The process of drug development requires close monitoring of medical events experienced by patients both during clinical trials and post-marketing. Without this critical safeguard, patient safety is put at risk, as well as jeopardizing company reputation, loss of revenue and fall in share price if a product is subsequently withdrawn. Such diligent monitoring relies upon comprehensive reporting together with accurate statistical evaluation.
During a clinical trial, a patient is being reviewed at regular intervals yet during post-marketing, the healthcare professional may not see them as frequently and, therefore, miss the opportunity to record any adverse events. In both scenarios, accurate reporting is dependent upon the patient expressing their experiences as clearly as possible, since they alone know the precise nature of their symptoms.
Under-reporting of adverse events is common when patients do not realize the need to report to a medical professional or directly to the manufacturer. When they do contact a healthcare professional or the marketing authorization holder (MAH), patients may not communicate clearly and, therefore, accuracy of the report is influenced by any interpretation the listener makes of the story being presented.
Once the reported event reaches the offices of the MAH for processing, it is subject to further interpretation by data entry and coding staff. All adverse events are classified using a standardized medical terminology, commonly the Medical Dictionary for Regulatory Activities, MedDRA. Coding accurately to MedDRA is critical because this provides the standardized groupings used for data analysis, signal detection and safety evaluation.
MedDRA expert Jane Knight explores the changing world of Pharmacovigilance through advances in technology in this white paper, and highlights the benefits of terminology and technology working in alignment to revolutionise the future of safety data capture. “Key objectives remain identical as they develop and evolve; to maximise transparency, resource-efficiency, speed, accuracy and consistency in submissions to regulatory authorities through real-time risk management systems”.
The whitepaper was provided by MyMeds&Me. Click here for more information.