Trial Drift: Defining the Challenge and Solutions

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Trial DriftDefining the Challenge and
Solutions
Ruth Ann Nylen, PhD The RAN Institute
Al Oviedo Pacino IIHillicon Training Campuses
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Trial DriftDefining 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?

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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.

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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

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Main Causes of Trial Drift

• Regulatory delays
• Logistical delays
• Unable to collect real time benchmark data
• Lack of proactive and real time intervention

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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
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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

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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
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Solutions to Trial Drift

• What
• Develop a strategy for training and
  communications with sites

• How
• Define the timing, content and frequency of
  training for each study.
• Define the content and frequency for follow-up
  communications

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Solutions to Trial Drift

• What
• Standardize systems used at investigative sites
  whenever possible

• How
• Identify areas where differences among sites
  jeopardizes the integrity/validity of the study
  data.
• Provide the same information, in the same way.

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Solutions to Trial Drift

• What
• Monitor communications and training with sponsor
  and site personnel

• How
• Confirm the communication has reached its target.
• Verify the training has been completed and
  document competency.

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Solutions to Trial Drift

• What
• Track clinical trial knowledge base

• How
• Measure baseline knowledge
• Reinforce original knowledge
• Train on new content
• Measure at each subsequent training

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Solutions to Trial Drift

• What
• Measure benchmark data in real time

• How
• Regularly monitor training and communication
  performance results via a web-based tool.

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Sample Real-time Data Review
Strong Site
Weak Question
Group Issue
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Solutions to Trial Drift

• How
• Evaluate performance inadequacies compared to
  baseline.
• Develop communication, training, or managerial
  solutions.

• What
• Assess solutions according to benchmark

• Train
• Communicate
• Manage

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Solutions to Trial Drift

• How
• Implement the best solution(s)
• Deliver a consistent and accurate message to all
  centers
• Evaluate and document knowledge.

• What
• Administer a plan of intervention

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Solutions to Trial Drift

• How
• Provide quality, easy-to-use training and
  communications
• Measure and document knowledge training
• Monitor performance
• Intervene promptly

• What
• Intervene today not a few days, weeks, or months
  from now

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A Training Solution Model

• Deliver on-line pre-study GCP training for all
  study staff
• Develop study-specific training modules
• Repeat and update training at regular intervals

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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.

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Pre-study GCP Training Course Content

• 1572 Responsiblities
• Obtaining and Documenting Consent
• Protocol Compliance
• AE and SAE reporting
• investigational supplies

• IRB reporting
• Study documentation
• Working with a CRO
• Monitoring visits
• Record maintenance
• Audits

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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

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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

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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

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• Please contact us at

• Al Oviedo Pacino II
• Hillicon Technologies, Inc
• alpacino_at_hillicon.com
• 512-302-3113

Ruth Ann Nylen, PhD The RAN Institute,
Inc rnylen_at_raninstitute.com 813-929-9269