An adaptive platform trial for evaluating treatments in patients with life‐threatening hemorrhage from traumatic injuries: Ethical and US regulatory considerations

An adaptive platform trial for evaluating treatments in patients with life‐threatening hemorrhage from traumatic injuries: Rationale and proposal

“…Further, conducting such a trial is an opportunity to generate data on the treatment of populations who are typically excluded from such trials, for example, pediatric patients and pregnant women. 32 Determining the scale of the trial (e.g., the number of participating sites, number of domains to be considered, and the number of factors in each domain) involves practical and statistical considerations. Not all trial sites may participate in all domains, depending on local site capability to offer specific treatments.…”

“…A number of these complex issues are addressed in companion manuscripts. 31,32 We acknowledge that investigating the effectiveness of therapies-both current and novel-for the treatment of patients with life-threatening hemorrhagic shock is a daunting task. Variability in patient injury, hemodynamic status, location of care and available resources, and the complexity of administering multifaceted and multidisciplinary care in a time-sensitive setting all create additional challenges and barriers.…”

“…Table 2 summarizes how the features of the proposed adaptive platform design address the previously identified challenges associated with conducting an RCT in post‐traumatic hemorrhage. An accompanying manuscript will delve into the operational details of an adaptive platform trial for post‐traumatic hemorrhage, 31 and another will address key ethical and regulatory challenges of conducting such a trial in resource‐limited settings (including military environments) as well as considerations surrounding the inclusion of children and pregnant women 32 …”

“…This can be accommodated without any pause in the trial or change to the underlying trial and statistical methodology hemorrhage, 31 and another will address key ethical and regulatory challenges of conducting such a trial in resource-limited settings (including military environments) as well as considerations surrounding the inclusion of children and pregnant women. 32 2 | THE PROPOSED TRIAL DESIGN…”

An adaptive platform trial for evaluating treatments in patients with life‐threatening hemorrhage from traumatic injuries: Planning and execution

“…However, the military has approached interventional clinical research with a great deal of caution, particularly among active‐duty forces and those with combat injuries. Concerns for the semblance of “experimentation on military members” has established a barrier to research in military medicine, particularly regarding EFIC, which is discussed in more detail in a companion article 18 …”