August 29, 2024
In this final part of our series on the Complexity Spectrum in Clinical Trials, we explore the rigorous demands of high-complexity clinical trials in chemotherapy.
These trials, especially those involving complex calculations and weight-based dosing, require meticulous planning and execution to ensure precision and safety. Discover how advanced methodologies and systems are essential in navigating these intricate studies, paving the way for groundbreaking cancer treatments.
Clinical trials are indispensable in the realm of chemotherapy, serving as critical pathways for testing and refining new treatments. By meticulously assessing the efficacy and safety profiles of experimental therapies, these trials provide crucial insights that guide the development of innovative chemotherapy approaches. A chemotherapy clinical trial is a meticulously designed research study aimed at evaluating new or improved chemotherapy treatments for cancer. These trials are essential for advancing cancer care, as they test various chemotherapy regimens under controlled conditions to determine their impact on tumor progression, patient survival, and quality of life. By employing rigorous methodologies, including randomization and blinded assessments, these studies ensure that the results are scientifically valid and reliable. With the assistance of tools such as RTSM and IRT systems, the insights gained from chemotherapy clinical trials not only contribute to refining existing treatment protocols but also pave the way for innovative therapeutic approaches. The following study ultimately strives to offer more effective and less toxic options for cancer patients.
Take for example, in a Phase 1/1b study in combination with conventional chemotherapy for pediatric and young adults with acute leukemias. A leading global pharma company is dealing with both complex calculations and high complexity throughout their study. The complex calculations approach enabled weight-based dispensation, +/-10% weight change, calculated total mL dose from cohort dose level (mg/kg), determined kit type & quantity to dispense, and rounding rules. Also, the system was prepared to deal with the study’s highly complex, intricate design. Going into the study, the benefit of this approach includes freedom from the parameters of a configuration. There is quicker visibility for reviewing dosing data, rather than waiting for the site to enter data within EDC.
Also, the study team does not need to configure parameters on a cohort by cohort basis. With that being said, this approach is more restrictive and can increase user error when entering a high volume of information. There is a higher risk of amendments, which can cause lengthy timelines. Amendments are more burdensome since they are not as straightforward as those done with configurations. Therefore, more effort is required for reconciliation and data cleanup by the sites and data management team. There is also a higher risk for patient waiting issues and increases in data changes if incorrect data was entered (i.e. weight).
With the aforementioned factors considered, this approach can be built in 11-12 weeks if parameters are known. Additional weeks are added if parameters are unknown at the start of the process. *Throughout the study, sites are unable to deviate from their protocol so there is increased study adherence to protocol. Sponsor ensures that all sites are calculating the dose in the same manner across the trial with the help of their IRT system.
