Clinical trial protocol documents play an important role in clinical research. However, clinical protocol writing remains a complex and relatively un-studied process. Protocols are often written by teams of people, yet little prior research has captured the problems or analyzed the collaboration support needs of protocol writers. Here we present the results of an initial ethnographic study into the clinical trial protocol writing processes at a representative cooperative clinical trial group funded by National Cancer Institute (NCI). We analyzed the collaborative nature of the writing process, identified common problems, derived information and communication support needs of collaborative clinical protocol writers, and provided recommendations to streamline the process. We believe that this paper contributes useful implications for the design of future collaborative clinical protocol writing tools.
Download full-text PDF |
Source |
|---|
Publication Analysis
Top Keywords
Similar Publications
Flexible progestin-primed ovarian stimulation versus a GnRH antagonist protocol in predicted suboptimal responders undergoing freeze-all cycles: a randomized non-inferiority trial.
Hum Reprod
December 2024
Assisted Reproduction Center, Northwest Women's and Children's Hospital, Xi'an, China.
Study Question: Are live birth rates (LBRs) per woman following flexible progestin-primed ovarian stimulation (fPPOS) treatment non-inferior to LBRs per woman following the conventional GnRH-antagonist protocol in expected suboptimal responders undergoing freeze-all cycles in assisted reproduction treatment?
Summary Answer: In women expected to have a suboptimal response, the 12-month likelihood of live birth with the fPPOS treatment did not achieve the non-inferiority criteria when compared to the standard GnRH antagonist protocol for IVF/ICSI treatment with a freeze-all strategy.
What Is Known Already: The standard PPOS protocol is effective for ovarian stimulation, where medroxyprogesterone acetate (MPA) is conventionally administered in the early follicular phase for ovulatory suppression. Recent retrospective cohort studies on donor cycles have shown the potential to prevent premature ovulation and maintain oocyte yields by delaying the administration of MPA until the midcycle (referred to as fPPOS), similar to GnRH antagonist injections.
Effect of glyceryl trinitrate and clevidipine administration on CT angiogram findings in dogs undergoing prostatic artery embolization for prostatic carcinoma.
PLoS One
December 2024
Department of Surgical and Radiological Sciences, From the University of California-Davis, School of Veterinary Medicine, Davis, Davis, California, United States of America.
Objectives: The primary aim of this study was to evaluate the effects of vasodilator administration on CT angiography (CTA) prostatic artery diameter and peak opacification in dogs with prostatic carcinoma prior to prostatic artery embolization (PAE).
Materials And Methods: A prospective clinical trial was performed. Ten dogs with naturally occurring prostatic carcinoma and no evidence of cardiovascular disease were enrolled.
Improving patient satisfaction based on service quality in clinical trials: A cross-sectional study.
PLoS One
December 2024
College of Nursing, Yonsei University, Seoul, Republic of Korea.
Background: Participants' satisfaction is an important factor in securing competitiveness in clinical trials. In many industries, such as healthcare, customer service quality has been analyzed to increase customer satisfaction. However, no study so far has attempted to measure participants' perceptions of service quality in the clinical trial area and identify its effect on participant satisfaction.
View Article and Find Full Text PDFA randomized controlled trial on anonymizing reviewers to each other in peer review discussions.
PLoS One
December 2024
Machine Learning Department, Carnegie Mellon University, Pittsburgh, Pennsylvania, United States of America.
Many peer-review processes involve reviewers submitting their independent reviews, followed by a discussion between the reviewers of each paper. A common question among policymakers is whether the reviewers of a paper should be anonymous to each other during the discussion. We shed light on this question by conducting a randomized controlled trial at the Conference on Uncertainty in Artificial Intelligence (UAI) 2022 conference where reviewer discussions were conducted over a typed forum.
View Article and Find Full Text PDFApplication of Causal Forest Model to Examine Treatment Effect Heterogeneity in Substance Use Disorder Psychosocial Treatments.
Int J Methods Psychiatr Res
March 2025
Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Objectives: Heterogeneity of treatment effect (HTE) is a concern in substance use disorder (SUD) treatments but has not been rigorously examined. This exploratory study applied a causal forest approach to examine HTE in psychosocial SUD treatments, considering multiple covariates simultaneously.
Methods: Data from 12 randomized controlled trials of nine psychosocial treatments were obtained from the National Institute on Drug Abuse Clinical Trials Network.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!