Svetlana Nikic: Emphasizing the need for informed consent for Including Tissue Biopsies in Clinical Trials
Svetlana Nikic shared on LinkedIn:
“A few days ago, the FDA released a new guidance document intended to serve as a recommendation for industry, investigators, institutions, and IRBs regarding the ethical and scientific considerations surrounding tissue biopsies in clinical trials.
This guidance particularly emphasizes the need for informed consent and the careful assessment of risks and benefits.
Biopsies inherently carry risks, so this guidance aims to ensure biopsies are only required when the information obtained is necessary to identify eligible participants, evaluate primary endpoints, or ensure the trial can otherwise answer its scientific questions. Moreover, in trials involving younger patients, any direct benefit to the child should be considered, and risks must be minimized. Important and quick read!”
Svetlana Nikic is the Founder of Precision Oncology Consulting. With a background including roles at Roche Diagnostics and Illumina, she focuses on advancing molecular methods in clinical settings. Svetlana spearheaded initiatives to integrate genomics-based approaches like whole-genome sequencing into oncology routine testing. Her achievements include establishing an oncology expert network and supporting the introduction of advanced genomic analysis in Swedish leukemia patient care. Svetlana holds advanced degrees in biochemistry, molecular biology, and marketing management, currently pursuing Harvard Medical School courses in Clinical Drug Development and Pharmacology.
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