So different, yet so similar: meta-analysis and policy modeling of willingness to participate in clinical trials among Brazilians and Indians.
Ontology highlight
ABSTRACT: Background
With the global expansion of clinical trials and the expectations of the rise of the emerging economies known as BRICs (Brazil, Russia, India and China), the understanding of factors that affect the willingness to participate in clinical trials of patients from those countries assumes a central role in the future of health research.Methods
We conducted a systematic review and meta-analysis (SRMA) of willingness to participate in clinical trials among Brazilian patients and then we compared it with Indian patients (with results of another SRMA previously conducted by our group) through a system dynamics model.Results
Five studies were included in the SRMA of Brazilian patients. Our main findings are 1) the major motivation for Brazilian patients to participate in clinical trials is altruism, 2) monetary reimbursement is the least important factor motivating Brazilian patients, 3) the major barrier for Brazilian patients to not participate in clinical trials is the fear of side effects, and 4) Brazilian patients are more likely willing to participate in clinical trials than Indians.Conclusion
Our study provides important insights for investigators and sponsors for planning trials in Brazil (and India) in the future. Ignoring these results may lead to unnecessary fund/time spending. More studies are needed to validate our results and for better understanding of this poorly studied theme.
SUBMITTER: Zammar G
PROVIDER: S-EPMC3002940 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundWith the globalization of clinical trials, large developing nations have substantially increased their participation in multi-site studies. This participation has raised ethical concerns, among them the fear that local customs, habits and culture are not respected while asking potential participants to take part in study. This knowledge gap is particularly noticeable among Indian subjects, since despite the large number of participants, little is known regarding what factors affect their willingness to participate in clinical trials.MethodsWe conducted a meta-analysis of all studies evaluating the factors and barriers, from the perspective of potential Indian participants, contributing to their participation in clinical trials. We searched both international as well as Indian-specific bibliographic databases, including Pubmed, Cochrane, Openjgate, MedInd, Scirus and Medknow, also performing hand searches and communicating with authors to obtain additional references. We enrolled studies dealing exclusively with the participation of Indians in clinical trials. Data extraction was conducted by three researchers, with disagreement being resolved by consensus.ResultsSix qualitative studies and one survey were found evaluating the main themes affecting the participation of Indian subjects. Themes included Personal health benefits, Altruism, Trust in physicians, Source of extra income, Detailed knowledge, Methods for motivating participants as factors favoring, while Mistrust on trial organizations, Concerns about efficacy and safety of trials, Psychological reasons, Trial burden, Loss of confidentiality, Dependency issues, Language as the barriers.ConclusionWe identified factors that facilitated and barriers that have negative implications on trial participation decisions in Indian subjects. Due consideration and weightage should be assigned to these factors while planning future trials in India.
| S-EPMC2873955 | biostudies-literature
Project description:BackgroundSubjects of Chinese heritage have been found to participate in clinical research at lower rates than other groups despite growing in numbers as a population. While much research has examined research participants' motivation, there has not been a comprehensive synthesis of this information with respect to participants of Chinese descent. We sought to identify the factors that promote and hinder participation in clinical research among participants of Chinese heritage.Methodology/principal findingsWe conducted a systematic review of the literature in Pubmed, OpenJGATE, SCIRUS, and COCHRANE databases and performed a meta-synthesis of retrieved articles. We extracted qualitative data, such as quotes to identify emerging themes. We identified five studies that met our selection criteria. Of them, only one (1/5) was conducted in China while other studies involved Chinese emigrants in USA (3/5) and Singapore (1/5). Participants from China were similar to emigrants with regard to factors that either promoted or decreased research participation. Four studies reported data exclusively on Chinese subjects. Three of the five studies involved qualitative interviews while the others were conducted using a survey design. Six themes favoring research participation were identified: Personal Benefit to Participants, Financial Incentives, Participant Sense of Altruism, Family or Physician Recommendations, Advertisements, and Convenience to the Participant. Five factors were seen as a barrier to participation in clinical trials: Mistrust of Researchers, Language Barrier, Lack of Financial and Other Support, Cultural and Social Barriers, Lack of Knowledge about Clinical Trials.Conclusions/significanceChinese heritage clinical research participants value personal benefit, financial incentives, the ability to help others, recommendations of others, advertisements, and convenience when considering clinical research participation. In addition, the establishment of trust and addressing knowledge deficits are important factors to them. Investigators seeking to optimize enrolment in these populations should incorporate these findings into their study design and subject handouts.
| S-EPMC3547937 | biostudies-literature
Project description:BackgroundBreast cancer patients experienced heightened anxiety during the pandemic. Also, modifications to clinical trial activities allowing for virtual platforms, local assessments, and greater flexibility were introduced to facilitate participation. We sought to evaluate the association between pandemic-related anxiety and willingness to participate in trials and how pandemic-era modifications to trial activities affect the decision to participate.MethodsWe conducted an online survey from August to September, 2021 of patients with breast cancer assessing pandemic-related anxiety; clinical trials knowledge and attitudes; willingness to participate during and before the pandemic; and how each modification affects the decision to participate. Fisher's exact tests evaluated differences in proportions and two-sample t-tests evaluated differences in means. The association of pandemic-related anxiety with a decline in willingness to participate during compared to prior to the pandemic was modeled using logistic regression.ResultsAmong 385 respondents who completed the survey, 81% reported moderate-severe pandemic-related anxiety. Mean willingness to participate in a trial was lower during the pandemic than prior [2.97 (SD 1.17) vs. 3.10 (SD 1.09), (p < 0.001)]. Severe anxiety was associated with higher odds of diminished willingness to participate during the pandemic compared to prior (OR 5.07). Each of the modifications, with the exception of opting out of research-only blood tests, were endorsed by >50% of respondents as strategies that would increase their likelihood of deciding to participate.ConclusionsWhile pandemic-related anxiety was associated with diminished willingness to participate in trials, the leading reasons for reluctance to consider trial participation were unrelated to the pandemic but included worries about not getting the best treatment, side effects, and delaying care. Patients view trial modifications favorably, supporting continuation of these modifications, as endorsed by the National Cancer Institute and others.
| S-EPMC10926883 | biostudies-literature
Project description:Knowledge, attitude and willingness of ethnic minorities in China towards cadaver donation programs were assessed. Questionnaire and interviews were conducted to investigate Yi, Bai, Hani, Dai and Han ethnicities. Educational level and per capita income of ethnic minorities were lesser than those of Han ethnicity (p<0.01). Agriculture was the primary occupation and proportions of technical personnel and public officials was lesser among ethnic minorities (p<0.01). Surveyed ethnic minorities universally practice religious traditions, Bai and Dai ethnicities practice Buddhist beliefs also (p<0.01). Knowledge of Yi, Bai, Hani and Dai ethnic respondents was lesser than those of Han ethnicity (p<0.01). Over 83.8% of Yi, Bai, Hani and Dai ethnicity residents were unwilling to register for body donation programs with receiving a driver's license (p<0.01). Less than 46.9% of ethnic minorities supported use of honorary certificates (p<0.01). Ethnic minorities were supportive of financial compensation for body donations and denied that financial compensation led to the commercialization of cadaver donation (p<0.01, p<0.01). Willingness of ethnic minorities to participate in cadaver donation programs was primarily related to religious beliefs (p<0.01), economic status (p<0.01). Knowledge, attitude and willingness of ethnic minorities to participate in cadaver donation programs were markedly different from those of Han ethnicity, and the religious belief and economic status played a decisive role. To increase participation, programs based on respecting religious belief should be developed to support improvements in economy, education, medical care and social security system.
| S-EPMC7067454 | biostudies-literature
Project description:BACKGROUND: More and more HIV therapeutic vaccines will enter clinical trials; however, little is known about the willingness to participate (WTP) in HIV therapeutic vaccine trials among HIV-positive individuals. OBJECTIVE: To investigate the WTP in HIV therapeutic vaccine trials among Chinese HIV-infected patients. METHODS: We conducted a cross-sectional survey on HIV-positive inpatients and outpatients at Shanghai Public Health Center. A total of 447 participants were recruited into this study. Following an introduction with general information on HIV therapeutic vaccine and its potential effectiveness and side effects, each participant completed a questionnaire in a self-administered form. The questionnaires covered demographics, high-risk behaviors, clinical characteristics and willingness to participate in HIV therapeutic vaccine trial. RESULTS: The overall willingness to participate in HIV therapeutic vaccine trials was 91.5%. Interestingly, multivariate logistic regression analyses demonstrated that the willingness was higher for those sexually infected by HIV (odds ratio [OR]: 4.36; 95% confidence interval [CI]: 1.53-12.41), diagnosed as HIV-1 infection for greater than 5 years (OR: 7.12, 95% CI: 1.83-27.76), and with the presence of infectious complications (OR: 2.75; 95% CI: 1.02-7.45). The primary reason for participation was to delay or reduce antiretroviral treatment (ART) and to avoid ART side effects (76.6%), and then followed by delaying disease progression (74.9%), increasing immune response to suppress opportunistic infections (57.7%) and preventing the development of drug resistance (37.1%). Reasons for unwillingness to participate mainly included concern for safety (37.0%), lack of knowledge on therapeutic vaccine (33.3%), and satisfaction with ART effectiveness (22.2%). CONCLUSIONS: The WTP in HIV therapeutic vaccine trials was high among HIV-infected Chinese patients. HIV+ subjects who acquired infection through sexual contact and who were diagnosed for more than 5 years may represent a good candidate population for enrollment in therapeutic vaccine trials.
| S-EPMC4221013 | biostudies-other
Project description:IntroductionPsychotherapy is considered part of the standard treatment of cancer in Western countries. However, there is no literature on the attitudes of Chinese cancer patients toward psychotherapy.MethodsIn a multicenter, cross-sectional study in China, a homemade questionnaire was delivered to cancer patients. The targeted population was Chinese hospitalized cancer patients who were informed of their state of illness.ResultsFive hundred and fifty cancer patients received our questionnaire, and 83.3% completed the questionnaire. Among the 458 patients, 43.2% indicated that they had never heard of psychotherapy before the survey. However, after a brief introduction of psychotherapy, most (92.1%) cancer patients indicated that psychotherapy is essential for cancer patients, and over half of patients (57.4%) were willing to take psychotherapy on the advice of the oncologist in charge. Participants aged 45 years or younger, had a family income > 10000 yuan per month, and had an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 2-4 were more willing to receive psychotherapy. Of all patients, 59.2% and 57.6% were willing to participate in individual and group psychotherapy clinical trials, respectively. Participants who had a bachelor's degree or higher (odds ratio, OR = 2.09) and were aged 45 years or younger (OR = 1.67) were more willing to participate in individual and group psychotherapy clinical trials, respectively.ConclusionThe unmet psychological needs of cancer patients in China remain high, and doctors' advice is likely to positively impact the patients' acceptance of psychotherapy. Psychological education for Chinese cancer patients should be strengthened. More high-quality clinical trials of psychotherapy should be conducted in China to achieve greater benefits for cancer patients and their families.
| S-EPMC9260575 | biostudies-literature
Project description:BackgroundClinical trials are essential to improve knowledge of anesthesia and perioperative medicine. Unfortunately, many studies face participant-recruitment issues and fail to include the planned number of participants. There is limited published data about how information delivered about the study or how the experiences and attitudes of prospective participants influence willingness to participate. The purpose of this study was to identify such factors in the domain of anesthesia care.MethodsWe performed a cross-sectional study at the Geneva University Hospitals (Switzerland) using a newly developed paper-based questionnaire on a sample of outpatients with a recent hospital stay and that were aged over 18 years, confident speaking French and free of any disease that could hinder participation. We explored patient personal factors, such as current health, past exposure to clinical research and anesthesia, as well as study-related factors. Six different scenarios for clinical studies were assessed. Linear regression modeling was used to assess the specific association between personal and study-related factors and willingness to participate in the studies described in the scenarios.ResultsOn the 1318 eligible patients, 398 fully completed the questionnaire. Multivariable adjustment revealed that factors related to altruistic values (β, 9.6, 95% CI 3.4 to 15.7, P = 0.002), to the feeling of benefiting from a more effective treatment (β, 4.7, 95% CI 0.2 to 9.2, P = 0.041) and to the absence of fear about double blinding (β, 5.7, 95% CI 1.3 to 10.2, P = 0.012) were positively associated with willingness to participate. Conversely, concerns about drug-related adverse effects (β, - 11.7, 95% CI - 16.9 to - 6.5, P < 0.001) and anxiety about surgery (β, - 5.2, 95% CI - 10.0 to - 0.5, P = 0.031) were negatively associated with willingness to participate.ConclusionOur study was based on vignettes illustrating typical scenarios of clinical trials performed in anesthesia. However, their similarities with real studies still remains hypothetical and our results should be interpreted as such. Nevertheless, the study contributes to improve understanding of factors that may act as incentives or barriers to participation in clinical trials. It highlights the importance of providing appropriate information and reassurance to patients.
| S-EPMC7082904 | biostudies-literature
Project description:The rising penetration of smartphones now gives researchers the chance to collect data from smartphone users through passive mobile data collection via apps. Examples of passively collected data include geolocation, physical movements, online behavior and browser history, and app usage. However, to passively collect data from smartphones, participants need to agree to download a research app to their smartphone. This leads to concerns about nonconsent and nonparticipation. In the current study, we assess the circumstances under which smartphone users are willing to participate in passive mobile data collection. We surveyed 1,947 members of a German nonprobability online panel who own a smartphone using vignettes that described hypothetical studies where data are automatically collected by a research app on a participant's smartphone. The vignettes varied the levels of several dimensions of the hypothetical study, and respondents were asked to rate their willingness to participate in such a study. Willingness to participate in passive mobile data collection is strongly influenced by the incentive promised for study participation but also by other study characteristics (sponsor, duration of data collection period, option to switch off the app) as well as respondent characteristics (privacy and security concerns, smartphone experience).
| S-EPMC6639765 | biostudies-literature
Project description:BackgroundHealthcare workers (HCWs) are at high risk of acquiring SARS-CoV-2 and COVID-19 and may therefore be a suitable population for COVID-19 vaccine trials. We conducted a survey to evaluate willingness-to-participate in COVID-19 vaccine trials in a population of HCWs at three hospitals in Uganda.MethodsThe survey was conducted between September and November 2020. Using a standardised questionnaire, data were collected on socio-demographics, previous participation in health research, COVID-19 information sources, underlying health conditions, and willingness-to-participate in COVID-19 vaccine trials. Data were analysed descriptively and a binomial generalised linear model with a log link function used to investigate factors associated with unwillingness to participate.Results657 HCWs (female, 63%) were enrolled with a mean age of 33 years (Standard Deviation, 10). Overall willingness-to-participate was 70.2%. Key motivating factors for participation were: hope of being protected against COVID-19 (81.1%), altruism (73.3%), and the opportunity to get health care (26.0%). Selected hypothetical trial attributes reduced willingness-to-participate as follows: weekly-quarterly study visits over a 12-month period (70.2%-63.2%, P = 0.026); provision of approximately 50ml of blood at each study visit (70.2%-63.2%, P = 0.026); risk of mild-moderate local adverse reactions (70.2%-60.3%, P<0.001); chance of receiving candidate vaccine or placebo (70.2%-56.9%, P<0.001); and delay of pregnancy [Overall, 70.2%-57.1% P<0.001); Female, 62.8%-48.4% (P = 0.002); Male, 82.5%-71.5% (P = 0.003)]. Collectively, these attributes reduced willingness-to-participate from [70.2%-42.2% (P<0.001) overall; 82.5%-58.1% (P<0.001) in men; 62.8%-32.6% (P<0.001) in women]. Among individuals that were unwilling to participate, the commonest barriers were concerns over vaccine safety (54.6%) and fear of catching SARS-CoV-2 (31.6%). Unwillingness to participate was associated with being female (aRR 1.97, CI 1.46-2.67, P<0.001) and having university or other higher-level education (aRR 1.52, CI 1.05-2.2, P = 0.026).ConclusionsWillingness-to-participate in COVID-19 vaccine trials among HCWs in Uganda is high but may be affected by vaccine trial requirements and concerns about the safety of candidate vaccines.
| S-EPMC8158909 | biostudies-literature
Project description:BackgroundWhile women are under-represented in research on cardiovascular disease (CVD), little is known about the attitudes of men and women with CVD regarding participation in clinical research studies/clinical trials.MethodsPatients with CVD (and/or risk factors) and patients with other chronic conditions from Iowa were recruited from a commercial panel. An on-line survey assessed willingness to participate (WTP) and other attitudes towards aspects of clinical research studies.ResultsBased on 504 respondents, there were no differences in WTP in patients with CVD compared to patients with other chronic diseases. Across all respondents, men had 14% lower WTP (relative risk (RR) for men, 0.86, 95% CI, 0.72-1.02). Among patients with CVD, there was no significant difference in WTP between women (RR for women = 1) and men (RR for men, 0.96, 95% CI, 0.82-1.14). There were no significant differences based on sex or CVD status for attitudes on randomization, blinding, side effects, conflict of interest, experimental treatments or willingness to talk to one's physician. Women had more favorable attitudes about participants being treated like "guinea pigs" (RR for men, 0.84, 95% CI, 0.73-0.98) and clinical trials being associated with terminally ill patients (RR for men, 0.93, 95% CI, 0.86-1.00).ConclusionsThe findings reported here suggest that the observed lower levels of participation by women are due to factors other than a lower WTP or to women having more negative attitudes towards aspects of study participation. Patients with CVD have similar attitudes and WTP as patients with other chronic conditions.
| S-EPMC5975677 | biostudies-literature