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ClnicalTrialDrift Nylen and Pacino April 4_ 2005

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					         Trial Drift:
Defining the Challenge and
         Solutions

 Al Oviedo Pacino II   Ruth Ann Nylen, PhD
  Hillicon Training
                        The RAN Institute
     Campuses
              Trial Drift:
Defining the Challenge and Solutions
What is trial drift?
What causes trial drift?
What are the consequences of trial drift?
How can trial drift be managed?
What are the solutions?
          What is “Trial Drift”
Trial drift normally occurs when the interest
  level in a clinical trial deteriorates and the
  average knowledge base of personnel
  involved in a study decreases and as the
  trial extends its time line.

    The longer the trial, the more the trial drifts
    when proper intervention is not performed.
      Main Causes of Trial Drift
Improper planning and the inability to choose
productive sites

Trial competition - multiple studies running at
the investigative site

Inability to foresee technology obstacles due to
lack of expertise

Staff turnover

Site turnover

Personnel and investigative site culture
       Main Causes of Trial Drift
Regulatory delays

Logistical delays

Unable to collect real time benchmark data

Lack of proactive and real time intervention
                                          What normally happens!
  (Graphical Representation. Varies Depending on Therapeutic Area)




                                        PI meeting




Low interest at (-3) months, increasing at investigator meeting (0) Drifting interest and knowledge base throughout the duration of the clinical trial
    Primary Consequences of Trial Drift

Decreased patient recruiting

Repeated miscommunication between involved personnel

Increased out of scope fees and study budgets

Fast deterioration of managerial activities

Time-lines not met
                                       What Needs to Happen!




Low interest at (-3) months, increasing at investigator meeting (0) High interest and knowledge base maintained throughout the duration of the clinical trial
      Solutions to Trial Drift

What              How
 Develop a         Define the timing,
 strategy for       content and
 training and       frequency of
 communications     training for each
 with sites         study.
                   Define the
                    content and
                    frequency for
                    follow-up
                    communications
       Solutions to Trial Drift
What                   How
 Standardize            Identify areas
 systems used at         where differences
 investigative sites     among sites
 whenever                jeopardizes the
 possible                integrity/validity
                         of the study data.
                        Provide the same
                         information, in
                         the same way.
       Solutions to Trial Drift
What                 How
 Monitor              Confirm the
 communications        communication
 and training with     has reached its
 sponsor and site      target.
 personnel            Verify the training
                       has been
                       completed and
                       document
                       competency.
                    Solutions to Trial Drift
      What:                                   How:
       Track clinical                          Measure baseline
       trial knowledge                          knowledge
       base                                    Reinforce original
100
                                                knowledge
 90
 80
                                               Train on new
 70                                             content
 60
 50                                   PI       Measure at each
 40
 30
                                      Sub-I
                                      CRC
                                                subsequent
 20                                             training
 10
  0
      Study   1st   2nd   3rd   4th
      Start   Qtr   Qtr   Qtr   Qtr
     Solutions to Trial Drift
What             How
 Measure          Regularly monitor
 benchmark         training and
 data in real      communication
 time              performance
                   results via a web-
                   based tool.
   Sample Real-time Data Review
         Score   Q1   Q2   Q3   Q4   Q5
Karen    100%    1    1    1    1    1
David    100%    1    1    1    1    1    Strong
Josh     100%    1    1    1    1    1     Site
Hadley   80%     1    1    1    1    0
Chris    60%     1    1    0    0    1
Justin   80%     1    1    0    1    1
                                           Weak
Frieda
                                          Question
         40%     1    1    0    0    0
Erica    80%     1    1    0    1    1
Wyatt    80%     0    0    0    0    0
                                          Group
Ryan     70%     0    0    0    0    0
                                          Issue
Harold 80%       0    0    0    0    0
    Solutions to Trial Drift
What            How
 Assess          Evaluate
 solutions        performance
 according to     inadequacies
 benchmark        compared to
                  baseline.
                 Develop
                  communication,
                  training, or
                  managerial
                  solutions.
    Solutions to Trial Drift
What            How
 Administer a    Implement the
 plan of          best solution(s)
 intervention    Deliver a
                  consistent and
                  accurate
                  message to all
                  centers
                 Evaluate and
                  document
                  knowledge.
    Solutions to Trial Drift
What               How
 Intervene today    Provide quality,
 not a few days,     easy-to-use
 weeks, or           training and
 months from         communications
 now                Measure and
                     document
                     knowledge &
                     training
                    Monitor
                     performance
                    Intervene
                     promptly
     A Training Solution Model
1. Deliver on-line pre-study GCP training for
   all study staff
2. Develop study-specific training modules
3. Repeat and update training at regular
   intervals
   On-line Pre-study GCP Training

All investigators, sub-investigators and CRCs are
required to complete an on-line GCP Overview Course
within 45 days prior to the study initiation meeting.
Replaces the “GCP” regulatory review during the PI
meeting.
Includes training component with unlimited access and
case studies.
Includes testing component, following mastery of
content.
  Pre-study GCP Training Course
             Content
1572 Responsiblities   IRB reporting
Obtaining and          Study documentation
Documenting            Working with a CRO
Consent                Monitoring visits
Protocol Compliance    Record maintenance
AE and SAE reporting   Audits
investigational
supplies
Advantages to On-line GCP Training
      for Investigative Sites

Training is completed by all participants.
Training is documented to support GCP
compliance.
Knowledge level is ascertained.
Problem areas can be addressed. BEFORE
study errors are made.
Can increase protocol compliance and expedite
study completion           Decreasing costs
 Benefits to The Training Solution

Continuous 24/7 access to Trial knowledge

Immediate and Increased Training - Real
Time (Sites, CRO, Vendors)

Standardization is immediate with
documentation certificates for regulatory
files
  Benefits to The Training Solution

Collect Trial Knowledge Base and
benchmark data - in Real Time

Measure Trial Knowledge Base in real time-
Reporting

Analyze Benchmark Data and Issue Proper
Resolutions Immediately

Eliminate the need to wait for the next site
visit to resolve turnover issues
    Al Oviedo Pacino II
Hillicon Technologies, Inc
 alpacino@hillicon.com
       512-302-3113

  Ruth Ann Nylen, PhD
 The RAN Institute, Inc
rnylen@raninstitute.com
      813-929-9269

				
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