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You’ve Just Been Invited to Participate in a Clinical Trial with Imaging Endpoints – Now What?!

You’ve 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. Presentation Objectives. Discuss the critical role of Technologists in imaging trials

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You’ve Just Been Invited to Participate in a Clinical Trial with Imaging Endpoints – Now What?!

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  1. You’ve 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

  2. 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

  3. To Ensure a Successful Clinical Study: • You are already a GOOD investigative site… • How do you become a GREAT investigative site… • Learn! • Educate!! • Communicate!!!

  4. Learn! • Are your Nuclear Medicine Technologists on board with the study? • REMEMBER: your Research Coordinator is primarily hired to do research…your 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!

  5. 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?

  6. 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?

  7. 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?

  8. 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”

  9. 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!

  10. 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!!!

  11. Learn! Practice the study procedure prior to the first patient!!!!!

  12. 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.)

  13. 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

  14. 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

  15. 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!!

  16. Communicate!!! • Regular meetings with all study staff to evaluate: • What is working and what isn’t • 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!

  17. 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.

  18. 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 site’s research reputation can take years as most Sponsor’s are not willing to be burned twice!

  19. 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 find…so news travels fast!!

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