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 (

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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