Evidence map›Paper›PMID 27401246›Full record

ReviewClinical cancer research : an official journal of the American Association for Cancer Research2016

Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual.

Holly A Massett, Grace Mishkin, Larry Rubinstein, S Percy Ivy, Andrea Denicoff, Elizabeth Godwin, Kate DiPiazza, Jennifer Bolognese, James A Zwiebel, Jeffrey S Abrams

Abstract readReview
In one paragraph

Review in Clinical cancer research : an official journal of the American Association for Cancer Research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–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.

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

20 citing papers in PubMed.

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  20. Digital Tools and Strategies for Engaging Patients in Cancer Clinical Trials.Cancer control : journal of the Moffitt Cancer Center
    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

10 authors.

Holly A MassettNational Cancer Institute, Bethesda, Maryland. massetth@mail.nih.gov.
Grace MishkinNational Cancer Institute, Bethesda, Maryland.
Larry RubinsteinNational Cancer Institute, Bethesda, Maryland.
S Percy IvyNational Cancer Institute, Bethesda, Maryland.
Andrea DenicoffNational Cancer Institute, Bethesda, Maryland.
Elizabeth GodwinEmmes Corporation, Rockville, Maryland.
Kate DiPiazzaEmmes Corporation, Rockville, Maryland.
Jennifer BologneseWestat, Rockville, Maryland.
James A ZwiebelNational Cancer Institute, Bethesda, Maryland.
Jeffrey S AbramsNational Cancer Institute, Bethesda, Maryland.

Funding

Intramural NIH HHS Z99 CA999999
6 · The paper itself

Abstract

Accruing patients in a timely manner represents a significant challenge to early phase cancer clinical trials. The NCI Cancer Therapy Evaluation Program analyzed 19 months of corrective action plans (CAP) received for slow-accruing phase I and II trials to identify slow accrual reasons, evaluate whether proposed corrective actions matched these reasons, and assess the CAP impact on trial accrual, duration, and likelihood of meeting primary scientific objectives. Of the 135 CAPs analyzed, 69 were for phase I trials and 66 for phase II trials. Primary reasons cited for slow accrual were safety/toxicity (phase I: 48%), design/protocol concerns (phase I: 42%, phase II: 33%), and eligibility criteria (phase I: 41%, phase II: 35%). The most commonly proposed corrective actions were adding institutions (phase I: 43%, phase II: 85%) and amending the trial to change eligibility or design (phase I: 55%, phase II: 44%). Only 40% of CAPs provided proposed corrective actions that matched the reasons given for slow accrual. Seventy percent of trials were closed to accrual at time of analysis (phase I = 48; phase II = 46). Of these, 67% of phase I and 70% of phase II trials met their primary objectives, but they were active three times longer than projected. Among closed trials, 24% had an accrual rate increase associated with a greater likelihood of meeting their primary scientific objectives. Ultimately, trials receiving CAPs saw improved accrual rates. Future trials may benefit from implementing CAPs early in trial life cycles, but it may be more beneficial to invest in earlier accrual planning. Clin Cancer Res; 22(22); 5408-16. ©2016 AACRSee related commentary by Mileham and Kim, p. 5397.

Indexed as

Clinical Trials, Phase I as TopicClinical Trials, Phase II as TopicHumansNational Cancer Institute (U.S.)NeoplasmsPatient SelectionResearch DesignUnited States

Identifiers

PMID27401246
PMCPMC5226927

What OpenQuestion holds

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Registered trials

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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.