Therapeutic area (TA) knowledge is an increasingly sought-out skill in clinical programmers (also referred to as clinical data scientists). Programmers with strong TA expertise possess a deep understanding of patient and disease characteristics, existing and future industry standards, regulatory agency requirements, complexities of the study design(s), dosing regimens and challenges in collection and reporting of the study data.
Although the principles of clinical trials remain the same across TAs, there are features inherent to each TA mainly due to the underlying patient population and type of disease. Unfortunately, there is a significant lack of resources for programmers to acquire therapeutic area specific expertise.
Recognising this gap, PHUSE Education established the Therapeutic Areas cluster to help programmers develop TA-specific expertise.
Currently, the TA cluster team members are working on putting together a high-level overview of different TAs, starting with Diabetes and Oncology. Each TA-specific document will contain:
- a description of the disease
- demographic and disease characteristics
- CDISC & industry standards
- regulatory guidelines
- study design(s) & common primary endpoints
- data challenges
The aim is to provide programmers at all levels a starting point to get familiar with the basics of the TA they are supporting and easy access to CDISC and regulatory guidelines.
The Therapeutic Areas cluster team is also responsible for the Clinical Documents cluster. Although these are separate PHUSE Education sub-groups, there is a significant overlap between the two. The team envisions using this cluster to provide education and guidance materials on different clinical/study documents, both overall and TA-specific. The latter will be aligned with the TA cluster.
For example, the team will develop a guidance document explaining the various parts of the study protocol and list any TA-specific protocol features (if applicable). They will list key TA-specific disease-characteristic eCRF form content for rheumatology and oncology studies.
The Clinical Documents cluster is still in the planning phase and more information will be shared as the plan solidifies.
There are some truly exciting activities planned at PHUSE Education in 2021! So, stay tuned for the PHUSE Education Therapeutic Areas and Clinical Documents cluster deliverables!
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