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Clinical Trial Results Transparency and the Changing Paradigm of Medical Communications

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Clinical Trial Results Transparency and the Changing Paradigm of Medical Communications

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Clinical Trial Results Transparency and the Changing Paradigm of Medical Communications

  1. 1. Clinical Trial Results Transparency: Challenging the Traditional Paradigm of Medical Communications Christopher Viereck, PhD March 29, 2010
  2. 2. Clinical Trial Results Transparency: Challenging the Traditional Paradigm of Medical Communications <ul><li>Definition </li></ul><ul><li>How we got here </li></ul><ul><li>How the paradigm may change </li></ul><ul><li>Early examples of the impact </li></ul><ul><li>Changing the problem into an opportunity </li></ul>
  3. 3. Clinical Trial Transparency: Broad Definition <ul><ul><li>Public accessibility of: </li></ul></ul><ul><ul><ul><li>Ongoing clinical trials </li></ul></ul></ul><ul><ul><ul><li>Results of completed trials in approved indications . </li></ul></ul></ul>
  4. 4. How We Got Here <ul><li>ICH-GCP (1995) = Informed Consent: </li></ul><ul><ul><li>All relevant information from clinical trials and other therapeutic options must be included. </li></ul></ul><ul><li>FDA Modernization Act (1997) </li></ul><ul><ul><li>Public registry posting of clinical trials in serious life-threatening diseases & ClinicalTrials.gov (2000) </li></ul></ul><ul><li>Declaration of Helsinki – Edinburgh Amendment (2000): </li></ul><ul><ul><li>Ethical obligations of authors and publishers to publish or publicize an accurate depiction of results from all clinical trials whether positive or negative. </li></ul></ul><ul><li>Section 801, FDA Amendments Act (“FDAAA” 2007) </li></ul>
  5. 5. Evolution of “Transparency” <ul><ul><li>Regulatory Agencies </li></ul></ul><ul><ul><li>Investigators </li></ul></ul><ul><ul><li>Patients </li></ul></ul><ul><ul><li>Scientific Community </li></ul></ul><ul><ul><li>Regulatory Agencies </li></ul></ul><ul><ul><li>Investigators </li></ul></ul><ul><ul><li>Patients </li></ul></ul><ul><ul><li>Scientific Community </li></ul></ul><ul><ul><ul><li>+ </li></ul></ul></ul><ul><ul><ul><li>Public </li></ul></ul></ul>Post-FDAA Success = Finding what is good about the problem and turning it into an opportunity.
  6. 6. Dissemination of Clinical Trial Results: Traditional Paradigm CT.gov LPLV Press Release Abstract 1 o Publication Clinical Trial Lifecycle Training 2 o Publications FPFV Med Info Stds.
  7. 7. Dissemination of Clinical Trial Results: Impact of FDAAA <ul><ul><li>All trials (phases 2+) to be published; </li></ul></ul><ul><ul><li>More rapid dissemination and less formal control; </li></ul></ul><ul><ul><li>End-user empowerment – customized outputs. </li></ul></ul>CT.gov LPLV Press Release Abstract 1 o Publication Clinical Trial Lifecycle Training 2 o Publications CT.gov Results FPFV Med Info Stds.
  8. 8. Dissemination of Clinical Trial Results: Early Examples of Impact <ul><li>Enhance (Ezetimibe/simvastatin vs. simvastatin; 2-year imaging study): </li></ul><ul><ul><li>Completed April, 2006 (CT.gov); </li></ul></ul><ul><ul><li>Trial Results: January 2008 (press release); NEJM & CSR.org: March 2008. </li></ul></ul><ul><li>Pristiq (desvenlafaxine) Protocol 3151A1-335: </li></ul><ul><ul><li>Completed September 2007. Trial Results: March 2008 (CSR.org); </li></ul></ul><ul><ul><li>Not published elsewhere; </li></ul></ul><ul><ul><li>Negative results for FDA approved 50mg/day dose. </li></ul></ul><ul><li>Challenge: Add contingencies for –ive trials to publication plans. </li></ul>
  9. 9. Implications of Section 801, FDAAA on Dissemination of Scientific Information: Less Control <ul><li>Rosiglitazone meta-analysis (Nissen & Wolski, NEJM, 2007) </li></ul><ul><li>42 clinical trials included. </li></ul><ul><li>Results data from 26 trials obtained from publicly-accessible GSK trial results registry. </li></ul><ul><li>Time to FDA Advisory panel and Black Box Warning accelerated. </li></ul>
  10. 10. Barriers to End-User Empowerment <ul><li>CT results databanks: </li></ul><ul><ul><li>Hard to find; </li></ul></ul><ul><ul><li>Hard to navigate through; </li></ul></ul><ul><ul><li>Hard to understand. </li></ul></ul><ul><li>Why? </li></ul><ul><ul><li>Risk of off-label promotion </li></ul></ul><ul><ul><li>Challenge of communicating complexities to new audience(s). </li></ul></ul>
  11. 11. A Model for Effectively Leveraging CTR: “Gout Resource Center” for GPs. <ul><li>Centralize trial results in gout from CT.gov, CSR.org for e.g. febuzostat, allopurinol, colchicine, etc. </li></ul><ul><li>Organize into standard format including brief unbiased text. </li></ul><ul><li>Tag based on type of patient (e.g. renal insufficiency, cardiac disease), phase, NCT number, prior failure with xanthine oxidase inhibitors, efficacy parameter(s), safety subsets (e.g. GI, LFT). </li></ul><ul><li>Add user-friendly tools: Effective search engine, mouse-over pop-up definitions, tour, etc. </li></ul>
  12. 12. A Model for Effectively Leveraging CTR “Gout Resource Center” – cont’d <ul><li>Integrate with Medical Information. </li></ul><ul><li>Control content associated with search terms. </li></ul><ul><li>Can create “DDMAC” application for use in other product venues. Addition of fair balance. </li></ul><ul><li>Potential Advantages: </li></ul><ul><ul><li>“ Leapfrog” to end user without marketing/sales complex. </li></ul></ul><ul><ul><li>Customized for end-user; </li></ul></ul><ul><ul><li>Rapid access 24/7 </li></ul></ul><ul><ul><li>Minimal FTEs impact; </li></ul></ul>
  13. 13. Clinical Trial Results Transparency: Challenging the Traditional Paradigm of Medical Communications <ul><li>Definition </li></ul><ul><li>How we got here </li></ul><ul><li>How the paradigm may change </li></ul><ul><li>Early examples of the impact </li></ul><ul><li>Changing the problem into an opportunity </li></ul>

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