Use of CDISC Data in the Danish Medicines Agency

Today applications for market authorisations of drugs sent to EMA only include aggregated results from the non-clinical and clinical trials, which documents the effects of the drug. Thus the assessment is based solely on the results prepared from the collected data by the applicant, and in case that additional results are needed a clock stop is required with time delay for final assessment as a consequence. The benefits of making use of subject level data, e.g. in CDISC format, are numerous, such as a higher granularity of the data used in the assessment, the ability to generate additional output not already included in the application like descriptive statistics for sub groups or sensitivity analyses and verification of the robustness of the results, and would likely increase the overall quality of the assessment of the applications. DKMA presents learning from a series of pilots that has been conducted, investigating the ability to make use of CDISC data as a mean to increase the quality of the assessment or to reduce lag time due to insufficient documentation of results, evaluate the quality of the evidence provided and support on optimising the benefit-risk assessment of the drug. It is assumed that including subject level data in MAA's to EMA will be regarded as something that requires little additional efforts when compiling the application as this is already standard for major markets outside EMA. However that assumption relies on incorporating procedures similar to those in place where use of subject level data is currently a standard.