outsourcing in clinical trials europe 2014 · outsourcing in clinical trials europe 2014 21-22 may...
TRANSCRIPT
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
Time to bust e-recruitment myths!
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
Time to bust e-recruitment myths!
....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
Time to bust e-recruitment myths!
…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)
(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
Time to bust e-recruitment myths!
…patients aren't on the internet
6
EUROPE – Regional Facts
Internet Usage and Population Statistics for Europe
Population
(in Millions)
Internet Usage
(in Millions)
% Population
(Penetration)
(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
Time to bust e-recruitment myths!
…patients aren't on the internet
7
Asia – Regional Facts
Internet Usage and Population Statistics for Asia
Population
(in Millions)
Internet Usage
(in Millions)
% Population
(Penetration)
(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
Time to bust e-recruitment myths!
…patients aren't on the internet
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 %
Time to bust e-recruitment myths!
…patients aren't on the internet
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
Time to bust e-recruitment myths!
…e-recruitment doesn't work
Agenda
10
....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
Tactic Channel % of Conversions
Search Engine Marketing(SEM – i.e. AdWords)
10% of conversions
Time to bust e-recruitment myths!
…e-recruitment doesn't work
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
Time to bust e-recruitment myths!
…e-recruitment doesn't work
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
Time to bust e-recruitment myths!
…e-recruitment doesn't work
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
Time to bust e-recruitment myths!
…e-recruitment doesn't work
It works! But only if you track every single step constantly!
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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
Advertising
Direct
Mailing
Tracking
Reporting
SMO
Hospital
Practice
Call Center
Screening
Time to bust e-recruitment myths!
…e-recruitment doesn't work
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
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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
Time to bust e-recruitment myths!
…e-recruitment doesn't work
Online advertising / recruitment will not be accepted by ECs / IRBs!
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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
Time to bust e-recruitment myths!
Agenda
17
....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
Time to bust e-recruitment myths!
…sites don’t like it
Site Survey 2013
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• 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
Time to bust e-recruitment myths!
…sites don’t like it
• Green bars are above average rate of completed survey per invitations
(15.5%)
• Receiving the survey invitation in native language had no impact19Strictly Confidential
Time to bust e-recruitment myths!
…sites don’t like it
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%
Time to bust e-recruitment myths!
…sites don’t like it
While >80% work only half-time or less (<20h) on clinical trials, more than
half state that they work on clinical trials exclusively
21Strictly Confidential
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%
Time to bust e-recruitment myths!
…sites don’t like it
22Strictly Confidential
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
Time to bust e-recruitment myths!
…sites don’t like it
23Strictly Confidential
Would you recommend using
Online Recruitment? (n = 242)
By background: MD vs. other
(n = 242)
24
ReferPre-ScreenEstablish
ContactReach Patient Randomize
Time to bust e-recruitment myths!
…sites don’t like it
Step ❷-❸-❹-❺
Online- / Call Center-
Pre-Screening
Step ❻
Investigator Account
Step ❶
Online Awareness Campaign
6.000referrals
~11.000
Pre-Screens
~18.000 DB Reg’s
Time to bust e-recruitment myths!
…sites don’t like it
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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
Time to bust e-recruitment myths!
Agenda
28
....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
Time to bust e-recruitment myths!
…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
Time to bust e-recruitment myths!
…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