August 16, 2024
The following series of three use cases explores the varying levels of complexity involved in clinical trials, highlighting how configurable and flexible approaches are strategically adapted to meet the unique demands of each scenario. Ranging from a low-complexity, site-managed prostate cancer trial to a medium-complexity study for non-Hodgkin lymphoma and chronic lymphocytic leukemia and culminating in a high-complexity chemotherapy trial requiring intricate calculations.
These examples illustrate how tailored strategies and advanced technological integrations optimize trial execution, ensure rigorous protocol adherence, and effectively mitigate risks, ultimately driving the development of more effective therapies.
Use Case #1 - Configurable and Flexible Approach, Low Complexity
The integration of advanced technology into clinical trials has revolutionized the search for effective therapies for prostate cancer, ushering in a new era of precision medicine and enhanced research capabilities. Cutting-edge developments in tools such as randomization and trial supply management (RTSM) enable researchers to delve deeper into the genetic and molecular underpinnings of prostate cancer, allowing for more targeted and personalized treatment approaches.
These technological advancements facilitate the efficient design and execution of clinical trials, improving the accuracy of data collection and analysis, and accelerating the discovery of innovative therapies. By harnessing the power of technology, clinical trials are not only advancing our understanding of prostate cancer but also significantly increasing the potential for developing novel and effective treatment options.
With said technology, a Phase 1, open label study for advanced stage prostate cancer is conducted by a Top 10 global pharma company. For its study, the company opted to use a flexible configuration approach, or a vending machine model, which allowed the selection of vial quantities between two different kit types. This approach was chosen due to the study’s low complexity. There are fewer high-risk changes needed in the IRT. Also, this approach allows for site flexibility to handle many different scenarios for dosing. Additionally, since fewer data points are captured in IRT, there are fewer reconciliation efforts for sites and data managers. However, the main risk of this approach is that the protocol is open ended.
The control is in the study team’s hands. Luckily, they can circumvent the system if needed. Another risk is that there is more accountability put back on site to select the correct quantity of IP.
For this example, the pharma company is able to work within 4G’s standard timeline of 9 weeks. Throughout the duration, maximum flexibility for dose escalation/expansion studies and implementing amendments can be done both quickly and easily. Sites can efficiently control the quantity of medication that can be assigned on a kit type level in each cohort level. Sponsor control is provided to manage how much medication the sites can assign per visit, but the site is ultimately responsible for ensuring the correct quantity and therefore dose is administered to the patient for a given visit.
