Sex and cardiovascular disease status differences in attitudes and willingness to participate in clinical research studies/clinical trials

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.

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Setting up clinical research studies in the National Health Service in England

Journal of Clinical Urology ◽

10.1177/2051415816657764 ◽

2016 ◽

Vol 10 (2) ◽

pp. 145-147 ◽

Cited By ~ 2

Author(s):

Jessica Whitburn ◽

Surjeet Singh ◽

Prasanna Sooriakumaran

Keyword(s):

Clinical Trials ◽

National Health Service ◽

Health Service ◽

Research And Development ◽

Clinical Research ◽

National Health ◽

Health Research ◽

Application Process ◽

Regulatory Bodies ◽

Research Studies

Starting and conducting clinical trials in England can be a complicated and time-consuming process. Before your study can begin it is necessary to gain approval from the appropriate regulatory bodies. Prior to March 2016, studies required National Health Service (NHS) permission (also referred to as Research and Development (R&D) approval) obtained via the National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission (CSP). Since March 2016, a new streamlined system has been introduced with the aim of making it easier to gain regulatory approvals. Now studies must go through the process of Health Research Authority (HRA) approval. In this article we review the process of gaining HRA approval in England. The article is aimed at junior researchers to help them understand the application process, and to give tips on how to succeed in gaining approval.

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58 Factors Determining Patient Willingness to Participate in Clinical Research Studies in the Emergency Department: A Pilot Study

Annals of Emergency Medicine ◽

10.1016/j.annemergmed.2011.06.084 ◽

2011 ◽

Vol 58 (4) ◽

pp. S196-S197

Author(s):

D.J. Woodyard ◽

F. Shofer ◽

P. Prabhakar ◽

K. Howard ◽

A. Felton ◽

...

Keyword(s):

Emergency Department ◽

Pilot Study ◽

Clinical Research ◽

Willingness To Participate ◽

Patient Willingness ◽

Research Studies

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Impact of the COVID-19 pandemic on the oncologic activities (diagnosis, treatment, clinical trials enrollment) of a general hospital in a district with high prevalence of SARS-COV-2 in Italy

Supportive Care in Cancer ◽

10.1007/s00520-021-06667-y ◽

2022 ◽

Author(s):

Massimo Ambroggi ◽

Chiara Citterio ◽

Stefano Vecchia ◽

Alessandra Riva ◽

Patrizia Mordenti ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Cancer Patients ◽

General Hospital ◽

Cancer Diagnosis ◽

Real World ◽

Oral Treatment ◽

The Real ◽

High Prevalence ◽

Research Studies

Abstract Purpose Little is known about the real impact of the COVID-19 outbreak on the qualitative and quantitative fall-out on the management of cancer patients. Our objective was to provide evidence of the effects of SARS-COV-2 on the management of cancer patients in the real world. Methods In a general hospital in a district in Italy with high prevalence of COVID-19 during the first wave, we retrospectively analyzed the data of oncologic activity, namely new cancer diagnosis, types of treatment (intravenous or by mouth), clinical research studies, and drug utilization, and compared the findings with those of 2019, before the pandemic. The data have been summarized in boxplot figures for median and interquartile range. Results In 2020, a significant reduction in new cancer diagnosis was demonstrated when compared with 2019, with 17.4% fewer cancer diagnoses, 84.5% fewer patients enrolled in clinical trials, a 10.6% reduction in intravenous antitumor treatment, and a 42.7% increase in oral anticancer treatment. Conclusion Our data indicate a significant reduction in cancer diagnosis, antitumor venous treatment, and patients enrolled in clinical research studies in 2020 compared with 2019, although there was a significant increase in oral treatment. These data suggest that the COVID-19 pandemic had a deep impact on the real-world management of cancer patients in a district of Italy with a high prevalence of COVID-19.

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PO 8538 STRENGTHENING SOCIAL STRATEGIES TO ENGAGE SUB-SAHARAN AFRICAN SOCIETIES TO VALUE CLINICAL RESEARCH: THE EXPERIENCE IN CONDUCTING CLINICAL TRIALS IN LAMBARéNé

BMJ Global Health ◽

10.1136/bmjgh-2019-edc.133 ◽

2019 ◽

Vol 4 (Suppl 3) ◽

pp. A51.1-A51

Author(s):

Pamela C Angoissa Minsoko ◽

Selidji T Agnandji

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Community Engagement ◽

Sub Saharan Africa ◽

Social Meaning ◽

Willingness To Participate ◽

The Social ◽

Social Meanings ◽

Sub Saharan ◽

Social Components

BackgroundOver the last two decades, clinical research activities have increased significantly in sub-Saharan Africa but societal engagement to make research socially and economically valuable is limited. Thus, engaging communities when designing clinical research and promoting social impacts of research are becoming key objectives among stakeholders involved in clinical research in sub-Saharan Africa. However, there is a need to define concepts and indicators to assess the strength of community engagement as well as the social impacts of clinical research.Here, we hypothesised that the social meanings of willingness to participate and compliance to clinical trial procedures are relevant indicators to assess community engagement.MethodsWe conducted a retrospective, prospective case study of clinical trials conducted in CERMEL between 1995 and 2017. We performed a social meaning framework analysis of the following processes: protocol design, ethical and regulatory clearance, informed consent and medical study procedures. We identified the social meanings of each procedure according to the involvement of social components (actors, ideas, communication strategies).ResultsA total of 42 clinical trials were identified in the ClinicalTrials.gov and Pan-African Clinical Trials Registry databases and confirmed by the top management of CERMEL. Between 1995 and 2004, there was little social meaning connected to trial procedures. This period was associated with poor compliance to study procedures. Between 2005 and 2017, compliance to study procedures improved. Detailed results will be presented during the meeting.ConclusionThe rise in willingness to participate in clinical research and improved compliance with study procedures were associated with the introduction of social components to medical procedures. Both indicators may be relevant to assess the strength of community engagement.

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2130The patient in clinical research: disposable guinea pig or involved actor?

European Heart Journal ◽

10.1093/eurheartj/ehz748.0083 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

D Cosmi ◽

B Mariottoni ◽

F Cosmi

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Guinea Pig ◽

Clinical Research ◽

Control Procedure ◽

Level Of Education ◽

Internet Searches ◽

Subsequent Withdrawal ◽

High Level ◽

Research Studies

Abstract Background The request for informed consent to join a clinical trial often creates mistrust and hesitation in the patient who should be enrolled. Methods In the last ten years of cardiovascular clinical research we asked an informed consent to 2,586 patients. 59% agreed to join clinical trials, 40% refused. The 1% initially accepted and then withdrew the consent. We asked all the patients who refused the consent to answer a brief interview about the reasons for rejection. Patients who refused to join clinical trials were relatively young (mean age 62±5) and had a high level of education; 619 (60%) had a high school diploma or a degree. Results Of 1031 patients, 629 (61%), accepted to answer the interview; 176 (28%) answered they refused on relatives', friends' or other doctors' advices, or after Internet searches; 157 (25%) answered they didn't agree about how the trials were carried out (double blind control procedure, use of placebo, ecc); 126 (20%) didn't trust official medicine. 63 (10%) couldn't guarantee their presence at the controls. 69 (11%) didn't want to undergo additional medical examinations. 31 (5%) had previous bad research experiences (feeling like a guinea pig, ecc). 7 (about 1%) refused for other reasons. Table 1. Acceptance or refusal to join cardiological intervention or observational clinical trials in the last 10 years Informed consent Immediately after reading and Principal Investigator's explanation After discussion with family, GP or Internet searches Total Accepted 914 (35%) 608 (24%) 1522 (29%) Initially accepted with subsequent withdrawal before randomization 1 (0.03%) 30 (1.2%) 31 (1%) Initially accepted with subsequent withdrawal after randomization 0 2 (0.07%) 2 (0.07%) Refused 151 (6%) 880 (34%) 1.031 (40%) Total 1.066 (41%) 1.520 (59%) 2.586 (100%) Conclusions Recruitment into clinical research studies is still a major challenge; patients are not fully aware of the importance of participation in clinical research studies for the development and implementation of medical advances. Paradoxically, people who refuse to participate in a trial are young and have a high level of education. Researcher's duty is to involve the patient in the trial and clarify the benefits of join the research.

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KNOWLEDGE, ATTITUDE, AND PERCEPTION OF NURSES AND PHYSICIANS REGARDING PHARMACEUTICAL-INITIATED CLINICAL RESEARCH IN UAE, QATAR, OMAN, BAHRAIN, AND JORDAN

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2020.v13i1.35513 ◽

2019 ◽

pp. 44-49

Author(s):

SHEREEN HAMMAD

Keyword(s):

Clinical Trials ◽

Middle East ◽

Clinical Research ◽

Health Care Professionals ◽

Legal Protection ◽

Willingness To Participate ◽

Online Questionnaire ◽

Research Activities ◽

East Region ◽

Middle East Region

Objective: The objective of the study was to understand the reasons for the limited number of pharmaceutical-initiated clinical studies in the Middle East region, by assessing the knowledge, attitudes, and perceptions related to pharmaceutical-initiated clinical trials among health-care professionals (HCPs) in UAE, Qatar, Oman, Bahrain, and Jordan. Methods: The study was conducted using an online questionnaire-based survey. The HCP respondents were from UAE, Qatar, Oman, Bahrain, and Jordan and had a good understanding of the English language. Descriptive statistical analysis was used to analyze the responses. Results: The HCPs were not inclined toward participation in clinical trials and research activities. The reasons for their limited participation included a lack of time, resources, and limited awareness about their legal protection associated with such studies, and the lack of necessary training and education related to clinical research. Conclusions: Although there is a willingness to participate in clinical trials conducted by pharmaceutical companies, HCPs face various ethical, administrative, and academic barriers. Addressing these issues would help increase the number of trials conducted in the Middle East region.

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