Collaboration with the Pharmaceutical Industry in Observational Studies
The statutory requirements and regulations of the authorities responsible for medication marketing authorisations, and also the interest of the general public in the efficacy and safety features of medications necessitate the systematic collection and documentation of the effects and adverse events occurring in connection with drugs both before and after marketing authorisation. Also important is information on the long-term effects of these medications.
This was one of the reasons behind the foundation of the SCQM register. Taken together with information supplied by patients on their perceptions of the diseases, pain levels, restrictions on everyday life and impaired work capability, the clinical data, X-ray images, ultrasound findings and, more recently, biosamples (blood, joint fluids and tissue) should shed light on the effect of various therapies on disease profiles.
In parallel to this, some pharma companies are running studies known as observational studies with which they want to learn more about the efficacy and tolerability of their products. Additional purposes are verification of how medication dosage instructions are followed in everyday clinical practice and of levels of patient compliance.
The data from observational studies is generally collected by means of paper questionnaires and less commonly online. Because of the additional work involved, rheumatologists are not willing in many cases to collect data both for the observational study and also for the SCQM Registry. As a result, important data from observational studies is missing from the national SCQM rheumatology database, which is very detrimental to research. For this reason, the SCQM Foundation has decided for the future to aim at collaborating with pharma companies on observational studies. With a view to preventing particular interests having an effect, the Council of the SCQM Foundation together with representatives of the pharmaceutical industry has produced the following rules:
Rules for Collaboration between the SCQM and Pharma Companies in Observational Studies