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Letters of Intent (LOIs) Through the NCI’s Cancer Therapy Evaluation Program (CTEP)

Letters of Intent (LOIs) Through the NCI’s Cancer Therapy Evaluation Program (CTEP). Dr. Patricia M. LoRusso, D.O. Karmanos Cancer Institute Wayne State University. Benefits of the CTEP LOI. Allows investigators to perform clinical research instead of clinical trials

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Letters of Intent (LOIs) Through the NCI’s Cancer Therapy Evaluation Program (CTEP)

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  1. Letters of Intent (LOIs)Through the NCI’s Cancer Therapy Evaluation Program (CTEP) Dr. Patricia M. LoRusso, D.O. Karmanos Cancer Institute Wayne State University

  2. Benefits of the CTEP LOI • Allows investigators to perform clinical researchinstead of clinical trials • Allows access to exciting novel agents • Potential for novel-novel combination • Potential combinations from different companies • CTEP holds the IND, less paperwork • Novel trial designs • Investigator initiated studies important for CCSGs • Successful competition attractive to funding agencies

  3. The NCI-CTEP LOI • Required to conduct clinical trial with CTEP IND agents • Solicited - submitted in response to development plan designed by CTEP Investigational Drug Steering Committee (IDSC) and industry collaborator • Unsolicited - submitted to address novel hypotheses supported by published or unpublished preclinical data

  4. Correlative Studies • Correlative studies provide a better understanding of the effects of agents on their tumor targets • Pharmacokinetics • Pharmacodynamics • Pharmacogenetics • Biomarker analyses • Molecular Profiling • Each correlate should include rationale, hypothesis, and methods

  5. Tips for a successful LOI • START EARLY AND GIVE YOURSELF ENOUGH TIME!! • Gather a team to help in design: • clinicians • scientists • statisticians • budgetary specialists • Design aims / hypotheses in conjunction with a biostatistician • Consider funding – if approved, is there $ to actually carry out the work? • Remember quality is the key – not quantity

  6. The Value of Partnerships • Collaboration with other institutions allows: • Better science • Increased patient recruitment • Intellectual input • Momentum

  7. More tips • Don’t be afraid to think outside the box!!! • Be creative • Schedule meetings far in advance • Be mindful of the deadline • Don’t be on an island – ask for help! • CTEP is there to help you!!!!!

  8. What I HATE about writing an LOI • It takes a lot of time to write • It competes with other commitments • You don’t always get them!!!! • It is critical to learn from your failures!!!!

  9. What I LOVE about writing an LOI • Creative fun • Allows translation of the science • Allows collaboration • Leadership, negotiation and organization • Helps organize and focus concepts • Often can lead to grant funding • Exciting

  10. The beauty of this process is to allow you to perform clinical researchinstead of simply clinical trials

  11. Thank you!

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