Attracting Clinical Trials To Ireland - Insights From The Pharmaceutical IndustryDr Itziar Canamasas, Bayer Ltd

May 13, 2019Mansion House, Dublin

Overview

• Clinical Trials Performance - Our Shared Ambition

• The IPHA survey of members

• How can we attract more trials?

• Questions and Answers

Clinical Trials Performance - Our Shared Ambition

Ireland Can Have a Lead Role for Clinical Trials in Europe

• Clinical trials have a key role in evaluating the safety and effectiveness of a medicine

• They can save lives and improve the standard of patient care

• A strong clinical trials infrastructure gives patients access to often life-saving trials

• Ireland is not as strong a location for trials in comparison to similar-sized countries such as Denmark

• We have recommendations for strengthening Ireland’s attractiveness – a shared ambition!

IPHA SurveyClinical Research Executive Group (CREG)

Survey Purpose• Baseline our current performance with start-up activities

• Explore the number and spread of trials

• Investigate the time it takes to get a site ready to recruit

• Identify whether sites are meeting their recruitment commitments

This will help us to…

• Gain an understanding of recent performance in terms of start-up speed and ability to deliver recruitment targets

• Identify roadblocks, quantify the extent of delays and propose policy recommendations

• Quantify a baseline to set and measure future targets against

Focus of CREG Survey

• Quantify and compare performance of nine metrics from 2013-2018

• Six start-up metrics measuring days between eight pre-defined dates

• Three recruitment metrics measuring % recruitment achieved

Data Collection

• Survey was designed to capture standard dates associated with initiating a clinical trial and recruitment metrics

• Survey data received from 14 companies totaling 189 clinical trials (to varying degrees of validity/completion)

• Data collection took place in November 2018

• Companies and trial brand anonymized

• Data was cleaned and validated

• A data model was created to explore trends

Responses From IPHA Membership

Sample Population Captured Is Just An Initial Snapshot

Source: i) HPRA Annual Reports ii) IPHA clinical research pilot survey 2018

96108108

8095

26312014120

20

40

60

80

100

120

20172016201520142013

Nu

mb

er

of

Tria

ls

Year of HPRA Approval

IPHA Survey Data Sample Capture

Clinical Trials Approved IPHA Survey Capture

ResultsA. Start-Up Metrics

Trial Start-Up Metrics – A Shared ResponsibilityRed = Industry; Blue = Competent Authorities; Green = Hospitals

Days from EC Submission to First Patient In242 Days (n=90)

Company Sub to HPRA:52 Days (n=80)

Date of R.E.C

Approval

Date of HPRA

Approval

58 Days (n=122)

86 Days (n=128)

EC Approval: 86 Days (n=128)

HPRA Approval:58 Days (n=122)

Final Sign-off on First

Contract

82 Days (n=111)

Contract Finalisation: 82 Days (n=111)

Site Green Light

37 Days (n=111)

Site Green Light: 37 Days (n=111)

62 Days (n=110)

First Patient In:62 Days (n=110)

Average Days

(n=Number of Trials Average is based)

Source: IPHA Clinical Research Survey 2018

Company Submission

to R.E.C

Company Submission

to HPRA

52 Days (n=80)

Study Submission

Package Release

Average of 9 months (260 Days; n=83)First

Patient In

62

18

11

6

5

5

4

2

2

1

1

1

175

180

202

199

346

116

254

174

169

128

171

264

0 50 100 150 200 250 300 350 400

Oncology

Cardiovascular

Immunology

Respiratory

Neurology

Infectious diseases

Haematology

Metabolic diseases

CNS

Nephrology

Womens Healthcare

Diabetes

Variances in Approval Timings From Ethics Committee Submission to Site Green Light

Ther

apy

Are

a

Number trials datacollected

Average of Dayscompany ECSubmission to SiteGreen Light

Increasing Trend in Post Ethics Approval Days

2013 2014 2015 2016 2017

Average of Days EC Approval to Contract Finalisation 74 70 59 74 77

Average of Days Contract Finalisation to Site Green Light 16 24 21 36 51

Number of Trials 11 10 17 26 29

7470

59

74 77

1624 21

36

51

0

5

10

15

20

25

30

35

0

10

20

30

40

50

60

70

80

90

Nu

mb

er t

rial

s d

ata

Cal

end

ar D

ays

Days Post EC-Approvalto Site Green Light

Average of Days EC Approval toContract Finalisation

Average of Days ContractFinalisation to Site Green Light

Number of Trials

Linear (Average of Days ECApproval to Contract Finalisation)

Linear (Average of Days ContractFinalisation to Site Green Light)

ResultsB. Recruitment Metrics by Therapeutic Area

Oncology 24 out of 45 (53%) Trials Hit Recruitment Target

Cardiology 7 out of 17 (41%) Trials Hit Recruitment Target

Immunology O Trials (0%)Hit Recruitment Target

Infectious Diseases

1 in 4 (25%) Hit Recruitment Target

Respiratory 1 in 5 (20%) hit recruitment target

How Can We Attract More Studies?

How Can We Attract More Studies to Ireland?

▪ Assess how start up activities can be more streamlined▪ Adopting an Ireland-wide standard site contract (The Clinical Trial Agreement)

▪ Protected research time for clinicians and hospital staff

▪ Understand how can we can shorten the timeline from contract signature to site green light

▪ Provide realistic targets that are achievable and be relied upon▪ Meeting a lower target is better than partially meeting a higher target

How Can We Attract More Studies to Ireland?

▪ Be consistent in our approach to clinical research across all institutions▪ Empower a central body to drive performance and ensure accountability ▪ Facilitate sharing best practice across sites

▪ Require more data to show our competitiveness with other countries▪ As an industry, we need to provide CT metrics to CREG to build on this initial baseline

research▪ As an industry, we need to consistently produce good quality documents for

Regulatory Bodies and Ethics Committees▪ Be more transparent around expectations - both from an industry and site

perspective

Generate discussion to create partnerships to improve landscape.

Thank You Feedback and Questions