IQWiG: ‘Quality’ Registry Data Suitable for Benefit Assessments
A new report from Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) finds that patient registries can be used to conduct added benefit assessments for new drugs, especially in situations where there is limited evidence available at the time of market authorization.“Extensive analyses of the methodological literature and intensive discussions with registry operators and external statisticians have led us to the conclusion that, in the case of high-quality patient registries, it is possible to base studies on these registries that use the routine practice data collected either with or without randomization,” said IQWiG Director Jürgen Windeler.
While the report found that data from patient registries can be used to assess a drug’s added benefit, the authors pour cold water on the notion that electronic health records and insurance claims data could be used to the same end.
“The collection and processing of routine practice data from electronic patient records and claims data from health insurance funds is currently not possible with regard to benefit assessment of drugs and will not be possible in the near future,” IQWiG writes, noting that important data are not collected through these sources.
IQWiG also found that the quality of data in patient registries has improved and that registries are easier to adapt to data collection requirements than other sources.
“In recent years, the objectives and scope of documentation of registries have been extended. In particular, the increasing documentation of clinical information in registries that can be used to describe patient populations, interventions and outcomes for benefit assessments is an important step forward,” said Thomas Kaiser, head of IQWiG’s drug assessment department.
While the authors found that benefit assessments could be conducted from comparative studies based on registry data, they stress that it is “generally not possible to derive more than a hint of an effect from comparative studies without randomization.”
For studies without randomization, IQWiG says that steps should be taken early on to ensure the study conduct and quality of data will be sufficient to provide interpretable results, including having an analysis plan and pre-specified confounder adjustments.
IQWiG says that randomized routine practice comparative studies with adequate data quality should require less effort than similar studies without randomization “as confounder data collection and confounder adjustment can be omitted.”
The report also provides a list of criteria to ensure that data collected for comparative studies via patient registries are of sufficient quality. The list is broken up into four categories:
- “Mandatory criteria for ensuring data quality;
- General criteria that are always relevant for registry studies used in benefit assessment of drugs;
- General criteria that, depending on the research question, are relevant for registry studies used in benefit assessment of drugs; and
- Criteria whose degree of fulfillment is to be assessed in relation to the research question”
For each category, IQWiG has identified a set of criteria that should be addressed depending on the registry and research question at hand.
IQWiG