Assessment of Long-term Follow-up of Randomized Trial Participants by Linkage to Routinely Collected Data
Sign Up to like & getrecommendations! Published in 2018 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2018.6019
Abstract: Key Points Question Does follow-up of clinical trial participants by linkage to routinely collected data sources provide important insights into the long-term benefits and harms of treatment? Findings This scoping review of the published literature… read more here.
Keywords: trial participants; trial; linkage routinely; collected data ... See more keywords
Comparison of Clinical Characteristics Between Clinical Trial Participants and Nonparticipants Using Electronic Health Record Data
Sign Up to like & getrecommendations! Published in 2021 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2021.4732
Abstract: This cross-sectional study uses electronic health records and clinical trial enrollment data to assess differences in the clinical characteristics of trial participants and nonparticipants. read more here.
Keywords: trial participants; clinical trial; trial; participants nonparticipants ... See more keywords
Leveraging system sciences methods in clinical trial evaluation: An example concerning African American women diagnosed with breast cancer via the Patient Navigation in Medically Underserved Areas study
Sign Up to like & getrecommendations! Published in 2019 at "Contemporary Clinical Trials Communications"
DOI: 10.1016/j.conctc.2019.100411
Abstract: Background Systems science methodologies offer a promising assessment approach for clinical trials by: 1) providing an in-silico laboratory to conduct investigations where purely empirical research may be infeasible or unethical; and, 2) offering a more… read more here.
Keywords: trial participants; trial; network; breast cancer ... See more keywords
Exploring evidence for behavioral risk compensation among participants in an HIV vaccine clinical trial.
Sign Up to like & getrecommendations! Published in 2017 at "Vaccine"
DOI: 10.1016/j.vaccine.2017.05.024
Abstract: BACKGROUND HIV vaccine trial participants may engage in behavioral risk compensation due to a false sense of protection. We conducted an ancillary study of an HIV Vaccine Trials Network (HVTN) vaccine efficacy trial to explore… read more here.
Keywords: trial participants; trial; vaccine trial; risk compensation ... See more keywords
Feedback of results to trial participants: be upfront or risk affront
Sign Up to like & getrecommendations! Published in 2017 at "The Lancet"
DOI: 10.1016/s0140-6736(17)30778-x
Abstract: www.thelancet.com Vol 389 March 25, 2017 1191 1 Jungebluth P, Alici E, Baiguera S, et al. Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study. Lancet 2011; 378: 1997–2004. 2 Backman S, Björling G,… read more here.
Keywords: trial participants; results trial; upfront risk; participants upfront ... See more keywords
Experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST): a nested qualitative study
Sign Up to like & getrecommendations! Published in 2021 at "BMJ Open"
DOI: 10.1136/bmjopen-2020-040829
Abstract: Objectives To explore the experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST), a multicentre randomised controlled trial that compared manipulation under anaesthesia (MUA), arthroscopic capsular release… read more here.
Keywords: trial participants; trial; frost; experiences perceptions ... See more keywords
MHC-restricted phosphopeptide antigens: preclinical validation and first-in-humans clinical trial in participants with high-risk melanoma
Sign Up to like & getrecommendations! Published in 2020 at "Journal for Immunotherapy of Cancer"
DOI: 10.1136/jitc-2019-000262
Abstract: Background Phosphorylated peptides presented by MHC molecules represent a new class of neoantigens expressed on cancer cells and recognized by CD8 T-cells. These peptides are promising targets for cancer immunotherapy. Previous work identified an HLA-A*0201-restricted… read more here.
Keywords: trial participants; clinical trial; trial; pbcar3126 134 ... See more keywords
Are investigators’ access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials
Sign Up to like & getrecommendations! Published in 2021 at "BMC Medical Ethics"
DOI: 10.1186/s12910-021-00681-9
Abstract: Objectives To determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators. Methods Cohort study of trial protocols, publication agreements and other documents obtained… read more here.
Keywords: trial participants; industry partner; trial; industry ... See more keywords
Factors contributing to fidelity in a pilot trial of individualized resistant starches for pediatric inflammatory bowel disease: a fidelity study protocol
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DOI: 10.1186/s40814-021-00815-1
Abstract: Background The consumption of resistant starches is a promising adjuvant therapy for patients with inflammatory bowel disease. Rigorous evaluation of resistant starches in this setting depends on the intervention being delivered, received, and enacted as… read more here.
Keywords: trial participants; intervention; fidelity; trial ... See more keywords
Potential research participants’ use of information during the consent process: A qualitative pilot study of patients enrolled in a clinical trial
Sign Up to like & getrecommendations! Published in 2020 at "PLoS ONE"
DOI: 10.1371/journal.pone.0234388
Abstract: There is increasing evidence that clinical trial participants are uninformed about the trials in which they participate, raising ethical concerns regarding informed consent. The aim of this pilot study was to explore clinical trial participants’… read more here.
Keywords: trial participants; clinical trial; information; trial ... See more keywords