Pharma Clinical Affairs Excellence Research Summary


Published on

Emerging markets are fast-growing regions that present future growth opportunities for organizations that have seen sales growth slow in mature markets. This primary research informs clinical affairs leaders at pharmaceutical companies on emerging approaches to staffing, outsourcing and managing clinical trials outside of the European and U.S. regions.

Published in: Health & Medicine, Business
  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Pharma Clinical Affairs Excellence Research Summary

  1. 1. Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies forPharmaceutical Success in a Global Marketplace Best Practices, LLC Strategic Benchmarking Research BEST PRACTICES, ® LLC
  2. 2. TABLE OF CONTENTSI. Executive Brief, Framework for Clinical, Preparing Clinical, p.2-3II. Executive Summary  Business Issue and Project Blueprint, p.6-7  Participants, p.8  Key Findings, p.9-12III. Outside-U.S. Clinical Trial Overview and Insights, p.13-17IV. Clinical Affairs Budget and FTEs, p. 18-25V. Clinical Affairs Presence Around the World, p.26-30VI. Cost and Quality of Outside-U.S. Trials and Outsourcing, p.31-37VII. Outsourcing Levels for Key Clinical Activities, p.38-47VIII. Vendor Selection and Outsourcing Attributes, p.48-54IX. CRA, CRM, and CRD Competencies & Outsourcing Levels, p. 55-64X. Clinical Affairs Organizational Fit, p.65-72XI. Outsourcing Success Factors and Pitfalls, p. 73-75XII. Trends and Directions for Outside-U.S. Trials & Outsourcing, p.76-78XIII. Appendix, p. 79-81XIV. About Best Practices, LLC, p.82 BEST PRACTICES, ® LLC
  3. 3. Business Issue & ObjectivesBest Practices, LLC conducted this benchmarking study to help biopharma organizationsset a strategic direction for conducting clinical trial activities in emerging regions of theworld. Objectives:  Determine the regions where pharma organizations conduct clinical trials and percent of patients recruited annually from each region.  Identify which Clinical Affairs activities are best suited to be outsourced or kept in- house.  Gauge what the experience of pharma organizations has been relative to the cost of outsourcing clinical trial activities.  Rate the value of benefits associated with outsourcing clinical trial activities. Field Research & Insight Development: Objective:  Survey 7 clinical leaders at 6 pharma companies. Formulate a Strategic INFORM Approach for Engaging  Conduct four executive interviews to collect Emerging Regions in Clinical qualitative insights from selected survey participants. Affairs Activities BEST PRACTICES, 3 ® Copyright © Best Practices, LLC LLC
  4. 4. Pharma Universe of Learning: Leveraging Group KnowledgeSeven participants from six pharmaceutical companies participated. The study attracted astrong group of experienced pharmaceutical Clinical Affairs executives. Two were at thevice president level and five were at the director level. Pharma Segment Respondent Job Level Companies Head of Clinical Operations 29% Directors & Senior Directors 71% (n = 7) BEST PRACTICES, 4 ® Copyright © Best Practices, LLC LLC
  5. 5. Pharma Segment: Average Revenue $14B with $460M Clinical Budget An outlier pushed the pharmaceutical segment’s average Clinical Affairs budget to 7 percent of an organizations total revenues. Due to the outlier effect, a more comparative measure may be the median, which had clinical affairs budget representing 6 percent of organizations’ overall revenues. Q. What were the approximate total 2010 revenues for your company and the corresponding Clinical Affairs Spend? Pharma Segment: Revenue and Clinical Affairs Spend Estimated Revenue Clinical Affairs Spend Clinical Affairs Spend/ ($USD): ($USD): Company Revenue: Max - - - Mean $14,760,000,000 $460,500,000 7.43% Median $7,000,000,000 $315,000,000 6.15% Min - - - (n = 5 4 4) (Note : able to report mean and median only) BEST PRACTICES, 5 ® Copyright © Best Practices, LLC LLC
  6. 6. Pharma Segment: Most Trial Staff OutsourcedPharma participants said 60 percent of their clinical trial staff are outsourced, on average.In-house staff represented only a third of the staff devoted to clinical trials. The pharmasector has seized on use of CROs as a way to reduce long-term clinical costs. Q. What is the approximate staff sourcing percentage mix of Clinical Trials conducted across your global enterprise in terms of % In sourced Staffing, % Offshore Staffing, and % Outsourced Staffing Pharma Segment: Staff Resourcing Mix Staff Sourcing Mix Pharma Average Staff Sourcing Mix Offshored In sourced Offshore Outsourced 6% Staffing of Staffing Staffing of Clinical Clinical Clinical Affairs/ Affairs/ Affairs/ Insourced Clinical Trials Clinical Trials Clinical Trials 34% Max 70% 15% 80% Mean 34% 6% 60% Median 30% 5% 60% Outsourced Min 15% 0% 30% 60% (n = 6) BEST PRACTICES, 6 ® Copyright © Best Practices, LLC LLC
  7. 7. Pharma Segment Sees Few to No Questions on DataPharma participants appeared more comfortable with data from trials conducted outsidethe U.S. Fifty-seven percent of the pharma segment felt regulators had few to noquestions about data from outside regions. Still, a third felt the data led to extensiveconversations. Q. In general, how do regulatory authorities react to clinical trial data from research conducted outside the U.S.? Pharma Segment: Reaction of Regulators to Outside-US Clinical Trial Data Other No 14% questions 14% Extensive conversations about data Other: 29% • “No Phase IV trial Few conducted questions outside the US about data requiring label (n = 7) 43% change.” BEST PRACTICES, 7 ® Copyright © Best Practices, LLC LLC
  8. 8. Pharma Segment: Clinical Activities Overview ShowsOutsourcing a Major Tool for All Key ActivitiesThis slide presents an overview of pharma participants’ outsourcing levels for seven keyClinical activities. Participants outsource a majority of the tasks associated with eachactivity. The activities with the most outsourcing are data management and patientenrollment. Q. By clinical affairs activity, note the percent of activities that outsourced and the percent that are handled in-house (Total of each row = 100%). Pharma Segment: Outsourced vs. In-house Breakdown Summary Outsourced In-house n= Site Evaluation 60% 40% 6 Investigator Recruitment 60% 40% 6 Data Management 78% 22% 5 Patient Enrollment 74% 26% 5 Trial Management 68% 32% 5 Data Analysis 52% 48% 5 Site Mangement 70% 30% 3 BEST PRACTICES, 8 ® Copyright © Best Practices, LLC LLC
  9. 9. Pharma Segment: Staff Experience Best Vendor PredictorPharma participants felt that the best quality predictor of an outsourcing vendor was theexperience of its staff. The vendor’s track record in the target geography and its staff turn-over rate also were viewed as valuable indicators. Q. If you outsource, what capabilities are best predictors that the your outsource vendor will provide a high quality service that meets your expectations: Pharma Segment: Predictors of Vendor Quality Highly Inaccurate Somewhat Inaccurate Inconsistent Somewhat Accurate Highly Accurate Experience of staff in relevant areas 20% 40% 40% Proven track record in the 80% 20% geography Turn-over rates of their staff 20% 60% 20% Tenure of their staff 20% 80% Proven track record in therapeutic 20% 80% area Educational credentials 20% 20% 60% (n = 5) 9 Copyright © Best Practices, LLC BEST PRACTICES, ® LLC
  10. 10. Successful CRO has Local Office & Strong ManagementWhen considering a CRO for a device trial in an emerging market, two of the most criticaltraits to look for are 1) Experience in that region and preferably a local office there and 2)Strong management, both at its main office and at the local office in the market whereyou want to do a trial. CRO Dos and Don’ts• The CRO should have a main office in your geography so you can manage them, but CRO also needs to have office in emerging area “We had a CRO running a global so they have local presence. “So they can do the local work but then project that did not include Japan we can still drive our timelines and push from here. It’s hard to push a and China – it was a huge project. CRO when you can’t get over to their office quickly – they’re too far That same company was also away.” helping us run a Japan trial. It was• The CRO has to have experience in the geographic region night and day difference and it• The CRO has to have people knowledgeable in the management side was all because we had very good of clinical trials and have strong local management as well. “If they management on the global project don’t have a strong manager in that local area that knows what it and poor management on the takes to get clinical trials done, it’s not going to work.” Japan trial.”Don’t… – Director, Global Clinical• Automatically assume a U.S. CRO has a presence in an emerging market because they say they can work there. That may translate to we’ll hire another, locally based CRO to do our work. BEST PRACTICES, 10 ® Copyright © Best Practices, LLC LLC
  11. 11. Pharma: Critical Success Factors/ Lessons LearnedPharma participants felt the critical success factors behind successful clinical outsourcingwere communication, a dedicated outsourcing group, appropriate oversight andestablished relationships. Q. What are the three most valuable lessons learned or critical success factors to make clinical affairs outsourcing work? Pharma Segment: Critical Success Factors/Lessons Learned(n = 4) BEST PRACTICES, 11 ® Copyright © Best Practices, LLC LLC
  12. 12. About Best Practices, LLCBest Practices, LLC is a research and consulting firm that conductswork based on the simple yet profound principle that organizationscan chart a course to superior economic performance by studyingthe best business practices, operating tactics and winning strategies of world-class companies. Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 919-403-0251 BEST PRACTICES, ® LLC