Trial outline

Give a one-page diagrammatic summary of the trial, indicating its design (e.g. factorial, open-label, double-blind, etc.) and showing the main eligibility criteria, the timing of

Treatment

Report forms

Week Treatment

Report forms

Surgery

Initial + Treatment

Follow-up

(one month after surgery)

Follow-up

(four months after surgery)

Follow-up + SF-36

10 11 12

20 21 22

Chemotherapy Chemotherapy Chemotherapy

Surgery

Initial + Treatment Follow-up + Treatment Follow-up + Treatment

Follow-up + Treatment

Follow-up

(one month after surgery)

Follow-up + SF-36

Follow-up every three months to two years and every six months thereafter SF-36 questionnaires at six and twelve months and then annually thereafter

Main outcome measures: survival, quality of life, clinical and pathological stage, resectability rates, extent of surgery, time to and site of relapse

Fig. 7.2 Example of a one-page trial outline from a lung-cancer protocol registration or randomization, the treatment regimens in summary form, the sequence of reports, the frequency of follow-up assessments, and the outcome measures. This one-page diagrammatic summary can be a useful reference document for clinical centres that have already entered patients into the trial and are familiar with the procedures. An example is given in Fig. 7.2.

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