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Transparency in Clinical Trials and its Impact on the Intelligence Community

Transparency in Clinical Trials and its Impact on the Intelligence Community. Mark R Little, PhD Vice President, Business Intelligence Covance, Inc. SLA, Boston March 20, 2007. What’s Ahead.

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Transparency in Clinical Trials and its Impact on the Intelligence Community

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  1. Transparency in Clinical Trialsand its Impact on the Intelligence Community Mark R Little, PhD Vice President, Business Intelligence Covance, Inc SLA, Boston March 20, 2007

  2. What’s Ahead • Objective: to explore the impact of clinical trial transparency initiatives on pharma competitive intelligence units • Has it been useful for CI activities? • If so, useful for what? • How do new sources rate • Amongst themselves? • Vs more traditional sources? • Vs primary sources?

  3. What’s Ahead • Introduction • A History Clinical Trials • What is clinical trial intelligence • What makes clinical trial intelligence predictive • What impact might clinical trial intelligence have • Case study • Impact on First in class exclusivity • The Push toward Clinical Trial transparency • Survey of Pharma CI units • Conclusions

  4. A Brief History of the Clinical Trial 1980: First Issue of Controlled Clinical Trials 1747: James Lind – On Board the Salisbury 1962: Kefauver/ Harris Amendment The Present-Day Controlled Clinical Trial is a relatively new Tool for Drug Development

  5. Pharma Companies Reveal Clinical Trial Studies in various formats DRUG LABEL PUBLISHED CLINICAL STUDIES Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H, for the Sitagliptin Study 023 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia 2006 Nov;49(11):2564-71. PMID: 17001471 Aschner P, Kipnes M, Lunceford J, Sanchez M, Mickel C, Williams-Herman D. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care 2006; 29:2632-2637. PMID: 17130196 A Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose-Range Finding Study of Once-Daily Dosing of MK-0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control Charbonnel B, Karasik A, Liu J, Wu M, Meininger G. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled on metformin alone. Diabetes Care 2006;29:2638-2643. PMID: 17130197 Clinical Trials predict the dose, patient population, efficacy endpoints and safety of future drug indications

  6. Clinical Trial Intelligence – Defined • Clinical Trial Intelligence: Actionable information and/or insights about the • Design: patient population, study arms, # sites, endpoints • Status: enrollment, efficacy trends, side effect (AE) trends • Results of a clinical trial: statistical significance, AEs, clinical profile • Clinical Trial Intelligence is a subset of Competitive Technical Intelligence (CTI) Like all intelligence, clinical trial intelligence needs to be actionable

  7. Clinical Trial Intelligence – in Context • Pharma CI Units have traditionally focused on competitor pipelines & near-market assets • CI units have leveraged a variety of sources to gain insights into competitor pipeline activities • One-stop shopping does not exist • Different internal customers require different analytical outputs and perpectives Clinical Trial intelligence adds a layer of granularity to Pipeline Intelligence

  8. Clinical Trial Intelligence – in Action • Clinical trial intelligence needs to be actionable • Likely impact • Direct licensing activities • Stir / accelerate fast-follower activities • Influence design of clinical trials • Build counter marketing strategies Clinical trial intelligence can make an important contribution to Pharma CI

  9. CASE REPORT • Company A desires to fill void in key therapeutic area • Using typical pipeline databases and industry trade press, Company A targets a specific drug in Phase II testing at a smaller company • Business Case for in-licensing established, and the compound target is of the highest priority. • CI unit charged with gathering clinical trial intelligence • CI unit hires third party to attend upcoming conference, where target company is presenting • Clinical abstract is reassuring: compound has met efficacy / safety profile & POC • However, in after-hour discussions, company reveals that due to issues in non-clinical testing, compound is to be discontinued in favor of back-up • RESULTS: Licensing jets cooled • Post-script: neither target compound nor backup reached the market Pursuit of clinical trial intelligence extremely important – in this case – to licensing

  10. Market Exclusivity for First-in-Class has Declined: Mean Time to First Follow-on Approval Source: DiMasi and Paquette, PharmacoEconomics 2004;22(Suppl 2):1-14 Can adoption of Competitive Intelligence units be partly to blame for diminishing exclusivity?

  11. Market Exclusivity Vs Average SCIP membership: An interesting observation Inverse relationship between Time of Market Exclusivity and Average SCIP Membership

  12. The Push Toward Clinical Trial Transparency • Safety concerns in two widely prescribed drug classes have fueled the drive to Transparency: • Safety issues involving the use of SSRI antidepressants in children (Jun04) • Safety issues involving COX-II inhibitors (VIOXX withdrawal, Sep04)…and the Post-Vioxx Era begins • GSK announces clinical trial database • Merck, Lilly follow and PhRMA launches voluntary clinical trial results database in Sep04 However, “Data without perspective is still data, and not information” – Felix Gyi, Pharm D

  13. Effects of a Post- Vioxx Era BEFORE • 2006: Welcome to the AstraZeneca Clinical Trials web site: This web site provides clinical trial data, results and other information from or regarding AstraZeneca-sponsored clinical trials….In line with our Group Corporate Responsibility Policy on transparency, we are committed to open communication of information on AstraZeneca’s clinical trials.  We will provide details of new and ongoing clinical trials sponsored by AstraZeneca.   • June 2003: “As a disclosure of compound information is balanced by the business need to maintain competitive advantage, some compound information has not been disclosed at this time.”* AFTER *Source: Surfing the Pipeline: Comparing the coverage and content of drugs in development databases, June, 2003 Initiatives in clinical trial transparency have made competitor pipelines more accessible, but to what end?

  14. Effects of a Post-Vioxx Era: All Aboard • All of top 15 Biopharm Co's are posting active clinical trials online • 93% on clinicaltrials.gov • 60% centerwatch.com • 33% on their own website • Trial results are being published by most on the PhRMA site, clinicalstudyresults.org • 15 companies have posted 1300 trials • GSK has dedicated 40 FTEs for summaries and its registry. • On average 40 FTE's / per company are dedicated to clinical trial transparency efforts; once backlog has been processed, 5-10 FTE's will be needed. *Source: "State of the Clinical Trials Industry" Report, 2006 ClinicalTrials.gov appears to be the most widely used registry for industry posting

  15. A Word about Clinicaltrials.gov The Debut of ClinicalTrials.gov • The debut of ClinicalTrials.gov (http://clinicaltrials.gov) took place on February 29, 2000. This service provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. • ClinicalTrials.gov contained over 4,000 clinical studies sponsored primarily by the National Institutes of Health. • ClinicalTrials.gov grew out of 1997 legislation that required the Department of Health and Human Services, through the NIH, to broaden the public's access to information about clinical trials on a wide range of diseases by establishing a registry for both federally and privately funded trials "on drugs for serious or life-threatening diseases and conditions.“ • Appears to be the registry of choice for clinical trial listing

  16. R&D spend and trial listing* of a select Pharma cohort 311 350 246 355 160 143 194 209 174 193 90 62 69 22 24 37 67 23 *Source: ClinicalTrials.gov

  17. Ranking Companies by Trials per R&D $ Spent Novartis Bristol-Myers Squibb Co. Eli Lilly and Co. Wyeth GlaxoSmithKline Plc. Abbott Laboratories AstraZeneca Plc. Sanofi-Aventis Boehringer Ingelheim GmbH Pfizer Inc. Roche Amgen Inc. Merck & Co. Schering-Plough Corp. Astellas Schering AG Daiichi-Sankyo Takeda Chemical Industries Ltd.

  18. A SURVEY OF CI PROFESSIONALS CBI’s 3rd Annual Predictive Intelligence For Pharmaceutical and Biotech Companies January 22-23, 2007

  19. Survey Method • Survey Tool: Zoomerang • Participants: CI network across Biopharma companies • Invited: ~35 • Completed Responses: N= 15 • Objective: Assess the value of clinical trial transparency as a bolt-on tool for the competitive intelligence professional Survey to assess value of CT Transparency as a tool for the CI Professonal

  20. 1 5 10 How important is CT Intelligence to your work? Extremely Important 10 Important 3 Extremely Unimportant 2 Unimportant 0 13/15 Respondents described CT Intelligence as Important or Extremely Important

  21. 1 5 10 Respondent breakdown according to company revenue > $10Billion 6 < $1Billion 4 > $1B, but <$5B 4 >$5B, but <$10B 1 Large, medium and small biopharma companies represented

  22. How often is CT Intelligence incorporated into your output? As might be expected, clinical trial intelligence is frequently used in reporting

  23. How is the CT Intelligence used? Product Positioning and Trial Design were most often selected uses

  24. Who is the internal customer? “Other”: New Product Planning, Corporate Strategy, Various The Internal Customer tended to Map to Medical/ Marketing Departments

  25. 1 5 10 Has Clinical transparency helped you in your job? Agree 11 Disagree 3 Stongly Agree 1 Stongly Disagree 0 The ‘Transparency’ push has helped the CI community…….

  26. 1 5 10 What improvements are needed? More comprehensive 10 Up-to-date 6 Structure/Searchable 5 Other 0 …..but more postings are needed to significantly improve the registries.

  27. 1 5 10 What is the level of satisfaction with external sources? Somewhat satisfied 13 Somewhat dissatisfied 2 Very satisfied 0 Very dissatisfied 0 In general, External Sources only partially satisfy demand

  28. How effective are some common sources? *For Trialtrove, N=13; all others N=15.

  29. Sources: Force Ranked ….. *For Trialtrove, N=13; all others N=15. Effectiveness is most effectively linked to contracted primary research

  30. Categorization of the forced rank…. Human Intelligence Secondary Sources *For Trialtrove, N=13; all others N=15. Interestingly, Effectiveness is linked to Humint activities using internal networks, contracted vendors, and conference coverage

  31. Intelligence Information DATA ….Or are we simply viewing the Intelligence Pyramid in action…. *For Trialtrove, N=13; all others N=15.

  32. CONCLUSIONS • Key Findings following 30 months of transparency initiatives • 12 of 15 respondents agree that transparency has had a significant impact on their CI activities • 12/13 who consider clinical trial intelligence important to their work, agree to the above • 13/15 respondents are somewhat satisfied with all external sources • 8/15 and 7/15 respondents selected “competitor product positioning” and “influencing clinical trial design”, resp, as a key action taken from clinical trial intelligence • Human intelligence sources rate slightly more effective than secondary sources – indicative of analysis and action (moving up the pyramid)

  33. CONCLUSIONS: Final Thoughts • Intellectual Property • Product Profile • Clinical design • Competitive Advantage • Legal / Regulatory • Public Safety & Trust • Business Ethics Protect Provide April – 2nd Annual Premier Forum on Clinical Trial Registries and Results Databases http://www.cbinet.com/show_conference.cfm?confCode=HB735

  34. ACKNOWLEDGEMENTS Jamie Denison-Pender, CIS Scott Taylor, BMS Debra Weintraub, MedImmune Tracy Degregorio, Citeline, Inc Jan Herring, Herring & Associates Joe Bedford, Covance N= 15

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