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					Clinical Research at the
Community-Based Clinic
        Marty Frazier
   Principal & Co-Founder
    Trial Concierge, LLC
Today’s Agenda

• Snapshot of Clinical Research in 2011
• The Community-Based Research Site
• Impact on your Clinic
• Impact on your Patient Care
• Getting Started
•Q&A

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                Trial Concierge, LLC     2
Clinical Research in 2011

• It is Medical Science
• It is Modern Healthcare
• It is Patient Access to new treatments
• It is a Regulatory Process
• It is a Business
• It is Exciting

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Clinical Research in 2011

• It is NOT an invasion of your clinic
• It is NOT an invasion of your patients
• It is NOT “Secret Science”
• It is NOT without Regulatory Oversight
• It is NOT a “Get Rich Quick” scheme


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  Why the Community-Based
           Clinic?
• Interest from the BioPharm industry
• Interest from the FDA
• Access to mainstream patients
• Access to mainstream clinicians
• Access to “Real World” data
• Need for more research sites

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      Is my clinic a potential
          Research Site?
• Requirements:
  – Current Medical License
  – Clinical Research Coordinator
  – Clinic Setting with standard equipment
  – Access to patient populations
  – Commitment



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                  Trial Concierge, LLC       6
     Is my clinic a potential
         Research Site?
• Recommendations
 – Interest and excitement
 – Good communications
 – Business Manager
    • Internal
    • External
 – Patience


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                 Trial Concierge, LLC     7
Impact of Clinical Trials

• It is a commitment
  – On   the   part   of   the clinician/investigator
  – On   the   part   of   your clinic staff
  – On   the   part   of   your patients
  – On   the   part   of   your community




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                         Trial Concierge, LLC           8
Impact of Clinical Trials
• As a Principal Investigator
  – Responsible for trial activities
  – Responsible for trial management
  – Responsible for Site staff
     • Sub-Investigators
     • Clinical Research Coordinators
     • Other site staff
  – Mal-Practice Insurance
     • Check with your carrier
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                  Trial Concierge, LLC     9
Impact of Clinical Trials
• As a member of the clinic staff
  – New responsibilities
     • Patient outreach
     • Patient contact
     • Patient consenting
     • Clinical Research Coordinator
  – New hours
     • Possibly but generally not
  – Compensation
     • Possible promotion opportunity
                    SCORH Annual Meeting 2011
                       Trial Concierge, LLC     10
Impact of Clinical Trials
• On you patient base
  – Access to new treatment options
  – Access to healthcare for underserved patients
  – Complete control of participation and
    termination in any/all trials
  – Protected by Institutional Review Boards
  – Modest compensation for participating
  – Opportunity to affect future patients
  – Contribution to medicine and healthcare

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                    Trial Concierge, LLC            11
Impact of Clinical Trials

• On your community
 – Brings research to smaller communities
 – Brings research to your local clinician
 – Provides state of the art medicine
 – Brings revenue into the community
 – Can be embraced by the entire
   community


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Patient Care
• Trial participation is completely voluntary
     • Principal Investigator
     • Patient
• Trial participation can be terminated at any
  time
     • Principal Investigator
     • Patient
• Trials may be Placebo Controlled
     • Baseline to compare safety & efficacy

• Potential access to new treatments
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                        Trial Concierge, LLC     13
Getting Started

• Discuss with your clinic team
• Evaluate your patient pool
• Consider outside support
  – Mentor from experienced PI
  – GCP Training Course
  – Trial Management Organization
• Market your site
              SCORH Annual Meeting 2011
                 Trial Concierge, LLC     14
Clinical Research Factoids
• Clinical Development can take up to 15 years and
    cost up to $1 Billion for a single new product
•   There are over 50,000 active trials in the US alone
•   Less than 4% of physicians are involved with
    clinical trials
•   Research sites can generate $100,000 to
    $1,000,000 annually
•   Clinical Trials are not limited to Academia, Hospital
    or Metropolitan settings



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                        Trial Concierge, LLC           15
Current Research Areas
•   Cancer                       •   Parkinson’s
•   Asthma/COPD                  •   Lupus
•   Infectious Disease           •   Rheumatoid arthritis
•   Antivirals                   •   IBS/UC/Crohn’s
•   Antibiotics                  •   Insomnia
•   Diabetes                     •   Depression
•   Alzheimer’s                  •   Schizophrenia
•   Vaccines                     •   Obesity
•   AFIB/CAD/ACS                 •   Pain
•   Sexual Dysfunction           •   Women’s Health


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                      Trial Concierge, LLC                  16
Clinical Trial Resources

• www.FDA.gov
• www.ACRPnet.org
• www.ciscrp.org
• www.acrohealth.org
  – Drug Development Process
• www.clinicaltrials.gov
• www.TrialConcierge.com
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                 Trial Concierge, LLC     17
                 Q&A
• Please stand
• State your name
• Ask your question

     Thank You for your attention!
        MFrazier@TrialConcierge.com
           919-803-5322 Direct

              SCORH Annual Meeting 2011
                 Trial Concierge, LLC     18

				
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posted:8/9/2011
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