The current study provides the first nationwide population-based data of Koreans’ awareness of CTs and willingness to participate in CTs. Awareness is the first step to the successful implementation of CTs. The main finding of this study was that willingness to participate in CTs in the future was affected by respondent awareness and perception of CTs, such as favorable feeling, safety and necessity of CTs.
The willingness to participate in CTs was significantly higher among respondents with awareness of CTs than it was in those who did not know about CTs. This result is consistent with previous reports [6,11]. Comis et al. [6] reported that respondents who had a high level of understanding of CTs were more likely to have a positive attitude toward participation than those with lower levels of understanding. These results show that the understanding of CTs is a cornerstone to the successful recruitment and retention of trial participants. Most of the respondents in the present study (86%) had a general idea about CTs from the mass media, such as TV or radio. Therefore, mass media campaigns could be a good strategy to increase the awareness of CTs, which was also suggested by previous researchers [11].
A strong association between positive perception (especially for safety and favorable feeling) and willingness to participate in CTs was found in this study. Participants who perceived CTs to be highly safe were approximately 11 times more likely to be willing to participate in CTs compared to those who were less sure of the safety. These results suggest that a fear of adverse effects from the drug or treatment is one of the most prominent barriers to participation in CTs. The issue of safety in CTs was also addressed in previous studies. Concern about drug side effects was the most important cause of unwillingness to participate in CTs [12], and recruitment remained a challenge for participants worried about being assigned to a less effective treatment [13]. Studies have also shown that a previous bad experience or mistrust in the process of obtaining informed consent or establishing a trusting relationship with their doctors is also a barrier to participation in CTs [12,14]. A reduction in trust as a result of knowledge of the Tuskegee Study, an example of a deliberately misleading CT that harmed some participants, has decreased the willingness of African Americans to participate in a medical research study [15]. Therefore, effective communication between participants and researchers is crucial to establish trust and facilitate CT participation. Researchers must make more efforts and dedicate time to offer balanced information between benefits and risks, and to explain the expected adverse reactions or disadvantages to participants, as well as to address the responses that would be taken in such situations. Most of all, adherence to research ethics, which provide investigator guidance for human rights protection in order to maximize research benefits, reduce risks and assure distributive justice to CT participants during trials, is the most important factor in the success of a CT [9]. Therefore, nurses need to be well-informed of related ethics and guidelines, as existential advocates for clients.
Although 75% of adult respondents were aware of clinical trials and perceived the high necessity of CTs, only 25% of participants reported willingness to participate in CTs in the future. These results are very similar to those of a study in Germany that reported that while 89.5% of survey participants judged CTs to be important, only 25% expressed willingness to participate [16]. In their study, the willingness to participate was significantly higher in people who thought CTs were important, had knowledge about CTs and had previously participated in CTs. In our survey, 25% of the respondents were willing to participate, which was somewhat lower than the results of other previous results, and may be an indication of differences in race, ethnicity or culture in the study participants [6,8,9]. A survey of 1,022 adults in England reported that the majority of respondents were willing to participate in CTs for major illnesses (63%) and cancer (65%) [17]. However, the lower rate of willingness to participate in our study increased about two-fold (48.6%) when participants were given a scenario in which their family member had a disease and needed a new treatment or drug. This finding may reflect that participation does not only depend on the perception or attitude of respondents, but also on other factors. Actual CT participation may be different from reported actions, especially when people are confronted with a family member’s diagnosis of illness. Various factors that were not measured in this study can affect actual participation rates, such as participant health status, comorbidities, availability of treatment options, economic benefit, participant burden, and inconvenience.
The likelihood of the general population to participate in CTs was not different by age, educational level or socioeconomic status in this study. However, residents of metropolitan cities, those who were male, and people in their 40s and 50s were more likely to participate in CTs. These results are interesting because a previous study indicated that a busy lifestyle, lack of time due to work and the existence of family were some barriers to participation in CTs [12]. In our study, younger adults were significantly more likely to have negative views on the necessity of CTs than were middle-aged adults, and younger people also had a negative tendency to participate in CTs. These results were different from those of a previous study [6], which reported that younger adults are more likely to have a positive perspective on participation in CTs than are older adults. However, our findings agreed with those of another study [18]. A literature review found altruism to be a major factor of CT participation among the general population [5]; weak altruism, which is an unwillingness to accept more than minimal personal risk for the sake of communal benefit, may hinder participation [19]. The younger generation in Asia grew up in an era of a conspicuous trend toward nuclear families, a rapidly developing economy and likelihood for adapting Western culture and values; these factors might have different effects on public altruism compared to those of the older generation. However, in concordance with earlier studies, associations between altruism and participation intention were also identified in the present study. Respondents who believed that the ultimate beneficiaries of CTs were the patients or advances in medical science rather than pharmaceutical companies were more likely to participate in CTs.
Previous experience with CT participation was associated with the willingness to participate in CTs in the univariate analysis, but this prior experience did not affect the likelihood of participating in CTs in this study. About 2% of our respondents had previously taken part in CTs. A very small fraction of previous CT participants among the respondents may mask a true difference in willingness in this study. Ohmann and Deimling [16] reported that previous participation in a CT was significantly associated with positive trial participation intention. Therefore, the strategy to share previous participant experience regarding the processes involved, the process of informed consent and individual or social benefits as outcomes of CTs with the general public through the mass media could have an impact on CT awareness and attitude toward CTs.
Recently, Korea Food and Drug Administration (KFDA) had announced the roadmap to foster the growth of CTs toward a leading country in participating in biopharmaceutical CTs including a strategy to enhance communication to the general public on CTs. As a part of this, the Korea National Enterprise for CTs (KoNECT) distributed a 4 minute movie enhancing awareness of and necessity for CTs to any institution with the educational purpose for patients or the general public. We expect that the mass media campaign to improve public awareness and trust on CTs would be carried out in the near future in Korea. However, a mass media campaign itself might not guarantee the increment of patient willingness to participate in and accrual to CTs [20]. The higher enrollment rates could be achieved through positively changing patients and their family’s attitude toward participation in CTs using more targeted educational approaches [21].
Strengths of this study included the use of a sufficiently large probability sample to represent a nationwide population and to compare the differences among geographical regional area within 5% of the sampling error. However, this study had several limitations. First, willingness to participate in CTs does not reflect actual enrollment: only a behavioral intention. Respondents may be more likely to answer positively about willingness to participate due to a tendency to exhibit pleasing behavior. Future studies should examine the extent to which behavioral intention predicts actual enrollment in CTs and also the circumstances under which participation does not occur. Second, the willingness to participate in CTs depends on factors other than the attitude of the patient. Therefore, various factors which were not measured in this study can affect the actual participation rates in CTs. Nonetheless, findings from this study can be useful in understanding the willingness of Asians to participate in CTs.
