Multicentre study approvals are delayed when submitted to multiple HREC. The three HREC raised similar issues without substantive differences in their recommendations. A process for the mutual acceptance of HREC recommendations could facilitate multicentre research.
A transient deterioration in neurological status following commencement of chemotherapy for high-grade gliomas has not been previously described. We report eight cases of transient deterioration following administration of temozolomide, a relatively new cytotoxic agent used in the treatment of high-grade gliomas. We believe this represents the novel clinical entity of temozolomide-induced tumour flare.
Our (MA) model resulted in clear improvements in HREC processes and timelines. Stakeholder acceptance was high. This model provides a framework for a broader program of MA.
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