Data Safety Monitoring Boards
1. High risk or vulnerable populations 2. Trials investigating new interventions with few or no safety data available 3. Trials with primary endpoints such as mortality or major morbidity 4….
Clinical Trials: Handling the Data
Died Survived Drug A 27 498 525 Placebo 75 500 575 102 998 1,100 The row totals are the total number of patients receiving Drug A and placebo, whereas…
Regulatory Considerations in Human Subjects Research
1. The voluntary consent of the human subject is absolutely essential. The person involved should have legal capacity to give consent; should be so situated as to be able to…
Planning for Data Monitoring and Audits
Timothy M. Pawlik and Julie A. Sosa (eds.)Success in Academic SurgerySuccess in Academic Surgery: Clinical Trials201410.1007/978-1-4471-4679-7_6 © Springer-Verlag London 2014 6. Planning for Data Monitoring and Audits Lisa Jacobs1 (1) Department of Surgery, Johns Hopkins University,…
Statistics: Setting the Stage
Fig. 3.1 Power curve. A power curve demonstrates the increasing differences (δ) between the control group and the intervention group with a one-sided significance level of 0.05 and a total…
The Budget
Fig. 7.1 Steps for submitting the NIH budget 7.3 Complying with Federal Cost Principles For a grant to be accepted by the NIH, not only should it be scientifically sound…
Building Your Clinical Trial Research Team
Fig. 1.1 Members of the clinical trial research team (IRB institutional review board, Co–PI coprincipal investigator) 1.2 Key Members of the Clinical Trial Research Team 1.2.1 Principal Investigator The principal…
Surgical Decompression for Pituitary Apoplexy
Fig. 18.1 (a–f) MRI sequence: (a axial T1, b coronal T1, c coronal enhanced T1 and d sagittal T1) of a 40-year-old woman presenting with classical apoplexy, who suffered sudden…
Carotid Artery Aneurysm
Fig. 14.1 (a) CT scan shows hemorrhagic PA extending locally to the suprasellar cisterns. (b) Postoperative CT scan after pituitary removal When SAH is secondary to a preexisting intracranial aneurysm,…
Rathke’s Cleft Cysts Mimicking Pituitary Apoplexy
Fig. 16.1 An illustrative case of haemorrhagic RCC (Komatsu et al. 2010). A 46-year-old man had a 4-day history of severe headache. Neurological and endocrinological findings were normal. Coronal MR…
