Assuntos
Adenocarcinoma/metabolismo , Adenosina Trifosfatases/metabolismo , Neoplasias Colorretais Hereditárias sem Polipose/metabolismo , Neoplasias Colorretais/metabolismo , Enzimas Reparadoras do DNA/metabolismo , Proteínas de Ligação a DNA/metabolismo , Adenocarcinoma/diagnóstico , Adenocarcinoma/genética , Adenosina Trifosfatases/genética , Artefatos , Biomarcadores Tumorais/metabolismo , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/genética , Neoplasias Colorretais Hereditárias sem Polipose/diagnóstico , Neoplasias Colorretais Hereditárias sem Polipose/genética , Reparo de Erro de Pareamento de DNA/genética , Enzimas Reparadoras do DNA/deficiência , Enzimas Reparadoras do DNA/genética , Enzimas Reparadoras do DNA/fisiologia , Proteínas de Ligação a DNA/genética , Humanos , Técnicas Imunoenzimáticas , Programas de Rastreamento/métodos , Endonuclease PMS2 de Reparo de Erro de Pareamento , Valor Preditivo dos TestesRESUMO
OBJECTIVE: To evaluate the difference in time taken for ethics and site governance approval for multicentre clinical trials using two different systems of ethics review. DESIGN: We evaluated the times to final ethics and governance approval for two international, multicentre clinical trials of treatment for metastatic colorectal cancer: the MAX trial, using a non-centralised ethics review system, and the CO.20 trial, using the new New South Wales centralised ethics review system. MAIN OUTCOME MEASURE: Time from trial submission to overall study approval. RESULTS: The median time taken to obtain ethics approval for the MAX trial at 16 NSW sites was 100 days (range, 36-161 days). The median time to obtain central ethics approval for the CO.20 trial at 14 NSW sites was 77 days, with an additional 60 days (range 20-79 days) required to obtain site-specific research governance approval. CONCLUSIONS: Any difference in time to approval between the review systems was outweighed by the overall time taken. However, the time spent by both the coordinating centre and local sites in collation, submission and correspondence was greatly reduced, and the centralised process allowed for standardised documentation at all study sites.
