Evidence map›Paper›PMID 30175231›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2018

Statistical advances in clinical trials and clinical research.

Guogen Shan, Sarah Banks, Justin B Miller, Aaron Ritter, Charles Bernick, Joseph Lombardo, Jeffrey L Cummings

Abstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Effects of dose change on the success of clinical trials.Contemporary clinical trials communications · 2022
    Article
  6. Article
  7. Randomized two-stage optimal design for interval-censored data.Journal of biopharmaceutical statistics · 2022
    Article
  8. Article
  9. Article
  10. Partial correlation coefficient for a study with repeated measurements.Statistics in biopharmaceutical research · 2021
    Article
  11. Review
  12. Article
  13. Correlation Coefficients for a Study with Repeated Measures.Computational and mathematical methods in medicine · 2020
    Article
  14. Article
  15. Alzheimer's disease drug development pipeline: 2019.Alzheimer's & dementia (New York, N. Y.) · 2019
    Article
  16. 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

7 authors.

Guogen ShanEpidemiology and Biostatistics Program, Department of Environmental and Occupational Health School of Community Health Sciences, University of Nevada Las Vegas, Las Vegas, NV, USA.
Sarah BanksCleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
Justin B MillerCleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
Aaron RitterCleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
Charles BernickCleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
Joseph LombardoNational Supercomputing Institute, University of Nevada Las Vegas, Las Vegas, NV, USA.
Jeffrey L CummingsCleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.

Funding

Renewal of Centers of Biomedical Research Excellence (COBRE) (Phase 2) CNTN - ResubmissionP20GM109025 · NIGMS · CLEVELAND CLINIC FOUNDATION · PI JESSICA KIRKLAND CALDWELL · 2015 to 2026
$22.8M
NIGMS NIH HHS P20 GM109025
6 · The paper itself

Abstract

introductionNew treatments for neurodegenerative disease are urgently needed, and clinical trial methods are an essential component of new drug development. Although a parallel-group study design for neurological disorder clinical trials is commonly used to test the effectiveness of a new treatment as compared to placebo, it does not efficiently use information from the on-going study to increase the success rate of a trial or to stop a trial earlier when the new treatment is indeed ineffective.

methodsWe review some recent advances in designs for clinical trials, including futility designs and adaptive designs.

resultsFutility designs and noninferiority designs are used to test the nonsuperiority and the noninferiority of a new treatment, respectively. We provide some guidance on using these two designs and analyzing data from these studies properly. Adaptive designs are increasingly used in clinical trials to improve the flexibility and efficiency of trials with the potential to reduce resources, time, and costs. We review some typical adaptive designs and new statistical methods to handle the statistical challenges from adaptive designs. DISCUSSION: Statistical advances in clinical trial designs may be helpful to shorten study length and benefit more patients being treated with a better treatment during the discovery of new therapies for neurological disorders. Advancing statistical underpinnings of neuroscience research is a critical aspect of the core activities supported by the Center of Biomedical Research Excellence award supporting the Center for Neurodegeneration and Translational Neuroscience.

Indexed as

Adaptive designsClinical trialsFutility designNeurological disordersProper statistical inference

Identifiers

PMID30175231
PMCPMC6118095

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.