Section. Clinical CRO Future Industry Leadership & Performance Benchmarking. October, Syndicated Report

Transcription

1 Section Clinical CRO Future Industry Leadership & Performance Benchmarking Syndicated Report October,

2 Table of Contents I. Study Background and Methodology 3 II. Study Respondent Demographics 6 III. Executive Summary 10 IV. Future Perceptions of CROs 15 V. Satisfaction with CRO Performance 19 VI. CRO Performance Benchmarking 30 Study Start-Up Activities 31 Patient Recruitment 38 Clinical Trial Technology 42 Therapeutic Area 48 CRO Differentiators 54 2

3 Study Background and Methodology Background This study was undertaken by Life Science Strategy Group, LLC (LSSG) to provide greater insight into user perceptions of various phase II/III clinical development providers in the areas of study start-up, patient recruitment, clinical trial technologies, therapeutic area expertise, key differentiators, and future perspectives. Methodology The primary research for this report was fielded in August Study participants (161) draw from LSSGs OutsourcePharma Advisory Board and represent more than half of the Top-25, global pharmaceutical/biopharmaceutical companies, among many other leading mid-tier and emerging industry players. Respondent position titles include Director / Senior Director through Vice President of Clinical, Clinical Operations/Development, among many others. All study participants were prescreened by LSSG to ensure a high level of involvement and/or key decision-making authority in selecting outsourcing partners for phase II/III clinical development. All data analysis and reporting was performed by LSSG. Study respondents were asked to provide non-proprietary information about their experiences with current clinical development partners as well as their perceptions of other providers in the areas of study start-up, patient recruitment, clinical trial technologies, therapeutic area expertise, key differentiators, and future perspectives. Source: Life Science Strategy Group, LLC 3

4 Respondent Demographics 78% of respondents are located in North America; 20% are located in Europe, 1% in Japan, and 1% in Asia/ Pacific. Year s Experience in Position Company Size (Approx. Yearly Sales) Between 3 and 5 years 1% More than 15 years 62% Between 6 and 10 years 11% Between 11 and 15 years 26% Advise a team/individu al that makes the final decision 10% Final decision maker 19% Part of a team that makes the final decision 71% N = 161 N = 161 Q: Where are you located? Q: How many years' experience do you have in your position? Q: Which best describes your role in selecting outsourcing partners for Phase II/III clinical development? 4

5 Respondent Demographics Respondents spend an average of 29% of their 40 hour work week managing CRO relationships. Company Company Size (Approx. Yearly Sales) 40% 35% 38% 36% Large biopharma company 45% Small biopharma company 31% Mid-sized biopharma company 24% Percent of Respondents 30% 25% 20% 15% 10% 5% 4% 9% 6% 7% N = 161 0% Less than $1M $1M to $200M $201M to $500M $501M to $1B $1.1B to $2B More than $2B N = 161 Q: How much time in an average 40 hour week did you spend managing your most recent CRO relationship(s)? Please enter as a percentage (%) of the total work week. Q: Which best describes the company you work for? Q: What best describes your company size (based on approximate yearly sales)? 5

6 Strategic Conclusions Future Perceptions of CROs When asked which CRO is making the right moves to be successful in the future, respondents indicate X(29%) followed by Y(23%) as the top 2 CROs. - There is a significant gap between X and the other CROs evaluated in the survey. LSSG believes this to be a function of both CROs focus on Z, but also Y S... LSSG believes that Sponsors view these two... favorably and perceive synergies/improved capabilities/performance in the future. When asked what CRO respondents will definitely work with over the next 1-3 years, A (29%) followed by B (19%) are most frequently mentioned while C (16%) is the CRO the most respondents will definitely not work with (followed by 1, 2, and 3 at 11%) LSSG is not surprised to see A and B as the CROs the most respondents will definitely work with given their size, capabilities and expertise. LSSG believes respondents will not work with D due in part to the low (comparatively) performance scores in this study, but also because it is a smaller clinical player. Following a similar trend, nearly one quarter of respondents (24%) expect X, followed by Y (17%) and B (14%) to have a much bigger leadership presence in the space in the next 1-3 years. For W, this may be an indicator of growth for its 4 business as well as perceived benefit from its X. For B, this is likely a reflection of A and B in an increasingly challenging and global clinical development arena. Interestingly, respondents also select 1 (21%), followed by 3 (15%) and 5 (14%) as the CROs in need of major changes over the next 1-3 years to consider working with them. - LSSG interprets these results as driven by Z, B and A and perceived lack of 1 and 7 CROs. 6

7 Strategic Conclusions Satisfaction with CRO Performance (Operational) X and Y are the top rated attributes when selecting a specific CRO for a phase II/III trial. A, B and C are also highly rated. Respondents report that the CROs they work with best meet expectations in 1 and 2. CROs are least effective in A and B. - When Q delivery does not meet the Sponsor s standards, it is largely due to 1, 2 and sub-par 3. The top area of needed improvement cited by respondents is X, by a large margin. A, B and also C on the CROs part are also commonly mentioned areas. In general, CROs are meeting Sponsors expectations for X (3.4/5) as rated by their CROs most recent trial. All X sub-activities evaluated scored... - When asked about key areas of improvement, Sponsors cite factors such as A, B and C. Sponsors are generally satisfied with their CRO s 1 rating their most recent experience favorably (3.4/5) as well as sub areas ( /5). - Key areas of improvement mentioned by Sponsors include 2, 4 and 6. When asked about the D in selecting a CRO for a phase II or III trial respondents indicate a varying degree of importance, depending on the particular tool ( /5) Overall, CROs are doing a good job of X ( /5) 7

8 Strategic Conclusions CRO Performance Benchmarking When evaluated across a wide range of clinical trial operational performance criteria, X, followed by Y, are the top-performing CROs 2 and 9 also rate strong to very strong across most performance criteria CLINICAL CRO PERFORMANCE SUMMARY* Performance Area CRO A CRO B CRO C CRO D CRO E CRO F CRO G CRO H Area 1 Rank 3 Rank 7 Rank 5 Rank 8 Rank 6 Rank 4 Rank 1 Rank 2 Area 2 Rank 2 Rank 7 Rank 5 Rank 8 Rank 4 Rank 3 Rank 6 Rank 1 SAMPLE PAGES Area 3 Rank 2 Rank 6 Rank 7 Rank 8 Rank 3 Rank 4 Rank 5 Rank 1 Area 4 Rank 2 Rank 3 Rank 7 Rank 8 Rank 4 Rank 5 Rank 6 Rank 1 Legend Rank 1,2 Rank 3,4 Rank 5,6 Rank 7,8 *Rating Scale: CROs rated by Sponsors across multiple Performance Area subsegments. Analysis based on Performance Area cumulative average score across subsegments. Rank 1=Best. See pages for Performance Area scores. 8

9 More respondents believe X and Y are the CROs making all the RIGHT moves to be successful in the future, though they also say Z needs to make some major changes in the next 1-3 years. CRO PERFORMANCE IN THE FUTURE Percent of Respondents 30% 25% 20% 15% 10% 5% 0% is the CRO making all of the RIGHT moves to be successful in the future. 29% 23% 12% 8% 8% 8% 6% 3% 3% Covance Quintiles PPD ICON Parexel PRA INC inventiv Other* A B C D E F G H *Other includes: Chiltern, Clinipace, DCRI, depends on the trial, Medpace, N/A none don t know (4), Pharma Olam, Quotient (2), TKL N=161 Over the next 1-3 years, will need to make some major changes to ever consider working with them. Percent of Respondents 25% 20% 15% 10% 5% 0% 21% 15% Q: is the clinical Phase II/III CRO making all of the RIGHT moves to be successful in the future. Q: Over the next 1-3 years, will need to make some major changes for our company to ever consider working with them. 14% 14% 9 12% Covance PPD Parexel Quintiles inventiv ICON PRA INC Other* A B C D E F G H *Other includes: All of them will need to prove that they have right sourcing formula figured out, Chiltern, Clinipace, N/A none don t know (4) 9% 6% 5% 4% N=161

10 Respondents rate A and B as the most important criteria when selecting a specific CRO for a recent Phase II/III clinical trial. Interestingly, Q is rated as least important. IMPORTANCE OF SELECTION CRITERIA Average A Data Quality/ Accuracy 1% 9% 30% 59% 4.5 B On-time Delivery 2% 6% 36% 57% 4.5 Communication 2% 1% C Technical Expertise 5% D Project Management 1% E Customer Service 1% 3% 17% 18% 24% 22% 44% 41% 40% 47% 36% 36% 35% 27% X Y Z A 1=not important =critical F Therapeutic Area Expertise 3% 8% 16% 39% 35% B Cost Effectiveness 8% 29% 37% 26% C 0% 20% 40% 60% 80% 100% Percent of Respondents N = 161 Q: Thinking about your most recent Phase II/III clinical trial CRO partner, how important were the following in the decision to SELECT that specific CRO? Please rate on a scale of 5 to 1 where 5=critical and 1=not important. 10