Expert advisers and independent assessors

Most trials require expert advice from an early stage in their development. The advice needed depends on the trial, but it can include, for example, advice on details of chemotherapy dosage and administration, radiotherapy dosage and fractionation, surgical procedures, ways of avoiding and treating adverse effects of treatment, histo-pathological definitions, quality of life assessment, health economics, patient advocacy, microbiology, and pharmacy. Additional advisers may also be needed on such matters as novel radiotherapy or surgical techniques and on new treatment modalities. They should be involved in the trial from the early planning stages. The clinical advisers can provide much of the expertise needed, but many trials require advice from other specialists as well.

Few cancer trials can be conducted on a double-blind basis (see Section 4.8). This may be because the treatments being compared differ too much from each other (radiotherapy versus surgery, for example) or because a blind comparison would be unethical: for example, subjecting patients to dummy invasive procedures. Under these circumstances, it may be important to ensure that some assessments of subjective outcome measures, such as tumour response and disease-free survival, are made blind, that is, by expert advisers unaware of the patient's treatment group. Blind assessment is not necessary if the assessments can be made objectively without being affected by knowledge of the treatment group. The protocol should state who will make any blind assessments.

Consideration should be given to making blind assessments on a random sample of patients if to do so on all would be administratively problematic.

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