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O-CAT Helps Study Team Package Key Endpoints to Reduce Patient Burden

Featured Solution: Operational Complexity Assessment Tool (O-CAT)

For one clinical trial sponsor, patient experience is key to decision-making for clinical trial design and operationalization. They are focused on engaging research participants as partners and providing them with options. Decentralized clinical trial (DCT) elements provide patient flexibility. However, they are not widely used in all therapeutic areas.

A study team was invited to pilot the O-CAT. Their initial thinking was that modern solutions would not be a great fit for their study design, given that their primary endpoint assessment warranted specialized equipment and assessors, meaning it could only be done on-site. Similarly, their investigational medicinal product (IMP) was an injectable that required controlled conditions for administration. Nonetheless, they were keen to explore which DCT elements they could implement in order to improve the patient experience and support engagement.

The study team used the O-CAT to check their initial thinking. They systematically worked through all the O-CAT tabs to consider which DCT elements would make sense for their patients and their study.

They described the O-CAT as organized and sequential. They learned from the discussion that patients would prefer DCT elements wherever possible. 

Completing the O-CAT also encouraged the team to think more broadly about patient burden. As a result, they reduced the number of study visits by packaging key endpoints, imaging, and blood sampling assessments together.

Additionally, the O-CAT reinforced the value of cross-functional remote monitoring (wherever possible), which the team had already factored in as part of their Risk Based Quality Management (RBQM) strategy.

The time invested in completing the O-CAT added value to study planning. The O-CAT has been shared within the therapeutic area franchise to encourage other teams to assess the applicability of DCT elements for their clinical trials.

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