scholarly journals Adaptive Semantic Tag Mining from Heterogeneous Clinical Research Texts

2015 ◽  
Vol 54 (02) ◽  
pp. 164-170 ◽  
Author(s):  
T. Hao ◽  
C. Weng
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Architectural Design ◽  
Semantic Equivalence ◽  
Clinical Text ◽  
Mining Algorithm ◽  
Prevalence Trends ◽  
Trial Protocols ◽  
Mining Methods ◽  
Frequency Threshold

SummaryObjectives: To develop an adaptive approach to mine frequent semantic tags (FSTs) from heterogeneous clinical research texts.Methods: We develop a “plug-n-play” framework that integrates replaceable un-supervised kernel algorithms with formatting, functional, and utility wrappers for FST mining. Temporal information identification and semantic equivalence detection were two example functional wrappers. We first compared this approach’s recall and efficiency for mining FSTs from ClinicalTrials.gov to that of a recently published tag-mining algorithm. Then we assessed this approach’s adaptability to two other types of clinical research texts: clinical data requests and clinical trial protocols, by comparing the prevalence trends of FSTs across three texts.Results: Our approach increased the average recall and speed by 12.8% and 47.02% respectively upon the baseline when mining FSTs from ClinicalTrials.gov, and maintained an overlap in relevant FSTs with the baseline ranging between 76.9% and 100% for varying FST frequency thresholds. The FSTs saturated when the data size reached 200 documents. Consistent trends in the prevalence of FST were observed across the three texts as the data size or frequency threshold changed.Conclusions: This paper contributes an adaptive tag-mining framework that is scalable and adaptable without sacrificing its recall. This component-based architectural design can be potentially generalizable to improve the adaptability of other clinical text mining methods.

OPTIMISATION OF PHARMACY CONTENT IN PAEDIATRIC ONCOLOGY AND HAEMATOLOGY CLINICAL TRIAL PROTOCOLS. EXPERIENCE OF CHEMOTHERAPY PHARMACY ADVISORY SERVICE (CPAS) FROM 2011 TO PRESENT

2016 ◽  
Vol 101 (9) ◽  
pp. e2.67-e2
Author(s):  
Rachel Greer ◽  
Sally Harvey
Keyword(s):  
Clinical Trial ◽  
Patient Safety ◽  
Clinical Research ◽  
Paediatric Oncology ◽  
Cancer Clinical Trial ◽  
Research Network ◽  
Advisory Service ◽  
Trial Protocols ◽  
The Impact ◽  
Protocol Review

AimClarity and accuracy of the pharmacy aspects of cancer clinical trial protocols is essential. Inconsistencies and ambiguities in protocols have the potential to delay research and jeopardise both patient safety and the collection of credible data. The Chemotherapy and Pharmacy Advisory Service (CPAS) was established in 2007 by the UK National Cancer Research Network, currently known as National Institute for Health Research Clinical Research Network, to improve the quality of pharmacy-related content in cancer clinical trial protocols. This abstract describes the scope of CPAS, its methodology of mandated protocol review and an analysis of the issues found and reported in paediatric oncology and haematology trials.MethodAll paediatric oncology and haematology clinical trial protocols from 2011 to present were included in this study. A review checklist was developed by CPAS and used by the review panel, consisting of pharmacists, doctors and nurses, to standardise the evaluation of all protocols. Once completed, all reviews were collated and any queries and inconsistencies were fed back to Chief Investigators and study sponsors. The most common remarks made at protocol review were summarised and categorised through retrospective analysis. It is at the discretion of the study Sponsor and Chief Investigator to accept any recommendations or amendments based on the findings. In order to evaluate the impact of the service, Chief Investigators were asked to respond to queries made at protocol review and make appropriate changes to their protocols. Responses from Chief Investigators have been collated and acceptance rates determined.ResultsA total of 13 paediatric protocols were reviewed during this period. The mean number of comments per protocol was 32 and these mainly concerned the drug regimen, support medication, dose calculation, drug information and administration. Eleven of the Chief investigators returned responses to their protocols reviews. All responses were positive with an overall acceptance rate of 82% of the proposed protocol changes.ConclusionReview by CPAS of pharmacy content of paediatric oncology and haematology clinical trial protocols prior to final approval is feasible and exposes many undetected clinically relevant issues that could hinder efficient trial conduct and/or patient safety. This analysis has highlighted that the majority of suggestions were deemed clinically significant and effectively incorporated into the final protocols. The refinement of existing and development of further pharmacy-related guidance documents by CPAS might support more effective and safer clinical research.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Clinical Trials ◽  
Clinical Research ◽  
Substantial Reduction ◽  
Text Message ◽  
High Volume ◽  
Text Messages ◽  
Shared Task ◽  
Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

scholarly journals ‘Give Us The Tools!’: development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046450
Author(s):  
Samantha Cruz Rivera ◽  
Richard Stephens ◽  
Rebecca Mercieca-Bebber ◽  
Ameeta Retzer ◽  
Claudia Rutherford ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Patient Reported Outcome ◽  
Flow Diagram ◽  
Additional Patient ◽  
The Public ◽  
Patient Reported ◽  
Trial Protocols ◽  
User Friendly

Objectives(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.DesignA 1-day patient and public involvement session.ParticipantsSeven patient partners.MethodsA patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.ResultsTwo user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.ConclusionsThese tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.

scholarly journals Efficacy and safety of Suxiao Jiuxin Pill in the treatment of stable angina (Qi stagnation and blood stasis syndrome): study protocol of a randomized, double-blind, placebo-controlled, multi-center clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiaofen Ruan ◽  
Yiping Li ◽  
Yuanlong Sun ◽  
Meijun Jia ◽  
Xiaowen Xu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Stable Angina ◽  
Conventional Therapy ◽  
Blood Stasis ◽  
Chronic Stable Angina ◽  
Blood Stasis Syndrome ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Qi Stagnation

Abstract Background Coronary heart disease (CHD) has become one of the biggest health problems in the world. Stable angina is a common clinical type of CHD with poor prognosis and high mortality. Although there are various interventions for stable angina, none of them can significantly reduce mortality. Both basic and clinical research have shown that Suxiao Jiuxin Pill (SJP) can relieve the symptoms of angina pectoris and improve the clinical efficacy, but there is a lack of high-quality clinical research to provide research-based evidence. We design a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of SJP for stable angina. Methods/design This is a prospective, randomized, double-blind, placebo-controlled, and multicenter trial. The trial will enroll 324 participants with chronic stable angina (Qi Stagnation and Blood Stasis syndrome). All participants will have received the conventional therapy of chronic stable angina. Participants will be randomized into two groups, conventional therapy plus SJP group and conventional therapy plus placebo group. Eligible participants will receive either SJP or placebo (five pills administered orally, three times daily) in addition to conventional treatment for 24 weeks. The primary outcomes are the symptom improvement rate of angina from baseline to 4 weeks after inclusion and major adverse cardiovascular events (MACE). The secondary outcomes are angina classification (CCS), improvement of traditional Chinese medicine (TCM) syndromes, Seattle Angina Scale score, the dosage of emergency drugs and the stopping rate, and electrocardiogram (EKG) efficacy. Adverse events will be monitored throughout the trial. Discussion Integrated traditional Chinese and Western Medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of SJP for angina. The results of the trial will provide high-level clinical research-based evidence for the application of SJP instable angina. Trial registration This study protocol was registered on 14 March 2019. The registration number is ChiCTR1900021876 on the Chinese Clinical Trial Registry.

Clinical Trial Protocols

2016 ◽  
pp. 231-237
Author(s):  
Cemal Cingi ◽  
Nuray Bayar Muluk
Keyword(s):  
Clinical Trial ◽  
Trial Protocols

scholarly journals Clinical Trial Units in Italy: the perception of the Clinical Research Coordinators

2016 ◽  
Vol 27 ◽  
pp. iv111 ◽  
Author(s):  
C. Cagnazzo ◽  
O. Nanni ◽  
S. Campora ◽  
P. Frati ◽  
R. Camisa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Clinical Research Coordinators
Sign in / Sign up

Export Citation Format

Share Document