scholarly journals Readiness to Participate in Psychiatric Research

2003 ◽  
Vol 48 (7) ◽  
pp. 480-484 ◽  
Author(s):  
Daniele Zullino ◽  
Philippe Conus ◽  
François Borgeat ◽  
Charles Bonsack
Keyword(s):  
Clinical Trials ◽  
Financial Incentive ◽  
University Hospital ◽  
Psychiatric Research ◽  
Willingness To Participate ◽  
Research Projects ◽  
Hospital Physician ◽  
Recruitment Process ◽  
Consent Rate ◽  
Retention Strategies

Background: The feasibility of clinical trials depends, among other factors, on the number of eligible patients, the recruitment process, and the readiness of patients to participate in research. Seeking patients' views about their experience in research projects may allow investigators to develop more effective recruitment and retention strategies. Methods: A total of 100 patients consecutively admitted to a psychiatric university hospital were interviewed with respect to their willingness to participate in a study. For a different study scenario, patients were asked whether they would be ready to participate if such a study were organized in the service and to indicate their reasons for refusing or for participating. Results: The general readiness to participate in a study ranged between 70% and 96%. The prospect of remuneration did not notably augment the potential consent rate. The most common and spontaneous motivation for agreeing to take part in a study was to help science progress and to allow future patients to benefit from improved diagnosis and treatment (87%). The presence or lack of a financial incentive was rarely chosen as an argument to agree (23%) or to refuse (7%) to participate. Patients relied mainly on their treating physicians when contemplating possible participation in a study (family physician [65%] and hospital physician [54%]). Conclusions: Clinicians and, in particular, treating doctors can play an important role in facilitating the recruitment process.

Patients’ retention strategies in clinical trials

2015 ◽  
Vol 62 (10) ◽  
pp. 475-477 ◽  
Author(s):  
Pedro Mezquita Raya ◽  
Rebeca Reyes García ◽  
Alejandra de Torres Sánchez
Keyword(s):  
Clinical Trials ◽  
Retention Strategies

Knowledge and attitudes regarding clinical trials and willingness to participate among prostate cancer patients

2015 ◽  
Vol 45 ◽  
pp. 443-448 ◽  
Author(s):  
Celia P. Kaplan ◽  
Anna Maria Nápoles ◽  
Steven Narine ◽  
Steven Gregorich ◽  
Jennifer Livaudais-Toman ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Willingness To Participate ◽  
Knowledge And Attitudes

scholarly journals Willingness to Participate in Vaccine-Related Clinical Trials among Older Adults

2018 ◽  
Vol 15 (8) ◽  
pp. 1743 ◽  
Author(s):  
Divyanshu Raheja ◽  
Evelyn Davila ◽  
Eric Johnson ◽  
Rijalda Deović ◽  
Michele Paine ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Clinical Research ◽  
Elderly Person ◽  
The Elderly ◽  
Cross Sectional Study ◽  
Willingness To Participate ◽  
Cross Sectional ◽  
Convenience Sample ◽  
Research Findings

The purpose of this study is to understand among a convenience sample of 400 adults aged 60 years of age or older (1) reasons for being willing or unwilling to participate in a vaccine clinical research study and (2) overall perceptions about vaccine clinical research. A cross-sectional study using a sample of older adults residing in the metro-Atlanta area and surrounding neighborhoods was conducted. The study questionnaire contained 37 questions, including questions about socio-demographics and perceptions about clinical trial processes. Statistical analysis was conducted using logistic regression. The adjusted modeling results indicated that sex, distance to research clinic, and being informed about the research findings played a role in the likelihood of an elderly person participating in a vaccine study. Males were more likely to participate in clinical trials as compared to females (OR: 2.486; CI: 1.042–5.934). Most participants were willing to travel up to 25 miles from the research clinic. Of the respondents, 45% were unlikely to participate if the results of the current trial are not shared. Improving access to clinical trials in terms of distance traveled and ensuring streamlined processes to inform participants about the results of the trial in the future would increase willingness to participate in vaccine clinical trials. The survey could serve as a useful tool for conducting vaccine studies and other clinical trials by understanding the barriers specific to the elderly.

scholarly journals Attribution of non-ClinicalTrials.gov registries among WHO International Clinical Trials Registry Platform-registered trials from 2014 to 2018: A protocol for a meta-epidemiological study

2018 ◽  
Author(s):  
Masahiro Banno ◽  
Yasushi Tsujimoto ◽  
Yuki Kataoka
Keyword(s):  
Clinical Trials ◽  
Epidemiological Study ◽  
Medical Information ◽  
University Hospital ◽  
World Health ◽  
Study Phase ◽  
Target Sample Size ◽  
Registration Number ◽  
Health Organization ◽  
Clinical Trials Registry

Background. The attribution of non-ClinicalTrials.gov registries among registered trials of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) had increased until 2013. However, the attribution after 2013 is unknown. Moreover, no study has investigated the usage of non-ClinicalTrials.gov registries after 2015 or compared the characteristics of trials under non-ClinicalTrials.gov and ClinicalTrials.gov registries. Methods. This will be a meta-epidemiological study. It will include all trials registered on the ICTRP from January 1, 2014, to December 31, 2018. First, we will describe the total attribution of non-ClinicalTrials.gov registries among the ICTRP-registered trials for each year and each registry worldwide. Second, we will compare the recruitment status, target sample size, study type, study design, countries, prospective registration, funding, and study phase of the trials on ClinicalTrials.gov and other registries from 2014 to 2018. Third, we will report on the distribution of primary registries of trials from the top five countries in order of the quantity of registered trials on the ICTRP. Ethics & Dissemination. Ethics approval is not required for this study. This protocol has been registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The findings will be published in a peer-reviewed journal and may be presented at conferences. Trial Registration Number. UMIN000034401

scholarly journals Clinical trials for drug approval: a pilot study of the view of doctors at Tokushima University Hospital

2006 ◽  
Vol 53 (3,4) ◽  
pp. 292-296 ◽  
Author(s):  
Hiroaki Yanagawa ◽  
Masako Nishiya ◽  
Toshiko Miyamoto ◽  
Michiyo Shikishima ◽  
Mitsuko Imura ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pilot Study ◽  
Drug Approval ◽  
University Hospital

scholarly journals Deep Learning Approach to Parse Eligibility Criteria in Dietary Supplements Clinical Trials Following OMOP Common Data Model

2020 ◽  
Author(s):  
Anusha Bompelli ◽  
Jianfu Li ◽  
Yiqi Xu ◽  
Nan Wang ◽  
Yanshan Wang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Deep Learning ◽  
Dietary Supplements ◽  
Data Model ◽  
Common Data Model ◽  
Recruitment Process ◽  
Eligibility Criteria ◽  
Cohort Identification ◽  
Timely Fashion ◽  
Deep Learning Model

Dietary supplements (DSs) have been widely used in the U.S. and evaluated in clinical trials as potential interventions for various diseases. However, many clinical trials face challenges in recruiting enough eligible patients in a timely fashion, causing delays or even early termination. Using electronic health records to find eligible patients who meet clinical trial eligibility criteria has been shown as a promising way to assess recruitment feasibility and accelerate the recruitment process. In this study, we analyzed the eligibility criteria of 100 randomly selected DS clinical trials and identified both computable and non-computable criteria. We mapped annotated entities to OMOP Common Data Model (CDM) with novel entities (e.g., DS). We also evaluated a deep learning model (Bi-LSTM-CRF) for extracting these entities on CLAMP platform, with an average F1 measure of 0.601. This study shows the feasibility of automatic parsing of the eligibility criteria following OMOP CDM for future cohort identification.

Tools in a clinical information system supporting clinical trials at a Swiss University Hospital

2014 ◽  
Vol 11 (6) ◽  
pp. 673-680 ◽  
Author(s):  
Michael Weisskopf ◽  
Guido Bucklar ◽  
Jürg Blaser
Keyword(s):  
Information System ◽  
Clinical Trials ◽  
Clinical Research ◽  
Hospital Admissions ◽  
Clinical Information System ◽  
Clinical Information ◽  
University Hospital ◽  
Trial Registry ◽  
Trial Participants ◽  
Year 2013

Background: Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. Methods: In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient–trial–assignment–tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. Results: The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of hospital admission alerts of trial participants, 107 running trials have activated this option, including 48 out of 97 studies (49.5%) registered in the year 2013, generating approximately 85 alerts per month. Conclusions: The popularity of the presented tools in the clinical information system illustrates their potential to facilitate the conduct of clinical trials. The tools also allow for enhanced transparency on trials conducted at the hospital. Future studies on monitoring and inspection findings will have to evaluate their impact on quality and safety.

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