Role of a Central Laboratory in Clinical Trials - WHITE PAPER | AUGUST 2021
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Role of a Central Laboratory
in Clinical Trials
WHITE PAPER | AUGUST 2021
© GreenLight Clinical 2021
Role of a Central Laboratory
in Clinical Trials
Types of Laboratories
In broad terms, there are two types of A Local Laboratory is one located close to the
laboratories that may be utilised during clinical trial site, normally within a hospital wing
a clinical trial: a Central Laboratory and or within a short distance. Sites may choose to
a Local Laboratory. use a local lab to get a fast turnaround time of
participant results (within hours of collection)
A Central Laboratory, as its name implies,
if required. While eliminating the disadvantage
is a laboratory where all the samples from the
of having to courier samples from one site to
clinical sites involved in a trial are sent. This
another, Local Laboratories do not normally have
may create logistic problems, depending on the
a complete range of diagnostic facilities. This then
location of the Central Laboratory in relation to
necessitates the use of another Local Laboratory
the site(s). However, the Central Laboratory is
to conduct some of the other tests required,
set up to run all the laboratory tests requested
which often leads to inaccuracies due to different
by the sponsor and uses validated machinery,
equipment; operating procedures; reference
standardised methods and reference ranges, and
ranges;and reporting methods being used.
trial-specific testing kits. This ensures consistent
results and analyses. Central Laboratories are Other benefits using a Central Lab over a local
also equipped with modern electronic data lab include:
storage and transmission facilities.
• For reporting purposes, Central Labs can
perform study specific blinding, create alerts
and flags, as well as apply customised study
specific reference intervals.
• Central Labs have a dedicated project manager
who manages all aspects of laboratory testing
and is a dedicated point of contact for sponsors.
This is not offered by local labs.
Image: https://medlineplus.gov/lab-tests/liver-function-tests/
ROLE OF A CENTRAL LABORATORY IN CLINICAL TRIALS
WHITE PAPER | AUGUST 2021 © GreenLight Clinical 2021 | 2
What is the function of a Clinical Liver Function
Laboratory in Clinical Trials? This is assessed by examining levels of Total
protein, Albumin, Bilirubin, Alkaline Phosphatase,
There is a myriad of clinical tests that a sponsor
Gamma Glutamyl Transpeptidase, Alanine Amino
may request during a clinical trial, which cover
Transferase, Aspartate Amino Transferase,
a multitude of indications from adrenal hormone
and Ammonia. A properly functioning liver is
profiles at one end of the spectrum through to
essential since it is often the primary site of
urine analysis at the other end (excuse the pun).
IND metabolism.
Participant safety is of paramount importance
in a clinical trial, and it usually involves the Renal Function
three musketeers of laboratory tests: Complete
Blood urea nitrogen, creatinine clearance, serum
Blood Count; Liver Function; and Renal Function.
creatinine, glomerular filtration rate, albumin,
Urinalysis and Coagulation testing is common
glucose, minerals (phosphorous, calcium),
for safety testing. Serology testing is also done
and electrolytes (sodium, potassium, chloride,
for screening patients for Hep B, Hep C and
bicarbonate) are normally assessed to ensure
HIV infections.
the participant’s kidneys are functioning properly.1
This is particularly important since the kidney
Complete Blood Count is often the site of excretion of the IND.
This comprises White blood cell count (WBC),
WBC differential count, Red blood cell count (RBC),
Haematocrit, Haemoglobin, Mean corpuscular
volume, Mean corpuscular haemoglobin, Mean
corpuscular haemoglobin concentration, Platelet
count, Mean platelet volume, and RBC distribution
width. These tests are essential in ensuring that
a participant’s baseline measures are within the
normal range for a healthy individual prior to
entering into the trial. Regular blood sampling
conducted during the trial can indicate if the
Investigational New Drug (IND) is exerting an
adverse effect on these blood parameters.
1
https://healthtalk.org/kidney-health/how-and-why-is-kidney-function-monitored#:~:text=Kidney%20performance%20is%20
measured%20using,glomerular%20filtration%20rate%20(eGFR).
Image: www.medicalgraphics.de
ROLE OF A CENTRAL LABORATORY IN CLINICAL TRIALS
WHITE PAPER | AUGUST 2021 © GreenLight Clinical 2021 | 3
Our Laboratory’s
Many Advantages
OUR BACKGROUND
In March 2020, we commenced construction
of our Central Laboratory, equipping it with
state-of-the-art, high throughput equipment
to undertake all clinical trial testing, and
servicing it with experienced scientists and
technicians. Our experts!
In June 2021, we received ISO17025
accreditation from NATA.
With outputs sourced from central or local
laboratories often taking up more that 40% of
data collected in clinical trials, any inefficiencies
can have wide-ranging effects on timelines,
deliverables, and reporting, all of which can
significantly impact a sponsor’s bottom line.
As sites and labs operate around the clock to
As part of our focus to help our clients advance collect and conduct the analysis needed for
their drug development programs, we’ve clinical trials, accessing the required resources
investigated what works – and what doesn’t and capacity for new trials with your central
– in terms of laboratory services for clinical lab partner can be challenging.
trials in Australia and how labs can help
Our Central Laboratory has the capacity and
sponsors and sites work through these issues.
the project teams to help you scale up quickly
to meet your corporate deadlines, get your kits
Start-up built, lab manuals finalised, data integration
set up, methods validated, and logistics sorted
With the recent huge influx of trials into Australia,
to get the job done!
the need for new, agile players in the Central
Laboratory space has never been more evident.
ROLE OF A CENTRAL LABORATORY IN CLINICAL TRIALS
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Communication
Prior to creating our Central Laboratory,
a fundamental step we took was to engage
with and listen carefully to our sponsors.
We identified the following Pain Points
associated with laboratories:
Pain Points using specialty labs in Australia:
• Too expensive
• At full capacity – unable to pick up a new
project with immediate start-up
• Cannot perform PK analysis in-house,
so it’s outsourced
• Cannot perform safety testing in-house,
so it’s outsourced
Pain Points using local pathology labs in Australia:
• Samples lost
• Sample analysis overlooked
• Unable to customise reports
Logistics
• Unable to cater for study specific requirements
With COVID still casting a long shadow over such as reference ranges, blinding, flagging,
day-to-day operations, global supply chains and alerts
into Australia remain impacted.
Pain Points using global central labs (that do not
The effects of fewer flights to key international have a lab in Australia):
locations on a clinical trial are wide-ranging.
• With COVID and less international flights,
The most visible impact is on the delivery of
kits don’t reach Australian sites in time
collection kits for resupply to sites, and the
and samples don’t reach labs in time
ability to ship samples for time-sensitive
analysis to overseas central laboratories. • Poor communication
• Unclear who to contact when an issue arises
With less international flights to key destinations,
at sites when immediate attention needed
our Sydney based Central Laboratory eliminates
• Difficulty with different time zones
the need to go overseas for critical kit resupply
activities and sample analysis. This removes
a potential bottleneck and turns your results
around quickly.
Our integrated Logistics team can coordinate,
update, and manage the process from our Sydney
office. Help is only a phone-call away and in the
same time-zone as your site and investigators.
ROLE OF A CENTRAL LABORATORY IN CLINICAL TRIALS
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What Sets Us Apart
Our central lab can provide a full suite of services,
tailor-made for your trial requirements. We can
leverage in-house services to drive efficiency,
speed, and cost reduction. We also provide a
complete Central Lab solution with the following
advantages:
• Standardised in-house methods of testing
and results ensure validity of results and
consistency in interpretation throughout
the trial
• Kit building department builds study, site,
and visit specific kits
• Dedicated Laboratory Project Manager provides • Our Logistics department contracts all courier
end-to-end clinical trial management service services to commercial 3rd party courier
and sponsor updates providers who have undergone and been
• Use of Laboratory Information Management approved by our vendor qualification
System/Laboratory Information System (LIMS/ • Managed and traceable supply chain uses our
LIS) that records and stores participant details logistics department – together with our trusted
(e.g., date of entry, demographics, specimen 3rd party couriers, we ensure timely delivery of
details), and Senior Systems Engineer execute kits to sites, samples are shipped under
monthly database maintenance and provide specified conditions (e.g., temperature),
continuous support and a better deal is secured for sponsors
• Reports are delivered • Close integration between other functions and
in real time Central Lab staff enables efficient and rapid
• Complete traceability resolution of potential problems/bottlenecks
of all samples at all • Ensure completion of study closeout procedures
times (e.g., archive essential documents, destruction
• Dedicated Central of kits and samples, ship and store samples as
Lab staff to assist requested by the sponsor)
site staff with lab • Fully customisable systems, processes to study
queries requirements
Like other labs, we offer Digital data input
and transfer, which mimimises errors.
ROLE OF A CENTRAL LABORATORY IN CLINICAL TRIALS
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Benefits of conducting your trial with us in Australia
The services we provide in Australia for your This time effective approach benefits sponsors,
trial are amongst the best in the world, with delivering lower costs and a faster time to market
state-of-the-art facilities, and assisted by the and the general population, with faster access to
Australian Government’s continuous investment new medicines and medical devices.
in infrastructure and research.
An additional benefit is that Australia abides
If you are a sponsor running a clinical trial in by ICH, ISO, and GCP standards. This means
Australia, and you have an annual turnover your trial results will be acceptable to global
of less than AU$20 million, the Australian agencies such as the United States Food and
Government provides a generous 43.5% Drug Administration and the European
return of your trial expenditure. Medicines Agency.
Australia has an efficient Ethics approval process.
This, combined with the TGA Clinical Trials
Notification Scheme, gets your trial up and
running significantly faster than in the USA
or European countries.
ROLE OF A CENTRAL LABORATORY IN CLINICAL TRIALS
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CENTRAL LABORATORY CASE STUDY
Oncology
Our Central Laboratory secured its first trial The sites were very responsive to the
for Laboratory testing for an Oncology study transition. Our Lab was complemented on
in September 2020. This was a multi-site the reports and the ease of use of the blood
rescue study, as the laboratory performing collection kits that were supplied. All safety
the work at the time could no longer continue. testing for the study was performed within
The testing required was general safety 4 hours of receipt into the laboratory.
testing as well as immunohistochemistry Reports were issued automatically. Any
staining on tumour biopsies to measure the patient-related demographic issues or
suppression of specific markers on the tumour discrepancies were dealt with immediately
tissue following treatment. Our Laboratory by our highly responsive project management
was equipped to perform all the testing team – ensuring no delays in getting the
required for the study using brand new, patient results back to the sites.
state-of-the-art equipment, including
Our Lab is also currently performing safety,
digital imaging for histopathology slides.
pharmacokinetics, and pharmacodynamics
The Lab set up a study specific database testing on other active clinical trials, as well
in record time to be able to accept the as a method transfer for pharmacokinetics
samples into the lab and proceed with on an upcoming trial.
a seamless transition from one testing
laboratory to another.
Patient Image Courtesy of National Cancer Institute (US)
ROLE OF A CENTRAL LABORATORY IN CLINICAL TRIALS
WHITE PAPER | AUGUST 2021 © GreenLight Clinical 2021 | 8
Contact us
134 William Street
Woolloomooloo NSW 2011
T: +61 2 9191 0640
E: info@greenlightclinical.com
www.greenlightclinical.com
Dr Priyashiel Parikh
Business Development Manager
E:priya.parikh@greenlightclinical.com
M: (+61)451 464 898
© GreenLight Clinical 2021
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