Korea has been facing a rapid increase in cancer incidence , and the volume of cancer clinical trials has increased accordingly. Progress in cancer treatment can only come from investigations of novel therapies and treatment strategies performed in the setting of well conducted clinical trials . Because participation in clinical trials has frequently been associated with a higher survival rate , clinical trials have become an important facet of oncology, and the need for clinical studies continues to grow. Our study has shown that willingness to participate in clinical trials is intermediate in Asian patients with GI and hepatobiliary-pancreatic cancer. The mean VAS score of 5.0, the median score of 5, and evenly distributed total score from 0 to 10 showed some differences from results of prior studies performed in Western countries, where the majority of patients with cancer were willing to consider participating in clinical trials [14, 17, 20, 21].
Overall, Korean cancer patients understood the need for two treatment arms to prove drug efficacy (N=361, 53.5%), which is considerably higher than in the Western studies (33% of the public and 37% of cancer survivors) . Nevertheless, our study indicated that more than 70% of patients did not possess accurate knowledge of randomized trials: 31.7% (n=214) of patients thought they could choose the study treatment arm in a randomized trial and 43.7% (n=311) answered that a doctor’s decision is the most influential factor for randomization. Only 5.3% of patients understood the exact meaning of randomization, which is substantially lower than the percentage reported in Western studies (63% of the public and 67% of cancer survivors). Furthermore, less than half of our cancer patients were aware that standard treatment referred to the best current practice for a specific disease while 66% of the Western cancer patients were aware of the meaning of standard treatment in cancer care . Taken together, although a higher rate of cancer patients were aware of randomized trials than in the West, a much smaller percentage of cancer patients had precise knowledge of the randomization process or of assignment of a treatment arm in randomized trials. Based on our results, more detailed explanations on the randomization procedure should be provided to patients at our hospital, since there was a high discordance rate between the awareness and the understanding of a randomized clinical trial.
Interestingly, a higher level of awareness did not always result in increased willingness to participate in clinical trials, in contrast to the findings of previous Western studies [4, 7, 21–24]. This might represent one of the peculiar features of Asian cancer patients that should be confirmed in another cancer patient cohort.
As shown in Tables 4 and 5, the most influential factor for willingness to participate in clinical trials was ‘physician’s recommendation’ (26.8%) and this was similar to Western findings which showed the strongest predictor of expected enrollment of clinical trials was encouragement by the physician . In contrast to a common belief, however, the main decision-making person for clinical trial participation in Korea was the patient (473 of 675, 62.4%).
In this study cohort, a total of 127 participants (18.8%) had a prior history of clinical trial enrollment. This population represented a unique patient population with different behavior from the remaining patients. For instance, there was high concordance between clinical trial awareness and willingness to participate (p<0.001). In addition, the most common motivation for clinical trial participation was exposure to a new drug (30.7% vs. 18.8%; prior experience vs. no experience group, Table 5). In addition, the negative perception of clinical trials was significantly lower in patients (n=28 of 127, 22%) with prior experience when compared with no experience (n=165 of 548, 30.1%).
We note that our study has some limitations. First, an inherent selection bias may exist owing to the fact that the study was conducted in only one tertiary academic hospital. Second, another selection bias was introduced because our data did not include all 1000 patients who were asked to join this survey and only 67.5% of patients completed the questionnaire. In addition, the percentage of clinical trial participants may have influenced and altered the results of this survey. The rate of clinical trial participants for GI and hepatobiliary-pancreatic cancer at Samsung Medical Center ranges from 10 – 20% at all times which is in accordance with the proportion of clinical trial participants in this study (18.8%). Hence, the proportion of participants was not biased or misrepresented in this study.