Ticking Boxes Following the guidelines for best practices within immuno-oncology trials can be made easier by following this comprehensive ...
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| Good Laboratory Practices
Ticking Boxes
Elizabeth Koury
Following the guidelines for best practices within immuno-oncology trials and Jeff Mayhew
at LabConnect
can be made easier by following this comprehensive checklist
With the advent of novel immuno-therapeutic The field of immuno-oncology (IO) Kiernan, pharmaceutical research analyst
approaches to cancer, the world has focuses on determining how to activate at Thomson Reuters, therapeutic cancer
entered a new stage of medicine. Rather pre-existing immune cells to attack vaccines currently comprise 14%
than targeting cancer cells directly with cancerous targets. Monoclonal antibody of IO clinical trials (1). Although many
traditional tools like chemotherapy or therapies have shown to be successful vaccine trials are in early stages,
radiation, immunotherapy seeks ways in many indications and continue to advancement has been made into
to use the body’s own immune system to be an effective and viable approach later stages, showing potential for
eradicate or inhibit the growth of cancers. to treating cancer. According to Beth desirable outcomes using this strategy.
12 l February 2018
To maintain control of specimen logistics, IO studies benefit from
sophisticated sample tracking systems combining point-of-collection
accessioning and global tracking with condition monitoring
Perhaps the most groundbreaking and Significant Research Complexities with condition monitoring. In this way,
rapidly expanding modality of IO is the study managers can accurately track
development of the utilisation of checkpoint IO studies pose a significant set of individual samples from collection through
inhibitors. Though the industry is just operational challenges for clinical research testing and/or processing and then to
scratching the surface of its promise, companies and their development teams. the sponsor for further study or into a
checkpoint inhibitors have profound These trials often comprise complex and biorepository for secure storage. In IO
implications on the future of oncological adaptive study designs that require the studies in particular, recognising the value
therapies, revolutionising the research collection of multiple specimen types of biological samples and guaranteeing the
industry. Checkpoint inhibitor therapies as well as specialised testing on different integrity and ready retrievability of each
are able to span across cancer types and platforms, such as flow cytometry, genomics, sample is imperative. Finally, development
stages, providing hope even in the most and antibody testing. Due to analytical teams must find new ways to collect,
despairing of circumstances. complexity, studies often require the organise, and analyse the staggering volume
utilisation of multiple specialty laboratories, of data produced during IO trials. Not only
Because of its promising outcomes, IO is a which – combined with tight turnaround must speciality lab data be integrated from
significant and growing segment of clinical timelines, the need to maintain specimen multiple, disparate lab datasets, it must be
research, but one that does not come integrity, and the need for sites that are available in real time for safety and efficacy
without challenges. Aside from the R&D geographically diverse – can lead to many assessments and be able to be visualised
of these therapies, identifying the most logistical challenges. It is not uncommon graphically to discover anomalies and trends
efficacious treatment regimen for each for development teams to be utilising that might otherwise go unnoticed.
indication poses numerous challenges. multiple specialty laboratories that –
As a result, combination studies have depending on the study – may be in Best Practices Checklist
increased dramatically, as have the volume different countries or even regions of
of studies, due to the potential of efficacy the world, additionally complicating Handling the central and specialised
of one therapy in multiple indications. customs and regulatory compliance. lab requirements is a significant project
Studies have become fast-paced and management challenge in IO research,
complex, requiring appropriate support To maintain control of specimen logistics, and it is one that is often augmented
from the beginning to the very end of IO studies benefit from sophisticated sample by specialised personnel or outsourced
all studies, as the race to the market and tracking systems combining point-of- entirely. The following is a checklist
the race to save lives is in the balance. collection accessioning and global tracking of best practices for sample and lab
www.samedanltd.com l 13Consistency is key in IO
trials, and one of the best ways
to maximise the value of samples
and data collected from a range
of different investigator sites is to
standardise clinical supplies and
collection procedures
14 l www.samedanltd.commanagement to ensure the success a variety of platforms. Only by mapping Future Outlook
of IO studies. sources, standardising formats, and merging
data can programmers achieve needed data With its new potential to make a significant
Dedicated Project Management consistency, accuracy, and usability. difference in patients’ lives, IO research is
IO trials have too many moving parts not to poised for continued growth. New methods
have an operational and scientific support BioVisualisation of action will come to light, and personalised
team dedicated to handling the testing, When sample management and integrated therapies will become a standard of care.
sample management, logistics, and lab data management are combined with data
oversight aspects of a study. Dedicated visualisation programmes, complex data All indications are that IO trials will become
project managers with experience in becomes more accessible, understandable, even faster paced, more complex, and data-
logistically complex IO trials and scientific and usable. Data visualisation programmes centric in the future. To accommodate the
project managers with platform-specific enable researchers to query clinical unique needs of these studies, development
experience for lab oversight can use their sample databases in real time, facilitate teams are best served when they identify
knowledge to streamline test schedules diverse, intuitive views of the most current and partner with central lab and clinical
and improve efficiencies, as well as oversee information, and provide alert flagging for development specialists who can provide
vendors, individual labs, and assays to critical sample analytes. comprehensive operational and scientific
ensure testing is being done properly. guidance during the time that protocols
Study-Specific Clinical Supplies are being developed.
Specialised Testing Experience Consistency is key in IO trials, and one of the
In addition to standard safety tests, IO studies best ways to maximise the value of samples Reference
require specialised testing capabilities that and data collected from a range of different 1. Visit: www.stateofinnovation.com/clinical-
are not likely to be available in local or investigator sites is to standardise clinical trends-and-challenges-in-immuno-oncology
even regional labs. Common platforms supplies and collection procedures. It is
and procedures include the following: important to make sure sites are supplied with
customised and standardised collection kits
• Flow cytometry that are easy to use, with all the components
• Cytotoxic T-cell assays clearly labelled for the specific collection Elizabeth Koury is Vice
• Cytokine/chemokine assays and profiling programme for which it is intended. Kits President of Scientific
• IF/IHC should also include detailed sample collection Affairs at LabConnect. She
• ELISA and transport instructions and contain is responsible for leading a
• ELISPOT preformatted air bills to appropriate labs team of scientists, sample
• PBMC processing to save time and reduce the risk of error. management professionals, and
• RNA/DNA extraction contract managers strategically supporting
Biorepository clients within the pharma industry. Elizabeth
Sample Management, Tracking, After analysis, samples must be maintained earned a bachelor’s in biology/allied health
and Logistics in varying storage temperatures on a short- from Elizabethtown College, US, and a
To be research-viable, IO sample logistics must or long-term basis both as insurance against master’s in pharmaceutical chemistry from
be tightly controlled from sample collection, possible regulatory inquiries and as vital keys Lehigh University, US. She has more than
to transport, to eventual processing, analysis, to future research. After initial testing and 20 years of experience in conducting and
and storage. Chief among the best practices analysis, samples should be secured in a state- overseeing scientific research in the areas of
to preserve sample and data integrity is the of-the-art biorepository that is constantly neuroscience, oncology, and immunology.
development of a comprehensive logistics monitored to ensure sample integrity and Email: ekoury@labconnectllc.com
plan before the trial begins by identifying the that is tightly controlled so that both samples
labs, procedures, and couriers necessary to and their annotated data are always accessible Jeff Mayhew is Chief
a successful outcome. Virtual accessioning for prompt retrieval and shipment. Development Officer at
of each sample at the time of collection and LabConnect. As one of the
monitoring the location and condition of each Global Presence founding partners in 2002, he
one during transport are vital to maintaining Owing, in part, to a shortage of patients has three decades of operations
the integrity of the sample and the study. for clinical trials, IO studies are increasingly and business development
global, with many taking place in experience within the healthcare industry.
Data Integration multiple regions of the world. Because of Before starting LabConnect, Jeff was founder
Reliable lab data is essential in clinical research. complications with sample stability and and Director of Nexus Health Management
In IO trials, this is further complicated by the turnaround time, logistics are simplified International, where he was involved in the
frequent utilisation of numerous speciality when the lab is in relative proximity to the development of inpatient behavioural health
labs to support their analytical requirements. investigator site. Depending on the size and services in Southeast Asia. Prior to that,
The clinical data integration process scope of the study, an outsourced partner he served as Vice President of Strategic Alliance
involves developing an infrastructure and with access to a network of labs around the Development for Charter Behavioural Health
coordinating programming, coding, cleaning, world and an understanding of country- Systems, among other key leadership positions.
and conditioning data that may come from specific requirements can streamline studies. Email: jmayhew@labconnectllc.com
www.samedanltd.com l 15You can also read
