Multiple elements go into designing and carrying out a successful clinical trial; the appropriate participants must be recruited, consent forms processed and regulatory permissions granted. On the supply side, the investigational drug must arrive on time, along with any peripheral equipment. While all these aspects are crucial to ensuring a trial runs as successfully as possible, one critical task that tends to be overlooked is selecting the right clinical laboratory partner. The central laboratory concept was first implemented in the mid 1980s in the US, prior to which most testing was processed by local or regional laboratories and coordinated by each investigator. Clinical trial sponsors found gathering data from multiple local laboratories that used different testing methodologies, reference ranges and standard operating procedures (SOPs) increased the possibility for errors in the data, method, reagent and reference range changes, leading to lengthened timelines along with increased testing costs.
“Central laboratories play a crucial role in global trials,” says Tara Lehner, vice president of clinical operations at INmune Bio. “They help to standardise results for safety and in certain studies, efficiency.” Once the benefits were realised and the world became more globalised after the end of the Cold War, more and more central labs were set up across Europe and North America, and shortly after in the Asia-Pacific region – where many companies look to for partners due to lower costs.
“The speed at which samples are tested and collected are big factors. Lots of companies and hospitals have big problems with couriers not turning up, the wrong paperwork being filed, and, of course, Brexit has [had] an impact on this and the increased cost of petrol has pushed up costs a lot too.”
Christina Hamilton
A critical partnership
Of course, picking which central lab to partner with isn’t as simple as it sounds. “Choosing the right partner requires several criteria, including working with a group that understands your objectives, can meet your timelines with the correct cost and quality, and will think critically about what you are asking them to do, and push back if it doesn’t make sense,” Lehner explains. One marker of competence among central labs is accreditation. In the UK, for instance, the United Kingdom Accreditation Service (UKAS) assesses the testing, calibration, sampling and measurement services performed by labs to ensure they operate at the highest possible standards. Outside of accreditation, Lehner emphasises looking for a solid reputation and track record of working with industry partners. “This is important, especially over the past three years when so many labs struggled to maintain supply and personnel,” she says. “We are looking for partners and collaborators for our work, so reputation and references matter.”
Global problems
Reputation and services offered by a lab aren’t the only things that clinical trials operators need to take into consideration when choosing which central lab to partner with – especially as economic circumstances have placed a heavier emphasis on cost. “Costs and timelines are crucial when picking which lab to partner with,” says Christina Hamilton, senior CRA at Caritas Science Solutions. “Bigger companies can afford to use central labs more, but at the same time, smaller companies need to outsource to central labs as they do not have their own labs. The speed at which samples are tested and collected are big factors. Lots of companies and hospitals have big problems with couriers not turning up, the wrong paperwork being filed, and, of course, Brexit has [had] an impact on this and the increased cost of petrol has pushed up costs a lot too.”
As well as trial specific capabilities, data handling and reporting can also play a key role in choosing a lab with which to partner. “Some sponsors need real-time results transferred daily into their online tools,” says Lehner. “Others are fine with set transfer timelines and may not see data for a long period of 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 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.
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.
