Evidence map›Paper›PMID 26160883›Full record

Observational studyJournal of the National Cancer Institute2015

Participation in Cancer Pharmacogenomic Studies: A Study of 8456 Patients Registered to Clinical Trials in the Cancer and Leukemia Group B (Alliance).

Lynn G Dressler, Allison M Deal, Kouros Owzar, Dorothy Watson, Katherine Donahue, Paula N Friedman, Mark J Ratain, Howard L McLeod

Open access · hybridAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of the National Cancer Institute, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Review
  3. Inequities in Alliance Acute Leukemia Clinical Trial and Biobank Participation: Defining Targets for Intervention.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Article
  4. Article
  5. Article
  6. Review
  7. Genome-Wide Association Studies of Chemotherapeutic Toxicities: Genomics of Inequality.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Lynn G DresslerPersonalized Medicine, Mission Cancer Care, Mission Health, Asheville, NC (LGD); Biostatistics Core, Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC (AMD); Alliance Statistics and Data Center, Duke University, Durham, NC (formerly the Cancer and Leukemia Group B Statistical and Data Management Center, Duke University, Durham, NC) (KO); GlaxoSmithKline, Research Triangle Park, NC (DW); Independent contractor, Williamsville, NY (KD); Department of Medicine and Center for Personalized Therapeutics, University of Chicago, Chicago, IL (PNF, MJR); DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL (HLM). lynn.dressler@msj.org.
Allison M DealPersonalized Medicine, Mission Cancer Care, Mission Health, Asheville, NC (LGD); Biostatistics Core, Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC (AMD); Alliance Statistics and Data Center, Duke University, Durham, NC (formerly the Cancer and Leukemia Group B Statistical and Data Management Center, Duke University, Durham, NC) (KO); GlaxoSmithKline, Research Triangle Park, NC (DW); Independent contractor, Williamsville, NY (KD); Department of Medicine and Center for Personalized Therapeutics, University of Chicago, Chicago, IL (PNF, MJR); DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL (HLM).
Kouros OwzarPersonalized Medicine, Mission Cancer Care, Mission Health, Asheville, NC (LGD); Biostatistics Core, Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC (AMD); Alliance Statistics and Data Center, Duke University, Durham, NC (formerly the Cancer and Leukemia Group B Statistical and Data Management Center, Duke University, Durham, NC) (KO); GlaxoSmithKline, Research Triangle Park, NC (DW); Independent contractor, Williamsville, NY (KD); Department of Medicine and Center for Personalized Therapeutics, University of Chicago, Chicago, IL (PNF, MJR); DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL (HLM).
Dorothy WatsonPersonalized Medicine, Mission Cancer Care, Mission Health, Asheville, NC (LGD); Biostatistics Core, Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC (AMD); Alliance Statistics and Data Center, Duke University, Durham, NC (formerly the Cancer and Leukemia Group B Statistical and Data Management Center, Duke University, Durham, NC) (KO); GlaxoSmithKline, Research Triangle Park, NC (DW); Independent contractor, Williamsville, NY (KD); Department of Medicine and Center for Personalized Therapeutics, University of Chicago, Chicago, IL (PNF, MJR); DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL (HLM).
Katherine DonahuePersonalized Medicine, Mission Cancer Care, Mission Health, Asheville, NC (LGD); Biostatistics Core, Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC (AMD); Alliance Statistics and Data Center, Duke University, Durham, NC (formerly the Cancer and Leukemia Group B Statistical and Data Management Center, Duke University, Durham, NC) (KO); GlaxoSmithKline, Research Triangle Park, NC (DW); Independent contractor, Williamsville, NY (KD); Department of Medicine and Center for Personalized Therapeutics, University of Chicago, Chicago, IL (PNF, MJR); DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL (HLM).
Paula N FriedmanPersonalized Medicine, Mission Cancer Care, Mission Health, Asheville, NC (LGD); Biostatistics Core, Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC (AMD); Alliance Statistics and Data Center, Duke University, Durham, NC (formerly the Cancer and Leukemia Group B Statistical and Data Management Center, Duke University, Durham, NC) (KO); GlaxoSmithKline, Research Triangle Park, NC (DW); Independent contractor, Williamsville, NY (KD); Department of Medicine and Center for Personalized Therapeutics, University of Chicago, Chicago, IL (PNF, MJR); DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL (HLM).
Mark J RatainPersonalized Medicine, Mission Cancer Care, Mission Health, Asheville, NC (LGD); Biostatistics Core, Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC (AMD); Alliance Statistics and Data Center, Duke University, Durham, NC (formerly the Cancer and Leukemia Group B Statistical and Data Management Center, Duke University, Durham, NC) (KO); GlaxoSmithKline, Research Triangle Park, NC (DW); Independent contractor, Williamsville, NY (KD); Department of Medicine and Center for Personalized Therapeutics, University of Chicago, Chicago, IL (PNF, MJR); DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL (HLM).
Howard L McLeodPersonalized Medicine, Mission Cancer Care, Mission Health, Asheville, NC (LGD); Biostatistics Core, Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC (AMD); Alliance Statistics and Data Center, Duke University, Durham, NC (formerly the Cancer and Leukemia Group B Statistical and Data Management Center, Duke University, Durham, NC) (KO); GlaxoSmithKline, Research Triangle Park, NC (DW); Independent contractor, Williamsville, NY (KD); Department of Medicine and Center for Personalized Therapeutics, University of Chicago, Chicago, IL (PNF, MJR); DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL (HLM).
Research Triangle Park Foundation · USUniversity of North Carolina at Chapel Hill · USDuke University · USGlaxoSmithKline (United States) · USUniversity of Chicago · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Whole GenomeU01GM061393 · NIGMS · UNIVERSITY OF CHICAGO · PI COX, NANCY J, DOLAN, MARY EILEEN · 2000 to 2014
$39.0M
CANCER AND LEUKEMIA GROUP B GRANT REVISED APPLICATIONU10CA041287 · NCI · UNIVERSITY OF CHICAGO · PI KINDLER, HEDY L · 1986 to 2013
$3.9M
CANCER AND LEUKEMIA GROUP BU10CA047559 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI SHEA, THOMAS C. · 1991 to 2013
$1.8M
NCI NIH HHS CA31946NCI NIH HHS CA41287NCI NIH HHS CA47559NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA047559NCI NIH HHS U10 CA180821NCI NIH HHS U10CA180821NCI NIH HHS U10CA180882NIGMS NIH HHS GM61393
6 · The paper itself

Abstract

backgroundClinically annotated specimens from cancer clinical trial participants offer an opportunity for discovery and validation of pharmacogenomic findings. The purpose of this observational study is to better understand patient/institution factors that may contribute to participation in the pharmacogenomic component of prospective cancer clinical trials.

methodsPatient demographic information (age, sex, self-reported race) and institutional characteristics (CALGB/CTSU site, "diversity," and accrual) were evaluated for 8456 patients enrolled in seven CALGB phase III studies with a pharmacogenomic component. All statistical tests were two-sided.

resultsThe majority of patients (81%) consented to participate in the pharmacogenomic component. However, in a multivariable analysis, site (CALGB vs CTSU) and "institutional diversity" (percent minority cancer patients on national trials) were statistically significantly associated with participation. For both whites and nonwhites, patients from CALGB sites were more likely to participate compared with patients from CTSU sites (whites: odds ratio [OR] = 2.26, 95% confidence interval [CI] = 1.68 to 3.04, P < .001; nonwhites: OR = 1.79, 95% CI = 1.52 to 2.11, P < .001). However, as "institutional diversity" increased, the likelihood of participation in the pharmacogenomics component decreased for both white (OR = 0.94, 95% CI = 0.91 to 0.97, P < .001) and nonwhite patients (OR = 0.90, 95% CI = 0.81 to 1.00, P = .05).

conclusionsMost clinical trial cancer patients across geographical, racial, and practice settings are willing to participate in pharmacogenomic studies. However, to promote equitable benefit to the larger cancer community, optimization of both patient and institutional participation are needed. Institutional factors may be even more compelling than patient demographics. Prospective studies are needed to identify and address barriers/incentives to participation in pharmacogenomic research at the patient, clinician, and institutional levels.

Indexed as

Healthcare DisparitiesLeukemiaNeoplasmsPharmacogeneticsAdultAgedAged, 80 and overClinical Trials, Phase III as TopicFemaleHumansMaleMiddle AgedMulticenter Studies as TopicOdds RatioPatient Participation

Identifiers

PMID26160883
PMCPMC5758036
OpenAlexW2395793519

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.