Ir Ireland - In Insights From The Pharmaceutical In Industry ry - - PowerPoint PPT Presentation

Attracting Cli linical Tria ials To Ir Ireland - In Insights From The Pharmaceutical In Industry ry

Dr Itziar Canamasas, Bayer Ltd

May 13, 2019 Mansion House, Dublin

Overview

• Clinical Trials Performance - Our Shared Ambition
• The IPHA survey of members
• How can we attract more trials?
• Questions and Answers

Cli linical Tria ials Performance

• Our Shared Ambition

Ir 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!

IP IPHA Survey

Clinical 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 f 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 IP IPHA Membership

Sample Population Captured Is Is Ju Just An In Initial Snapshot

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

96 108 108 80 95 26 31 20 14 12

20 40 60 80 100 120

2017 2016 2015 2014 2013

Number of Trials

Year of HPRA Approval

IPHA Survey Data Sample Capture

Clinical Trials Approved IPHA Survey Capture

Results

• A. Start-Up Metrics

Tri rial Start-Up Metrics – A Shared Responsibility

Red = Industry; Blue = Competent Authorities; Green = Hospitals

Days from EC Submission to First Patient In

242 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-

• ff 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

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

Therapy Area

Number trials data collected Average of Days company EC Submission to Site Green Light

In 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

74 70 59 74 77

16 24 21 36 51

5 10 15 20 25 30 35 10

20 30 40 50 60 70 80 90

Number trials data

Calendar Days

Days Post EC-Approval to Site Green Light

Average of Days EC Approval to Contract Finalisation Average of Days Contract Finalisation to Site Green Light Number of Trials Linear (Average of Days EC Approval to Contract Finalisation) Linear (Average of Days Contract Finalisation to Site Green Light)

Results

• B. 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 Ir 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 Ir 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