TY - JOUR
T1 - Time and Effort Required for Tissue Acquisition and Submission in Lung Cancer Clinical Trials
AU - Garcia, Sandra
AU - Saltarski, Jessica M.
AU - Yan, Jingsheng
AU - Xie, Xian Jin
AU - Gerber, David E.
N1 - Funding Information:
Funded in part by the UT Southwestern Medical Student Summer Research Program (to SG) and by a National Cancer Institute (NCI) Midcareer Investigator Award in Patient-Oriented Research (K24CA201543-01 to D.E.G.). Biostatistical support was provided by the Biostatistics and Bioinformatics Shared Resource at the Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX, which is supported in part by a National Cancer Institute Cancer Center Support grant ( 1P30 CA142543-03 ). The authors thank Helen Mayo, MLS, UT Southwestern Medical Library, for assistance performing literature searches. The authors thank Dru Gray for assistance with article preparation.
Funding Information:
Funded in part by the UT Southwestern Medical Student Summer Research Program (to SG) and by a National Cancer Institute (NCI) Midcareer Investigator Award in Patient-Oriented Research (K24CA201543-01 to D.E.G.). Biostatistical support was provided by the Biostatistics and Bioinformatics Shared Resource at the Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX, which is supported in part by a National Cancer Institute Cancer Center Support grant (1P30 CA142543-03). The authors thank Helen Mayo, MLS, UT Southwestern Medical Library, for assistance performing literature searches. The authors thank Dru Gray for assistance with article preparation.
Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2017/11
Y1 - 2017/11
N2 - We analyzed data from 129 patients enrolled onto 19 lung cancer trials with mandatory or optional tumor tissue submission to determine the impact of these requirements on treatment timelines and staff effort. On average, tissue requirements delayed treatment initiation 21 days and required 3 staff communications. Improved systems to expedite these processes and use of non–tissue-based biomarkers may address these issues. Background Increasingly, analysis of tumor tissue samples for predictive and pharmacodynamic biomarkers is incorporated into lung cancer clinical trials. We determined the time and effort required for tissue acquisition and submission. Patients and Methods We analyzed data from patients enrolled from 2009 to 2016 at UT Southwestern onto lung cancer trials with mandatory or optional submission of tumor tissue. We collected dates of treatment-related events and staff communications; nature of tissue requirement and biomarker analysis; and location of archival tissue. Associations between case characteristics, clinical intervals, and number of staff communications were analyzed by Fisher's exact test, Wilcoxon 2-sample test, and Kruskal-Wallis test. Results We identified 129 patients enrolled onto 19 clinical trials, of whom 108 (84%) ultimately received study therapy. For cases in which tissue submission was required if available or optional, 16% and 0%, respectively, had tissue sent. The median interval between consent and treatment was 28 (interquartile range, 11-43) days if tissue was requested and 7 (interquartile range, 6-13) days if tissue was not requested (P <.001). Among cases with requested tissue, the median number of related research staff communications was 3 (range, 0-10). Over time, the number of staff communications increased (P <.001). Location of archival tissue was not associated with number of staff communications or treatment intervals. Conclusion Lung cancer clinical trial requirements for tissue acquisition and submission affect the time to treatment initiation and require increasing staff effort. Improved systems to expedite these processes, as well as use of blood- or imaging-based biomarkers, may help address these issues.
AB - We analyzed data from 129 patients enrolled onto 19 lung cancer trials with mandatory or optional tumor tissue submission to determine the impact of these requirements on treatment timelines and staff effort. On average, tissue requirements delayed treatment initiation 21 days and required 3 staff communications. Improved systems to expedite these processes and use of non–tissue-based biomarkers may address these issues. Background Increasingly, analysis of tumor tissue samples for predictive and pharmacodynamic biomarkers is incorporated into lung cancer clinical trials. We determined the time and effort required for tissue acquisition and submission. Patients and Methods We analyzed data from patients enrolled from 2009 to 2016 at UT Southwestern onto lung cancer trials with mandatory or optional submission of tumor tissue. We collected dates of treatment-related events and staff communications; nature of tissue requirement and biomarker analysis; and location of archival tissue. Associations between case characteristics, clinical intervals, and number of staff communications were analyzed by Fisher's exact test, Wilcoxon 2-sample test, and Kruskal-Wallis test. Results We identified 129 patients enrolled onto 19 clinical trials, of whom 108 (84%) ultimately received study therapy. For cases in which tissue submission was required if available or optional, 16% and 0%, respectively, had tissue sent. The median interval between consent and treatment was 28 (interquartile range, 11-43) days if tissue was requested and 7 (interquartile range, 6-13) days if tissue was not requested (P <.001). Among cases with requested tissue, the median number of related research staff communications was 3 (range, 0-10). Over time, the number of staff communications increased (P <.001). Location of archival tissue was not associated with number of staff communications or treatment intervals. Conclusion Lung cancer clinical trial requirements for tissue acquisition and submission affect the time to treatment initiation and require increasing staff effort. Improved systems to expedite these processes, as well as use of blood- or imaging-based biomarkers, may help address these issues.
KW - Biomarkers
KW - Biospecimens
KW - Clinical research
KW - Delay
KW - Personalized medicine
KW - Targeted therapy
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UR - http://www.scopus.com/inward/citedby.url?scp=85019724556&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2017.04.012
DO - 10.1016/j.cllc.2017.04.012
M3 - Article
C2 - 28576594
AN - SCOPUS:85019724556
SN - 1525-7304
VL - 18
SP - 626
EP - 630
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
IS - 6
ER -