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 IPHA Survey Data Sample Capture 108 108 120 96 95 Number of Trials 100 80 80 60 31 26 40 20 14 12 20 0 2013 2014 2015 2016 2017 Year of HPRA Approval Clinical Trials Approved IPHA Survey Capture Source: i) HPRA Annual Reports ii) IPHA clinical research pilot survey 2018
Results A. Start-Up Metrics
Tri rial Start-Up Metrics – A Shared Responsibility Red = Industry; Blue = Competent Authorities; Green = Hospitals First Study Average of 9 months (260 Days; n=83) Submission Patient Package In Release 242 Days (n=90) Days from EC Submission to First Patient In 82 Days (n=111) 86 Days (n=128) 37 Days (n=111) 62 Days (n=110) Company Date of Final Sign- Site Green Submission R.E.C off on First Light to R.E.C Approval Contract 52 Days (n=80) Company Date of Submission HPRA to HPRA Approval 58 Days (n=122) Company Sub to HPRA: Contract Finalisation: Site Green Light: First Patient In: EC Approval: 86 Average Days 52 Days (n=80) 82 Days (n=111) 37 Days (n=111) 62 Days (n=110) Days (n=128) (n=Number of Trials HPRA Approval: Average is based) 58 Days (n=122) Source: IPHA Clinical Research Survey 2018
Variances in Approval Timings From Ethics Committee Submission to Site Green Light 0 50 100 150 200 250 300 350 400 62 Oncology 175 18 Cardiovascular 180 Number trials data collected 11 Immunology Therapy Area 202 6 Respiratory 199 5 Neurology 346 Average of Days 5 Infectious diseases company EC 116 Submission to Site 4 Haematology Green Light 254 2 Metabolic diseases 174 2 CNS 169 1 Nephrology 128 1 Womens Healthcare 171 1 Diabetes 264
In Increasing Trend in Post Ethics Approval Days Days Post EC-Approval to Site Green Light 90 35 Average of Days EC Approval to Contract Finalisation 77 74 74 80 70 30 Average of Days Contract 70 59 Finalisation to Site Green Light 25 Number trials data 60 Calendar Days 51 20 Number of Trials 50 36 40 15 Linear (Average of Days EC 24 30 Approval to Contract Finalisation) 21 10 16 20 Linear (Average of Days Contract 5 10 Finalisation to Site Green Light) 0 0 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
Results B. Recruitment Metrics by Therapeutic Area
24 out of 45 (53%) Trials Oncology Hit Recruitment Target
Cardiology 7 out of 17 (41%) Trials Hit Recruitment Target
O Trials (0%) Immunology Hit Recruitment Target
Infectious 1 in 4 (25%) Hit Recruitment Target Diseases
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
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