Law & Health Weekly
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Bone Marrow Transplantation
Research from S. Corbacioglu and co-researchers in the area of bone marrow transplantation described
August 2nd, 2008
"In contrast to adults, 50% or more of medicines used in children have never been actually studied in the paediatric population in the European Union community (EU). Under the impression that compliance with good clinical practice (GCP) requirements will lead to an improved quality of clinical trials, the ratification of the EU Directive 2001/20/EG now imposes the same GCP regulations demanded for commercial clinical trials on non-commercial trials or so-called investigator-initiated trials (IITs)," scientists writing in the journal Bone Marrow Transplantation report. "Although it is desirable that all clinical trials comply with ICH-GCP, ensuring that an IIT...
Source: Law & Health Weekly (2008-08-02)
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