자료유형  

 학위논문

Control Number  

0016931436

International Standard Book Number  

9798379953171

Dewey Decimal Classification Number  

610

Main Entry-Personal Name  

Caruana, Dennis Louis.

Publication, Distribution, etc. (Imprint  

[S.l.] : Yale University., 2023

Publication, Distribution, etc. (Imprint  

Ann Arbor : ProQuest Dissertations & Theses, 2023

Physical Description  

1 online resource(43 p.)

General Note  

Source: Dissertations Abstracts International, Volume: 85-01, Section: B.

General Note  

Advisor: Grauer, Jonathan N.

Dissertation Note  

Thesis (M.D.)--Yale University, 2023.

Restrictions on Access Note  

This item must not be sold to any third party vendors.

Summary, Etc.  

요약Clinical trials are key to the advancement of products and procedures related to musculoskeletal conditions. Unfortunately, many trials are terminated prior to completion. ClinicalTrials.gov is a registry and results database maintained by the National Library of Medicine that catalogs trial characteristics and tracks overall recruitment status (e.g., ongoing, completed, terminated) for each study as well as reasons for termination. Reasons for termination have not been specifically evaluated for musculoskeletal trials and those related to the spine and shoulder/elbow were selected for characterization and assessment of independent predictors of termination by comparing characteristics of completed and terminated trials.The ClinicalTrials.gov database was queried for all completed and terminated interventional studies using search terms built into the ClinicalTrials.gov search engine related to the spine on June 20, 2021 and those related to the shoulder/elbow on August 6, 2021, respectively. Trial characteristics and reasons for termination were abstracted. Univariate and multivariate analyses were performed to determine independent predictors of trial termination.For clinical trials related to the spine, a total of 969 were identified and characterized, of which 136 (14%) were terminated. Insufficient rate of participant accrual was the most frequently reported reason for trial termination, accounting for 33.8% of terminated trials. Multivariate analysis demonstrated increased odds of trial termination for industry-sponsorship (odds ratio [OR] = 1.59) relative to sponsorship from local groups, device studies (OR = 2.18) relative to investigations of drug or biological product(s), and phase II (OR = 3.07) relative to phase III studies (p 0.05 for each).For clinical trials related to the shoulder, a total of 662 were identified and characterized, of which 51 (8%) were terminated. Difficulties with participant recruitment and/or retention was the individual reason most frequently reported for trial termination, accounting for 51% of terminated clinical trials related to the shoulder. For clinical trials related to the shoulder, multivariate analysis of primary trial characteristics demonstrated increased odds of trial termination for industry-sponsorship (OR = 4.2, p = 0.001) relative to sponsorship from local groups, and blinded studies (OR = 45.8, p = 0.0003) relative to studies that did not implement any form of blinding.For clinical trials related to the elbow, a total of 126 were identified and characterized, of which 16 (13%) were terminated. Difficulties with participant recruitment and/or retention was the individual reason most frequently reported for trial termination, accounting for 38% of terminated clinical trials related to the elbow. For clinical trials related to the elbow, logistic regression did not reveal any of the primary trial characteristics evaluated to be correlated with odds of termination.Clinical trials related to the spine, shoulder, and elbow were terminated at a rate of 14%, 8%, and 13%, respectively. Overall, difficulties in the recruitment and/or retention of trial participants was the reason most frequently reported for trial termination. With significant resources put into clinical trials and the need to advance scientific objectives, independent predictors and reasons for trial termination should be considered and addressed, when possible, to optimize the completion rate of trials that are initiated.

Subject Added Entry-Topical Term  

Medicine.

Subject Added Entry-Topical Term  

Pharmacology.

Subject Added Entry-Topical Term  

Pharmaceutical sciences.

Index Term-Uncontrolled  

Clinical trials

Index Term-Uncontrolled  

Elbow

Index Term-Uncontrolled  

Interventional studies

Index Term-Uncontrolled  

Musculoskeletal system

Index Term-Uncontrolled  

Shoulder

Index Term-Uncontrolled  

Spine

Added Entry-Corporate Name  

Yale University Yale School of Medicine

Host Item Entry  

Dissertations Abstracts International. 85-01B.

Host Item Entry  

Dissertation Abstract International

Electronic Location and Access  

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Control Number  

joongbu:642399