Biospecimen Reporting for Improved Study Quality

Moore, Helen M.; Kelly, Andrea; Jewell, Scott D.; McShane, Lisa M.; Clark, Douglas P.; Greenspan, Renata; Hainaut, Pierre; Hayes, Daniel F.; Kim, Paula; Mansfield, Elizabeth; Potapova, Olga; Riegman, Peter; Rubinstein, Yaffa; Seijo, Edward; Somiari, Stella; Watson, Peter H.; Weier, Heinz Ulrich G.; Zhu, Claire S.; Vaught, Jim

doi:10.1089/bio.2010.0036

Cited by 107 publications

(52 citation statements)

References 71 publications

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“…This checklist is reproduced with permission. [71][72][73] Abbreviations: BRISQ, Biospecimen Reporting for Improved Study Quality; HER2, human epidermal growth factor receptor 2; USP, United States Pharmacopeia.…”

Section: Standards For Reporting Within Published Manuscripts To Decrmentioning

confidence: 99%

“…49,60 Complete and transparent reporting for prognostic and predictive marker studies requires attention to the relevant elements of the CONSORT guidelines as well as other aspects of these studies, including issues surrounding specimens and marker assays. Two reporting guidelines highly relevant to prognostic and predictive tumor marker studies are the Biospecimen Reporting for Improved Study Quality (BRISQ) [71][72][73] guidelines and the Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) guidelines.…”

Section: Wwwjcoorgmentioning

confidence: 99%

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Publication of Tumor Marker Research Results: The Necessity for Complete and Transparent Reporting

McShane

Hayes

2012

JCO

Self Cite

169

137

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A B S T R A C TClinical management decisions for patients with cancer are increasingly being guided by prognostic and predictive markers. Use of these markers should be based on a sufficiently comprehensive body of unbiased evidence to establish that benefits to patients outweigh harms and to justify expenditure of health care dollars. Careful assessments of the clinical utility of markers by using comparative effectiveness research methods are urgently needed to more rigorously summarize and evaluate the evidence, but multiple factors have made such assessments difficult. The literature on tumor markers is plagued by nonpublication bias, selective reporting, and incomplete reporting. Several measures to address these problems are discussed, including development of a tumor marker study registry, greater attention to assay analytic performance and specimen quality, use of more rigorous study designs and analysis plans to establish clinical utility, and adherence to higher standards for reporting tumor marker studies. More complete and transparent reporting by adhering to criteria such as BRISQ [Biospecimen Reporting for Improved Study Quality] criteria for reporting details about specimens and REMARK [Reporting Recommendations for Tumor Marker Prognostic Studies] criteria for reporting a multitude of aspects relating to study design, analysis, and results, is essential for reliable assessment of study quality, detection of potential biases, and proper interpretation of study findings. Adopting these measures will improve the quality of the body of evidence available for comparative effectiveness research and enhance the ability to establish the clinical utility of prognostic and predictive tumor markers.

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Section: Standards For Reporting Within Published Manuscripts To Decrmentioning

confidence: 99%

Section: Wwwjcoorgmentioning

confidence: 99%

Publication of Tumor Marker Research Results: The Necessity for Complete and Transparent Reporting

McShane

Hayes

2012

JCO

Self Cite

169

137

View full text Add to dashboard Cite

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“…5 Just as investigators are being encouraged to strengthen the reporting of epidemiology studies (STROBE), 26 investigators should be encouraged to standardize and strengthen the reporting of biospecimen collection, processing, storage, and analysis in their molecular epidemiology studies. [21][22][23][24]27 This analysis serves as a first step at understanding our inventory of DCCPS supported biospecimen collections. However, it also suggests an opportunity to help shape the future of biospecimen research and improve how NCI collects information about biospecimens being used in populationscience studies to foster even greater sharing.…”

Section: Fig 2 a Specimen Types For The 455 Biospecimenmentioning

confidence: 99%

The Use of Biospecimens in Population-Based Research: A Review of the National Cancer Institute's Division of Cancer Control and Population Sciences Grant Portfolio

Carrick

Mette²,

Hoyle³

et al. 2014

Biopreservation and Biobanking

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Over the past two decades, researchers have increasingly used human biospecimens to evaluate hypotheses related to disease risk, outcomes and treatment. We conducted an analysis of population-science cancer research grants funded by the National Cancer Institute (NCI) to gain a more comprehensive understanding of biospecimens and common derivatives involved in those studies and identify opportunities for advancing the field. Data available for 1,018 extramural, peer-reviewed grants (active as of July 2012) supported by the Division of Cancer Control and Population Sciences (DCCPS), the NCI Division that supports cancer control and population-science extramural research grants, were analyzed. 455 of the grants were determined to involve biospecimens or derivatives. The most common specimen types included were whole blood (51% of grants), serum or plasma (40%), tissue (39%), and the biospecimen derivative, DNA (66%). While use of biospecimens in molecular epidemiology has become common, biospecimens for behavioral and social research is emerging, as observed in our analysis. Additionally, we found the majority of grants were using already existing biospecimens (63%). Grants that involved use of existing biospecimens resulted in lower costs (studies that used existing serum/plasma biospecimens were 4.2 times less expensive) and more publications per year (1.4 times) than grants collecting new biospecimens. This analysis serves as a first step at understanding the types of biospecimen collections supported by NCI DCCPS. There is room to encourage increased use of archived biospecimens and new collections of rarer specimen and cancer types, as well as for behavioral and social research. To facilitate these efforts, we are working to better catalogue our funded resources and make that data available to the extramural community.

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“…73 So far, these journals include Histopathology and Journal of Pathology. 74 Beyond academic sustainability, economic sustainability and long-term funding of biobank networks is a critical issue.…”

mentioning

confidence: 99%

Biobank networking for dissemination of data and resources: an overview

Meir¹,

Cohen²,

Mee³

et al. 2014

BSAM

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Abstract:In response to the increasing global demand for high quality biospecimens and data for biomedical research, biobanking is rapidly gaining popularity as an efficient and user-friendly platform for translational research. The advent of increasingly sophisticated technologies for specimen and data analysis, in the face of growing economic pressures, are converging to encourage consolidation, centralization, and harmonization of biobanks into networks. Several types of biobank networks exist worldwide. Individuals involved in network establishment and day-to-day function hail from varying disciplines, including health care, academia, information technology, and the pharmaceutical industry. However, they may work together within and between networks to enhance the rapid progression of patient/donor-centered research through standardization of procedures and robust quality management systems. Regularly updated standards, policies, and guidelines are published by large biobanking organizations and made available to biobankers and those interested in biospecimen science. A biobank network's ability to reliably disseminate specimens and data depends on a variety of factors, including a well stocked inventory, a robust information technology platform, and adequate support, including the goodwill of collectors who supply specimens, and of end-users who return experimental data to the network. High quality experimental data may be recycled, thus accelerating biomarker discovery. Access to large amounts of personal data, however, carries risk, and ethical issues surrounding data protection are of paramount importance. All biobank networks require data security measures in keeping with local ethical and legal requirements. Return of results to individual donors is another emerging ethical and administrative challenge for biobank networks as technology steadily increases the overlap between research and patient care. Finally, as the bioresource impact factor concept is further developed, and as more scientific journals require biospecimen and source details in submitted manuscripts, biobank networks will be securely established as an essential platform for biomedical research.

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Biospecimen Reporting for Improved Study Quality

Cited by 107 publications

References 71 publications

Publication of Tumor Marker Research Results: The Necessity for Complete and Transparent Reporting

Publication of Tumor Marker Research Results: The Necessity for Complete and Transparent Reporting

The Use of Biospecimens in Population-Based Research: A Review of the National Cancer Institute's Division of Cancer Control and Population Sciences Grant Portfolio

Biobank networking for dissemination of data and resources: an overview

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