Choosing the right data to answer research questions is important, especially when it comes to developing an external control arm. External comparators or controls (also known as historical controls) have the potential to improve the evaluation of novel experimental agents in clinical trials.
Read MoreIn 2016, the 21st Century Cures Act (Cures Act) directed the Food and Drug Administration (FDA) to accept statistical methods that include Real-World Data (RWD) and Real-World Evidence (RWE). The next year, the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issued guidance regarding the submission of RWD and RWE to the FDA.
Read MoreDesignated, "Long COVID", there is significant concern over the potential long-term effects among COVID-19 survivors. The most prominent end-organ systems at risk for long-term effects are pulmonary, cardiovascular, and central nervous system (CNS). The CNS effects can result either from primary involvement by COVID, like hyposmia, or risk from secondary morbidity, such as hypercoagulability causing a stroke.
Read MoreCookie | Duration | Description |
---|---|---|
cookielawinfo-checbox-analytics | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics". |
cookielawinfo-checbox-functional | 11 months | The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". |
cookielawinfo-checbox-others | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other. |
cookielawinfo-checkbox-necessary | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary". |
cookielawinfo-checkbox-performance | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance". |
viewed_cookie_policy | 11 months | The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data. |