Profit Margin

Source: SCRS Summit Survey 2011, 2013, 2014, 2015

0% 20% 40% 60% 80% 100%

Guaranteed payment in 30 days

Same payment system acrosssponsors

67%

64%

77%

64%

<5 Studies 5+ Studies

Associated Value

Source: DrugDev Investigator Survey 2015; 572 responses 9 countries

Current Payment Term Practices

Monthly 37%

Quarterly 63%

Source: Greenphire n=520 sites, 2016

80% prefer monthly payments

60% quarterly payments negatively impact study operations

85% prefer to work with sponsors and CROs that automate

& pay monthly

Source: Greenphire n=520 sites, 2016

6. SCRS Site Payment Initiative

Inc Research, Novartis, HCA: Co-Chairs

• Terms & Process

nimblif y

• Education and tools focused on being a sustainable site

• Diverse patient engagement

• Best Site Practices

• Technology and Sites

• Site Advocacy Groups

• Ambassador Program:

Australia, New Zealand, Korea, Twain, Japan, UK, Poland

SCRS Forward Thinking

Our Voice. Our Community.

• Recognizes the site whose recruitment plan & execution

demonstrates dedication to innovation and excellence in patient

recruitment

• Finalists notified August 26th

• Finalists will present their ideas during the Global Summit

• Winner will be announced following the presentations

Site Patient Recruitment Innovation

Award

sitesolutionssummit.com/agenda/site-patient-recruitment-innovation-

award/

• A platform for sites to share innovative technology ideas which

would enhance their operations

• Sites will be asked to submit their ideas prior to the Global

Summit; 3 finalists will be selected by panel of independent

judges to present at the Global Summit

• Winner will be announced following the presentations

sitesolutionssummit.com/agenda/site-tank

Site Tank

Let Your Voice be Heard

• Summit Survey

• Eagle Award

October 13-16, 2016 Boca Raton, Florida

Together We Are Stronger

Thank You for Being SCRS Strong

71

• A leading full-service provider of clinical trial patient enrollment and

retention solutions for the life sciences industry.

• Increases the enrollment performance of investigator sites worldwide by

identifying, contacting, prescreening, and referring people who live in

the local community but are unknown to a research site.

• As a result, trial sponsors complete enrollment without incurring the

unexpected expense of adding sites, time, or CRO change orders.