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As often as not, a protocol will almost certainly have to contain Appendices. For example, in many cancer clinical trials toxicity is a major concern so that the criteria for reporting adverse events as recommended by the National Cancer Institute (2003) will often be reproduced.

As informed consent is such a critical process, reviewing committees will almost certainly wish to see the proposed patient information sheets and the consent forms to be used. Figure 3.2 gives part of the patient information provided and Figure 3.3 the corresponding consent form for the COMPLIANCE (2015) trial protocol described by He, Tan, Wong, et al. (2018) concerning compliance with medication in women with breast cancer.

Figure 3.2 Part of the Information Sheet utilised in the multicentre COMPLIANCE (2015) trial in patients with breast cancer.

Source: COMPLIANCE (2015).

Figure 3.3 facilitates the consent approval process in cases when a prospective patient may not speak, in this case, English, is illiterate, or is otherwise compromised.