Outsourcing in Clinical Trials Europe 2014 · Outsourcing in Clinical Trials Europe 2014 21-22 May 2014, Brussels, Belgium. ... Colombia - NEW South Africa Australia New Zealand -

TIME TO BUST E-RECRUITMENT MYTHS!

Outsourcing in Clinical Trials Europe 2014

21-22 May 2014, Brussels, Belgium

Time to bust e-recruitment myths!

2

…you not only saved us a couple of months time,

but definitively disproved two myths

that have kept us very skeptical…

1st

Online

patient recruitment

doesn't work

internationally

2nd

Online advertising

will not randomize

a large number

of patients


3

Germany

Switzerland

Austria

France

Spain

(Portugal)

Netherlands

Belgium

Italy

UK

Ireland - NEW

Denmark

Sweden

Finland

Norway - NEW

Poland

Czech Republic

Russia

Hungary

Latvia

Estonia

(Romania)

Ukraine - NEW

Israel

Turkey

India

Japan

Korea, South - NEW

Canada

USA

Mexico

Brazil

Argentina

Chile

Colombia - NEW

South Africa

Australia

New Zealand - NEW

USA

60 – 70 % of business

EUROPE

30 – 40 % of business

Industries attitude towards patient recruitment services

1st Question = HOW? 1st Question = WHAT??

low acceptance

low experience

well established

very experienced


....a sales conversation

4

....my patients aren't on the internet

we've already done online recruitment and it doesn't work

sites don't like it, low quality of patients

online patient recruitment only works in certain countries


…patients aren't on the internet

5

North America – Regional Facts

Internet Usage and Population Statistics for North America

Population

(in Millions)

Internet Usage

(in Millions)

% Population

(Penetration)

Facebook

(in Millions)

Canada 34,3 28,5 83.0 % 18,1

Mexico 114,9 42,0 36,5 % 38,5

United States 313,8 245,2 78.1 % 166,0

TOTAL 463,0 316,0 68,3 % 222,6



6

EUROPE – Regional Facts

Internet Usage and Population Statistics for Europe

Population

(in Millions)

Internet Usage

(in Millions)

% Population

(Penetration)

Facebook

(in Millions)

TOTAL 820,9 M 518,5 M 63,2 % 250,9 M

Russia 142,5 M 67,9 M 47,7 % 8,0 M

Monaco 30,510 30,700 100,6 % 36,220

Vatikan City 535 480 89,7 % 20



7

Asia – Regional Facts

Internet Usage and Population Statistics for Asia

Population

(in Millions)

Internet Usage

(in Millions)

% Population

(Penetration)

Facebook

(in Millions)

TOTAL 3,922 1,076 27,2 % 254,3

China 1,343 538,0 40,1 % 633,3

Korea, South 48,9 40,3 82,5 % 10,0

India 1,205 137,0 11,4 % 62,7



8

Germany

Austria

France

Spain

Netherlands

Belgium

Italy

UK

Denmark

Sweden

Poland

Czech Republic

Russia

Hungary

Israel

Japan

Korea, South

China / Taiwan

Australia

Canada

USA

Mexico

Brazil

Argentina

Top 25 Countries (CT.gov)*

excl. China / Taiwan*(Recruiting | Excl. Unknown | Interventional Studies | Adult, Senior |

Phase 2, 3, 4 | Industry)

= 77% of global recruiting trials

Internet Usage and Population Statistics for Top 25 countries

Population

(in Millions)

Internet Usage

(in Millions)

% Population

(Penetration)

TOTAL 1,345 847,8 63,1 %



9

MDD – 12 Countries – 1 Y CVD – 14 Countries – 3 M AD – 1 Country (NA) – 6 M

1,8 Million Responses2,3 Million Responses

30,067 Registrations

9,828 Referrals

2,665 Scheduled

572 Enrolled

0,6 Million Responses

2,990 Registrations

570 Referrals

190 Scheduled

94 Enrolled

1,203

1,139

917 726

568 479

298

119 65

13 1 1

1,046

1,257

1,017

880

571 416

319 385

289 223

138

30

RE

FE

RR

AL

S

CALENDER WEEKS


…e-recruitment doesn't work

Agenda

10





Tactic Channel % of Conversions

Search Engine Marketing(SEM – i.e. AdWords)

10% of conversions



What's e-recruitment / online patient recruitment for you?

11

Display-Marketing(Banner)

60% of conversions

Social Media(Banner / Text)

20% of conversions

Database- /

Affiliate-MarketingSubjects who have opted into receive

emails about a specific disease10% of conversions



12

Develop and optimize online

media campaign

Example:

Targeted on region of the site (i.e.

Brussels, 1.9 million user)

Population, total = 10.4 million

Internet penetration = 77.8%

(8.1 million user)

Social media / Facebook = 42.3%

(4.4 million user)

Top websites visited differ in each

country

13



Advertising targeted to people

around the clinical trial center

Using internet protocol (IP)

information, ads can be limited to a

specific area

Radius can be increased/decreased

depending on the population in the

area

Sites provide input on the size of

the advertising radius

Reduces the number of subjects

submitting referrals from too far

away



It works! But only if you track every single step constantly!

14

Tracking

Reporting

SMO

Hospital

Practice

Call Center

Screening

Online

Screening

Patients

&

Relatives

Patient

Organizations

HC-Profs.

Information

Registration

Awareness

CampaignWebsite

Pre-

ScreeningReferral Enrollment

SEM

Google etc.

Banner

Advertising

Enrolled

Online

Social Media

Print

Advertising

Direct

Mailing

Tracking

Reporting

SMO

Hospital

Practice

Call Center

Screening



Online

Screening

Patients

&

Relatives

Patient

Organizations

HC-Profs.

Information

Registration

Awareness

Campaign

ClinLife

Study Website

Pre-

ScreeningReferral Enrollment

SEM

Google etc.

Banner

Advertising

Enrolled

Online

Social Media

15

Print

Advertising

Direct

Mailing

Marketing

Report

Registration

& Funnel

Call Center

& Screening

Report

Site Activity

ReportOptimization

Approved = 174 of 187 - 93%(1st submission)

Average time to approval = 23 days



Online advertising / recruitment will not be accepted by ECs / IRBs!

16

In April 2008 we started to track

outcome of EC / IRB submissions for:

• campaigns & materials designed by Clariness

• the respective authorities in 33 countries

• a total of 187 submissions until 2014

• SEM Messages / AdWords / Banner

• Call Center Scripts

• Landing Pages / Study Descriptions

• Email Content etc.

• AND Data Protection MeasuresPortugal - Advertising not accepted

Slovakia - Advertising not accepted

Romania - Advertising not accepted

Croatia - Advertising not accepted


Agenda

17






…sites don’t like it

Site Survey 2013

18

• 361 of 1,564 invited investigators started to fill out the survey (23.1%)

• 242 participants completed the whole survey (15.5% and 67%, respectively)

• The survey participants are located in 18 countries, although 65.7% are from

the US and Germany

• The survey had a maximum of 64 questions, depending on certain answers

(Avg. time to complete: 17:25 min)

• The survey was available in 4 languages: EN, DE, PL, and ES

• 12% of the invitations were sent to non-native speakers in English. This had no

statistical effect on completion rate



• Green bars are above average rate of completed survey per invitations

(15.5%)

• Receiving the survey invitation in native language had no impact19Strictly Confidential



20Strictly Confidential

Site type of survey participants (n = 242)

Completed by site type

Site type Completed Percent

SMO 60 24,8%

Hospital, total 104 43,0%

Hospital, University 65 26,9%

Hospital, Governmental 18 7,4%

Hospital, Private 21 8,7%

Private practice 74 30,6%

Other 4 1,7%



While >80% work only half-time or less (<20h) on clinical trials, more than

half state that they work on clinical trials exclusively


Time worked on trials per week (n = 242) When do you manage clinical trials?

(n = 242)

0

10

20

30

40

50

60

70

80

90

100

≤ 5 h 6 - 10 h 11 - 15 h 16 - 20 h 21 - 25 h 26 - 30 h 30 - 35 h 36 - 40 h ≥ 40 h

80.6%




How do you decide which trials to prefer?

(n = 121; MC)

Average no. of simultaneous trials

(n = 242)

0

20

40

60

80

100

120

1 2 to 3 4 to 10 11 or more




Would you recommend using

Online Recruitment? (n = 242)

By background: MD vs. other

(n = 242)

24

ReferPre-ScreenEstablish

ContactReach Patient Randomize



Step ❷-❸-❹-❺

Online- / Call Center-

Pre-Screening

Step ❻

Investigator Account

Step ❶

Online Awareness Campaign



25

26



6.000referrals

~11.000

Pre-Screens

~18.000 DB Reg’s



27

1. 800.000 Responses / Clicks

2. 18.000 Trial / DB Registrations (100%)

3. 11.000 Online Pre-Screenings (60%)

4. x Call Center Screening (outbound, N/A)

5. 6.000 pre-qualified referrals (33%)

6. 15 % expected enrollment

Minimum Workload / Site (if ~200 out of ~400):

= ~ 30 pre-qualified referrals / Site

= ~ 10 pre-qualified referrals / Site / Month

= Feasible

30 Referrals / Site

WebWeb

~800.000 Responses /

Clicks

• Funnel calculated on 8 previous outreach campaigns / projects in EUROPE,

4 countries, adapted to protocol specifics

• No US campaigns included


Agenda

28






…is e-recruitment doable internationally?

29

ClinLife Regional Distribution

Visits & Page views 2013

Visits Pageviews %

North America 3,018,986 4,207,103 36 %

Western Europe 2,702,638 4,627,249 33 %

Eastern Europe 1,611,798 2,129,251 19 %

South America 555,635 699,745 7 %

APAC 207,279 273,898 3 %

Africa 178,591 270,773 2 %

TOTAL 8,274,927 12,208,019 100 %

HU – Hungary – Western Europe

#www

(in Millions)

%

(Penetration)

Hungary 9,9 6,5 65,4 %

Visits Studies %

872,470 351 2

ZA – South Africa - Africa

#www

(in Millions)

%

(Penetration)

Africa 48,8 8,5 17,4

Visits Studies %

178,591 187 1


…is e-recruitment doable internationally?

30

ClinLife Regional Distribution

Visits & Page views 2013

Visits Pageviews %

North America 3,018,986 4,207,103 36 %

Western Europe 2,702,638 4,627,249 33 %

Eastern Europe 1,611,798 2,129,251 19 %

South America 555,635 699,745 7 %

APAC 207,279 273,898 3 %

Africa 178,591 270,773 2 %

TOTAL 8,274,927 12,208,019 100 %

Argentina – South America

#www

(in Millions)

%

(Penetration)

Argentina 41,7 28,0 67,0

Visits Studies %

449,080 239 1

QUESTIONS ?

Clariness GmbH

Rütersbarg 46

D-22529 Hamburg

Germany

Phone: +49-(0)40-298 678 01

Fax: +49-(0)40-298 678 06

Mobile: +49-(0)171-659 20 16

Email: [email protected]

Web: www.clariness.com

Nils Drews, MDCMO, Executive VP

Documents

Outsourcing in Clinical Trials Europe 2014 · Outsourcing in Clinical Trials Europe 2014 21-22 May 2014, Brussels, Belgium. ... Colombia - NEW South Africa Australia New Zealand -