You

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Youve Just Been Invited to Participate in a
Clinical Trial with Imaging Endpoints Now What?!

• Marybeth Devine, BSRT, CNMT
• Sr. Clinical Program Manager
• Lantheus Medical Imaging

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Presentation Objectives

• Discuss the critical role of Technologists in
  imaging trials
• Provide strategies for ensuring GCP and protocol
  compliance in the Nuclear Medicine department
• Discuss the importance of Research Coordinator,
  Principal Investigator and Technologist
  interaction and open communication

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To Ensure a Successful Clinical Study

• You are already a GOOD investigative site
• How do you become a GREAT investigative site
• Learn!
• Educate!!
• Communicate!!!

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Learn!

• Are your Nuclear Medicine Technologists on board
  with the study?
• REMEMBER your Research Coordinator is primarily
  hired to do researchyour Technologists are not!
• If research is a critical component of your
  department, make sure to hire like-minded
  Technologists
• then support them, make them part of the team
  and make it FUN!

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Learn!

• Understand Good Clinical Practice (GCP) and your
  part in data collection and integrity
• Have you and your imaging team attended a GCP
  course?
• What are source documents?
• How is it expected the Technologist will complete
  the data worksheets?
• What is the responsibility of the Research
  Coordinator (RC) vs. the Nuclear Medicine team?

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Learn!

• Understand the imaging endpoint and study
  procedure flow
• How many imaging modalities are there?
• Is there a required sequence to study procedures?
• Are there blood draws, ECGs, vitals, EEGs, etc,
  which must be obtained concurrently to the
  imaging procedures?

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Learn!

• Know the clinical study and site-specific
  timelines for completion of imaging obligations
  the Technologist needs to be involved!
• Does the sponsor have an expectation of the
  timing of first patient in at your site?
• Are their any camera qualification requirements?
• Is it necessary to assign one Technologist to
  own the clinical study?
• Are the image submission time line requirements
  understood?
• When are the blinded reads?
• Will there be Data Monitoring Committee meetings
  requiring image data submission?

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Learn!

• Understand what data (images, imaging time
  points, assays, doses, etc.) will be needed from
  you
• Do you have a list of all the views and imaging
  time points needed?
• Do you fully understand what is required for
  image acquisition (list mode, dynamic, static)
• Do you fully understand what is needed for image
  processing (filters, etc.)?
• Does the Technologist understand their
  responsibility for image quality?
• Will IT need to be contacted to assist with image
  transfer via FTP?
• Will there be a sponsor representative with
  Nuclear experience onsite for your first subject
  dosing?
• Understand what is required and what is
  recommended

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Learn!

• Identify what, if any, camera qualification and
  image quality procedures will be needed
• Is all the information for camera qualification
  readily available?
• How quickly does the PI/sponsor expect the QC
  procedures to be completed?
• Accept that adjustments to existing systems and
  imaging techniques might be needed!

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Learn!

• Be open-minded clinical imaging and research
  imaging are not necessarily synonymous
• How do the acquisition parameters (sequence, set
  up, etc.) differ from clinical practice?
• How will you ensure the imaging protocol is
  adhered to?
• How will you educate your staff?
• What provisions will be made to ensure enough
  camera time is available to complete the imaging
  without jeopardizing image quality and data
  integrity?
• What other obligations will the Nuclear Medicine
  staff be undertaking?
• If a certain procedure does not appear to be
  logical ask for the rationale
• If in doubt on how to perform a certain procedure
  ASK!!!

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Learn!

• Practice the study procedure prior to the first
  patient!!!!!

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Educate!!

• Nuclear Medicine 101 for Research Coordinator and
  other staff
• Do not assume the RC has experience with Nuclear
  imaging
• Educate on Nuclear Medicine as well as the
  specific imaging being obtained for the research
  protocol (oncology, cardiac, etc.)
• Help the RC understand the uniqueness of Nuclear
  imaging (radiopharmaceutical half lives,
  evaluating organ function, etc.)

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Educate!!

• Offer to review imaging guidelines and data
  transmittal forms for Sponsor
• Offer imaging protocol advice, but understand
  where the Sponsor is coming from
• Not all Sponsors have an understanding of Nuclear
  imaging
• Request Nuclear Medicine Technologist presence at
  Investigator Meetings

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Communicate!!!

• Communicate questions, issues and concerns within
  the group and to the Sponsor
• Understanding of the clinical protocol
  (endpoints)
• Difficulties with imaging protocol
• Understanding of data transmittal forms
• Issues with image download and submission
• Difficulties with imaging core lab
• Role clarification

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Communicate!!!

• Ensure the Technologists are on board with the
  research obligations
• Evenings?
• Weekends?
• Make it worth their while
• Make it fun!
• Make sure the Technologists get to know the
  Sponsor representatives they should be at the
  Site Initiation Visit!!

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Communicate!!!

• Regular meetings with all study staff to
  evaluate
• What is working and what isnt
• Where are the log-jams?
• Is everyone comfortable with their role?
• Does each member of the team feel they have the
  resources and training to perform their duties?
• Lessons learned
• If you need to replace or remove a member of the
  team DO IT!

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Summary

• When the imaging study is a primary endpoint of a
  clinical trial, the Nuclear Medicine Technologist
  could very well play the most critical role in
  the success of the investigative site, clinical
  study and even the approval of investigative
  product!
• Following GCP guidelines is CRITICAL to the
  success of any clinical trial. Nuclear Medicine
  Technologists must be educated on and have a full
  understanding of GCP.

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Summary

• Adherence to the clinical trial protocol, as well
  as the trial-defined imaging protocol, is
  imperative. The PI should ensure the
  technologist has a full understanding of both the
  clinical study and imaging procedures.
• Uncommunicative, disjointed research teams can
  derail an investigative site quite rapidly.
  Re-establishing your sites research reputation
  can take years as most Sponsors are not willing
  to be burned twice!

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Success Bottom Line

• A successful clinical trial needs engaged,
  interactive, coordinated and knowledgeable
  clinical teams at the investigative sites
• Excellent investigative sites will never lack for
  research protocols you are hard to findso news
  travels fast!!