Natalie A. Dilts
A5068877440- Health Systems, Economic Evaluations, Quality of Life
- Ethics in Clinical Research
- Meta-analysis and systematic reviews
- Health and Medical Research Impacts
- Pharmacovigilance and Adverse Drug Reactions
- Statistical Methods in Clinical Trials
- Biomedical Ethics and Regulation
Vanderbilt University Medical Center
2022-2023
Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized (mRCT) presents challenges. The Trial Innovation Network (TIN), established 2016 partner with Clinical Translational Science Award (CTSA) Consortium of academic medical institutions implementation mRCTs, consists 3 Centers (TICs) 1 Recruitment Center (RIC). This unique partnership has aimed address...
After January 25, 2018, multicenter research applications submitted to the National Institutes of Health (NIH) were required use a single Institutional Review Board (IRB). This affected academic institutions by centralizing IRB oversight reduce redundancy. Although IRBs common in industry-sponsored and United Kingdom,1,2 States reluctant cede responsibility for NIH studies. article describes development, operation, onboarding timelines “APOL1 Long-term Kidney Transplantation Outcomes”...
As clinical trials were rapidly initiated in response to the COVID-19 pandemic, Data and Safety Monitoring Boards (DSMBs) faced unique challenges overseeing of therapies never tested a disease not yet characterized. Traditionally, individual DSMBs do interact or have benefit seeing data from other accruing for an aggregated analysis meaningfully interpret safety signals similar therapeutics. In response, we developed compliant DSMB Coordination (DSMBc) framework allow one study investigating...