Box 75 continued Treatment and other costs

♦ Costs of treatment additional to those of standard routine management outside the trial; when external funding is not available these costs have to be borne by the health care system

♦ The costs of investigations additional to those of standard routine management outside the trial

♦ The costs, for centres and patients, of additional attendances for treatment and follow-up required by the trial from the pharmaceutical industry, are likely to become available, this should be stated in the proposal or in a covering letter.

The periods over which these costs will be incurred need careful consideration. It is essential that statistical expertise is available throughout the total period of the trial, from planning to reporting, and that the clinical trials manager is appointed at an early stage, but it may be possible to stagger the appointments of some other staff. An example of a summary of staff required for the central coordination of a large randomized cancer trial is shown in Box 7.6.

The trial management group is likely to need to meet at least twice per year. Annual meetings of all collaborators, of the data monitoring and ethics committee, and of any trial supervisory committee will probably be desirable. Visits to centres by the trial management group might typically amount to two visits per centre by two members of the group during the course ofthe trial.

Treatment costs will depend upon the nature of the trial. The costs not only of anticancer drugs but also of supportive care need to be considered.

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