@article{038d2222742e44f39292996569161499,
title = "Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials",
abstract = "Objectives: The National Cancer Institute (NCI) National Clinical Trials Network performs phase II and III clinical trials, which increasingly rely on the submission of diagnostic formalin-fixed, paraffin-embedded tissue blocks for biomarker assessment. Simultaneously, advances in precision oncology require that clinical centers maintain diagnostic specimens for ancillary, standard-of-care diagnostics. This has caused tissue blocks to become a limited resource for advancing the NCI clinical trial enterprise and the practice of modern molecular pathology. Methods: The NCI convened a 1-day workshop of multidisciplined experts to discuss barriers and strategic solutions to facilitate diagnostic block submission for clinical trial science, from the perspective of patient advocates, legal experts, pathologists, and clinical oncologists. Results: The expert views and opinions were carefully noted and reported. Conclusions: Recommendations were proposed to reduce institutional barriers and to assist organizations in developing clear policies regarding diagnostic block submission for clinical trials.",
keywords = "Biobanks, Cancer, Clinical trials, FFPE blocks, NCTN, Oncology, Pathology, Policy",
author = "Hala Makhlouf and Watson, {Mark A.} and Lankes, {Heather A.} and Carol Weil and Maura Dickler and Michael Birrer and Christopher Moskaluk and Ramirez, {Nilsa C.} and Nader Okby and Edgar Alonsozana and Mark Barnes and Goldman, {Edward B.} and Rebecca Enos and Irina Lubensky",
note = "Funding Information: National Clinical Trials Network (NCTN) oncology groups conduct treatment trials supported by the National Cancer Institute (NCI). These trials include randomized phase III, phase II, and precision medicine trials across the United States, enrolling approximately 20,000 patients at more than 2,000 sites each year.2 NCTN trials often include biospecimen collection and biomarker testing, categorized as integral, integrated, and secondary correlative studies. Integral biomarkers are required for the trial to proceed (eg, to determine a patient{\textquoteright}s eligibility or arm assignment). If a clinical block is not submitted for integral biomarker studies, patients cannot be enrolled, and the trial is at risk of being statistically underpowered. Integrated biomarkers are those needed to address an end point of the trial. If a clinical block is not submitted for integrated biomarkers, the trial{\textquoteright}s biomarker-based science is jeopardized. Tissue can also be collected and banked for future secondary correlative studies. Most patients consent to this as an option, for future research beyond the immediate trial objectives. Because exact specimen requirements for future studies are unknown and because material may be stored for long after the trial conclusion, tissue blocks are particularly important for supporting future research. Publisher Copyright: {\textcopyright} 2019 American Society for Clinical Pathology, 2019.",
year = "2020",
month = jan,
day = "2",
doi = "10.1093/ajcp/aqz141",
language = "English",
volume = "153",
pages = "149--155",
journal = "American Journal of Clinical Pathology",
issn = "0002-9173",
number = "2",
}