Outsourcing Partnering for oncology trials
When it comes to oncology trials, central labs play a critical role by providing specialised testing and analysis related to cancer research. The capabilities of each lab may vary depending on the specific focus and expertise of the facility. Therefore, being aware of the specific capabilities of the lab you may partner with is crucial to ensuring it is aligned with the objectives of the trial. Specific capabilities that are offered by central labs that specialise in oncology trials include:
■ Genomic analysis: With advancements in genomics, central labs may offer next-generation sequencing (NGS) and other genomic analysis techniques. These methods enable the identification of genetic alterations, including somatic mutations, copy number variations and gene fusions, which can inform personalised treatment strategies and clinical trial eligibility.
■ Pharmacokinetic and pharmacodynamic analysis: Central labs can perform pharmacokinetic and pharmacodynamic (PK/PD) analysis of cancer drugs used in clinical trials. This involves measuring drug concentrations in blood samples, assessing drug metabolism and clearance, and evaluating the drug’s effect on tumour cells or relevant biomarkers.
■ Liquid biopsy: Central labs may have expertise in liquid biopsy analysis, which involves the detection and analysis of circulating tumour DNA (ctDNA), circulating tumour cells (CTCs) or other cancer-related biomarkers in blood samples. Liquid biopsies can provide a non-invasive of tumour progression, treatment response and the emergence of resistance mutations.
■ Immune profiling: With the growing focus on immunotherapy in cancer treatment, central labs may provide immune profiling services. This can include analysing immune cell populations, evaluating immune checkpoint molecules, assessing immune response markers and measuring cytokines or other immune-related factors.
■ Tumour tissue analysis: Central labs may offer histopathological analysis of tumour tissue samples obtained from patients in oncology trials. This can involve examining tumour morphology, determining tumour grade and stage, assessing tumour heterogeneity and evaluating the tumour microenvironment.
■ Digital pathology and imaging analysis: Central labs will continue to embrace digital pathology and advanced imaging techniques to improve the analysis of tumour tissues. Digital pathology allows for remote access, automated analysis and integration with artificial intelligence algorithms, enabling faster and more accurate interpretation of histopathological samples and imaging data.
time. The best central labs will have the full spectrum of reporting capabilities, but [will] also continue to build to accommodate sponsor requests.”
The future of central labs Rapid advancements in technology and the rise of AI are also bound to have a significant impact on central lab capabilities. This could include the adoption of high-throughput sequencing platforms, advanced imaging techniques and automation technologies, enabling faster and more accurate analyses. Integration of artificial intelligence and machine learning algorithms can also aid in data analysis and interpretation.
The Covid-19 pandemic has led to an increase in the number of remote and decentralised clinical trials, which has made it possible for organisers to collect samples from patients’ homes and analyse them in local clinics. Central labs are still trying to adapt to this change by developing innovative logistical solutions, remote monitoring capabilities and streamlining sample collection and analysis procedures. Although global clinical trials are on the rise, not all central labs are able to accommodate the needs of these trials. “Getting samples collected and tested in time is very important, so the labs need to have a base near airports,” Hamilton explains. Currently, sample management and logistics are two of the biggest issues faced by central labs when it comes to clinical trials. “Logistics and supply chain are both issues that can derail the ongoing collection
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and analysis of samples,” says Lehner. “It is critical our central lab partners have expertise in this area and mitigation plans for when, and not if, something goes wrong. It is very important to have a vendor that wants to collaborate with us and manage issues head on, together.” In Lehner’s experience, it’s this level of preparedness that can set a central lab apart from the competition. “When an issue arises, we want our vendor to say: ‘this went wrong, and we’d like to discuss these two options we have,’” She adds. “This type of relationship builds trust, as it allows for both teams to be on board, collaborating and often finding a better way to work around it than either team would have found on their own.” While it’s unlikely that the importance of central labs in clinical trials will decline at any point, the way they operate is changing with the move to decentralised trials, and will continue to do so as new technologies become more established in the industry. Despite this, their core function of providing specialised testing and analysis services is likely to remain relevant for the foreseeable future. After all, selecting the right central lab is a critical decision that can significantly impact the trial’s success. By considering factors such as expertise, technology, regulatory compliance, logistics and cost, clinical trials sponsors can form effective partnerships that contribute to the wider discovery of innovative treatments and improved patient care. ●
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