PREVIEW Benchmarking European Investigator Payments Info@ISRreports.com 2014 Industry Standard Research www.isrreports.com
Report Overview This report provides an analysis of Europe s clinical trial compensation for investigator payments across 18 therapeutic areas, 5 compound types, and the 4 phases of development. It provides pharmaceutical, biotech, and service providers an opportunity to gain a better understanding of what drives investigator payments so they can benchmark their payment levels and better plan for study costs. Methodologies: Germany = 40 respondents France = 39 respondents Eastern Europe = 20 respondents UK = 43 respondents ISR conducted 142 online quantitative surveys with respondents who Currently work at a research site are located in Western or Eastern Europe have responsibility for investigator payments 312 Charts and Graphs 104 Pages Q1, 2014 Publication Date Report Structure: 1. Executive Summary 2. Benchmarking Investigator Fees Phase comparison by specialty/therapeutic area Compound type compensation by specialty/therapeutic area Region/ country comparison by phase Region/ country comparison by compound type 3. Investigator Payment Dynamics Understand what motivates investigators to participate in clinical trials and where compensation falls in the rankings. ISR presents respondents with clinical trial scenarios and asks how investigator fee requirements would need to change as inclusion/exclusion criteria, visit frequency, and difficulty of test schedule are varied. 4. Profiled Specialty/Therapeutic Area 5. Site and Respondent Demographics Therapeutic Areas Evaluated: Analgesic/Pain Management Cardiovascular CNS Dermatology Gastrointestinal Hematology Infectious Diseases Internal Medicine Metabolic Diseases Musculoskeletal/ Arthritis Compound Types Included: Biologic Biosimilar Me-too Generic Oncology Ophthalmology Orthopedics Pediatric Respiratory/Allergy/ Pulmonology Novel Urology Vaccines Women s Health www.isrreports.com 2014 Preview of: Benchmarking European Investigator Payments 2
What you will learn in this report: Average compensation investigators receive per subject for each therapy area by phase and compound orientation/ type How study characteristics (length and complexity) change fee levels What motivates investigators to participate in a trial Therapeutic area profiles How you can use this report: Optimize your investigator payments across therapeutic areas, phases of development, compound type under investigation, and geography Establish and better negotiate investigator payments Use trial complexity and length of study as variables to create more accurate budget projections and lower costs Valuable for: Project Management Clinical Operations Outsourcing Trial Budgeting Feasibility CRO Proposals Up next: Full table of contents and sample pages www.isrreports.com 2014 Preview of: Benchmarking European Investigator Payments 3
Table of Contents Copyright and Usage Guidelines Introduction Methodology Respondent Demographics and Qualifications Primary Role at Research Site Office Location by Geography Office Setting Major Sections Executive Summary Average Compensation per Patient Average Compensation per Patient by Region Average Compensation across Phases Average Compensation across Compound Orientations Average Compensation per Patient by Therapeutic Area and Phase Average Compensation per Patient by Therapeutic Area and Compound Orientation Appeal of Innovative Compounds Milestone Payment Plans Payment Negotiation Environment Benchmarking Investigator Fees Phase Comparison by Specialty/ Therapeutic Areas Phase I Phase II Phase III Phase IV Compound Orientation Compensation by Specialty/ Therapeutic Area Biologic Biosimilar Me-too Generic Novel Region comparison by Phase Phase I Phase II Phase III Phase IV Region Comparison by Compound Orientation Novel Generic Me-too Biosimilar Biologic Investigator Payment Dynamics Most Researched Medical Specialties/ Therapeutic Areas Number of Studies Managed in the Past 24 Months by Therapeutic Area Therapeutic Areas conducted at sites Number of studies managed in a Therapeutic Area Views of Trial Site Capacity Most Frequent Payment Models Used Most Frequent Payment Milestones Used Payment Milestone Preference Top Non-monetary Incentives for Site Trial Participation Geographic Differences for Non-monetary incentives Master Service Agreements (MSA) Drivers of Investigator Fees Most Influential Motivators for Site Participation in a Study Study Characteristics that Warrant Higher Fees Site Motivation for Clinical Trial Participation Appeal of Innovative New Compound Studies Likelihood to Participate in Complex Clinical Trials How Study Complexity Impacts Higher Fees Leading Driver for Increased Fee How Study Complexity Impacts Lower Fees Study Complexity Impact Table How Study Length Impacts Higher Fees How Study Length Impacts Lower Fees Study Length Impact Table Profiled Specialty/ Therapeutic Analysis Analgesic / Pain Management Cardiovascular CNS Dermatology Gastrointestinal Hematology Infectious Diseases Internal Medicine Metabolic Diseases Musculoskeletal / Arthritis Oncology Ophthalmology Orthopedics Pediatric Respiratory / Allergy / Pulmonology Urology Vaccines Women s Health Site and Respondent Demographics Management to Determine Site Compensation Primary Role at Research Site Years in Clinical Trials Office Location Office Setting Medical Specialties/ Therapeutic Areas Negotiated Investigator Fees Clinical Trial Participation Office Location in Western Europe Location in Eastern Europe Sites Revenue from Clinical Trials About Industry Standard Research www.isrreports.com 2014 Preview of: Benchmarking European Investigator Payments 4
Sample Page: Report Introduction Introduction act with confidence Introduction Welcome to ISR s second Investigator Payments report One way to think about the Russian clinical trial and pharmaceutical environment is to think of the country as a publically traded pharmaceutical company. If you were highlighting Europe s clinical trial compensation. In this leafing through a prospectus or an investor presentation, you would find a company with ISR strong wanted macro fundamentals, to gain a better historic understanding growth, inconsistent of performance, what report, drives and some investigator regulatory uncertainty. payments In short, so Russia that sponsors has many of and the same CROs characteristics as a mid-stage pharmaceutical company. And, if you take a portfolio theory can approach to investing, you would likely want to invest some portion of your assets in Russia. Why? benchmark their payment levels and better plan for study costs. Determinants of investigator payments come in many forms Macroeconomics: Russia is the world s 10 th largest economy such as therapeutic area, compound orientation, trial complexity, and International patient needs. recognition: Is there Joined a the one-size-fits-all World Trade Organization formula (WTO) that in 2012 can Positive be applied balance uniformly sheet: Russia across has ~$240B studies trade surplus to produce from fossil the fuel most reserves effective Focus: Putin compensation announced $3.9B plan? aimed Perhaps at having not, 90% but of by medicines using to this be array locally of compensation produced by 2020 averages provided by site personnel and Reimbursement by understanding structure: their Medicines non-monetary Insurance System motivations (Aug 2012) is to for be in trial place by 2020 that will include tiered rate of reimbursement, depending on participation, ISR believes a sponsor or CRO can recruit and the nature of the illness, and improve access to medications retain high quality sites without breaking the budget. Growth: Russian pharmaceutical market has been growing 17% annually since 2005 Untapped potential: Many patients are treatment naïve, offering opportunities for clinical trial patient recruitment Uncertainty: Regulatory environment and customs practices are unstable and unpredictable Difficult: In 2012 the World Bank ranked Russia 122 nd on their list of economies by ease of doing business, 21 spots below China Skills: Finding highly qualified healthcare professionals can be difficult Protection: IP protection is concerning www.isrreports.com 2014 Preview of: Benchmarking European Investigator Payments 5
Sample Page Introduction act with confidence Average Compensation per Patient by Therapeutic Area and Phase Only therapeutic areas with 4 or more responses in a phase are included in the following sections. Internal terms Medicine of investigator had the payment highest compensation fees, only oncology for Phase I. ranked For Phase one II-IV, of Internal the Medicine top three received most expensive below average therapeutic compensation. area across phase II, III, and IV of development. Oncology received the highest compensation for Phase II and the third highest compensation for Phase III and Phase IV. Oncology received below average compensation for Phase I. Pediatric received the Phase highest I compensation Phase for Phase II III compounds. Phase III Pediatric did Phase not IV receive enough responses to be reported in the other phases. Highest Oncology Compensation Analgesic / Pain Management received the ($7,676) highest compensation for Phase IV. In all other phases, analgesic / pain management fell below average for compensation. Second Ophthalmology Highest received the Data second available highest average in full compensation report for Phase I and Phase III. Ophthalmology did not receive enough responses for Phase II or Phase IV. Third Highest Average Phase I Phase II Phase III Phase IV Highest Compensation Second Highest Internal Medicine ($12,125) Ophthalmology ($7,750) Oncology ($7,676) Metabolic Diseases ($5,333) Pediatric ($11,200) Ophthalmology ($7,250) Analgesic / Pain Management ($5,000) Hematology ($4,000) Third Highest Vaccines ($6,750) Musculoskeletal/ Arthritis ($5,071) Oncology ($7,136) Oncology ($2,591) Average $5,529 $4,159 $4,604 $2,441 2014 Industry Standard Research www.isrreports.com 2014 Preview of: Benchmarking European Investigator Payments 6
Sample Page Benchmarking Investigator Fees act with confidence Average per patient investigator fee for Me-too drugs Me-too Eastern Europe (n=6) $3,333 2014 Industry Standard Research Germany (n=7) $2,800 UK (n=22) $2,926 France (n=11) $2,733 $0 $5,000 $10,000 www.isrreports.com 2014 Preview of: Benchmarking European Investigator Payments 7
Sample Page Drivers of Investigator Fees act with confidence Most Influential Motivators for Site Participation in a Study Of the following motivating factors for a site to participate in a particular clinical trial please rank your top 3. With #1 being the most influential, #2 being the second most influential, #3 being the third most influential. (Base = 142) Access Access to to pafent populafon: ease ease of pafent of recruitment Reasonable inclusion/ Level of exclusion compensafon criteria 37% 37% 2014 Industry Standard Research 20% 21% 8% 17% 22% 22% 11% 16% 23% 11% Level of compound innovafon 19% 15% 13% Level of compound innovafon 19% 15% 13% Level of compensafon 8% 17% 23% Low number of tests/ visits 1% 4% 4% Most influenfal Possibility of future projects 8% 8% 18% Second Most most influenfal Past posifve experience Other with 4% 1% 4% 9% Sponsor/ CRO 12% Third most Second influenfal most influenfal Past posifve experience with Short length Sponsor/ of the CRO trial 4% 4% 3% 9% 12% Third most influenfal Possibility Low number of future of tests/ projects visits 4% 4% 8% 18% Reasonable inclusion/ Other 4% exclusion criteria Responses Alphabetized 21% 16% Data available in full report 0% 20% 40% 60% 80% Short length of the trial 1% 0% 20% 40% 60% 80% www.isrreports.com 2014 Preview of: Benchmarking European Investigator Payments 8
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The ISR Difference Custom-quality syndicated market research www.isrreports.com ISR's Reports How confident are you? The Common Syndicated Report Research methods Mostly primary research; always appropriate for the topic One size fits all; usually publically available data ISR's proprietary data collection tools and channels support fast, high quality data collection Data Collection Struggle to recruit the right targets and enough of them Sophisticated screening ensures genuine decision-makers Respondents Undisclosed methodologies and respondent demographics Robust sample sizes that instill confidence Sample Sizes Analysts Often insufficient industry representation that leaves you defending results Decades of experience means more insights that are immediately usable Junior analysts capable of reporting numbers www.isrreports.com 2013 2014 Preview Preview of: Benchmarking of: Benchmarking the Pharma European Industry s Investigator HEOR Functions Payments 10