Developing and drafting an outline proposal

Whatever processes are used for assessing proposals for new trials, the group developing an idea will often need to draft an outline proposal for independent assessment before developing a detailed protocol. An outline proposal may be required for presenting to sponsors, potential collaborators, and patient advocacy groups, and will sometimes be needed in applying for funding. The drafting of such a proposal for a new trial must therefore be done with care and thoroughness.

The ways proposals are assessed and prioritized, and decisions reached about whether or not they should be funded, vary between sponsors, but the principle remains that to attract funding from a sponsor and enthusiastic support from the clinical community and patient advocacy groups, the proposal must make a persuasive case for conducting the trial. It must show that the trial is needed to answer important questions, that it is appropriately designed, and that it stands a good chance of answering the questions reliably, of accruing the required number of patients during the planned accrual period, and of leading, ultimately, to improvements in clinical practice.

Groups submitting outline proposals need to bear in mind that their proposals are likely to be judged in comparison with others and that it may not necessarily be possible even for all highly rated proposals to be funded. This emphasizes the need to ensure the relevance and timeliness of proposed new trials, and of making the application clear and compelling, even to a non-specialist reader.

To fulfill these requirements, a proposal should be drawn up as follows. Different sponsors have different formats, but the information required is essentially the same.

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