Comparison between protocols and publications for prognostic and predictive cancer biomarker studies.

Comparison between protocols and publications for prognostic and predictive cancer biomarker studies.

Publication date: Oct 05, 2019

Method prespecification in study protocols is important for controlling bias in reports. The primary goal of this study was to assess potential for discordance between study protocols and publications reporting predictive or prognostic cancer biomarker research. Secondary objectives included comparing characteristics of publications with accessible protocols compared to those without.

Publications reporting predictive or prognostic cancer biomarker research were identified from 15 major journals, 2012-2015. Protocols were sought online or through repeated queries of corresponding authors. The following four items were extracted: (1) biomarkers, (2) biospecimen/assays, (3) sample size, (4) endpoints. We defined “explicit discordance” as the presence of major inconsistencies on these items.

Of 149 eligible publications, we obtained 19 eligible protocols online (13%). Out of a random sample of 103 publications where protocols were not available online, 12 protocols (12%) were furnished by corresponding authors; 8 (8% of authors) explicitly stated the absence of a protocol. Among 24 retrospective cohort studies, no protocol could be accessed. We found explicit discordance between publications and protocols for 18 studies (58%), in particular choice of biomarkers (36%), biospecimen/assays (6%), or endpoints (29%).

Protocols are generally not accessible or not used for cancer biomarker studies. Publications were often explicitly discordant with protocols, particularly regarding biomarkers and endpoints. Our findings point to common unaddressed risk of bias in publications of major journals reporting the relationship between cancer biomarkers and clinical endpoints.

Doussau, A., Vinarov, E., Barsanti-Innes, B., and Kimmelman, J. Comparison between protocols and publications for prognostic and predictive cancer biomarker studies. 05530. 2019 Clin Trials.

Concepts Keywords
Biomarker Eligible protocols
Biomarkers Characteristics accessible protocols
Cohort Studies Precision protocol
Protocol Explicit discordance protocols
Size 4 Comparison protocols
Potential discordance protocols
Medicine
Biomarkers
Clinical medicine
Branches of biology
Clinical endpoint
Protocol
29 Protocols
2012 2015 Protocols
Explicit discordance protocols
Characteristics accessible protocols
Comparison protocols

Semantics

Type Source Name
disease DOID cancer
disease MESH cancer

Similar

Original Article

Leave a Comment

Your email address will not be published. Required fields are marked *