February 26, 2009 Ron Marks, Ph.D. Chief Scientific Officer Clinipace
Is this necessary? www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Pharmaceutical Research and Manufact...
We already know www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Thomson CenterWatch 2003, 2005 survey o...
Take action <ul><li>Focus on your circle of influence </li></ul><ul><ul><li>Design it right </li></ul></ul><ul><ul><li>Pow...
Be design “intelligent” <ul><li>Prioritize your objectives & outcomes </li></ul><ul><li>Seek 3 rd  party input early </li>...
Power it right <ul><li>Number of subjects needed to answer your primary objective </li></ul><ul><li>Depends on type & vari...
Listen to the FDA <ul><li>Get to know your review division </li></ul><ul><li>Work with FDA to determine efficacy and safet...
Don’t over rely on a CRO <ul><li>Balance functional needs vs. complete outsourcing </li></ul><ul><li>Maintain control </li...
Create transparency <ul><li>Manage towards performance metrics </li></ul><ul><li>Accountability </li></ul><ul><li>No excus...
Do it now! <ul><li>Plan your study thoroughly – think “intelligent design” </li></ul><ul><li>Listen to the FDA </li></ul><...
Q&A www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Ron Marks, Ph.D. [email_address]
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Running A Better Clinical Trial

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  • Running A Better Clinical Trial

    1. 1. February 26, 2009 Ron Marks, Ph.D. Chief Scientific Officer Clinipace
    2. 2. Is this necessary? www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2008 (Washington, DC: PhRMA, March 2008). Regulatory Analysis Operations Design
    3. 3. We already know www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Thomson CenterWatch 2003, 2005 survey of sites in U.S.
    4. 4. Take action <ul><li>Focus on your circle of influence </li></ul><ul><ul><li>Design it right </li></ul></ul><ul><ul><li>Power it right </li></ul></ul><ul><ul><li>Listen to the FDA </li></ul></ul><ul><ul><li>Don’t rely too heavily on a CRO </li></ul></ul><ul><ul><li>Create a transparent study </li></ul></ul>www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved.
    5. 5. Be design “intelligent” <ul><li>Prioritize your objectives & outcomes </li></ul><ul><li>Seek 3 rd party input early </li></ul><ul><li>Better manage randomization & monitoring </li></ul><ul><li>Must consider number of subjects and sites </li></ul><ul><li>Use “common sense” </li></ul>www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Consider Most data collected is never used…Furthermore, some data are collected excessively or in an inefficient manner. [ Dr. Gwendolyn Fyfe, senior staff scientist ,Genentech] <ul><li>Collect only what’s needed </li></ul><ul><li>What are you measuring – time to event vs. survival </li></ul><ul><li>Time to document efficacy is usually much shorter than determining safety </li></ul><ul><li>GCP allows for “appropriate” monitoring </li></ul><ul><li>Random sampling is appropriate for monitoring </li></ul>
    6. 6. Power it right <ul><li>Number of subjects needed to answer your primary objective </li></ul><ul><li>Depends on type & variability of primary outcome </li></ul><ul><li>Setting alpha (α) and beta (β) </li></ul>www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. I can tell within 15 minutes of reading a statistical plan if it will succeed. [ Dr. Blair Keagy, UNC School of Medicine]
    7. 7. Listen to the FDA <ul><li>Get to know your review division </li></ul><ul><li>Work with FDA to determine efficacy and safety criteria </li></ul><ul><li>Seek guidance early and often </li></ul>www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Red Flags There is no prescribed monitoring frequency. [Robert J. Temple, M.D., Associate Director for Medical Policy, Center for Drug Evaluation and Research, FDA] <ul><li>Objectives are not clear </li></ul><ul><li>Outcomes not well-defined or analyzed </li></ul><ul><li>Sample size not properly documented </li></ul><ul><li>Missing patients without explanation </li></ul><ul><li>Un-blinded analytic changes without explanation </li></ul><ul><li>SAEs that are dismissed without description as “inter-current illness” </li></ul><ul><li>Sloppiness; want most observations to be made by competent person and to be accurate </li></ul>
    8. 8. Don’t over rely on a CRO <ul><li>Balance functional needs vs. complete outsourcing </li></ul><ul><li>Maintain control </li></ul><ul><li>You’re the brains, hire for muscle </li></ul><ul><li>Expect transparency from your partners </li></ul><ul><li>Demand the use of technology </li></ul>www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Consider <ul><li>Performance metrics </li></ul><ul><li>Incentive mix </li></ul><ul><li>“ Appropriateness” of monitoring plan </li></ul><ul><li>Relationship with sites </li></ul>
    9. 9. Create transparency <ul><li>Manage towards performance metrics </li></ul><ul><li>Accountability </li></ul><ul><li>No excuses </li></ul><ul><li>Maintains study schedule </li></ul><ul><li>Allows future planning </li></ul>www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved.
    10. 10. Do it now! <ul><li>Plan your study thoroughly – think “intelligent design” </li></ul><ul><li>Listen to the FDA </li></ul><ul><li>Maintain control of your study </li></ul><ul><li>Maintain study schedule through transparency and comprehensive reporting </li></ul><ul><li>Invest in technology-driven processes </li></ul>www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved.
    11. 11. Q&A www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Ron Marks, Ph.D. [email_address]

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