Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research. In conditions of scarcity, prioritization approaches should minimize harm, maximize benefit, and promote fairness. To promote continued data collection, patients seeking access to unproven COVID-19 drugs should receive lower priority for allocation when they decline to participate in clinical trials, either of the requested drug or other investigational products, offering a comparable balance of risks and benefits; special attention should be paid to concerns of voluntariness and distrust. In addition, institutional treatment protocols that can contribute more robust real world data should be preferred to single patient requests for access, with priority for inclusion based on traditional clinical allocation criteria relying on available evidence. Fairness demands distribution of these protocols across a diverse range of sites, particularly those serving marginalized populations, among other protections.

通过预批准访问途径或紧急使用授权来分配对未经批准的COVID-19药物的访问权，在临床护理和研究的交汇处提出了独特的挑战。在稀缺的情况下，优先排序方法应将危害最小化，收益最大化并促进公平。为了促进持续的数据收集，寻求获得未证实的COVID-19药物的患者在拒绝参加所要求药物或其他研究产品的临床试验时，应享有较低的分配优先权，从而在风险和收益之间取得可比的平衡；应特别注意自愿和不信任的问题。此外，对于单个患者的访问请求，应首选能够提供更可靠的现实世界数据的机构治疗方案，根据传统的临床分配标准并根据现有证据优先纳入。公平要求将这些协议分布在各种各样的站点上，尤其是那些为边缘化人群服务的站点，以及其他保护措施。