9th MVF Annual Congress: Real World Evidence
29.08.2019 21:28
For the assessment of the benefit of medicinal products for the treatment of rare diseases, in the case of conditional approvals and approvals under exceptional circumstances, the G-BA is authorized by the law for more safety in the supply of medicinal products, GSAV for short, to require pharmaceutical companies to carry out "accompanying data collection". to demand. The question now to be answered by professional societies, health care researchers and registry specialists together with the G-BA and IQWiG is how the highest possible level of evidence can be maintained within the "application-accompanying data collection" required in the GSAV. The upcoming specialist congress of "Monitor Healthcare Research" with the title "Real World Evidence" should provide impetus for this, which took place on October 29, 2019 in the event rooms of the AOK Nordost.
Can you even compare or even match the data obtained with RCT, or PCT (Pragmatic Controlled Trials) and RWD? Which classes of evidence are we talking about? The experienced methodologist Prof. Dr. explains all this and much more. Franz Porzsolt in the 1st specialist seminar from MVF with the title: “Measuring effectiveness in everyday care”.
Randomized controlled trials, or RCTs for short, are considered the study design with the highest possible level of evidence. This assessment means that RCTs are used almost everywhere, even where they are not possible at all or only with difficulty, or where it is better not to do so - for example, whenever the necessary statistical power is lacking. However, RCT bashing is misplaced, because RCTs, when done well and used correctly, undeniably have high (if not the highest) internal validity. On the other hand, the results obtained with this study design can only be transferred to real care to a previously unknown extent due to the often very high inclusion and exclusion clauses. Now the law for more safety in the supply of medicinal products (GSAV) stipulates that in the future the G-BA can require manufacturers of new medicinal products to collect data during use after approval, which means that real world data, which has so far been neglected in Germany ( RWD) and the real world evidence approach suddenly comes into focus.
But how to deal with it? And can you even compare or even match the data obtained with RCT, or PCT (Pragmatic Controlled Trials) and RWD? Which classes of evidence are we talking about? The experienced methodologist Prof. Dr. explains all this and much more. Franz Porzsolt in the 1st specialist seminar from MVF with the title: “Measuring effectiveness in everyday care”. Don't worry, Porzsolt can explain that no one needs to have had a master's degree in statistics in order to understand the structural differences between RCT, RWE/RWD and PCT, but also to receive useful instructions on how to deal with the natural chaos of everyday care can best be converted into an evaluable care structure.
The specialist seminar took place on the day before, October 28th, the MVF Congress (October 29th) from 4:00 p.m. to 8:00 p.m. in an event room at AOK Nordost, Wilhelmstr. 1, 10963 Berlin.
Participants will find the password-protected lecture here
Greetings from the editor
Ladies and Gentlemen
Dear Colleagues,
For the assessment of the benefits of medicines for the treatment of rare diseases, for conditional approvals and approvals under exceptional circumstances, the G-BA receives the authority under the Act for More Safety in the Supply of Medicines, or GSAV for short, to require pharmaceutical companies to carry out “use-related data collection”. to demand. With this new instrument, which the Federal Committee can use but does not have to use, the legislature wants to ensure improved evidence in follow-up assessments, but it has left it completely open in what form and with what level of evidence these data collections should be designed. These can be registries on the one hand, and certain types of study designs on the other, whereby service providers are obliged to take part in these data collections if they want to use the corresponding new active ingredient.
This approach intended by politicians, which takes the discussion about real world data and real world evidence to a whole new level, comes very close to the “knowledge-generating care” that the German Society for Hematology and Medical Oncology e. V. (DGHO) calls for this in its research roadmap. For DGHO Chairman Prof. Dr. not using supply data for high-priced medications and rare indications means not using supply data. med. Carsten Bokemeyer (UKE) “a loss that society cannot afford”.
Specialist societies, healthcare researchers and registry specialists, together with G-BA and IQWiG, now have to answer the question of how the highest possible level of evidence can be maintained within the “use-accompanying data collection” required by the GSAV.
Therefore, take an active part in our 9th specialist congress, which will take place this year in the event rooms of the AOK Nordost in Berlin.
The congress will be chaired with me by Prof. Dr. Dr. Alfred Holzgreve.
With kind regards
Your professor Dr. Reinhold Roski
Publisher “Monitor Health Services Research”
Speakers & Lectures
Here you can find the speakers (in chronological order) of the “Real World Evidence” congress, which took place on August 29, 2019 in Berlin. The abstracts (as soon as they are available) are available to everyone, the lectures and their audio recordings exclusively to visitors to the MVF congress - after the congress and after they have logged in - for downloading or listening.
Theme
You can listen to the entire congress here
Speakers
Prof. Dr. Reinhold Roski,
MVF editor
Theme
greeting
Speakers
Dr. Antje Behring
G-BA
Theme
Are conditional approvals ready for early benefit assessment? Dealing with evidence gaps in the additional benefit assessment
Speakers
Prof. Dr. Jürgen diaperer,
IQWiG
Theme
Definition of the highest possible level of evidence from data collection
Speakers
Prof. Dr. Frank Griesinger,
University of Oldenburg
Theme
Knowledge-generating care from the perspective of medical science: Entity-related registers - quality of evidence for benefit assessment using the example of CRISP
Speakers
Daniela Teichert,
AOK Northeast
Theme
Application-accompanying data collection from the perspective of the cash registers
Speakers
Prof. Dr. Franz Porzsolt,
ICE, Ulm
Theme
Effectiveness in everyday care and pragmatic controlled trials
Speakers
Roland Nagel,
Health Forum Leipzig
Theme
Evaluation of routine data, registries and studies with causal inference models
Speakers
Prof. Dr. Reinhold Roski
Publisher “Monitor Health Services Research”
Theme
Overall moderation of the congress
