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Wednesday, 09/09/2020 7:34:00 AM

Wednesday, September 09, 2020 7:34:00 AM

Post# of 44690
Expanded access, sometimes called "compassionate use," is the use of an investigational medicine (i.e., one that has not been approved by Food and Drug Administration (FDA)) by a patient who cannot be enrolled in a clinical trial.

https://www.boehringer-ingelheim.us/innovation/clinical-trials/expanded-access-program

The fireman’s event was outside clinical trial (act of compassion) and not part of the clinical trial data deemed so important by Guilles Della Corte, MD and Relief Therapeutics Holding SA.

>>>>>>>>>
Multinational Randomized Clinical Trials (MRCTs) are challenging 
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But, despite the challenge, the need to conduct clinical research internationally is stronger than ever
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 The increasing shift from expert opinion towards evidence-based medicine enhances the importance of MRCTs
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In addition, the demand of Health Authorities (HAs) for high quality data is also increasing, leading to favor MRCTs

https://www.academia.edu/33494364/PITFALLS_in_MULTINATIONAL_CLINICAL_TRIALS_pptx