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Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies for Pharmaceutical Success in a Global Marketplace

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In the face of cost and regulatory pressures, clinical programs at pharmaceutical organizations have looked to less expensive and regulated areas of the world to perform clinical trial activities. …

In the face of cost and regulatory pressures, clinical programs at pharmaceutical organizations have looked to less expensive and regulated areas of the world to perform clinical trial activities. Emerging markets are also fast-growing regions that present future growth opportunities for organizations that have seen sales growth slow in mature markets.



However, there are still questions around the cost, acceptability, quality and pitfalls of conducting clinical trials in emerging regions.
Best Practices®, LLC conducted primary research to inform clinical affairs leaders at pharmaceutical companies on emerging approaches to staffing, outsourcing and managing clinical trials outside of the European and U.S. regions.

Critical outsourcing questions addressed in this survey include:

-What are the regions where pharmaceutical companies are conducting clinical trials and the percent of patients recruited annually from these regions?

-Which clinical trial activities are best suited for outsourcing?

-What is the appropriate staffing mix (in-house and outsourced) for clinical trials?

-What are the most important competencies for clinical research associates, managers, and directors?

This report will inform Clinical Affairs leaders on these questions and others regarding staffing, outsourcing and managing clinical trials outside of the U.S.

Published in Health & Medicine , Business
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  • 1. BEST PRACTICES, ® LLC Best Practices, LLC Strategic Benchmarking Research Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies for Pharmaceutical Success in a Global Marketplace
  • 2. BEST PRACTICES, ® LLC TABLE OF CONTENTS I. Executive Brief, Framework for Clinical, Preparing Clinical, p.2-3 II. Executive Summary  Business Issue and Project Blueprint, p.6-7  Participants, p.8  Key Findings, p.9-12 III. Outside-U.S. Clinical Trial Overview and Insights, p.13-17 IV. Clinical Affairs Budget and FTEs, p. 18-25 V. Clinical Affairs Presence Around the World, p.26-30 VI. Cost and Quality of Outside-U.S. Trials and Outsourcing, p.31-37 VII. Outsourcing Levels for Key Clinical Activities, p.38-47 VIII. Vendor Selection and Outsourcing Attributes, p.48-54 IX. CRA, CRM, and CRD Competencies & Outsourcing Levels, p. 55-64 X. Clinical Affairs Organizational Fit, p.65-72 XI. Outsourcing Success Factors and Pitfalls, p. 73-75 XII. Trends and Directions for Outside-U.S. Trials & Outsourcing, p.76-78 XIII. Appendix, p. 79-81 XIV. About Best Practices, LLC, p.82
  • 3. BEST PRACTICES, ® LLC 3 Copyright © Best Practices, LLC Formulate a Strategic Approach for Engaging Emerging Regions in Clinical Affairs Activities Business Issue & Objectives 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. Best Practices, LLC conducted this benchmarking study to help biopharma organizations set a strategic direction for conducting clinical trial activities in emerging regions of the world. Field Research & Insight Development: Survey 7 clinical leaders at 6 pharma companies. Conduct four executive interviews to collect qualitative insights from selected survey participants. INFORM Objective:
  • 4. BEST PRACTICES, ® LLC Directors & Senior Directors 71% Head of Clinical Operations 29% 4 Copyright © Best Practices, LLC Pharma Universe of Learning: Leveraging Group Knowledge (n = 7) Respondent Job Level Seven participants from six pharmaceutical companies participated. The study attracted a strong group of experienced pharmaceutical Clinical Affairs executives. Two were at the vice president level and five were at the director level. Companies Pharma Segment
  • 5. BEST PRACTICES, ® LLC 5 Copyright © Best Practices, LLC Q. What were the approximate total 2010 revenues for your company and the corresponding Clinical Affairs Spend? Estimated Revenue ($USD): Clinical Affairs Spend ($USD): Clinical Affairs Spend/ Company Revenue: Max - - - Mean $14,760,000,000 $460,500,000 7.43% Median $7,000,000,000 $315,000,000 6.15% Min - - - Pharma Segment: Revenue and Clinical Affairs Spend 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. (n = 5 4 4) (Note : able to report mean and median only)
  • 6. BEST PRACTICES, ® LLC Outsourced 60% Offshored 6% Insourced 34% 6 Copyright © Best Practices, LLC 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 (n = 6) In sourced Staffing of Clinical Affairs/ Clinical Trials Offshore Staffing Clinical Affairs/ Clinical Trials Outsourced Staffing of Clinical Affairs/ Clinical Trials Max 70% 15% 80% Mean 34% 6% 60% Median 30% 5% 60% Min 15% 0% 30% Average Staff Sourcing MixStaff Sourcing Mix Pharma Pharma Segment: Staff Resourcing Mix Pharma Segment: Most Trial Staff Outsourced Pharma 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 pharma sector has seized on use of CROs as a way to reduce long-term clinical costs.
  • 7. BEST PRACTICES, ® LLC 7 Copyright © Best Practices, LLC Q. In general, how do regulatory authorities react to clinical trial data from research conducted outside the U.S.? (n = 7) Few questions about data 43% Extensive conversations about data 29% No questions 14% Other 14% Other: • “No Phase IV trial conducted outside the US requiring label change.” Pharma Segment: Reaction of Regulators to Outside-US Clinical Trial Data Pharma participants appeared more comfortable with data from trials conducted outside the U.S. Fifty-seven percent of the pharma segment felt regulators had few to no questions about data from outside regions. Still, a third felt the data led to extensive conversations. Pharma Segment Sees Few to No Questions on Data
  • 8. BEST PRACTICES, ® LLC 8 Copyright © Best Practices, LLC 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 70% 52% 68% 74% 78% 60% 60% 30% 48% 32% 26% 22% 40% 40% Site Mangement Data Analysis Trial Management Patient Enrollment Data Management Investigator Recruitment Site Evaluation Outsourced In-house Pharma Segment: Clinical Activities Overview Shows Outsourcing a Major Tool for All Key Activities This slide presents an overview of pharma participants’ outsourcing levels for seven key Clinical activities. Participants outsource a majority of the tasks associated with each activity. The activities with the most outsourcing are data management and patient enrollment. n = 6 6 5 5 5 5 3
  • 9. BEST PRACTICES, ® LLC Highly Inaccurate Somewhat Inaccurate Inconsistent Somewhat Accurate Highly Accurate 9 Copyright © Best Practices, LLC Q. If you outsource, what capabilities are best predictors that the your outsource vendor will provide a high quality service that meets your expectations: (n = 5) Pharma Segment: Predictors of Vendor Quality Pharma Segment: Staff Experience Best Vendor Predictor Pharma participants felt that the best quality predictor of an outsourcing vendor was the experience of its staff. The vendor’s track record in the target geography and its staff turn- over rate also were viewed as valuable indicators. 20% 20% 20% 20% 20% 60% 80% 80% 60% 80% 40% 20% 20% 40% 20%Educational credentials Proven track record in therapeutic area Tenure of their staff Turn-over rates of their staff Proven track record in the geography Experience of staff in relevant areas
  • 10. BEST PRACTICES, ® LLC Successful CRO has Local Office & Strong Management When considering a CRO for a device trial in an emerging market, two of the most critical traits 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 where you want to do a trial. • 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 so they have local presence. “So they can do the local work but then we can still drive our timelines and push from here. It’s hard to push a CRO when you can’t get over to their office quickly – they’re too far away.” • The CRO has to have experience in the geographic region • The CRO has to have people knowledgeable in the management side of clinical trials and have strong local management as well. “If they don’t have a strong manager in that local area that knows what it takes to get clinical trials done, it’s not going to work.” Don’t… • 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. “We had a CRO running a global project that did not include Japan and China – it was a huge project. That same company was also helping us run a Japan trial. It was night and day difference and it was all because we had very good management on the global project and poor management on the Japan trial.” – Director, Global Clinical CRO Dos and Don’ts 10 Copyright © Best Practices, LLC
  • 11. BEST PRACTICES, ® LLC 11 Copyright © Best Practices, LLC 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 Pharma: Critical Success Factors/ Lessons Learned (n = 4) Pharma participants felt the critical success factors behind successful clinical outsourcing were communication, a dedicated outsourcing group, appropriate oversight and established relationships.
  • 12. BEST PRACTICES, ® LLC About Best Practices, LLC Best Practices, LLC is a research and consulting firm that conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the 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@best-in-class.com www.best-in-class.com