Show simple item record

dc.contributor.authorBurnett, Thomas
dc.contributor.authorMozgunov, Pavel
dc.contributor.authorPallmann, Philip
dc.contributor.authorVillar, Sofia S.
dc.contributor.authorWheeler, Graham M.
dc.contributor.authorJaki, Thomas
dc.date.accessioned2020-11-19T16:19:23Z
dc.date.available2020-11-19T16:19:23Z
dc.date.issued2020-11-19
dc.date.submitted2020-06-29
dc.identifier.others12916-020-01808-2
dc.identifier.other1808
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/313114
dc.descriptionFunder: Cancer Research UK; doi: http://dx.doi.org/10.13039/501100000289
dc.description.abstractAbstract: Adaptive designs for clinical trials permit alterations to a study in response to accumulating data in order to make trials more flexible, ethical, and efficient. These benefits are achieved while preserving the integrity and validity of the trial, through the pre-specification and proper adjustment for the possible alterations during the course of the trial. Despite much research in the statistical literature highlighting the potential advantages of adaptive designs over traditional fixed designs, the uptake of such methods in clinical research has been slow. One major reason for this is that different adaptations to trial designs, as well as their advantages and limitations, remain unfamiliar to large parts of the clinical community. The aim of this paper is to clarify where adaptive designs can be used to address specific questions of scientific interest; we introduce the main features of adaptive designs and commonly used terminology, highlighting their utility and pitfalls, and illustrate their use through case studies of adaptive trials ranging from early-phase dose escalation to confirmatory phase III studies.
dc.languageen
dc.publisherBioMed Central
dc.subjectCorrespondence
dc.subjectNovel designs
dc.subjectInnovative trials
dc.subjectEfficient methods
dc.subjectEnrichment designs
dc.subjectMulti-arm multi-stage platform trials
dc.titleAdding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs
dc.typeOther
dc.date.updated2020-11-19T16:19:22Z
prism.issueIdentifier1
prism.publicationNameBMC Medicine
prism.volume18
dc.identifier.doi10.17863/CAM.60217
dcterms.dateAccepted2020-10-07
rioxxterms.versionofrecord10.1186/s12916-020-01808-2
rioxxterms.versionVoR
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0/
dc.identifier.eissn1741-7015
pubs.funder-project-idMedical Research Council (MR/L004933/1)
pubs.funder-project-idMedical Research Council (MC UU 00002/3)
pubs.funder-project-idNational Institute for Health Research (NIHR-SRF-2015-08-001)
pubs.funder-project-idMedical Research Council (MC UU 0002/14)
pubs.funder-project-idNational Institute for Health Research (NIHR300576)


Files in this item

Thumbnail
Thumbnail

This item appears in the following Collection(s)

Show simple item record