Clinical trials are the principal means for evaluating new treatments in medicine. Although clinical trials aim to provide a high standard of care and help contribute to increased scientific knowledge, only a relatively small proportion of patients receive treatment as part of a formal clinical trial. Our evaluation of patient attitudes about clinical trials showed that 68% were interested in participating; however, 82% were not aware of readily available information about clinical trials specific to their illness and instead expected their treating physician to inform them. Importantly, 91% indicated that they would prefer to be contacted with the results of the study in which they had participated; if not informed, they were unlikely to participate in future clinical trials. Most patients indicated that they trusted that all possible measures about both their safety and their privacy would be taken in a clinical trial sponsored by Mayo Clinic. Although patients overall showed interest in participating in clinical trials and expressed trust in the medical system regarding how clinical trials are conducted, most of them possessed limited knowledge about the online clinical trials registries.
To our knowledge, this is the first report of a survey of outpatients at a general internal medicine practice in the United States on patient attitudes toward clinical trials. Our findings are similar to those of a Danish study reporting a positive attitude toward medical research participation8
but different from those of a German study reporting a relative unwillingness to participate.9
The latter finding may be related to the inclusion of surgical and dental trials in the questionnaire in that study, for which participant interest might have been low, or it may be related to regional variations in the attitudes of patients.
Most studies assessing barriers toward enrollment in clinical trials have focused on patients seen by physicians in particular subspecialties7
(eg, oncology and cardiology) or have focused on inpatients. In contrast, the current study involved outpatients, and the results, if confirmed by additional studies, might have greater implications for future clinical trials. As the research community learns more about patients' attitudes and preferences toward clinical trials, the information can be used to formulate measures that improve patient recruitment.
Although studies about attitudes toward clinical trials that have been conducted in subspecialty settings with specific patient groups (eg, patients with cancer) provide information about that specific group, they do not inform us about the attitudes of the average patient seen in general medical practice or about the attitudes of the general population. However, the general population comprises the potential pool of participants for future treatment and prevention studies. Two prior studies15,16
focused on the attitudes of adults in the general population who had not been diagnosed as having cancer. Both studies found a strong belief in the benefit of clinical trials for the advancement of medical knowledge, support for the conduct of clinical trials, a substantial willingness to participate in a study, and a belief that study participants would receive the best possible care. In one of those studies, slightly more than half of the respondents said that they would participate in a clinical trial if they were diagnosed as having cancer.16
As part of the 2000 Cancer Clinical Trial Study, telephone interviews were conducted with a national probability sample of 1000 US adults.17
The results showed that about 32% of the respondents indicated that they would be very willing to participate in a cancer clinical trial if they were diagnosed as having cancer. Although these studies were targeted at the general population, many of the survey questions concerned cancer clinical trials. Hence, it is difficult to draw direct comparisons or to identify similar results among these previous studies and the current study.
About 45% of the participants in the 2000 Cancer Clinical Trial Study indicated that patients in clinical trials are “treated like guinea pigs.” Patients have also expressed ethical concerns about randomized trials in general and about the additional requirements of informed consent for recruitment in clinical trials.18
In contrast, most of our study participants expressed agreement with the statement that all possible measures for their safety and privacy would be taken in a clinical trial sponsored by Mayo Clinic. To move clinical research forward, the research community must take the necessary steps to gain the confidence and trust of potential research participants.
People in rural settings and those who are members of ethnic minorities might be less receptive to participating in research than other populations.19-21
Possible reasons for such reservations include cultural beliefs, lack of knowledge, and personal attitude. Barriers to health care may also prove to be barriers to research participation.19-21
Currently, participants in clinical trials are not routinely given information about the aggregate results of those trials unless it might affect their future care.22
Prior research has shown that many study participants are interested in knowing the results,23
and some have even stated that there is an ethical imperative to offer results to participants.24
However, several unanswered questions remain about the potential benefits, harm, and cost of providing such information, as well as the best approach to provide such information. Participants in the current study indicated that they wanted to be informed about the results of the study. Furthermore, most of them said that, if they were not provided with the results of a clinical trial in which they had participated, they would not participate in future clinical trials. This finding provides important information for clinical researchers as we continue to study this area in greater depth. In a recent study in which participants in a clinical trial were offered study results, most chose to receive the results, and most reported this as a positive experience.25
Our study participants expressed similar desires.
The primary limitation of the current study is that it was conducted at a single midwestern tertiary care academic medical center in a general practice setting with a relatively homogeneous population of primarily white patients. All this limits the generalizability of our findings. However, 82% of the participants lived within 120 miles of Rochester, MN, which suggests that these patients are from the local community and hence are likely to be representative of the general population. Nevertheless, it would be helpful to conduct a similar study at other institutions to obtain results that have greater generalizability. Another limitation is that the current study was conducted with participants who had chosen Mayo Clinic's site in Rochester for their health care. These participants may be more likely to have a positive attitude about the integrity of clinical research at this institution. This study represents early-phase work but has enabled us to develop an effective survey tool that could be further validated and applied to a range of diverse settings. The results of these subsequent studies will provide more definitive conclusions. The strength of the current study lies in its design, which targeted outpatients receiving routine care in a general medical practice rather than being directed toward a patient group that had recently received a life-changing diagnosis such as cancer or that had recently been hospitalized for a major medical event.
With advances in the understanding of disease and the availability of new compounds with potential therapeutic and preventive applications, an increasing number of clinical research opportunities—preventive, curative, and palliative—will require increasing numbers of participants in clinical trials. Research directed at understanding the attitudes of patients about clinical trials is essential to future efforts in clinical research design and planning.