I assist UWCCC clinical researchers in developing their therapeutic, observational, and pilot research protocols, ensuring that all elements required by the UWCCC Protocol Review Monitoring Committee, the UW Health Sciences Institutional Review Boards, regulatory agencies, and the funding entity (the Sponsor) are included and clearly presented. The protocol is a document that describes how a clinical study will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical study), and ensures the safety of the study participants and integrity of the data collected. My background as a research professor in the Department of Anesthesia and Critical Care at the University of Chicago conducting NIH-funded research for over 2 decades also allows me to assist UWCCC clinical faculty and fellows in grant applications and journal submissions.
I can be contacted at zacny@wisc.edu.
Several examples of my work at UWCCC include the following:
- I assisted Dr. Inga Hofmann in 2017 and 2018 with her protocol that will soon be open to recruitment: “Treatment of CMV infections with viral-specific T cells against CMV in pediatric and adult immunocompromised patients or recipients of allogeneic stem cell transplantation.” My assistance included protocol development, preparation of three consent forms, and also help with certain sections of the IND application to the FDA.
- I assisted Dr. Mark Juckett in 2018 with his protocol: “Fludarabine, Melphalan and TBI With Peripheral Blood Stem Cell Transplantation and Post-Transplant Cyclophosphamide For Treatment Of Myeloproliferative Neoplasms”. My assistance included protocol development and preparation of the consent form.
- I assisted Dr. Vaishalee Kenkre and her colleagues in editing a systematic review for submission to Leukemia and Lymphoma: ”TCR αβ+/CD19+ Cell Depletion in Haploidentical Hematopoietic Allogeneic Stem Cell Transplantation: A Review of Current Literature”. First author is Kieran Sahasrabudhe. I also helped in finalizing page proofs after the manuscript’s acceptance by the journal (publication date: September 6, 2018, doi: 10.1080/10428194.2018.1485905).
- In August of 2018 I assisted Dr. Ruth O’Regan with her DoD Breast Cancer Research Program Level 3/4 grant application and Dr. Lisa Barroilhet with her DoD Ovarian Cancer Research Program Level 3/4 grant application. I helped edit different sections of the grant applications for clarity/accuracy.