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E-BOOK
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Chapter 2: The crucial role of kit design in sample collection
DIVERSE SAMPLE TYPES AND PARAMETERS
or sponsors by entrusting laboratory management to the central laboratory. This optimized approach also benefits the specialty laboratories, allowing them to concentrate on sample testing as they receive cleaned, consolidated and inventory-proofed samples. In addition, it optimizes data flow as the central laboratory can consolidate patient and visit data, eliminating the need for multiple databases and associated data cleaning tasks. This not only simplifies data management but also facilitates easier data analysis for CROs and sponsors.
In early oncology trials, the extensive collection of diverse data, various sample types, and numerous parameters can complicate the need for multiple specialized labs and specific sample testing. However, factoring a central laboratory into the process can streamline operations significantly. Central laboratories take charge of the entire sample workflow, ensuring that the right pre-processed samples are efficiently delivered to the specialty laboratories. This eases the burden of the complex task of sample logistics on study sites, and lightens the load for CROs
WHAT TO CONSIDER DURING STUDY PLANNING
During the study planning phase, there are key considerations to keep in mind: 1. Scientific advice for parameter selection In early study planning, seek scientific guidance for parameter selection. Identify valuable
3. A meticulously designed study protocol Compile the gathered information to shape a thorough study protocol. Include alternative scenarios to address possible trial developments, such as assessing the benefits of an investigational medicinal product (IMP). Consider the implementation of a Secure Data Office (SDO) – an independent blinded group handling unblinded data transfers in support of IDMCs – if early-stage outcomes remain inconclusive. Gain insights into their standard processes, like sample fixation protocols, to avoid unnecessary work caused by protocol deviations.
parameters, address pre-analytical considerations (such as sample handling and required tubes) and assess the ability to anticipate logistical challenges. Additionally, consult experts for recommendations on suitable laboratories for specific testing. 2. Site selection and collaboration During site selection, connect with experienced research sites. Openly discuss the anticipated trial-related efforts – including lab sample complexities – and verify their operational capabilities, including infrastructure and skilled staff.
CONCLUSION
Early oncology clinical trials are characterized by their complexity and the extensive collection of data and samples. While these trials present challenges, they are not unfeasible. By carefully planning and considering the advice outlined in this article, and by working with a central laboratory, clinical trial stakeholders can navigate these challenges more effectively. This will lead to higher motivation among stakeholders, reduced errors, and ultimately, higher-quality trials. Most importantly, these efforts will benefit the patients, who are at the heart of every oncology trial, bringing us closer to more effective and personalized cancer treatments.
sample collection tubes and specific pre-analytical requisites – adding more layers of complexity. Amid these complexities, the minimal time given to site staff for collecting samples emphasizes the importance of being efficient and precise.
Oncology clinical trials are a critical frontier in medical research, providing insights into potential treatments that can save lives. However, these trials are no straightforward endeavor. They involve multiple blood-drawing time points and require multiple sample types – resulting in diverse
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