'Expanded access' refers to a type of nontrial preapproval access, specifically when the investigational product is being used for treatment, not research. The TPOXX program is different from the typical expanded-access scenario. MedTwitter
Clinical trials are research, intended primarily to obtain generalizable data that serve the social good of understanding medical conditions and how to treat or prevent them. This does not mean that patients cannot benefit from clinical trials nor does it mean that patients do not participate in clinical trials in hopes of personal medical benefit .
In most instances of expanded access, a physician treating a patient determines that there are no FDA-approved treatments available for use either because none exist or because they were already tried. The physician then decides that a particular investigational product is more likely to be beneficial to the patient than harmful and decides to try to obtain access to that product.
The TPOXX for treatment of monkeypox expanded-access program departs a bit from this typical scenario. First, TPOXX is FDA-approved for treating smallpox; as such, it is considered"investigational" because it is being used for an indication for which it was not approved rather than because it is unapproved.
Also different is the fact that the CDC decided to take upon itself the requirement, often left to individual physicians, to obtain IRB review and approval of expanded access. This means that instead of numerous IRBs across the country all reviewing requests to use TPOXX via expanded access in individual patients, a central IRB run by the CDC is handling this.
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