ObjectiveTo investigate the awareness, willingness, motivation, and influencing factors of outpatients for participating drug clinical trials, and provide references for decision-making of drug clinical trials. MethodsAn anmonymous survey was conducted in the departments of internal medicine, surgery, gynecology, and obstetrics of a randomly selected tertiary referral center, and the results were statistically analyzed. ResultsA total of 1 067 available questionnaires were received. The total awareness rate of clinical trials was 31.02%, which was closely correlated with age and the degree of education. 40.86% of respondents were willing to participate in drug clinical trials. And 55.28% of them chose yes because of the willingness to contribute to the development of medical science. People having cognition on clinical trials had more willingness to participate in drug(OR:1.361,95%CI:1.042-1.777).59.14% of the respondents refused to participate in drug clinical trials, 68.62% of whom refusing to participate mainly worried about the safety of drugs. 57.37% of the respondents comfirmed that they might change their idea if experts were involved. 41.33% were willing to accept training about clinical trials. ConclusionInvestigators' overall cognition on clinical trials is closely correlated with the willingness to participate in drug clinical trials. There should propagandize drug clinical trials to make sure the improvement of drug clinical trial progress.
表3
调查对象药物临床试验知晓状况与参与意愿影响因素分析
Tab.3
Analysis of the influencing factor on the awareness and willingness of the respondents to participating drug clinical trial
变量
知晓状况
参与意愿
OR
95%CI
OR
95%CI
年龄(以“≤20岁”为参照)
>20~40
0.504
0.308~0.824*1
2.370
1.331~4.218
>40
0.352
0.196~0.634*1
2.243
1.148~4.384
文化程度(以“高中及以下”为参照)
大专
0.998
0.669~1.489
1.066
0.744~1.529
本科及以上
1.510
1.061~2.148*1
1.603
1.191~2.158*1
就医压力(以“无”为参照)
轻度
0.672
0.504~0.895*1
中度
0.714
0.496~1.029
重度
0.517
0.260~1.026
知晓状况(以“不知晓”为参照)
知晓
1.361
1.042~1.777*2
*1P<0.01;*2P<0.05
表3
调查对象药物临床试验知晓状况与参与意愿影响因素分析
Tab.3
Analysis of the influencing factor on the awareness and willingness of the respondents to participating drug clinical trial
LEITERJ, DIEFENBACH MA, DOUCETTEJ,et al.Clinical trial awareness: changes over time and sociodemographic disparities[J].,2015,12(3):215-223.
ABSTRACT Lack of clinical trial awareness is a known obstacle to clinical trial enrollment. We sought to define the prevalence of clinical trial awareness in the US population, determine characteristics associated with increased trial awareness, and explore potential disparities in trial awareness. We utilized data from the Health Information National Trends Survey from 2008 and 2012. Logistic regression was utilized to assess predictors of clinical trial awareness, particularly sociodemographic variables and information-seeking preferences. Trial awareness and information-seeking preferences were compared in patient subgroups and between the two time periods. Clinical trial awareness increased from 68% to 74% between 2008 and 2012. In the 2012 dataset, higher education level (odds ratio: 3.52, 95% confidence interval: 2.16-5.74), higher yearly income category (odds ratio: 1.84, 95% confidence interval: 1.17-2.89), and Internet use (odds ratio: 2.13, 95% confidence interval: 1.52-3.00) were significantly associated with clinical trial awareness. Hispanic ethnicity (odds ratio: 0.41, 95% confidence interval: 0.25-0.68) was significantly associated with decreased awareness. Clinical trial awareness increased in African-American/Blacks (螖10.6%) and Hispanics (螖10.7%) between 2008 and 2012, as did Internet use in both subgroups (螖14.2%, 螖18.1%, respectively). Overall clinical trial awareness has increased between 2008 and 2012, although a large subset of the population still lacks general awareness of clinical trials. Racial and ethnic disparities in trial awareness exist, although disparities may be decreasing among the Black population. These findings may help target educational efforts and inform approaches to increasing trial awareness. 漏 The Author(s) 2015.
JOSHI VD, OKA GA,KULKARNI AA,et al.Public awareness and perception of clinical trials: quantitative study in Pune[J]. ,2013,4(3):169-174.
ABSTRACT Studies have reported that clinical research has experienced tremendous growth during past few decades with many multinational pharmaceutical companies recruiting millions of Indians in clinical trials (CTs). However, there is hardly any literature that talks about the participants, their knowledge, and awareness of CTs. It is important that the general public is aware about CTs so that they can take their own informed decision to participate in CTs. To assess public awareness, perceptions, and attitudes toward CTs and their views on various methods to create awareness about CTs. Cross sectional survey was conducted with 200 non trial participants (NTPs) and 40 trial participants (TPs). TPs were significantly (P < 0.0001) older than NTPs. More than 80% of both TPs and NTPs mentioned participation in CT helps advance medical science and strongly felt that there is a need to create awareness about CTs. Nearly 70% of TPs could not remember the phase of the trial while 20% did not know which type of trial they had participated. The main reason for participation in the trial was physician's advice. About 80% of both TPs and NTPs felt that participation in CT will increase with free medications and advice from friends/relatives who had good experience with trial. Results of this pilot study revealed need to create CT awareness among the general public. However, considering ethno-cultural, regional, and literacy-level differences throughout the country, a nationwide study would be appropriate to provide reliable results about awareness of CTs among Indians.
BURTT, DHILLONS, SHARMAP, et al.PARTAKE survey of public knowledge and perceptions of clinical research in India[J]. ,2013,8(7):e68666.
BackgroundA public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE – Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program.ObjectiveTo study public knowledge and perceptions of clinical research.MethodsA 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India.ResultsInterviewees were 18–84 old (mean: 39.6, SD±16.6), 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware): ‘research benefits society’ (94.1%/3.5%/2.3%), ‘the government protects against unethical clinical research’ (56.7%/26.3%/16.9%), ‘research hospitals provide better care’ (67.2%/8.7%/23.9%), ‘confidentiality is adequately protected’ (54.1%/12.3%/33.5%), ‘participation in research is voluntary’ (85.3%/5.8%/8.7%); ‘participants treated like ‘guinea pigs’’ (20.7%/53.2%/26.0%), and ‘compensation for participation is adequate’ (24.7%/12.9%/62.3%).ConclusionsResults suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation), and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants) and exhibits some distrust in the conduct and reporting of clinical trials. Larger, cross-cultural surveys are required to inform educational programs addressing these issues.
ADEWALEB, SCHOEMANL,ROUSSOUWT,et al.Knowledge and perceptions of research participants in Nigeria about clinical trials[J].,2015,12(4): 196-198.
ABSTRACT Benchmarks of ethical research in developing countries stipulate collaborative partnership, which necessitates the involvement of research participants and taking cognizance of their opinions in decisions regarding research activities. Little data regarding participants' perceptions about research activities exists in the developing world. This study assessed the knowledge and perceptions of research participants in Nigeria about clinical trials. A validated semi-structured questionnaire was used in a cross-sectional survey. Data were analysed using SPSS version 17. Seventy-five respondents (70.7% females, 29.3% males) with a mean age of 36.5卤10.3 years, enrolled in an efficacy and safety study of Artequin in Ikorodu LGA, Nigeria, participated in the survey. Most of them (64%) had secondary education while 6.7% were illiterate. Only 5 (6.7%) had previously participated in a clinical trial. The majority of respondents (70.7%) did not know how medicines are determined to be safe and none knew how new drugs are tested. While only 10(13.3%) respondents felt that people were well treated during clinical trials, only two knew of someone who had been harmed because of participation and only one respondent could report on the type of harm experienced by the participant. The majority (86.7%) did not know if people were well treated or abused or whether people's rights were protected during clinical trials (84%). Despite being enrolled in a clinical trial, participants have limited knowledge about such trials. This lack of knowledge might impact the quality of informed consent provided. If true collaboration is to be achieved in developing world settings, the community in general, and trial participants in particular, should be educated about the basic principles of research.
CHU SH, KIM EJ, JEONG SH,et al.Factors associated with willingness to participate in clinical trials: a nationwide survey study[J]. ,2015,15:10.
This study was conducted to investigate awareness of clinical trials (CTs) including perceptions of favorable feelings about, necessity for, and safety of CTs, the ultimate beneficiary of CTs and the factors associated with willingness to participate in CTs among the general population in South Korea. A cross sectional survey study was conducted in a randomly selected national sample of 1,515 Korean. Perception toward CTs was measured using a scale from 0 (strongly disagree) to 10 (strongly agree). Respondents readily understood the necessity for CTs (M65=657.27, SD65=652.15); had moderately favorable feelings (M65=655.32, SD65=652.31) toward CTs and felt that these CTs were moderately safe (M65=654.71, SD65=651.90). Twenty-five percent of the respondents answered that they would be willing to participate in a CT in the future. Perception of the ultimate benefits of CTs, awareness, favorable feelings, safety, and necessity regarding CTs were identified as significant predictors of willingness to participate in CTs. An awareness of CTs and the perceptions toward CTs were associated with general public willingness to participate in a CT. Findings from this study can be used in planning outreach and recruitment strategies, and to understand the predictors of CT participation.
DASD, CHEAH PY, AKTERF, et al.Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh[J]. ,2014,13:217.
Background Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects’ understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. Methods In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. Results Of 16 participants, the vast majority (81%) were illiterate. All subjects had a ‘therapeutic misconception’ i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients’ perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants’ satisfaction with treatment and nursing care. Conclusion There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings.
RMERS-VERHOEVEN CW, PERRONEF, OLIVERK.Exploratory research into cancer patients' attitudes to clinical trials[J]. ,2014,8:432.
A qualitative survey was carried out in six countries to gather insights into potential barriers to patient participation in cancer clinical trials (CTs) to help stakeholders develop strategies to improve recruitment and participation. While the research was exploratory in nature, the findings highlight the critical role that doctors play in terms of CTs participation. The research also indicates the need for outreach to raise awareness about CTs both outside and within the clinical research community as well as educating the general public to dispel misconceptions about CTs. The results also indicated that most patients who participated in the research believe all patients should be offered the chance to participate in CTs, wanting all available options presented to them.
CHALELAP, SUAREZL, MUNOZE, et al.Promoting factors and barriers to participation in early phase clinical trials:patients perspectives[J]. ,2014,4(281):1000281.
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[9]
D'ABRAMOF, SCHILDMANN J, VOLLMANN J,et al. Research participants' perceptions and views on consent for biobank research: a review of empirical data and ethical analysis[J]. ,2015,16:60.
Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent.
PORTERIC, PASQUALETTIP, TOGNIE, et al.Public’s attitudes on participation in a biobank for research: an Italian survey[J]. , 2014,15:81.
The creation of biobanks depends upon people’s willingness to donate their samples for research purposes and to agree to sample storage. Moreover, biobanks are a public good that requires active participation by all interested stakeholders at every stage of development. Therefore, knowing public’s attitudes towards participation in a biobank and biobank management is important and deserves investigation.
HOLMBERGC, KARNER JJ, RAPPENECKERJ, et al.Clinical trial participants’ experiences of completing questionnaires: a qualitative study[J]. ,2014 ,4(3):e004363.
ABSTRACT To improve clinical study developments for elderly populations, we aim to understand how they transfer their experiences into validated, standardised self-completed study measurement instruments. We analysed how women (mean 78卤8 years of age) participating in a randomised controlled trial (RCT) cognised study instruments used to evaluate outcomes of the intervention. The interview study was nested in an RCT on chronic neck pain using common measurement instruments situated in an elderly community in Berlin, Germany, which comprised of units for independent and assisted-living options. The sample (n=20 women) was selected from the RCT sample (n=117, 95% women, mean age 76 (SD卤8) years). Interview participants were selected using a purposive sampling list based on the RCT outcomes. We asked participants about their experiences completing the RCT questionnaires. Interviews were analysed thematically, then compared with the questionnaires. Interviewees had difficulties in translating complex experiences into a single value on a scale and understanding the relationship of the questionnaires to study aims. Interviewees considered important for the trial that their actual experiences were understood by trial organisers. This information was not transferrable by means of the questionnaires. To rectify these difficulties, interviewees used strategies such as adding notes, adding response categories or skipping an item. Elderly interview participants understood the importance of completing questionnaires for trial success. This led to strategies of completing the questionnaires that resulted in 'missing' or ambiguous data. To improve data collection in elderly populations, educational materials addressing the differential logics should be developed and tested. Pilot testing validated instruments using cognitive interviews may be particularly important in such populations. Finally, when the target of an intervention is a subjective experience, it seems important to create a method by which participants can convey their personal experiences. These could be nested qualitative studies. ISRCTN77108101807.
Al-AMADS, AWADM, SILVERMANH.Attitudes of dental patients towards participation in research[J]. ,2014,20(2):90-98.
ABSTRACT The attitudes of dental patients towards participation in research and the independent socioeconomic factors associated with these attitudes are not known. A self-administered questionnaire was distributed to 120 patients attending dental clinics in Amman, Jordan. For patients who had previously participated in research (n = 28), motivating factors for most (> 75%) included a desire to help others and to advance science. Most respondents (81.7%) showed interest in participating in questionnaire-based research, but fewer would participate in invasive research, e.g. biopsies (22.0%) and drilling teeth (21.2%). Reasons given for not participating in research included fear of infectious diseases (71.3%) and pain (62.1%). Factors considered important in enhancing research participation included being asked to give informed consent (98.2%), fairness in selection of participants (97.3%) and the prospect of humanitarian benefit (96.5%). Sex and education level were significantly associated with patients' perceptions for several of items. To enhance recruitment, researchers should be aware of people's perspectives regarding participation in research.
CEBALLOS RM,KNERRS,SCOTT MA,et al.Latino beliefs about biomedical research participation: a qualitative study on the U.S.-Mexico Border[J] .,2014,9(4):10-21.
Latinos are under-represented in biomedical research conducted in the United States, impeding disease prevention and treatment efforts for this growing demographic group. We gathered perceptions of biomedical research and gauged willingness to participate through elicitation interviews and focus groups with Latinos living on the U.S.-Mexico border. Themes that emerged included a strong willingness to participate in biomedical studies and suggested that Latinos may be under-represented due to limited formal education and access to health information, not distrust. The conflation of research and clinical care was common and motivated participation. Outreach efforts and educational interventions to inform Latinos of participation opportunities and clarify harms and benefits associated with biomedical research participation will be essential to maintain trust within Latino communities.
TANNERA, KIMSH, FRIEDMAN DB,et al.Promoting clinical research to medically underserved communities : current practice and perceptions about clinical trial recruiting strateaies[J]. ,2015,41:39-44.
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[16]
MAIDAS, DALLA COSTAG, RodegherM,et al.Overcoming recruitment challenges in patients with multiple sclerosis: results from an Italian survey[J]. ,2014,11(6):667-672.
Recruiting patients for randomized clinical trials is still extremely difficult. While there has been much research in oncology patients, no previous studies have consistently addressed specific factors affecting the willingness to enroll in multiple sclerosis trials from the patient's perspective. To this end, we conducted an exploratory study to assess the related factors and to find ways to improve recruitment.This is a single-center, observational study involving 352 consecutive outpatients followed at one site in Italy. Patients completed the Enrollment Problems Questionnaire and Beck Depression Inventory.Over 50% of the patients would consider participating in a randomized trial. Willing patients are frequently older, with no children, have a diagnosis of secondary progressive multiple sclerosis, and have already participated in clinical trials. Patients' choices were positively influenced by expectations of having (a) a greater chance of cure, (b) an unavailable drug, (c) a specialist's care, and (d) the chance to contribute to medical research. Willingness was significantly increased by the use of optimistic language and practical/psychological assistance during the decision-making process.Multiple sclerosis patients' willingness to participate in a randomized trial is mainly related to both altruistic and individual considerations, as well as to a greater chance of specialist/improved care. More effective information flow and an effective, long-standing patient-physician relationship may improve recruitment overall.
ANURUANGS, DAVIDSON PM, JACKSOND,et al.Strategies to enhance recruitment of rural-dwelling older people into community-based trials[J].,2015,23(1):40-43.
Abstract Aim To describe strategies that can enhance the recruitment of rural-dwelling older people into clinical trials. Background Recruitment to studies can be time-consuming and challenging. Moreover, there are challenges associated with recruiting older people, particularly those living in rural areas. Nevertheless, an adequate sample size is crucial to the validity of randomised controlled trials (RCTs). Data sources The authors draw on the literature and their personal experiences, to present a range of flexible and inclusive strategies that have been successfully used to recruit older people into clinical trials. Review methods This paper describes attempts to improve recruitment of rural-dwelling, older Thai people to a clinical trial. Discussion To attract potential participants, researchers should consider minimising the burden of their study and maximising its benefits or convenience for participants. Three factors that may influence participation rates are: personal factors of participants, researchers' personal attributes, and protocol factors. In addition, three important strategies contribute to improving recruitment: understanding the culture of the research setting, identifying the 'gatekeepers' in the setting and building trust with stakeholders. Conclusion Even though the study covered did not recruit a large number of participants, these understandings were crucial and enabled recruitment of a sufficient number of participants in a reasonable timeframe. Implications for practice/research These strategies may be of use in rural settings and with different communities including urban communities.
CHU SH, JEONG SH, KIM EJ, et al .The views of patients and healthy volunteers on participation in clinical trials: an exploratory survey study[J]. ,2012,33(4):611-619.
Background and aims: This study was conducted to investigate the views of patients and healthy volunteers on participation in clinical trials.<br/>Methods: A total of 291 clinical trial participants, including 140 patients and 151 healthy volunteers, were recruited from four university hospital-affiliated clinical trial centers among 15 Korean regional clinical trial centers in South Korea where the levels of information and care were sufficient to meet the global standard. Participants were recruited from phase I trials or bioequivalence tests, a short term hospitalization under close monitoring in the clinical trial centers, or from phase II, III or IV trials occurring in both wards and outpatient clinics. A structured questionnaire survey was performed to identify their perspectives on clinical trials.<br/>Results: Participants who were patients were significantly influenced by medical personnels regarding the decision making processes for participation in clinical trials when compared to healthy volunteers. However, no difference was found between the two groups in the level of willingness to participate in and satisfaction with clinical trials. More than 50% of patient subjects misunderstood and thought that their physicians could persuade them to participate in clinical trials or that all the participants would receive a new drug or treatment during trials.<br/>Conclusions: Clinical researchers who are involved ill clinical trials should make an extra effort to confirm the level of understanding of their patients regarding the clinical trial and to guarantee that each patient has sufficient time to make an informed decision before participating in a clinical trial. (C) 2012 Elsevier Inc. All rights reserved.
Public awareness and perception of clinical trials: quantitative study in Pune
0
2013
PARTAKE survey of public knowledge and perceptions of clinical research in India
0
2013
Knowledge and perceptions of research participants in Nigeria about clinical trials
0
2015
Factors associated with willingness to participate in clinical trials: a nationwide survey study
0
2015
Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh
0
2014
Exploratory research into cancer patients' attitudes to clinical trials
0
2014
Promoting factors and barriers to participation in early phase clinical trials:patients perspectives
0
2014
SCHILDMANN J, VOLLMANN J,et al. Research participants' perceptions and views on consent for biobank research: a review of empirical data and ethical analysis
0
2015
Public’s attitudes on participation in a biobank for research: an Italian survey
0
2014
Clinical trial participants’ experiences of completing questionnaires: a qualitative study
0
2014
Attitudes of dental patients towards participation in research
0
2014
Latino beliefs about biomedical research participation: a qualitative study on the U.S.-Mexico Border