Factors Influencing Participation in Clinical Trials: Emergency Medicine vs. Other Specialties

Abstract

IntroductionThis study investigated factors that influence emergency medicine (EM) patients’ decisions to participate in clinical trials and whether the impact of these factors differs from those of other medical specialties.MethodsA survey was distributed in EM, family medicine (FM), infectious disease (ID), and obstetrics/gynecology (OB/GYN) outpatient waiting areas. Eligibility criteria included those who were 18 years of age or older, active patients on the day of the survey, and able to complete the survey without assistance. We used the Kruskal-Wallis test and ordinal logistic regression analyses to identify differences in participants’ responses.ResultsA total of 2,893 eligible subjects were approached, and we included 1,841 surveys in the final analysis. Statistically significant differences (p≤0.009) were found for eight of the ten motivating factors between EM and one or more of the other specialties. Regardless of a patient’s gender, race, and education, the relationship with their doctor was more motivating to patients seen in other specialties than to EM patients (FM [odds ratio {OR}:1.752, 95% confidence interval {CI}{1.285–2.389}], ID [OR:3.281, 95% CI{2.293–4.695}], and OB/GYN [OR:2.408, 95% CI{1.741–3.330}]). EM’s rankings of “how well the research was explained” and whether “the knowledge learned would benefit others” as their top two motivating factors were similar across other specialties. All nine barriers showed statistically significant differences (p≤0.008) between EM and one or more other specialties. Participants from all specialties indicated “risk of unknown side effects” as their strongest barrier. Regardless of the patients’ race, “time commitment” was considered to be more of a barrier to other specialties when compared to EM (FM [OR:1.613, 95% CI{1.218–2.136}], ID [OR:1.340, 95% CI{1.006–1.784}], or OB/GYN [OR:1.901, 95% CI{1.431–2.526}]). Among the six resources assessed that help patients decide whether to participate in a clinical trial, only one scored statistically significantly different for EM (p<0.001). EM patients ranked “having all material provided in my own language” as the most helpful resource.ConclusionThere are significant differences between EM patients and those of other specialties in the factors that influence their participation in clinical trials. Providing material in the patient’s own language, explaining the study well, and elucidating how their participation might benefit others in the future may help to improve enrollment in EM-based clinical trials.

Study design factors influencing patients’ willingness to participate in clinical research: a randomised vignette-based study

“…For example, sicker patients were more likely to participate in research than healthier patients [3]. Patients expressed altruistic motivations, but also the hope of potential personal benefits from participation in cancer trials for example [4][5][6], but participation was not associated with tumor stage/type, age or gender [7]. Among factors related to the study design and logistics, prior approval from an ethics committee [8] and public release of results [9] were associated with greater participation, but random allocation of interventions [10,11], placebo use [12,13], complex or inadequate study information [14], and personal inconvenience (e.g.…”

“…Most previous studies used an observational design with quantitative or qualitative approaches [3][4][5][6][9][10][11][12][13][14]. Here, we conducted an experimental study among a representative sample of patients discharged from a Swiss university hospital to determine the study factors that influence patients' willingness to participate in clinical research.…”

“Fortunate are those who take the first steps”? The psychosocial impact of novel drug development

“…The majority of patients expend substantial time and energy considering participation [6,7]. Patients describe fears about the risks of participation, anxiety about financial cost of participation and concern about the effect on day-to-day lives [6,8,9].…”

“…During trial participation daily lives such as work, family commitments and education are impacted, particularly with early phase trials. The time commitment is consistently cited as one of the hardest parts of trial participation across all disease groups [3][4][5][6]10]. This effect may be more pronounced in our young patient group with busier lives.…”

“…Within cancer trials, many patients say they feel a moral duty to enroll, and feel guilty for choosing not to participate [20]. Before deciding to decline trial participation, patients may spend a lot of time considering the risks vs benefits [6], and the angst this can cause should not be underestimated. Within the CF trials space we suggest this guilt and anxiety may be accentuated by feeling they are turning down an opportunity unavailable to others with CF.…”