Proactively establishing a biologic specimens repository for large clinical trials: An idea whose time has come

Peter R. Casson, Stephen A. Krawetz, Michael P. Diamond, Heping Zhang, Richard Legro, William D. Schlaff, Christos Coutifaris, Robert G. Brzyski, Gregory M. Christman, Nanette Santoro, Esther Eisenberg

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Large randomized clinical trials are becoming more costly, and resources to support them increasingly scarce. Biologic materials, such as blood, DNA, body fluids, or tissue samples collected and stored as a component of these studies represent an invaluable resource, to answer immediate secondary hypotheses, but also as archived material, linked to the study data, for the use of investigators long into the future. The regulatory climate surrounding the storage and future unconstrained utilization of biologic materials is evolving quickly. It is no longer acceptable simply to store samples and use them in an unbridled and unregulated fashion. Thus, to fully utilize the tremendous potential of biologic samples generated from large clinical trials and their related databases, investigators should consider proactively creating a biologic specimen repository, or biorepository. A repository likely assures appropriate subject consent, sample provenance, secure storage, and codified procedures for sample and data retrieval and sharing that protect the subject's confidentiality, the investigator's need for accurate data, and the limited resource. Importantly, the biorepository specimens/samples are typically collected in addition to local and core specimens obtained for the parent study that provide baseline assessments for safety and efficacy outcomes.

Original languageEnglish (US)
Pages (from-to)217-221
Number of pages5
JournalSystems Biology in Reproductive Medicine
Volume57
Issue number5
DOIs
StatePublished - Oct 1 2011

Fingerprint

Research Personnel
Clinical Trials
Information Dissemination
Information Storage and Retrieval
Confidentiality
Body Fluids
Climate
Randomized Controlled Trials
Databases
Safety
DNA

All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Urology

Cite this

Casson, Peter R. ; Krawetz, Stephen A. ; Diamond, Michael P. ; Zhang, Heping ; Legro, Richard ; Schlaff, William D. ; Coutifaris, Christos ; Brzyski, Robert G. ; Christman, Gregory M. ; Santoro, Nanette ; Eisenberg, Esther. / Proactively establishing a biologic specimens repository for large clinical trials : An idea whose time has come. In: Systems Biology in Reproductive Medicine. 2011 ; Vol. 57, No. 5. pp. 217-221.
@article{cb32e2b7fa3648e9ac0a33098984c885,
title = "Proactively establishing a biologic specimens repository for large clinical trials: An idea whose time has come",
abstract = "Large randomized clinical trials are becoming more costly, and resources to support them increasingly scarce. Biologic materials, such as blood, DNA, body fluids, or tissue samples collected and stored as a component of these studies represent an invaluable resource, to answer immediate secondary hypotheses, but also as archived material, linked to the study data, for the use of investigators long into the future. The regulatory climate surrounding the storage and future unconstrained utilization of biologic materials is evolving quickly. It is no longer acceptable simply to store samples and use them in an unbridled and unregulated fashion. Thus, to fully utilize the tremendous potential of biologic samples generated from large clinical trials and their related databases, investigators should consider proactively creating a biologic specimen repository, or biorepository. A repository likely assures appropriate subject consent, sample provenance, secure storage, and codified procedures for sample and data retrieval and sharing that protect the subject's confidentiality, the investigator's need for accurate data, and the limited resource. Importantly, the biorepository specimens/samples are typically collected in addition to local and core specimens obtained for the parent study that provide baseline assessments for safety and efficacy outcomes.",
author = "Casson, {Peter R.} and Krawetz, {Stephen A.} and Diamond, {Michael P.} and Heping Zhang and Richard Legro and Schlaff, {William D.} and Christos Coutifaris and Brzyski, {Robert G.} and Christman, {Gregory M.} and Nanette Santoro and Esther Eisenberg",
year = "2011",
month = "10",
day = "1",
doi = "10.3109/19396368.2011.604818",
language = "English (US)",
volume = "57",
pages = "217--221",
journal = "Systems Biology in Reproductive Medicine",
issn = "1939-6368",
publisher = "Informa Healthcare",
number = "5",

}

Casson, PR, Krawetz, SA, Diamond, MP, Zhang, H, Legro, R, Schlaff, WD, Coutifaris, C, Brzyski, RG, Christman, GM, Santoro, N & Eisenberg, E 2011, 'Proactively establishing a biologic specimens repository for large clinical trials: An idea whose time has come', Systems Biology in Reproductive Medicine, vol. 57, no. 5, pp. 217-221. https://doi.org/10.3109/19396368.2011.604818

Proactively establishing a biologic specimens repository for large clinical trials : An idea whose time has come. / Casson, Peter R.; Krawetz, Stephen A.; Diamond, Michael P.; Zhang, Heping; Legro, Richard; Schlaff, William D.; Coutifaris, Christos; Brzyski, Robert G.; Christman, Gregory M.; Santoro, Nanette; Eisenberg, Esther.

In: Systems Biology in Reproductive Medicine, Vol. 57, No. 5, 01.10.2011, p. 217-221.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Proactively establishing a biologic specimens repository for large clinical trials

T2 - An idea whose time has come

AU - Casson, Peter R.

AU - Krawetz, Stephen A.

AU - Diamond, Michael P.

AU - Zhang, Heping

AU - Legro, Richard

AU - Schlaff, William D.

AU - Coutifaris, Christos

AU - Brzyski, Robert G.

AU - Christman, Gregory M.

AU - Santoro, Nanette

AU - Eisenberg, Esther

PY - 2011/10/1

Y1 - 2011/10/1

N2 - Large randomized clinical trials are becoming more costly, and resources to support them increasingly scarce. Biologic materials, such as blood, DNA, body fluids, or tissue samples collected and stored as a component of these studies represent an invaluable resource, to answer immediate secondary hypotheses, but also as archived material, linked to the study data, for the use of investigators long into the future. The regulatory climate surrounding the storage and future unconstrained utilization of biologic materials is evolving quickly. It is no longer acceptable simply to store samples and use them in an unbridled and unregulated fashion. Thus, to fully utilize the tremendous potential of biologic samples generated from large clinical trials and their related databases, investigators should consider proactively creating a biologic specimen repository, or biorepository. A repository likely assures appropriate subject consent, sample provenance, secure storage, and codified procedures for sample and data retrieval and sharing that protect the subject's confidentiality, the investigator's need for accurate data, and the limited resource. Importantly, the biorepository specimens/samples are typically collected in addition to local and core specimens obtained for the parent study that provide baseline assessments for safety and efficacy outcomes.

AB - Large randomized clinical trials are becoming more costly, and resources to support them increasingly scarce. Biologic materials, such as blood, DNA, body fluids, or tissue samples collected and stored as a component of these studies represent an invaluable resource, to answer immediate secondary hypotheses, but also as archived material, linked to the study data, for the use of investigators long into the future. The regulatory climate surrounding the storage and future unconstrained utilization of biologic materials is evolving quickly. It is no longer acceptable simply to store samples and use them in an unbridled and unregulated fashion. Thus, to fully utilize the tremendous potential of biologic samples generated from large clinical trials and their related databases, investigators should consider proactively creating a biologic specimen repository, or biorepository. A repository likely assures appropriate subject consent, sample provenance, secure storage, and codified procedures for sample and data retrieval and sharing that protect the subject's confidentiality, the investigator's need for accurate data, and the limited resource. Importantly, the biorepository specimens/samples are typically collected in addition to local and core specimens obtained for the parent study that provide baseline assessments for safety and efficacy outcomes.

UR - http://www.scopus.com/inward/record.url?scp=80053352004&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80053352004&partnerID=8YFLogxK

U2 - 10.3109/19396368.2011.604818

DO - 10.3109/19396368.2011.604818

M3 - Article

C2 - 21951166

AN - SCOPUS:80053352004

VL - 57

SP - 217

EP - 221

JO - Systems Biology in Reproductive Medicine

JF - Systems Biology in Reproductive Medicine

SN - 1939-6368

IS - 5

ER -