Too many clinical trials fail – where are the errors and how to remove them?
When looking at the overall process of a clinical trial, we can separate the sources of errors into the following classes:
- hypothesis: poor quality of the underlying hypothesis
- knowledge about the patient
- inherent statistical errors
- data errors during a trial
Looking at those types of trials where a paper-version of a CRF (case report form) is used, then one obvious source of error lies in the transcription phase: while the Form Filler at the study site manually enters data (i.e. answers to the predefined questions) into the CRF, the Data Enterer transcripts these data into a validated database. Since this manual step is erroneous, using an electronic CRF (eCRF) with direct or indirect link to the database...