Evidence map›Paper›PMID 24643646›Full record

ReviewCancer2014

Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials.

Moon S Chen, Primo N Lara, Julie H T Dang, Debora A Paterniti, Karen Kelly

Registry-linked trialAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02692755 (Phase II Safety Study of Palbociclib in Combination With Letrozole or Fulvestrant in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer), which is not on this map. Cited by 273 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
273citing papers in PubMed, 14 pooled it
–field-weighted citation impact
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.

NCT02692755 phase2 / phase3completednot on this mapstarted 2016, after this paper: background citation

Phase II Safety Study of Palbociclib in Combination With Letrozole or Fulvestrant in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

TypeinterventionalSponsorGeorgetown UniversityRan2016 to 2021Enrolled35ConditionsHormone Receptor Positive HER-2 Negative Breast CancerArmsPalbociclib + Letrozole or Fulvestrant
3 · Its place in the literature

Who cites it

273 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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213 more citing papers are in PubMed but not listed here.

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

5 authors.

Moon S ChenDivision of Hematology and Oncology, Department of Internal Medicine, School of Medicine, University of California, Davis, Sacramento, California; Cancer Control, University of California, Davis Comprehensive Cancer Center, Sacramento, California.
Primo N Lara
Julie H T Dang
Debora A Paterniti
Karen Kelly

Funding

Research ProjectU54CA153499 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI CHEN, MOON SHAO-CHUANG, CHOW, EDWARD A. · 2010 to 2015
$6.7M
Enhancing Minority Participation in Clinical Trials (EMPaCT):Phase IIU24MD006970 · NIMHD · UNIVERSITY OF MINNESOTA · PI DURANT, RAEGAN WINSTON, FOUAD, MONA N. · 2011 to 2015
$4.9M
NCI NIH HHS U54 CA153499NIMHD NIH HHS U24 MD006970
6 · The paper itself

Abstract

backgroundThe National Institutes of Health (NIH) Revitalization Act of 1993 mandated the appropriate inclusion of minorities in all NIH-funded research. Twenty years after this act, the proportion of minority patients enrolled in cancer clinical trials remains persistently low. Clinical trials are vehicles for the development and evaluation of therapeutic and preventive agents under scientifically rigorous conditions. Without representation in trials, it is projected that disparities in the cancer burden for minorities will increase.

methodsFor this review article, the authors counted the frequency with which minorities were the primary focus of National Cancer Institute-sponsored clinical trials, examined citations from the PubMed database focusing on the search terms "NIH Revitalization Act of 1993" and "enhancing minority accrual to cancer clinical trials," and supplemented the review with their expertise in NIH-funded research related to minority accrual in cancer clinical trials.

resultsThe reporting and analyses of data based on minorities in clinical trials remain inadequate. Less than 2% of the National Cancer Institute's clinical trials focus on any racial/minority population as their primary emphasis. The current review of the literature indicated that the percentage of authors who reported their study sample by race/ethnicity ranged from 1.5% to 58%, and only 20% of the randomized controlled studies published in a high-impact oncology journal reported analyzing results by race/ethnicity. Proportionately greater population increases in minorities, accompanied by their persistent and disproportionate cancer burden, reinforce the need for their greater representation in clinical trials.

conclusionsRenewing the emphasis for minority participation in clinical trials is warranted. Policy changes are recommended.

Indexed as

Minority GroupsPatient SelectionClinical Trials as TopicEthnicityFemaleHealthcare DisparitiesHealth Services AccessibilityHumansMaleNational Institutes of Health (U.S.)NeoplasmsRacial GroupsResearch DesignUnited Statescancer clinical trialsclinical trialdisparitiesminoritiesNational Institutes of Health Revitalization Act

Identifiers

PMID24643646
PMCPMC3980490

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.