THE MEDICAL RESEARCH NETWORK
      A ‘Clinical Trial Support Organisation’ (CTSO)




    The Trial Site & Beyond!
       ...
The Trial Site & Beyond!




   Feasibility …
                  What
                  When
                  Why


© Medi...
The Trial Site & Beyond!

       Key Stakeholders in Patient Recruitment ...




       Sponsor / CRO                Inves...
The Trial Site & Beyond!

       And their perception of clinical trials ...

                Sponsor             Investig...
The Patient’s Perception




© Medical Research Network 2007         www.themrn.co.uk
Factors Influencing Patients




         The Protocol & Study Design




         •                        The Site Staff...
Factors Influencing Patients

    • The Protocol & Study Design
           – Visits
                   • Total Number – Ov...
What Can We Do - Protocol

    • Keep It Simple!
           –    Limit Site Visits
           –    Limit Assessments
     ...
What Can Be Done In The Home

  • Anything Not Requiring Medic or Bulky
    Equipment!
      – Drug Administration
       ...
What Can Be Done In The Home

    • Ideal Protocols
           – Multiple Repetitive Visits
                   • Safety Bl...
Service Set Up

           – Nursing Manuals
                   • Detailed Home Care Instructions
                   • Sou...
How Does It Work

    • Site ID & Consent Patient
                                                                   » Sit...
How Does It Work

    • Site ID & Consent Patient
                                                                      » ...
Factors Influencing Patients




         The Protocol & Study Design




         •                        The Site Staff...
Factors Influencing Patients

    • Site Staff
           – Availability & Time
                   •   Who is doing what –...
What Can We Do? – Site Staff

    • Increase Time Assessing Resource
           –    Patient Numbers - Qualified
         ...
What Can We Do? – Site Staff

    • Outcome ... Terrible PI, No Patients
           – Drop Site!
    • Outcome ... Good PI...
Contingency Planning

    • Plans to Fix Problems ... When They Occur
           – Increase Sites
           – Increase Vi...
Contingency

                                                                                                   Standard a...
To Quote ...

    • Murphy’s Law
           – "Anything that can go wrong will go wrong.”


    • Finagle’s Law
          ...
The Facts ...


                                              Development Costs ($Billions)
                              ...
Prophylactic Contingency

                                                                                                ...
Additional Cost Benefit

                     Compound in Development for Treatment of Arthritis
                         ...
In Summary

    • Patient’s Perception Is Critical To Success
           – Keep It Simple
           – Ensure Adequate & A...
Thank You!

                                        Netherlands                          Germany
                         ...
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The Trial Site & Beyond! Stuart Redding, The MRN Ltd.

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The Trial Site & Beyond! Stuart Redding, The MRN Ltd.

  1. 1. THE MEDICAL RESEARCH NETWORK A ‘Clinical Trial Support Organisation’ (CTSO) The Trial Site & Beyond! Stuart Redding, Director www.themrn.co.uk
  2. 2. The Trial Site & Beyond! Feasibility … What When Why © Medical Research Network 2007 www.themrn.co.uk
  3. 3. The Trial Site & Beyond! Key Stakeholders in Patient Recruitment ... Sponsor / CRO Investigator Patients © Medical Research Network 2007 www.themrn.co.uk
  4. 4. The Trial Site & Beyond! And their perception of clinical trials ... Sponsor Investigator Patients Each day a drug is delayed from market, sponsors lose up to $8 million © Medical Research Network 2007 www.themrn.co.uk
  5. 5. The Patient’s Perception © Medical Research Network 2007 www.themrn.co.uk
  6. 6. Factors Influencing Patients The Protocol & Study Design • The Site Staff & Facilities © Medical Research Network 2007 www.themrn.co.uk
  7. 7. Factors Influencing Patients • The Protocol & Study Design – Visits • Total Number – Overall Trial Commitment • Frequency – Travel Cost, Distance, Time & Stress • Length – Time Commitments – Assessments • Blood Draws – Necessity & Discomfort • Infusions - Time & Discomfort • QOL – Time & Repetition – Drug • Safety & AEs – Risk of Participation • Placebo – How will Illness Progress © Medical Research Network 2007 www.themrn.co.uk
  8. 8. What Can We Do - Protocol • Keep It Simple! – Limit Site Visits – Limit Assessments – ‘Steamline’ Endpoints – Consider Home Care Visits • Take The Trial to the Patient • Reduce Visits to Site • Make Trials More Appealing • Can Account For Up To 50% of a Trial’s Visits • Shown to Increase Recruitment Rates Up to 60% • Shown to Maintain Retention Rates At Over 90% © Medical Research Network 2007 www.themrn.co.uk
  9. 9. What Can Be Done In The Home • Anything Not Requiring Medic or Bulky Equipment! – Drug Administration • Tablet counts, injections, infusions, compliance & accountability – Blood Sampling • Centrifuging, Courier collection, POC devices – Efficacy assessments – Safety assessments – QOL, Health Economics – ECG © Medical Research Network 2007 www.themrn.co.uk
  10. 10. What Can Be Done In The Home • Ideal Protocols – Multiple Repetitive Visits • Safety Bloods • Infusions – Subject Population • Elderly • Immobile • Working – Geography • Increases catchment • Potential Decrease Sites © Medical Research Network 2007 www.themrn.co.uk
  11. 11. Service Set Up – Nursing Manuals • Detailed Home Care Instructions • Source Documents • Training Material – Team Collation • Per Study, Per Country • Patient Dependent • Just in Time Trained – F2F, Webex – Protocol – Assessments – ICH – SAEs © Medical Research Network 2007 www.themrn.co.uk
  12. 12. How Does It Work • Site ID & Consent Patient » Site Complete CRF Site Refer Patient to Home Care Provider Source Document Completed Nurse Completes Visit In Home © Medical Research Network 2007 www.themrn.co.uk
  13. 13. How Does It Work • Site ID & Consent Patient » Site Review » Data Site Refer Patient to Home Care Provider Data Recorded Via Digital Pen Nurse Completes Visit In Home © Medical Research Network 2007 www.themrn.co.uk
  14. 14. Factors Influencing Patients The Protocol & Study Design • The Site Staff & Facilities © Medical Research Network 2007 www.themrn.co.uk
  15. 15. Factors Influencing Patients • Site Staff – Availability & Time • Who is doing what – Who will you see • When - Flexibility • For how long – Speed of visit • Patient Identification – Knowledge • Protocol – To conduct visits • IB – Safety issues • PIS – To explain the trial – Interest • Are they motivated © Medical Research Network 2007 www.themrn.co.uk
  16. 16. What Can We Do? – Site Staff • Increase Time Assessing Resource – Patient Numbers - Qualified – Review Inclusion Criteria – Patient Numbers – Assessments & Time – Staff Availability & Experience • Responsibilities – Patient Numbers – Clinic Space & Facilities – Patient Numbers © Medical Research Network 2007 www.themrn.co.uk
  17. 17. What Can We Do? – Site Staff • Outcome ... Terrible PI, No Patients – Drop Site! • Outcome ... Good PI, Loads Patients ... – Inadequate Resource • Research Nurse • Recruitment Nurse • Infusion Nurse • CTA – Data Transcription – Consider Home Care • Reduce On site Nurse & Clinic Time © Medical Research Network 2007 www.themrn.co.uk
  18. 18. Contingency Planning • Plans to Fix Problems ... When They Occur – Increase Sites – Increase Visits – PM, Sponsor – Increase Countries – Review Protocol & Issues – Add in Site Resource – Consider Homecare options © Medical Research Network 2007 www.themrn.co.uk
  19. 19. Contingency Standard approach Site resources identified as poor Poor recruiting sites start to C D perform, but costs ‘add on’ to original budget Site set Protocol Site ID Recruit Recruit Recruit Recruit RX RX up A B Recruitment HTS set up appears 2 to 4 months difficult Slow studies start to perform, but costs ‘add on’ to original budget © Medical Research Network 2007 www.themrn.co.uk
  20. 20. To Quote ... • Murphy’s Law – "Anything that can go wrong will go wrong.” • Finagle’s Law – "Whatever can go wrong will go wrong, and at the worst possible time, in the worst possible way." © Medical Research Network 2007 www.themrn.co.uk
  21. 21. The Facts ... Development Costs ($Billions) 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 1975 1987 2001 2006 • Phase II Trials Take 31% longer than planned; Phase III Trials 30% • 85-95% of days lost are due to recruitment issues © Medical Research Network 2007 www.themrn.co.uk
  22. 22. Prophylactic Contingency Ideal approach Site resources identified as poor Sites have resources they need from B C the start, recruit on time, Cost Neutral Site set Protocol Site ID Recruit Recruit Recruit RX RX up A Recruitment HTS set Cost neutral appears difficult up Speed up by 25% (3 months) 1 to 3 months © Medical Research Network 2007 www.themrn.co.uk
  23. 23. Additional Cost Benefit Compound in Development for Treatment of Arthritis Actual Hypothetical ~300 sites recruited 10 Select & Prepare or fewer patients each Sites Better 450 Average Patients per Site: 14.9 Average Patients per Site: 23.3 (+56%*) Number of Sites: 670 Number of Sites: 449 300 = Redistributed Sites No. = Existing Sites Sites 150 0 0–10 11-20 21-30 31-40 41-50 51-60 61-70 >70 Patients recruited / site Selecting sites that recruit >10 patients requires 221 less sites Cost savings @ $20K** / site = $4.42M. © Medical Research Network 2007 www.themrn.co.uk
  24. 24. In Summary • Patient’s Perception Is Critical To Success – Keep It Simple – Ensure Adequate & Appropriate Resource – Take The Trial To The Patient • Implement Strategy Early! – Speed Up Recruitment – Potentially Reduce Site Requirements – Potentially Reduce Patient Numbers – Offer Ultimate Cost Neutrality or Saving! © Medical Research Network 2007 www.themrn.co.uk
  25. 25. Thank You! Netherlands Germany UNITED KINGDOM Belgium Poland Republic of Ireland Hungary Canada France Czech Republic USA Portugal Spain Thailand Switzerland Australia Stuart Redding Stuart.Redding@themrn.co.uk +44 7764 965 039 The MRN Ltd - Global Site & Home Trial Support Specialists © Medical Research Network 2007 www.themrn.co.uk

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