Under the principle of clinical equipoise, individual providers may have beliefs about the superiority of one treatment over another in a randomized clinical trial but the trial is still ethical so long as there is no consensus in the community of medical experts. Stated by Freedman (as cited by Hey.):
Instead of emphasizing the lack of evidence favoring one arm over another that is required by [individual] equipoise, clinical equipoise places the emphasis in informing the patient on the honest disagreement among expert clinicians. The fact that the investigator has a “treatment preference,” if he or she does, could be disclosed; indeed, if the preference is a decided one, and based on something more than a hunch, it could be ethically mandatory to disclose it. At the same time, it would be emphasized that this preference is not shared by others (2015).
This is a relevant challenge that can impact this trial and its ethical direction, especially in a study in which particpants, are disproportionally randomized towards the investigative arm. Investigators and other stakeholders must address to the patient their reasoning in their approach beyond just wanting to see more patients with the study treatment. Summary of …show more content…
For the investigator the study will provide a better insight in the patterns and behaviors of these subjects beyond the treatment, as it requires documentation of the habits monitored over a year, with set follow-up check points. Discussing the potential improvement to the quality of life of the enrolled subjects and future beneficiaries of the study is solely on the investigators to convey the potential positive effects on their BMI, as well as the potential incidence of serious adverse events associated with their
Instead of emphasizing the lack of evidence favoring one arm over another that is required by [individual] equipoise, clinical equipoise places the emphasis in informing the patient on the honest disagreement among expert clinicians. The fact that the investigator has a “treatment preference,” if he or she does, could be disclosed; indeed, if the preference is a decided one, and based on something more than a hunch, it could be ethically mandatory to disclose it. At the same time, it would be emphasized that this preference is not shared by others (2015).
This is a relevant challenge that can impact this trial and its ethical direction, especially in a study in which particpants, are disproportionally randomized towards the investigative arm. Investigators and other stakeholders must address to the patient their reasoning in their approach beyond just wanting to see more patients with the study treatment. Summary of …show more content…
For the investigator the study will provide a better insight in the patterns and behaviors of these subjects beyond the treatment, as it requires documentation of the habits monitored over a year, with set follow-up check points. Discussing the potential improvement to the quality of life of the enrolled subjects and future beneficiaries of the study is solely on the investigators to convey the potential positive effects on their BMI, as well as the potential incidence of serious adverse events associated with their