The statutory duties of your risk management process in relation to your products are clear. The pharmacovigilance rules insist that you must collect, evaluate, and report all safety data, as it appears, from any channel. By its very nature and the way this is reported all new safety is detrimental to your product - it is all on one side of the balance.
All the data showing benefit has come from clinical trials. What is needed now is Real World Data showing benefit to patients in their normal life.
Patients can help redress the balance by giving data on:-
Patients Direct has the unique ability to find patients using your products and to invite them to feedback their experiences.