A Decision-Making Grid for Coenrollment in Multiple Clinical Trials.
Background: Although subject coenrollment into multiple trials is desirable, thoughtful consideration is required to avoid compromising each trial's scientific integrity. Objective: We developed a Decision-Making Grid (GRID) to help investigators determine whether a clinical trial is compatible with...
| Publicado en: | Nursing Research Vol. 74; no. 3; pp. 241 - 246 |
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| Autores principales: | , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Lippincott Williams & Wilkins
May/Jun2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=184654614&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 184654614 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00296562 1HA jtl: Nursing Research issn: 00296562 maglogo: N pubinfo: dt: May/Jun2025 vid: 74 iid: 3 pid: 433 pub: Lippincott Williams & Wilkins place: Baltimore, Maryland artinfo: ui: 184654614 184654614 184654614 10.1097/NNR.0000000000000802 184654614 ppf: 241 ppct: 5 formats: tig: atl: A Decision-Making Grid for Coenrollment in Multiple Clinical Trials. aug: au: Curley, Martha A.Q. Kalvas, Laura Beth Perry-Eaddy, Mallory A. Asaro, Lisa A. Wypij, David affil: Martha A.Q. Curley, PhD, RN, FAAN, is Ruth M. Colket Endowed Chair in Pediatric Nursing, University of Pennsylvania School of Nursing, The Children's Hospital of Philadelphia. sug: subj: Decision Support Techniques Randomized Controlled Trials Research Personnel Decision Making Patient Selection Research Subject Recruitment Human Pediatric Care Critical Care Funding Source Study Design Critically Ill Patients In Infancy and Childhood Child Child: 6-12 years ab: Background: Although subject coenrollment into multiple trials is desirable, thoughtful consideration is required to avoid compromising each trial's scientific integrity. Objective: We developed a Decision-Making Grid (GRID) to help investigators determine whether a clinical trial is compatible with a second clinical trial, thus allowing coenrollment, or if it should be considered competing, prohibiting coenrollment. Methods: The GRID evaluates 21 elements across four domains: scientific integrity, data interpretation, feasibility/burden, and additional considerations. Optimally, each principal investigator shares their protocol, completes the GRID independently, and then meets to compare their perspectives, seeking a mutually acceptable agreement. Results: The GRID has facilitated coenrollment decision-making for the RESTORE and PROSpect pediatric critical care clinical trials. In RESTORE , five trials were reviewed; one was approved for coenrollment, and four were deemed competing. In PROSpect , 26 trials have been reviewed; 20 are approved for coenrollment, and six were deemed competing. In both RESTORE and PROSpect , the principal investigators of multiple trials arranged a mutually acceptable sharing agreement. Discussion: The GRID provides a systematic process to help investigators evaluate the effect of coenrollment in multiple clinical trials. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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