Clarifying the choices available to patients and their physicians when standard treatments for an illness fail. #expandedaccess #clinicaltrials


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Patients diagnosed with critical or life-threatening illnesses face an often-dizzying array of medical choices for treatment. In an article recently published in the scholarly journal Pharmaceutical Medicine, Clinical Research Pathways Executive Director Marjorie Speers brings some clarity to the situation by explaining and discussing the three primary options: FDA's Expanded Access program through which patients can gain access to experimental drugs; entering a clinical trial as part of ongoing research; or pursuing an FDA-approved course of treatment for the particular illness. Among the key points made by Speers-a former CDC official and founding president and CEO of the Association for Accreditation of Human Research Protection Programs-is that patients need to carefully weigh with their physicians the advantages/disadvantages and timing issues when standard treatments fail. Clinical trials, for example, are part of extensive research efforts where eventual approval of new drugs might take years, Speers explains that this is why some patients might opt for FDA's expanded access process, which can shorten time frames considerably. Speers is available to discuss these issues with journalists. To read her article, visit https://bit.ly/2OlAOml.

 

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