Electronic patient records: The pharmaceutical industry's requirements

For the last 10 years Remote Data Entry (RDE) has been the great white hope of the pharmaceutical industry in achieving three main aims; cutting Clinical Trial duration times, saving resources and improving data quality. But where is it? Who is using it? I believe that RDE has failed to meet the three aims mentioned above. The tinre of the RDE paradigm is past and the future will be shaped by the new study site technologies which more and more are able to provide much of the required clinical data directly without the need for the transcription to paper and then re-entry to another system. Direct Data Capture (DDC) from machines such as patient record systems, MRI machines, ECG and EEG technologies, laboratory measurement equipment and an increasing range of other previously manual data providers will enable error free and resource efficient data capture. The substantial reduction and possible elimination of errors will allow early locking of the database and therefore potentially earlier product launch. There are three main players involved in this future vision. The future providers of the information required are one, that is the medical equipment manufacturers and the providers of patient record systems. From these we require standardised interfaces. The second are the doctors who will be using these systems and who have no desire to duplicate effort by recording information twice. The third is the pharmaceutical industry who produce the products to be dispensed to the patients. If we ape to get our products onto the market in time to benefit the patient and at a cost acceptable to the health service we need to reduce development times and costs. Direct Data Capture (DDC) will make this possible.