The need for the trial

♦ Indicate how common the disease is in the general population.

♦ Indicate the sorts of patients affected and what proportion of all patients with the relevant type of cancer they represent; grant applications are often assessed by people without experience in the specific disease area. Indicate also the scientific questions that the trial will answer, the ways in which it is likely to influence routine clinical practice, and how it may inform the planning of future research.

♦ Give a clear and full account of the issues that gave rise to the proposal for a new trial, explaining why they are important. Make sure that all relevant references are given, briefly summarizing the findings from any relevant previous studies. This will involve conducting a literature search, or preferably a systematic review (see Section 11.5.4), and consulting colleagues and other research groups. The aim should be to justify the need for the trial for external referees and sponsors.

♦ Describe what, if any, other trials studying the same or similar problems are currently being conducted or planned by other groups, making it clear why it would not be feasible to plan a joint or parallel trial with another group or to join an already open trial. This will involve consulting trial registers (see Section 11.5.4) and other research groups on currently open relevant trials.

♦ State the hypothesis to be tested by the trial. This should be a brief but comprehensive statement, for example: In the treatment of advanced A cancer, regimen B is more effective than the standard regimen C in terms of survival, symptom control, disease progression and quality of life, and/but is less/more toxic.

♦ State why the trial is needed now. Referees and sponsors, as well as potential collaborators, need to prioritize new research proposals, and need adequate reasons for supporting the trial in comparison with other competing proposals.

♦ If previous randomized trials have addressed the same question, explain why another trial is needed rather than a systematic review and meta-analysis of previous trials (see Chapter 11). If a systematic review has generated the hypothesis to be tested, then give details and explain how it has identified the need for the trial.

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