Box 710 Possible forms of collaboration between research groups

♦ Outline proposals are mutually drafted and agreed and are independently reviewed by a single set of referees on behalf of all collaborating groups

♦ By mutual agreement, one group is designated the lead group for a trial. This group develops the full protocol, in consultation with the other groups, which is then approved, if necessary, and applied by all groups

♦ All groups obtain ethics committee approval of the protocol according to their national requirements

♦ The lead group is responsible for data management and analyses, in close consultation with other groups. Randomization may be undertaken by one or each collaborating group

♦ The lead group provides the other groups with regular reports on accrual, patient characteristics, toxicity and total event rates

♦ The lead group organizes independent review of confidential interim analyses by a data monitoring and ethics committee, the members of which are agreed by all groups

♦ The lead group is responsible for preparing reports for publication, but closely consults and collaborates with the other groups and ensures that all groups agree final drafts management. The groups agree prospectively to undertake joint analyses of their data, even if each component trial is published individually as well. ( This is sometimes called a prospective meta-analysis.)

The advantages of this approach are that styles of protocols and forms and basic procedures, including randomization procedures, are familiar to collaborating centres because they are the same as for other trials. Collaborators also continue to relate to their usual coordinating office, often with people well known to them. Potential disadvantages are low levels of communication between groups, and differences in quality control, software, coding and databases and hence difficulties in merging data and conducting joint analyses. This may therefore be an inefficient method of collaboration.

♦ A trial has already been started by one group, and the same protocol is then adopted by one or more other groups without further independent review. New groups accept the original protocol without modification. The analyses are conducted by the instigating group and the trial is published as a collaborative trial.

♦ The optimal form of collaboration is full collaboration between groups in all aspects of the trial from design to publication. One group is designated the lead group and is responsible for data management. The other groups then become satellite groups doing minimal work except perhaps for collecting data for onward transmission, undertaking site visits, promoting and publicizing the trial and undertaking randomizations within their group.

When groups collaborate over an extended period in several trials, they may take it in turns to be the lead group. Close communication between collaborating groups is essential. Some groups may exchange minutes of all planning group meetings so that opportunities for running collaborative trials can be identified as soon as they arise.

A disadvantage of this model is that satellite groups can find it difficult to maintain a sense of corporate group identity among their collaborating centres. This is much less of a problem, however, once a programme of collaborative trials has been established, and groups take their turn in being the lead group for a trial.

Because of differences in timing and in style between countries, it can prove difficult to agree a common, identical protocol. It may then be necessary to accept one of the other approaches to collaboration. When this is necessary, every effort should be made to use randomization procedures, protocols and forms that are as similar as possible. Whenever feasible, all forms should be sent to one centre responsible for data management. If data are collected and processed by a number of groups, problems can arise in pooling data for analysis. On the other hand, agreeing to run parallel data management systems or even protocols is sometimes the only practicable way to make collaboration possible.

Whatever the level of collaboration adopted for a trial, the implications for staffing, funding, sponsoring by industry (if relevant), and indemnity need to be thoroughly discussed and agreed.

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