Box 79 Requirements for good trial report forms

♦ They identify the trial and the patient

♦ They include brief and clear instructions for their completion

♦ They request only data essential for full and unbiased evaluation of the treatments being compared

♦ They can be completed quickly and accurately

♦ They are in a format compatible with database and statistical software, allowing rapid and accurate computerization

♦ They request the name of the person completing the form and the date it was completed

♦ They state to whom the completed form should be sent

♦ Ask for height and weight as well as for surface area.

♦ Collect continuous data in original units used by the collaborating centre and ensure that the units are clearly noted.

♦ Be consistent with codes within and across forms: e.g. 1 = No; 2 = Yes; 9 = Not known.

♦ Use standard definitions whenever these are available. The following list of source documents is not intended to be comprehensive, but is widely used.

The National Cancer Institute toxicity criteria definitions (http://ctep.info. nih.gov/CTC3).

The World Health Organization criteria for reporting performance status, toxicity, and tumour response [8]. Revised guidelines (RECIST criteria) for evaluating tumour response [9]. Other performance status scales such as the Karnofsky scale and the ECOG scale [10,11].

The International Union Against Cancer definitions of tumour staging which are up-dated regularly (http://www3.uicc/tnm) [12].

The European Organization for Research and Treatment of Cancer core questionnaire, the QLQ-C30, for recording quality of life in cancer patients [13,14], for which a number of cancer-site-specific modules are available [15,16]. A number of other validated quality of life instruments are available and it is wise to seek the advice of an expert adviser on the most appropriate instruments for a particular trial. The assessment of quality of life is discussed in detail in Chapter 6. The basic set of forms likely to be required in a trial is shown in Fig. 7.5. Examples of forms from a multi-group randomized trial of chemotherapy with or without G-CSF in operable osteosarcoma are shown in Figs. 7.6-7.8.

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