Safety Data
Electronic collection of patient reported outcome (PRO) data using web-based technology is becoming an established way of obtaining health data. Its use for collecting adverse event data on medicines is less widely used, although the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK collect reports of possible or suspected adverse reactions from patients as well as healthcare professionals through the web-based Yellow Card reporting scheme. Recently Patients Direct methodology was submitted and accepted as part of the risk management plan (RMP) for a newly licensed medicine with the EMA. The PROBE system allows a prospective registry of patients with the condition/ therapy of interest to be built up. Advantages of a prospective registry are; · Avoids any selection bias from doctors regarding patient inclusion · Avoids selection bias of reporting of adverse events · Limits the effect of any media publicity regarding side effects as the patients are already present in the system database. · Events of special interest can be pre programmed but other events can still be captured The patients will be followed for a set time with the total duration of the evaluation from first patient responding to data cut off dependent on the client requirements. Collection of longitudinal follow-up data is promoted by the use of Email alerts and telephone reminders at specified time intervals. Typical information captured includes patients’ demographics, lifestyle and experiences of their condition, medications and adverse events. These adverse events can be pre specified to ensure capture of unusual or uncommon outcomes but also by system e.g. head, chest. The type of event and outcome from the event will be pre programmed so that the reporting mechanism and time scales will match the client and regulatory requirements.
