Evidence map›Paper›PMID 21878447›Full record

ArticleClinical trials (London, England)2011

Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials.

Anneke T Schroen, Gina R Petroni, Hongkun Wang, Monika J Thielen, Daniel Sargent, Jacqueline K Benedetti, Walter M Cronin, Donald L Wickerham, Xiaofei F Wang, Robert Gray and 3 more

Open access · greenAbstract read
In one paragraph

Article in Clinical trials (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.1field-weighted citation impact, top 9% 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

12 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Participation in Cancer Clinical Trials: Researching the Causes of Low Accrual.Journal of the advanced practitioner in oncology · 2016
    Article
  6. Article
  7. Design-phase prediction of potential cancer clinical trial accrual success using a research data mart.Journal of the American Medical Informatics Association : JAMIA · 2013
    Article
  8. Article
  9. Article
  10. Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U.S. Cooperative Oncology Groups.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012
    Article
  11. Article
  12. Phase III clinical trial development: a process of chutes and ladders.Clinical cancer research : an official journal of the American Association for Cancer Research · 2010
    Article
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

13 authors at 8 institutions in 1 country.

Anneke T SchroenDepartment of Surgery, University of Virginia, Charlottesville, VA 22908-0709, USA. ats2x@virginia.edu
Gina R Petroni
Hongkun Wang
Monika J Thielen
Daniel Sargent
Jacqueline K Benedetti
Walter M Cronin
Donald L Wickerham
Xiaofei F Wang
Robert Gray
Wendy F Cohn
Craig L Slingluff
Benjamin Djulbegovic
University of Virginia · USCancer Research And Biostatistics · USDana-Farber Cancer Institute · USDuke University · USMayo Clinic in Florida · USNSABP Foundation · USUniversity of Pittsburgh · USUniversity of South Florida · US

Funding

PRIMARY CANCER THERAPY GROUP--NSABP (HEADQUARTERS)U10CA012027 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WOLMARK, NORMAN · 1985 to 2012
$117.2M
NSABP Foreign AccrualsU10CA037377 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WOLMARK, NORMAN · 1985 to 2014
$116.5M
STUDY TO ASSESS RALOXIFENE FOR PREVENTING BREAST CANCERU10CA069974 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI COSTANTINO, JOSEPH P. · 1995 to 2013
$62.4M
PRIMARY BREAST CANCER THERAPY--BIOSTATISTICS CENTERU10CA069651 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI COSTANTINO, JOSEPH P. · 1995 to 2012
$52.1M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
NSABP Biological Specimen BanksU24CA114732 · NCI · NSABP FOUNDATION, INC. · PI WOLMARK, NORMAN · 2005 to 2014
$9.4M
Oncology Clinical Trial Accrual StudyR01CA118232 · NCI · UNIVERSITY OF VIRGINIA · PI SCHROEN, ANNEKE T · 2007 to 2009
$861k
NCI NIH HHS R01 CA118232NCI NIH HHS U10 CA012027NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA037377NCI NIH HHS U10 CA069651NCI NIH HHS U10 CA069974NCI NIH HHS U10CA-12027NCI NIH HHS U10CA-37377NCI NIH HHS U10CA-69651NCI NIH HHS U10CA-69974NCI NIH HHS U24 CA114732NCI NIH HHS U24-CA-114732
6 · The paper itself

Abstract

backgroundResearch on barriers to accrual has typically emphasized factors influencing participation after trial activation. PURPOSE: We sought to identify factors influencing trial design and accrual predictions prior to trial activation associated with sufficient accrual.

methodsA 30-question web-based survey was sent to the study chair and lead statistician for all 248 phase III trials open in 1993-2002 by five Clinical Trials Cooperative Groups. Questions addressed prior trial experience, trial design elements, accrual predictions, and perceived accrual influences. Accrual sufficiency categorization was derived from Clinical Trials Cooperative Group records: sufficient accrual included trials closed with complete accrual or at interim analysis, insufficient accrual included trials closed with inadequate accrual. Responses were analyzed by respondent role (study chair/lead statistician) and accrual sufficiency.

resultsThree hundred and nine eligible responses were included (response rate, 63%; lead statisticians, 81%; and study chairs, 45%), representing trials with sufficient (63%) and insufficient accruals (37%). Study chair seniority or lead statistician experience was not linked to accrual sufficiency. Literature review, study chair's personal experience, and expert opinion within Clinical Trials Cooperative Group most commonly influenced control arm selection. Clinical Trials Cooperative Group experience most influenced accrual predictions. These influences were not associated with accrual sufficiency. Among respondents citing accrual difficulties (41%), factors negatively influencing accrual were not consistently identified. Respondents credited three factors with positively influencing accrual: clinical relevance of study, lack of competing trials, and protocol paralleling normal practice. LIMITATIONS: Perceptions of lead statisticians and study chairs may not accurately reflect accrual barriers encountered by participating physicians or patients. Survey responses may be subject to recall bias.

conclusionConsistent factors explaining poor accrual were not identified, suggesting reasons for poor accrual are not well understood and warrant further study. Alternate strategies for accrual prediction are needed since Clinical Trials Cooperative Group experience is linked to successful and unsuccessful accrual.

Indexed as

BiostatisticsClinical Trials, Phase III as TopicData CollectionHumansInternetMedical OncologyNational Cancer Institute (U.S.)Patient ParticipationPatient SelectionResearch DesignSurveys and QuestionnairesTherapeutic EquipoiseUnited States

Identifiers

PMID21878447
PMCPMC3474201
OpenAlexW2132482196

What OpenQuestion holds

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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.