Exploring the Challenges and Inconsistencies in Implementing Therapeutic Area User Guides (TAUGs) in CDISC Standards
Abstract: Therapeutic Area User Guides (TAUGs) are essential resources that provide guidance on using CDISC standards for specific types of data in clinical trials. However, there are several challenges and inconsistencies in implementing TAUGs, such as the absence of clear guidance for data mapping, deprecated guidance, and incomplete information. This article discusses these issues in detail, highlighting the need for improved clarity and guidance to ensure the effective use of TAUGs across the industry.
Introduction
Therapeutic Area User Guides (TAUGs) play a crucial role in providing guidance on using Clinical Data Interchange Standards Consortium (CDISC) standards for specific types of data in clinical trials. CDISC standards aim to streamline the collection, management, and reporting of clinical data, making it easier for researchers to share and analyze the data. TAUGs offer valuable guidance to sponsors and researchers working within specific therapeutic areas, ensuring that their data is structured and mapped according to industry standards. However, implementing TAUGs can be challenging, and inconsistencies can arise from various factors. This article delves into the challenges and inconsistencies in implementing TAUGs and discusses potential reasons for the lack of implementation in certain cases.
Is My Type of Data in a TAUG?
One of the first challenges in implementing TAUGs is determining whether the type of data collected in a study is covered by an existing TAUG. In some cases, a study’s indication may not have an applicable TAUG, making it difficult for sponsors to know whether guidance exists for their specific data type. For example, the Asthma TAUG contains guidance for allergen skin tests, which may also be relevant for a study with an indication of allergic rhinitis. However, unless the sponsor is aware of the Asthma TAUG and chooses to implement their study according to this guidance, the data will not adhere to the guidance. This issue highlights the need for a comprehensive and easily accessible resource that lists all types of data covered by TAUGs, regardless of the indication.
Mapping is Provided as ‘Examples’, and not Guidance
A significant challenge in implementing TAUGs is the lack of strong guidance for data mapping. Instead, TAUGs provide examples of how data can be mapped, but these examples are not necessarily requirements. For instance, the Asthma TAUG states that the Skin Response (SR) domain is not final at the time of publication, leading to confusion about whether other SDTM domains can be used. While examples can be helpful, implementers need clearer and more definitive guidance on mapping data to ensure consistency across studies.
Previous Guidance is Sometimes Deprecated
Another issue with implementing TAUGs is that guidance can change between versions. For example, the Virology v2 TAUG deprecated the Viral Resistance (VR) domain and consolidated drug sensitivity testing in the Microbiology Susceptibility (MS) domain. As a result, studies that used the first version of the TAUG may be inconsistent with those using the newer version, causing the same data to be mapped to different SDTM domains. This inconsistency emphasizes the importance of keeping abreast of updates and changes in TAUGs to ensure data consistency across studies.
TAUGs May Be Incomplete
TAUGs may not address all essential data types or provide guidance on handling specific data points for a therapeutic area. For example, the Kidney Transplant TAUG does not address the date of the request for a biopsy or the C4d staining status in renal allografts. Consequently, sponsors may need to create their own implementations or consult review divisions for advice, leading to variations in data mapping across the industry.
Inconsistency in Mapping Similar Data
Inconsistency in mapping similar data across TAUGs has been a recurring issue in the industry. A PhUSE 2015 paper discussed variations in mapping to the Medical History domain across various TAUGs, emphasizing the need for greater consistency in data mapping across different therapeutic areas. Inconsistency in data mapping can lead to difficulties in comparing and analyzing data across studies, negatively impacting the overall efficiency and effectiveness of clinical research.
Suggested Reasons for Lack of Implementation
a. Regulatory Guidance Might Not Require It
At the time of writing, the Technical Conformance Guide (TCG) states that sponsors may use new Therapeutic Area (TA) extensions of a CDISC standard but are not required to until the extensions have been incorporated into a supported SDTMIG version. The TCG also mentions that sponsors should explain their rationale for using TA extensions that are not currently listed in the Guide. This lack of clarity can lead to confusion among sponsors about whether they are required to use a TAUG for their study. Furthermore, the requirement to explain the rationale for using an unsupported TAUG may discourage sponsors from adopting TAUGs, resulting in a lack of implementation across the industry.
Conclusion
Therapeutic Area User Guides (TAUGs) are essential tools for sponsors and researchers to ensure that their clinical data adheres to CDISC standards. However, the implementation of TAUGs is not without challenges, and inconsistencies can arise from various factors. The absence of clear guidance for data mapping, deprecated guidance, incomplete information, and inconsistency in mapping similar data are some of the issues that can hamper the effective use of TAUGs. To address these challenges, the industry must work towards providing clearer and more definitive guidance for data mapping, ensuring updates and changes to TAUGs are communicated effectively, and addressing gaps in existing TAUGs. Additionally, regulatory guidance should be more explicit regarding the requirement to use TAUGs, encouraging widespread adoption and implementation across the industry. By addressing these challenges, the industry can improve the consistency, efficiency, and effectiveness of clinical research, ultimately benefiting patients and healthcare providers alike.
