How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity, And Risk

By Keith Krenitsky, Global Director, Commercial Drug Sourcing, Catalent Pharma Solutions and Shaila Saeed, Strategic Advisor, Global Commercial Drug Sourcing, Catalent Pharma Solutions

Clinical trials are conducted according to a protocol, which is the master action plan for how the study will be conducted. Clinical trial protocol design can have a significant impact on the sourcing strategy for commercial drug products used as comparators.

Once the clinical trial protocol is approved and the trial is launched, changes to the clinical trial protocol will add time and cost. Obtaining early input from knowledgeable internal colleagues and an experienced external sourcing partner early in the process is essential to supporting the collection of the best research and to completing the clinical trial on time and within budget. In addition, an appropriate amount of clinical trial protocol design flexibility is required to achieve effective comparator sourcing. Proper planning, effective communication with specialized experts, and providing the appropriate level of detail in the clinical trial protocol can help avoid subsequent sourcing issues and can minimize the need for protocol amendments.