2010 to 2019: BFARM / PEI Guidelines on Drug Observation Studies (AWB) and Voluntary Post-Authorization Safety Studies (PASS) Updated
New recommendations of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute on observational drug studies (AWB) and on the notification of non-interventional voluntary PASS were published on Dec. 20, 2019:
BfArM: “The ‘Recommendations of the BfArM and the PEI on the planning, implementation and evaluation of observational drug studies’ dated July 7, 2010 are repealed with this announcement and replaced with by the ‘Joint recommendations of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute for observational drug studies (AWB) according to § 67 paragraph 6 of the Medicinal Products Act and for the notification of voluntary post-authorization safety studies (PASS) according to § 63f of the Medicinal Products Act’ of 20 December 2019.”
A non-interventional trial is according to Section 4 (23), s.3 AMG : “a study, in the context of which findings resulting from persons’ treatment with medicinal products are analysed using epidemiological methods; the treatment, including the diagnosis and monitoring, shall not follow a predetermined trial protocol but shall result exclusively from current medical practice.”
Non-interventional studies are purely observational. Additional, i.e. diagnosis or monitoring procedures for the patient beyond the usual therapeutic practice must not be part of the observational study plan. Such procedures, e.g. blood samples are only permitted in these studies if they are considered necessary in the context of the usual therapy as an individual decision by the doctor.
A Few Highlights
- A study classification algorithm
- A clearer picture of research study types that must not be notified to BFARM/PEI as “AWB”, including retrospective studies and disease registry studies without specific requirements regarding the collection of data of specific drugs or groups of active ingredients, e.g. registries, which are used to collect data on the disease and for which it was not specified in the study protocol to include by large patients receiving a specific drug therapy.
- Guidance on submission requirements, quality assurance, end-of-study reporting and archiving of AWB studies
- The recommendation to submit a positive ethics review outcome to BfArM/PEI for AWB studies