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To identify, characterize, and compare all FDA and EMA approvals that included real-world data on efficacy from expanded access programs
Cross-sectional study of FDA (1955-2018) and EMA (1995-2018) regulatory approval documentation. We automated searching for terms related to expanded access in 22,506 documents using machine learning techniques. We included all approvals where expanded access terms appeared in the regulatory documentation. Our main outcome was the inclusion of expanded access data as evidence of clinical efficacy. Characterization was based on approval date, disease area, orphan designation and whether the evidence was supportive or pivotal.
This article was published in the following journal.
Name: British journal of clinical pharmacology
Health-related information is increasingly being collected and stored digitally. These data, either structured or unstructured, are becoming the ubiquitous assets that might enable us to comprehensive...
The ROADMAP project aimed to provide an integrated overview of European real-world data on Alzheimer's disease (AD) across the disease spectrum.
Infants exposed to varicella zoster virus (VZV) in utero ≤5 days before or ≤48 hours after delivery and preterm infants are at high risk for varicella complications. An expanded-access program ass...
For decades, the U.S. Food and Drug Administration (FDA) has provided an "expanded access" pathway that allows patients who meet qualifying conditions to gain access outside a clinical trial to an inv...
Rheumatoid Arthritis (RA) is a highly prevalent autoimmune disease associated with joint inflammation and destruction. Treatment for RA, especially with biologic agents (biologics), improves patient f...
We will retrospectively review the case note of patients registered in the EAP of Nivolumab. A standard anonymous data collection form will be used to collect data and to analyze it. Pat...
This is an expanded access program (EAP) for eligible participants designed to provide access to AG-221.
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.
This is an expanded access program (EAP) for eligible participants designed to provide access to ACE-011.
Expanded access requests for AMG 714 may be considered for adult patients with biopsy proven Refractory Celiac Disease Type II who have failed all available treatment options and do not ha...
Reproduction of data in a new location or other destination, leaving the source data unchanged, although the physical form of the result may differ from that of the source.
Various units or machines that operate in combination or in conjunction with a computer but are not physically part of it. Peripheral devices typically display computer data, store data from the computer and return the data to the computer on demand, prepare data for human use, or acquire data from a source and convert it to a form usable by a computer. (Computer Dictionary, 4th ed.)
Protective measures against unauthorized access to or interference with computer operating systems, telecommunications, or data structures, especially the modification, deletion, destruction, or release of data in computers. It includes methods of forestalling interference by computer viruses or so-called computer hackers aiming to compromise stored data.
A historical and cultural entity dispersed across the wide geographical area of Europe, as opposed to the East, Asia, and Africa. The term was used by scholars through the late medieval period. Thereafter, with the impact of colonialism and the transmission of cultures, Western World was sometimes expanded to include the Americas. (Dr. James H. Cassedy, NLM History of Medicine Division)
A highly customized interactive medium or program that allows individuals to learn and practice real world activities in an accurate, realistic, safe and secure environment.
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...