Evidence map›Paper›PMID 37131229›Full record

ArticleAlzheimer's research & therapy2023

Centralizing prescreening data collection to inform data-driven approaches to clinical trial recruitment.

Dylan R Kirn, Joshua D Grill, Paul Aisen, Karin Ernstrom, Seth Gale, Judith Heidebrink, Gregory Jicha, Gustavo Jimenez-Maggiora, Leigh Johnson, Elaine Peskind and 6 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Alzheimer's research & therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04468659 (AHEAD 3-45 Study), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 19% 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.

NCT04468659 phase3active not recruitingnot on this map

AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study With an Extension Phase to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer's Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer's Disease and Intermediate Amyloid (A3 Trial)

TypeinterventionalSponsorEisai Inc.Ran2020 to 2031Enrolled1,400ConditionsPreclinical Alzheimer's Disease, Early Preclinical Alzheimer's DiseaseArmsLecanemab, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. 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

16 authors at 9 institutions in 1 country.

Dylan R KirnDepartment of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. dkirn@mgh.harvard.edu.
Joshua D GrillInstitute for Memory Impairments and Neurological Disorders, University of California Irvine, Irvine, CA, USA.
Paul AisenAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
Karin ErnstromAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
Seth GaleDepartment of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Judith HeidebrinkDepartment of Neurology, University of Michigan, Ann Arbor, MI, USA.
Gregory JichaSanders-Brown Center On Aging, University of Kentucky, Lexington, KY, USA.
Gustavo Jimenez-MaggioraAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
Leigh JohnsonInstitute for Translational Research, University of North Texas Health Science Center, Fort Worth, TX, USA.
Elaine PeskindVA Northwest Mental Illness Research, Education, and Clinical Center (MIRECC), VA Puget Sound Health Care System, Seattle, WA, USA.
Kelly McCannDepartment of Neurology, Georgetown University Medical Center, Washington, D.C, USA.
Elizabeth ShafferAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
David SultzerInstitute for Memory Impairments and Neurological Disorders, University of California Irvine, Irvine, CA, USA.
Shunran WangAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
Reisa SperlingDepartment of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Rema RamanAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
University of Southern California · USBrigham and Women's Hospital · USUniversity of California, Irvine · USGeorgetown University Medical Center · USHarvard University · USMental Illness Research, Education and Clinical Centers · USUniversity of Kentucky · USUniversity of Michigan · USUniversity of North Texas Health Science Center · US

Funding

The Alzheimer's Clinical Trial Consortium - Down Syndrome Network (ACTC- DSN)U24AG057437 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Paul S. Aisen, RONALD C PETERSEN · 2018 to 2026
$198.4M
The Alzheimer's Disease Research Center at the University of California, IrvineP30AG066519 · NIA · UNIVERSITY OF CALIFORNIA-IRVINE · PI Crystal M. Glover · 2020 to 2026
$27.9M
University of Kentucky Alzheimer's Disease Research CenterP30AG072946 · NIA · UNIVERSITY OF KENTUCKY · PI LINDA J VAN ELDIK · 2021 to 2026
$23.5M
NIA NIH HHS P30 AG066519NIA NIH HHS P30 AG072946NIA NIH HHS U24 AG057437
6 · The paper itself

Abstract

backgroundRecruiting to multi-site trials is challenging, particularly when striving to ensure the randomized sample is demographically representative of the larger disease-suffering population. While previous studies have reported disparities by race and ethnicity in enrollment and randomization, they have not typically investigated whether disparities exist in the recruitment process prior to consent. To identify participants most likely to be eligible for a trial, study sites frequently include a prescreening process, generally conducted by telephone, to conserve resources. Collection and analysis of such prescreening data across sites could provide valuable information to improve understanding of recruitment intervention effectiveness, including whether traditionally underrepresented participants are lost prior to screening.

methodsWe developed an infrastructure within the National Institute on Aging (NIA) Alzheimer's Clinical Trials Consortium (ACTC) to centrally collect a subset of prescreening variables. Prior to study-wide implementation in the AHEAD 3-45 study (NCT NCT04468659), an ongoing ACTC trial recruiting older cognitively unimpaired participants, we completed a vanguard phase with seven study sites. Variables collected included age, self-reported sex, self-reported race, self-reported ethnicity, self-reported education, self-reported occupation, zip code, recruitment source, prescreening eligibility status, reason for prescreen ineligibility, and the AHEAD 3-45 participant ID for those who continued to an in-person screening visit after study enrollment.

resultsEach of the sites was able to submit prescreening data. Vanguard sites provided prescreening data on a total of 1029 participants. The total number of prescreened participants varied widely among sites (range 3-611), with the differences driven mainly by the time to receive site approval for the main study. Key learnings instructed design/informatic/procedural changes prior to study-wide launch.

conclusionCentralized capture of prescreening data in multi-site clinical trials is feasible. Identifying and quantifying the impact of central and site recruitment activities, prior to participants signing consent, has the potential to identify and address selection bias, instruct resource use, contribute to effective trial design, and accelerate trial enrollment timelines.

Indexed as

Research DesignData CollectionEducational StatusHumansAlzheimer’s diseaseDiversityRecruitment

Identifiers

PMID37131229
PMCPMC10152012
OpenAlexW4367835369

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.