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

Personalized Behavioral Nutrition Intervention in Older Asian Americans with Type 2 Diabetes during COVID-19 Pandemic: Study Protocol for a Pilot, Hybrid, Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Jisook Ko ◽  
Yan Du ◽  
Rozmin Jiwani ◽  
Chengdong Li ◽  
Jing Wang
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Pilot Study ◽  
Glycemic Control ◽  
Asian Americans ◽  
Control Group ◽  
Management Approach ◽  
Self Monitoring ◽  
Behavioral Nutrition

BACKGROUND The COVID-19 pandemic has challenged the in-person-based self-management approach (i.e., face-to-face or group approach) of type 2 diabetes (T2D). Older adults with T2D, including Asian Americans (AAs), have experienced worsening of diabetes control due to various reasons, including uncertainty of continuous access to essential diabetes medications, devices, education, limited health literacy, as well as constant anxiety and stress. Hybrid clinical trials that incorporate virtual elements into the in-person-based study could provide these vulnerable populations with accessible and timely interventions OBJECTIVE The primary aims of this pilot study are to determine (1) the effect of personalized behavioral nutrition (PBN) intervention on glycemic control, weight control, and metabolites profiles; and (2) the acceptability of PBN. to enhance glycemic control using personalized behavioral nutrition. METHODS Participants will be recruited with a web-based registry, advertisements in ethnic newspapers, and social network services popular among AAs. A total of 60 AAs, aged 65 years or older, who are descendants of Chinese, Korean, or South Asian, and have a diagnosis of T2D will be randomized into two groups: a PBN group (n=30) and a control group (n=30). A 4-week PBN intervention comprises three components: 1) digital self-monitoring; 2) personal nutrition change goals and recommendations; and 3) diabetes nutrition educations. All participants will complete digital self-monitoring on diet, physical activity, and blood glucose. In addition, all participants will access an interactive digital platform to track their self-monitoring data and communicate with the research team. The effectiveness and acceptability of implementing the intervention will be assessed. RESULTS Funding support and institutional review board approval for this study have been secured. Data collection started in August 2020 and is ongoing. CONCLUSIONS To our knowledge, this is the first study to determine the effectiveness and acceptability of PBN utilizing a metabolomics approach and digital-assisted intervention with hybrid RCT among older AAs. The findings of this pilot study will inform the development of a full-scale PBN protocol and hybrid clinical trials that can be adapted for people with T2D in the ongoing pandemic.

scholarly journals Influence of chronotype on daily mood fluctuations: pilot study in patients with depression

BJPsych Open ◽  
2020 ◽  
Vol 6 (2) ◽  
Author(s):  
Konstantin F. Brückmann ◽  
Jürgen Hennig ◽  
Matthias J. Müller ◽  
Stanislava Fockenberg ◽  
Anne-Marthe Schmidt ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pilot Study ◽  
Negative Affect ◽  
Clinical Setting ◽  
Early Morning ◽  
Healthy Controls ◽  
Patient Subgroup ◽  
Depression Risk ◽  
Gender And Age ◽  
The Relationship

Summary Depression risk is associated with a late chronotype pattern often described as an ‘evening chronotype’. Fluctuations in mood over consecutive days have not yet been measured according to chronotype in in-patients with depression. A total of 30 in-patients with depression and 32 healthy controls matched for gender and age completed a chronotype questionnaire and twice-daily ratings on mood for 10 consecutive days (registered in the German Clinical Trials Register: DRKS00010215). The in-patients had Saturdays and Sundays as hospital-leave days. The relationship between chronotype and daily mood was mediated by the weekday–weekend schedule with higher levels of negative affect in the evening-chronotype patient subgroup at weekends. Results are discussed with respect to a probably advantageous standardised clinical setting with early morning routines, especially for patients with evening chronotypes.

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.

scholarly journals Assessing Risks Awareness in Operating Rooms among Post-Graduate Students: A Pilot Study

2021 ◽  
Vol 13 (7) ◽  
pp. 3860
Author(s):  
Anna Rita Corvino ◽  
Pasquale Manco ◽  
Elpidio Maria Garzillo ◽  
Maria Grazia Lourdes Monaco ◽  
Alessandro Greco ◽  
...  
Keyword(s):  
Risk Perception ◽  
Pilot Study ◽  
Graduate Students ◽  
Ionizing Radiation ◽  
Operating Room ◽  
Training Programs ◽  
Occupational Risk ◽  
University Hospital ◽  
Cross Sectional Survey ◽  
Post Graduate

Background: In this study, we promote a global approach to occupational risk perception in order to improve occupational health and safety training programs. The study investigates the occupational risk perception of operating room healthcare workers using an Analytic Hierarchy Process approach. Methods: A pilot study was carried out through a cross-sectional survey in a university hospital in Southern Italy. An ad hoc questionnaire was administered to enrolled medical post-graduate students working in the operating room. Results: Fifty medical specialists from seven fields (anaesthetists, digestive system surgeons, general surgeons, maxillofacial surgeons, thoracic surgeons, urologists, and gynaecologists) were questioned about perceived occupational risk by themselves. Biological, ionizing radiation, and chemical risks were the most commonly perceived in order of priority (w = 0.300, 0.219, 0.210). Concerning the biological risk, gynaecologists unexpected perceived this risk as less critical (w = 0.2820) than anaesthesiologists (w = 0.3354), which have the lowest perception of the risk of ionizing radiation (w = 0.1657). Conclusions: Prioritization methods could improve risk perception in healthcare settings and help detect training needs and perform sustainable training programs.

Enrollment disparities in cancer clinical trials leading to FDA approvals between 2008 and 2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18501-e18501
Author(s):  
Ryan Huu-Tuan Nguyen ◽  
Yomaira Silva ◽  
Vijayakrishna K. Gadi
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trials ◽  
Drug Approval ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cancer Prevalence ◽  
Fda Approval ◽  
The Us ◽  
Enrollment Data

e18501 Background: Cancer clinical trials based in the United States (US) have lacked adequate representation of racial and ethnic minorities, the elderly, and women. Pivotal clinical trials leading to United States Food and Drug Administration (FDA) approval are often multi-national trials and may also lack generalizability to underrepresented populations in the United States. We determined the racial, ethnic, age, and sex enrollment in pivotal trials relative to the US cancer population. Methods: We reviewed the FDA’s Drug Approvals and Databases for novel and new use drug approvals for breast, colorectal, lung, and prostate cancer indications from 2008 through 2020. Drugs@FDA was searched for drug approval summaries and FDA labels to identify clinical trials used to justify clinical efficacy that led to FDA approval. For eligible trials, enrollment data were obtained from FDA approval summaries, FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. Enrollment Fraction (EF) was calculated as enrollment in identified clinical trials divided by 2017 SEER cancer prevalence. All data sources were publicly available. Results: From 2008 through 2020, 60 drugs received novel or new use drug approval for breast, colorectal, lung, or prostate cancer indications based on 66 clinical trials with a total enrollment of 36,830. North America accounted for 9,259 (31%) enrollees of the 73% of trials reporting location of enrollment. Racial demographics were reported in 78% of manuscripts, 66% of ClinicalTrials.gov pages, and 98% of FDA labels or approval summaries. Compared with a 0.4% enrollment fraction among White patients, lower enrollment fractions were noted in Hispanic (0.2%, odds ratio [OR] vs White, 0.46; 95% confidence interval [CI], 0.43 to 0.49, P< 0.001) and Black (0.1%, OR 0.29; 95% CI 0.28 to 0.31, P< 0.001) patients. Elderly patients (age ≥ 65 years) were less likely than younger patients to be enrollees (EF 0.3% vs 0.9%, OR 0.27; 95% CI 0.26 to 0.27, P< 0.001) despite accounting for 61.3% of cancer prevalence. For colorectal and lung cancer trials, females were less likely than males (EF 0.7% vs 1.1%, OR 0.66; 95% CI 0.63 to 0.68, P< 0.001) to be enrolled. Conclusions: Black, Hispanic, elderly, and female patients were less likely to enroll in cancer clinical trials leading to FDA approvals from 2008 to 2020. Race and geographic enrollment data were inconsistently reported in journal manuscripts and ClinicalTrials.gov. The lack of appropriate representation of specific patient populations in these key clinical trials limits their generalizability. Future efforts must be made to ensure equitable access, representation, and reporting of enrollees that adequately represent the US population of patients with cancer.

THU0349 Analysis of Real Costs of Biologic Therapy for the Treatment of Chronic Inflammatory Arthropaties in a Tertiary University Hospital. A Pilot Study

2015 ◽  
Vol 74 (Suppl 2) ◽  
pp. 321.3-322
Author(s):  
J.M. Pego-Reigosa ◽  
M. Ucha ◽  
F. Maceiras ◽  
R. Melero ◽  
M. Άlvarez ◽  
...  
Keyword(s):  
Pilot Study ◽  
Biologic Therapy ◽  
University Hospital ◽  
Real Costs

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

Sign in / Sign up

Export Citation Format

Share Document