While this new benefit-risk guideline opens a door to partner with patients for conducting preference studies and to structure patient-focused benefit-risk assessment, we cannot forget that there is a lack of obligation to put these guidelines into effect, and how exactly patient communities and their representatives can get involved in this?
After they are published, clinical study results should be critically reviewed and assessed for such things as reliability, bias, significance, and fit with existing literature.
Information on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.
Pharmacovigilance is the practice of detecting, understanding, and preventing adverse events or any other medicine-related problem.
When performing a critical reading of clinical study results, the reader should take relevant information into account from the best available sources and should consider questions about the reliability, methodology, results, discussion, significance, and conclusions of the study.
Risk management is important in medicines development and pharmacovigilance in order to avoid crisis situations and harmful consequences. There are various kinds of risk; risk management strategies must assess and minimise these, and balance them with the benefits of the medicine being developed.