biostudies-literatureUnknown10Joly MMWhen seriously ill patients have exhausted all treatment options available as part of usual care, the use of investigational agents may be warranted. Food and Drug Administration's (FDA) Expanded Access (EA) pathway provides a mechanism for these patient's physicians to pursue use of an investigational agent outside of a clinical trial when trial enrollment is not a feasible option. Though FDA has recently implemented processes to significantly streamline the regulatory portion of the process, the overall pathway has several time-consuming components including communication with the pharmaceutical company and the associated institutional requirements for EA use (contracting, Institutional Review Board [IRB], pharmacy, billing). Here, we present our experience building infrastructure at theFrontiers in medicine1287449https://www.ebi.ac.uk/biostudies/studies/S-EPMC10590908biostudies-literatureTaking AIM at serious illness: implementing an access to investigational medicines expanded access program.PMC10590908Jerome RNPulley JMMainor ABernard GREdwards TLJoly MMfalseTaking AIM at serious illness: implementing an access to investigational medicines expanded access program.When seriously ill patients have exhausted all treatment options available as part of usual care, the use of investigational agents may be warranted. Food and Drug Administration's (FDA) Expanded Access (EA) pathway provides a mechanism for these patient's physicians to pursue use of an investigational agent outside of a clinical trial when trial enrollment is not a feasible option. Though FDA has recently implemented processes to significantly streamline the regulatory portion of the process, the overall pathway has several time-consuming components including communication with the pharmaceutical company and the associated institutional requirements for EA use (contracting, Institutional Review Board [IRB], pharmacy, billing). Here, we present our experience building infrastructure at the2023-01-01T00:00:00Z20232025-04-04T22:53:39.379Z2025-04-04T22:53:39.379ZS-EPMC105909083787702110.3389/fmed.2023.1287449