Overall, our patients showed a moderate-to-low willingness to participate in clinical trials. Clinical trials involving new drugs received the lowest willingness rating to participate. This could be related with their concerns towards the safety and efficacy of new drugs, which could be seen from their responses on their perceived benefit and risks of clinical trials in this study. Studies showed that perception towards unproven treatment and fear of its side effects were among the main reasons why individuals declines to participate in clinical trial [7, 8]. However, we found that cancer patients were more willing to participate in trials involving new drugs compare to non-cancer patients, possibly due to their greater need for alternative treatments.
Consistent with previous studies, our respondents' concerns revolved around the safety and inefficacy of the treatment [9–11]. We found that higher perceived benefits and lower perceived risks were associated with high willingness to participate in clinical trial trials. Effective communication about the potential benefits and risks of clinical trial participation and addressing patients' concerns is therefore crucial [12]. Researchers or healthcare providers need to provide the patients with clear information and education about the clinical trials, as well as offer support and reassurance throughout the study process.
Only about 40% of our respondents had heard of clinical trial before the survey. In addition, the majority had poor knowledge about clinical trials, but those with better knowledge about clinical trials were more willing to participate, which is consistent with previous studies [8, 13]. We also found significant disparities in clinical trial knowledge among patients from different socio-economic backgrounds in post hoc analysis (Supplementary materials, Table S3). There is a need for more targeted efforts, including public campaigns, community education programs, and other outreach initiatives, which are tailored to different communities to improve the public awareness and knowledge about clinical trials [14, 15]. Besides, that social media can be leveraged as an effective tool for disseminating clinical trial information and boosting recruitment [16, 17]. Nonetheless, caution is warranted as the use of social medial may pose challenges for the privacy, confidentiality, and integrity of clinical trials [18].
We also need to address the lack of confidence in the clinical trial processes and investigator’s roles among our patients. Building trust with the clinical team and ensuring ethical trial conduct is critical. Research indicates that patients’ distrust towards medical researchers hinders their participation in clinical trials [19, 20]. Misinformation from the internet and social media may also undermine confidence and attitudes towards trials [21, 22]. It is essential, therefore, to improve transparency in research and enhance communication regarding trial process and results with the public. Moreover, we suggest to enhance the visibility of Malaysia's clinical trial regulatory framework to reinforce public confidence in trial integrity. The entails highlighting the Medical Research and Ethics Committee’s oversights on research involving the MOH facilities, patients, and investigators, as well as other independent review boards across universities and non-MOH hospitals, alongside the National Pharmaceutical Regulatory Authority’s roles in ensuring trials’ compliance with regulations, ethical standards, and guidelines in this country [23].
In terms of demographic factors, our study revealed a significant disparity in the willingness to participate in clinical trials between female and male patients. Studies showed that women tend to be more risk-averse, [24, 25] which may be a contributing factor why the female patients are less willing to participate in a perceived high-risk activity such as clinical trials [26]. A further study is warranted to assess barriers to recruitment and inclusion of women in clinical trials in Malaysia.
Besides that, compared to employed patients, unemployed individuals showed a significantly lower willingness to participate in clinical trials. We postulate this could be attributed to their sensitivity to the costs of participating due to poorer income and financial insecurities. However, we did not find personal income to be a significant factors associated with willingness to participate in clinical trials in this study. On the other hand, our study showed that monetary compensation was not a significant driver for clinical trial participation among our patients. Only 30% of our respondents agreed that it is a benefit of participating in a trial. This was in contrast to a study from Indonesia that found increased willingness with higher financial compensation [27]. Nonetheless, we believe this could also be due to the poor understanding of clinical trials and the respondents might not be aware of possible monetary compensation for participating in a clinical trial.
Even though almost all our respondents reported having a religious affiliation, only a small fraction (10–11%) agreed that their religious beliefs, obligations, peers and leaders affected their decision to participate in clinical trials. This showed that religious practice and the religious community support may not play a significant role in affecting clinical trial participation in our community. This is in contrast with a study by Daverio-Zanetti et al., which found that higher religiosity was associated with a perceived lack of community support for clinical trial participation among Hispanic Americans [28]. Nevertheless, as we did not assess the religiosity of our patients in the present study and our findings may be specific to the local context, further research is needed.
Our study had several limitations. Firstly, it was a single-centred study conducted at SGH. However, SGH as the main tertiary referral centre in Sarawak region serves a large patient population. For instance, SGH is the only public oncology centre, providing care for the majority of cancer patients in Sarawak. Therefore, our study has a good representation of the patient population in Sarawak. Nevertheless, a larger national study is warranted to investigate clinical trial participation in the national population. Secondly, there was a possibility of sampling bias as we only approached patients who were able to answer the survey at the clinics. Illiterate, low-educated patients might have been underrepresented. Thirdly, the study was conducted in a hospital setting, which might have influenced the responses of the patients. They might feel pressured to respond quickly while waiting for their clinic appointments. However, we addressed this issue by ensuring anonymity in answering the questionnaire and allowing participants to submit their responses at a later time or on their next visit to the hospital.
In summary, our study highlighted the challenges in engaging Malaysian patients in clinical trials, with the factors such as poor knowledge, low perceived benefits, high perceived risks, and poor confidence in clinical trial conducts contributing to the overall lack of willingness to participate. Our findings suggest the need for targeted efforts to raise awareness and understanding, provide clear and balanced information on benefits and risks, and enhance the public’s confidence in the clinical trial process and investigator’ roles. The insights from the present study would be useful to understand the drivers and barriers to clinical trial participation, as well as for formulating strategies to promote such participations and patient inclusion in clinical trials in Malaysia.