Clinical trials software

Clinical trials software is a fast developing field and it is therefore impossible to make detailed or specific recommendations. Nevertheless, the software needs to be capable of functioning well in the light of the following issues.

♦ Trials often generate vast amounts of data, including demographics, disease characteristics, treatment given, and data on, for example, acute toxicity, long-term risks of adverse effects, tumour recurrence, metastatic spread, and quality of life.

♦ A number of outcome measures may be of interest in addition to survival.

♦ Follow-up is essential and can be prolonged or, indeed, indefinite.

♦ Many types of case report form may be used, including a randomization checklist, an entry form, one or more types of treatment form, an end of treatment assessment form, more than one type of repeating follow-up form, and several special forms, such as forms for reporting serious adverse events, tumour staging, histology, and death.

♦ Many trials include quality of life (or other) questionnaires completed by patients.

We recommend using a data management system that avoids the need for a new database to be programmed for each trial, a process that can take months to complete.

An appropriate clinical trials software package will possess many of the features shown in Box 8.8.

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