The Role Of The Clinical Trials Translational Lab In The New Era Of Clinical Trials

Background
Drug development in oncology is shifting from a one size fits all towards a more personalized, biomarker-driven approach. In order to facilitate this important shift, tissue acquisition from research biopsies and biological sampling requirements are crucial for exploring the impact of novel agents and retrospective analysis of biomarkers. In recent years, there has been an increased demand for high quality archival and fresh tumor tissue in oncology clinical trials for patient driven correlative studies. The clinical trial translational lab supports all biological sample requirements and assures strict quality control to streamline the process.

Objectives
To ensure that all biological samples required by the protocols are of the highest quality possible.

Methods
Standard operation procedures have been defined including:
-The Translational Lab staff review protocols to assess the feasibility of the specific requirements and are present at trial initiations ensuring that samples are being processed according to the protocol.
-The translational lab staff coordinates procedures with dedicated interventional radiologists and surgeons. Lab personnel are present at all trial related procedures in order to inform the radiologists/surgeons of the specific requirements for each trial, obtain high quantity and quality samples requirements.
-The translational lab is also responsible for archival tissue. Dedicated pathologists assess all newly obtained biopsies. The pathologists determine the tumor cell percentage and count the number of malignant cells in an expeditious time frame.
-The lab handles all other biological samples including blood, urine, fecal and buccal samples.
The lab is capable of performing all necessary processing methods including PBMCs separation, DNA/RNA extraction and can support pre-clinical models such as in-vivo work.

Conclusion
In the new era of oncology clinical trials, our translational lab offers an important platform to support all clinical trials and their requirements including pre-clinical models, investigator initiated trials, retrospective analysis of samples and correlative studies.