Evidence mapPaperPMID 37313381Full record

ReviewJournal of clinical and translational science2023

Recent innovations in adaptive trial designs: A review of design opportunities in translational research.

Alexander M Kaizer, Hayley M Belli, Zhongyang Ma, Andrew G Nicklawsky, Samantha C Roberts, Jessica Wild, Adane F Wogu, Mengli Xiao, Roy T Sabo

Registry-linked trialAbstract readReview
In one paragraph

Review in Journal of clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07275307 (Evaluating the Effects of Prontosan Wound Gel X on the Occurrence of Superficial Surgical Site Infections in Adult Cardiac Surgery Patients), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 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.

NCT07275307 recruitingnot on this mapstarted 2026, after this paper: background citation

Evaluating the Effects of Prontosan Wound Gel X on the Occurrence of Superficial Surgical Site Infections in Adult Cardiac Surgery Patients: A Single-Arm, Phase IV, Adaptive Feasibility Study

TypeobservationalSponsorIRCCS Policlinico S. DonatoRan2026 to 2027Enrolled456ConditionsSurgical Site Infection After Major SurgeryArmsApplication of Prontosan Wound Gel X
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Observational
  4. A Pragmatic Bayesian Adaptive Trial Design Based on the Value of Information: The Value-Driven Adaptive Design.Medical decision making : an international journal of the Society for Medical Decision Making · 2026
    Article
  5. Review
  6. Article
  7. Beyond RCTs-Better Research Designs and Methods for Psychosocial Efficacy Studies in Mental Health.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2026
    Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. The potential of artificial intelligence in clinical trials.European journal of clinical investigation · 2026
    Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Proof of concept studies in mental health systems research: strategy and steps.International journal of mental health systems · 2025
    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

9 authors.

Alexander M KaizerDepartment of Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.ORCID https://orcid.org/0000-0003-2334-5514
Hayley M BelliDepartment of Population Health, New York University Grossman School of Medicine, New York, NY, USA.
Zhongyang MaDepartment of Population Health, New York University Grossman School of Medicine, New York, NY, USA.
Andrew G NicklawskyDepartment of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Samantha C RobertsDepartment of Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Jessica WildDepartment of Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Adane F WoguDepartment of Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.ORCID https://orcid.org/0000-0002-6592-6512
Mengli XiaoDepartment of Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Roy T SaboDepartment of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.

Funding

Statistical Methods and Adaptive Trial Designs for Cardiovascular Outcomes with Information SharingK01HL151754 · UNIVERSITY OF COLORADO DENVER · 2025 to 2025
$148k
NHLBI NIH HHS K01 HL151754
6 · The paper itself

Abstract

Clinical trials are constantly evolving in the context of increasingly complex research questions and potentially limited resources. In this review article, we discuss the emergence of "adaptive" clinical trials that allow for the preplanned modification of an ongoing clinical trial based on the accumulating evidence with application across translational research. These modifications may include terminating a trial before completion due to futility or efficacy, re-estimating the needed sample size to ensure adequate power, enriching the target population enrolled in the study, selecting across multiple treatment arms, revising allocation ratios used for randomization, or selecting the most appropriate endpoint. Emerging topics related to borrowing information from historic or supplemental data sources, sequential multiple assignment randomized trials (SMART), master protocol and seamless designs, and phase I dose-finding studies are also presented. Each design element includes a brief overview with an accompanying case study to illustrate the design method in practice. We close with brief discussions relating to the statistical considerations for these contemporary designs.

Indexed as

Adaptive trialsmaster protocolssample size re-estimationsmart designstreatment arm selection

Identifiers

PMID37313381
PMCPMC10260347

What Socratic 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 Socratic graph.