The Data Standards Working Group within ISoP’s Standards and Best Practices Committee was
established in late 2015 and gathers approximately 30 scientists and programmers working
towards a harmonized standard for datasets used in pharmacometric analysis.
The motivation came due to the existence of various challenges during the creation of
pharmacometric datasets, e,g., the need to account for the deficiencies in dosing information, lack
of standard rules for handling source data issues, and variability in the data specifications. Given
these complexities, the datasets are prepared and documented inconsistently across the
companies and sometimes even within the same organization, making it difficult to review and
exchange the datasets. Our harmonized standard aims to address these issues.
Data Standard for Population PK Analysis
Since the inception, the group has been working on a standard for datasets used for population pharmacokinetic (PK) analysis with the goal to improve the quality, reduce the time required to specify, implement and review datasets, and to facilitate portability within and across organizations. This standard is developed in the spirit of CDISC (the Clinical Data Interchange Standards Consortium) standards. The first version of the standard has been published on November 10, 2020 under the sponsorship of ISoP.
The medium and long-term goals include bringing these standards into alignment with the requirements of CDISC and to extending them to pharmacodynamics (PD).
Survey on Data Preparation
An informal survey was conducted amongst representatives (pharmacometricians and data programmers) of 19 participating organizations in the Data Standards Working Group, in order to understand how pharmacometric data preparation is currently handled in practice. A total of 13 multinational pharmaceutical companies, 5 contract research organizations and a national regulatory agency responded, and were represented in the findings. You can find a high-level overview of the results below!
How To Get Involved
The Data Standards Working Group meets by teleconference twice a month. Want to join? Contact us!