Study monitoring

Long-lasting accrual periods have clearly hampered the quality of data and the enthusiasm of investigators has been shown to colour the results they report. Therefore it is important that protocols do optimally define issues such as:

♦ Measurability of the disease (e.g. minimum size of lesions still considered measurable).

♦ Criteria to use for toxicology reporting (e.g. the WHO or NCI Common Toxicity Criteria (CTC) grading systems) and monitoring of data which relate to both the anti-tumour response and side-effects.

To improve quality of data from clinical trials the implementation of systemic treatment checklists has proven to be of value.

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