Postlude 258 assessed on a case-by-case basis, instead of being judged solely based on guilt-by-association. It is unnecessary to dismiss private interests if they are in alignment with societal, ethical, and academical principles. Maintaining a steady grip on the slippery slopes of expanded access One prominent concern that has not yet been addressed is inherent to expanded access programs, and our research on the value of data generation through these programs may have amplified this issue: expanded access programs may hinder clinical development, as patients could bypass clinical trials or opt to withdraw from them.17 Patients may not be willing to participate in randomized trials due to the fear of being randomized to a control group, which in the context of expanded access typically consists of standard of care and/or placebo. Despite the fact that some patients actually benefit from being randomized to placebo rather than an investigational agent,31 patients most probably partake in these trials as a means to access investigational medicine. Well-connected and privileged patients are potentially more likely to know about the option to circumvent clinical trials and attempt to obtain experimental medicine via expanded access.7,32 This unease is grounded in reality, with evidence of patients dropping out of trials and seeking participation in expanded access programs.17 This loophole could lead to delays in recruitment and completion of trials. The ones who lose out are the non-privileged, as they are compelled to endure an extended waiting period until the clinical trial concludes and the drug attains approval, thereby delaying their access to the new treatment. Such a system raises ethical concerns, particularly with regard to distributive justice, as it may compromise the fair and equitable distribution of resources. Regulators may worry that not only patients but also companies would use expanded access as a bypass to clinical trials, particularly since we have demonstrated their ability to generate data. This fear remains largely hypothetical, as we were unable to identify examples of industry-led bypassing of trials through expanded access programs in the literature. Compared with traditional trials, expanded access programs may be rife with bias and are unable to match the sheer quantity and quality of data generated through trials. As long as regulators require the conduct of regulatory trials and companies primarily aim at obtaining such approval, the likelihood of companies using expanded access data as a backdoor as a means to obtain regulatory approvals is virtually zero.33,34 Though the foundational principle of expanded access is that patients should not be eligible for trials initially, we are not arguing against a strawman. The US convalescent plasma expanded access program for SARS-CoV-2 exemplified that this fear is not unfounded.35,36 With over 105,717
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