INTERVIEW TO LIEKE MAAS, NKI STUDY COORDINATOR AT CLINICAL RESEARCH UNIT (CRU)
In her role as study coordinator for phase 1 and 2 of clinical trials, Ms. Lieke Maas is responsible for setting up the clinical trials and coordinating a broad range of clinically related processes, ranging from managing the administration of study medication to drafting a study protocol. Her role requires systematic organization and meticulous time management.
'I have to make sure that all the operational processes are done in the right way, by enough people in the right place and at the right moment’
Lieke emphasizes the need for efficient and effective operational processes, ensuring that each step is executed accurately and at the right time. Collaborating closely with the quality officer, she upholds the institute's commitment to excellence and patient well-being.
How to successfully set up a clinical trial?
The initiation of any trial at the CRU starts with a rigorous feasibility assessment, which is the first contact between the pharmaceutical company and the institute, followed by an official site selection visit where it is established what is needed to have the trial up and running, including the contractual agreement, the financial and ethical consents.
Securing ethical approval is one of the most time-intensive steps during the start-up phase.
The detailed review and multiple iterations with the ethical committee often extend over several months. Ethical approval stands as a non-negotiable criterion; without it, the trial cannot commence. In parallel, the financial aspect cannot be overlooked and needs to be finalized before progressing any further
Lieke emphasizes the importance of capacity management. Already in these early stages in the start-up phase, 90% of equipment and devices need to be suitable for the trial, while the institute's human resources shall be adeptly trained and allocated.
Despite the use of capacity management tools and meticulous planning, some aspects are beyond NKI's control, including some ethical procedures. These delays often stretch the start-up phase over extended periods, which is why adaptability, communication, and the collective efforts of various parties are fundamental in navigating these challenges in a timely manner.
Transitioning from Initial Setup to Operational Efficiency: Blood Sample Management in Clinical Trials
As the study progresses to the 'active' stage - often denoted as cycle 1, day 1 - blood samples are collected just prior to administering the IMP and continue to be taken at various time points, sometimes for as many as three consecutive days.
In phase 1 and 2 clinical trials, the collection of blood samples for analysis is a core component. These samples help assess if and how tolerable, safe and effective the IMP is. The blood samples need to be collected on various time points throughout the entire treatment according to detailed protocols. Managing blood samples, (processing, worldwide shipping and stakeholder alignment), is a intricate process that necessitates the concerted efforts of the hospital, the central laboratory, providing pharmacokinetic material and protocols, and the pharmaceutical entities.
Alongside with securing a smooth cross-collaboration, Lieke is responsible for ensuring that every individual at CRU - from lab technicians to research scientists - is not only trained but is also consistently updated on lab manual procedures and protocols. These rules are almost continually subject to modification due to evolving methodologies, regulatory updates, or stakeholder requests.
"It's not just about getting everyone up to speed but keeping them there, especially as best practices evolve," Lieke adds
'It's so trial-specific what we have to do and how we do it. Every trial is a new chance to improve or to maintain a level of quality’
Each clinical trial presents its own unique set of challenges, leading to the need of distinct protocols and instructions. This complexity demands robust coordination, extensive training of all staff and commitment to preserve the highest standards of quality.
Lieke verifies that all internal departments are aligned (pathology, triallab, radiology, pharmacy amongst others) and that every team member is fully informed of their roles and details inherent to each trial. Given the unique nature of every trial but especially with patient safety as top priority, it is essential to keep the research team updated and aligned by regular training sessions and meetings. External partnerships are also managed to maintain a synergistic collaboration.
'If there is any issue or safety concern, we communicate immediately with the pharmaceutical company or its clinical research associate (CRA)’
From the very beginning of the trial, there is a consistent open line of communication with the pharmaceutical entity's CRA, who is responsible for answering any questions about safety or administration, and contacting the medical team to support any adverse circumstance. In the end, patient safety and adherence to the trial's protocol are everyone’s top priorities!
Setting the standard: what we can learn from successful trials
Lieke recounts an exemplary initiation of a trial: "Two years ago we started a trial that was very complex to set up, due to the several treatment arms and the high number of amendments.
Nonetheless, it showed actual results already during its primary end-point. Thanks to the data collected and the rigorous assessments we could reckon that the administered IMP was eligible for compassionate use outside the trial settings. This study is still active for further investigations/research, and the IMP is currently accessible.
The success of this study was determined not only by the efficiency in data collection and analysis, but also by a strong execution and close collaboration among all involved parties”.
As there are currently more than 60 active studies open for inclusion at the CRU, NKI offers a trial for each patient type. Given the complexity of creating customized protocols, the time spent and the number of people involved in a trial, to help us maintain success and efficiency we ask doctors that want to refer a patient to be aware of the inclusion criteria and the deadlines well in advance.
For a comprehensive understanding of the clinical backgrounds, and the intricacies of patient referral and selection, we invite our readers to stay informed via updates on our website.
