Simplified trial design. Protocols should be planned with a practical eye toward simplicity and patient benefit, even in early safety studies. Study
coordinators or others who have an understanding of patients’ experiences in a clinical trial should have input during protocol development.
Starting a study with a final protocol is important to avoid loss of time and resources, especially since almost half of all protocols have an amendment
prior to dosing the first patient.9 Because site staff may not want to enroll patients in a study with a cumbersome case report form, it is important to
choose to capture only data that is essential to the study endpoints.
Molecular profiling. In a recent webcast, Dr. John Marshall, chief of Hematology/
Figure 6. Con ͥ