Ticking Boxes Following the guidelines for best practices within immuno-oncology trials can be made easier by following this comprehensive ...

Page created by Jesse Gill
 
CONTINUE READING
Ticking Boxes Following the guidelines for best practices within immuno-oncology trials can be made easier by following this comprehensive ...
Images © Freepik
                                        | 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
Ticking Boxes Following the guidelines for best practices within immuno-oncology trials can be made easier by following this comprehensive ...
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   13
Consistency 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.com
management 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   15
You can also read