August 22, 2024
In Part Two of our series on the Complexity Spectrum in Clinical Trials, we explore the medium-complexity challenges presented in studies for non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
These trials require a balanced approach that combines flexibility with stringent oversight to ensure precise dosing and protocol adherence, all while navigating the complexities inherent in developing innovative therapies for these serious hematologic malignancies.
Use Case #2 - Configurable and Flexible Approach, Medium Complexity
Clinical trials serve as crucial platforms in the pursuit of improved therapies for individuals battling non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), two prevalent hematologic malignancies. These trials and the approaches utilized play a pivotal role in evaluating novel treatment strategies, ranging from targeted therapies and immunotherapies to combination regimens, aimed at enhancing patient outcomes and quality of life. By systematically testing experimental drugs and interventions in diverse patient populations, clinical trials not only contribute to expanding the variety of treatments but also foster innovations that could potentially redefine standards of care. Through rigorous investigation and meticulous data collection, clinical trials represent a cornerstone in the ongoing effort to address the complexities of NHL and CLL, offering hope for more effective therapies and ultimately, improved prognosis for affected individuals.
In one such example, a Phase 1, open label FIH study for non-Hodgkin lymphoma and chronic lymphocytic leukemia is being led by one of the top 10 pharma companies. Since this is a medium complexity study, a flexible configuration approach is adopted. By using this approach, dose dispensation was enabled where the IRT assigns the quantity of vials based on the dose entered. Also, this approach puts less accountability on sites, while also allowing a certain level of flexibility for dosing. By providing a higher level of oversight of the site for the sponsor, correct execution of dosing is ensured.
With this study approach, risk factors are taken into account. These risks include the need to define all doses upfront. Parameters are key at the beginning of the study which may not be the easiest aspect to predict. Knowing what the boundaries are is difficult oftentimes as they are difficult to predict upfront. This makes for many unknown variables in the protocol such as number of cohorts, number of subjects, dose levels, visit schedules, and number of doses per visit schedule. This approach also adds extra complexity if doses are not known. While it may seem daunting, the execution of the study is still achievable. This approach can be built in a standard time of 9 weeks if parameters are known. In the case where parameters are not certain, additional weeks can be added.
Within this example, the IRT system has more controls but is less rigid than a high complexity study. This means the system is able to move up and down when dealing with doses. The IRT system also assigns the correct quantity of medication based on the dose entered by the site users. The system maintains control of the acceptable dosing range and as a result assigns the correct quantity of medication for dispensation. This minimizes the potential risk of drug wastage and ensures adherence to clinical protocol. Sites can easily and flexibly control the quantity of medication that can be assigned on a kit type level per cohort level. Sponsor control is provided to oversee and address 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.
