What's in a sample? Increasing transparency in biospecimen procurement methods

Preanalytics and Precision Pathology: Pathology Practices to Ensure Molecular Integrity of Cancer Patient Biospecimens for Precision Medicine

“…The issue of unknown specimen quality profoundly affects biomedical research as well as clinical practice. 2,5,8,[16][17][18][53][54][55] Most of the biospecimens that fuel translational research and the correlative science in clinical trials are apportioned from clinical samples acquired for medical purposes, not research. This is true of most tumor samples used for correlative scientific studies in clinical trials and for so-called discard specimens that are ''left over'' following diagnostic evaluation and are then used in discovery research or product development.…”

“…In 2014, the National Biomarker Development Alliance (NBDA), 63 a nonprofit organization and think tank, convened a cross-sector national conference to address the critical issue of uneven and unknown quality of human biospecimens in clinical medicine and translational research. 18,54,55,64,65 The meeting brought together more than 50 experts and thought leaders from molecular pathology, laboratory medicine, surgery, genomics, proteomics, health care delivery, analysis platform technology along with payers, funders, regulators, patient advocacy, and profes-sional societies that set and enforce standards of care, including the CAP.…”

“…[1][2][3][4][5][6][7][8][9][10][11] As a result, patient care and safety may be affected [12][13][14][15] and medical research dependent on patient samples may be compromised. 2,5,7,8,[16][17][18] Despite these issues, there is no requirement to control or record preanalytical variables in routine clinical practice in pathology with the single exception of breast cancer tissue that is to be assayed for estrogen/progesterone receptor expression and/or HER2 protein overexpression. In that single context, the preanalytical steps of cold ischemia time, formalin fixation method, and total time in formalin are addressed in the guideline jointly developed by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) 19 and are included in the Accreditation Checklist of the CAP Laboratory Accreditation Program (LAP).…”

Recommendations for cellular and molecular pathology input into clinical trials: a systematic review and meta‐aggregation

“…Of the 40 guidance resources included [7,9,[34][35][36][37][38][39][40][41][42][65][66][67][68][69][70][71], around half (n = 21, 53%) offered recommendations pertaining to all aspects of pathology input within clinical trials (patient selection, risk stratification, and outcome assessment) [7,9,11,13,17,20,[26][27][28][29][30]35,36,38,41,42,65,[67][68][69][70]. Seven (17%) of the included guidance resources contained explicit recommendations [7,18,31,39,41,66,71], 24 (60%) contained implicit recommendations [9,11-16,19,22-25,27-30, 34-37,42,67,69,70], and the remaining 9 (23%) offered a combination of explicit and implicit recommendations [17,…”

“…Best practice recommendation statements that contributed to the recurring themes were gathered and synthesised from 22 of the guidance resources [7,9,11,13,17,19,22,24,[27][28][29][30]32,35,38,39,41,66,67,[69][70][71] using the JBI meta-aggregation approach (see supplementary material, Table S4). The GRADE-CERQual evidence profile (see supplementary material, Table S5) shows the CERQual assessment details, with reasons for reaching the judgements, for each of the four GRADE-CERQual components.…”