Editorial
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Point-of-care and utility in clinical trials:
making quicker decisions to transform
patient care and drug development
Saloumeh K Fischer*,1
1
Assay Development & Technology, Genentech Inc., 1 DNA Way, South San Francisco, CA 94080, USA
*Author for correspondence: Tel.: +1 650 225 4153; Fax: +1 650 2251998;
[email protected]First draft submitted: 8 June 2020; Accepted for publication: 26 June 2020; Published online:
31 July 2020
Keywords: chimeric antigen receptor T cells • coronavirus • COVID-19 • gyroslab • millipore SMCxPro • POC •
point-of-care • quanterix simoa
With the staggering costs of drug development, it is important to find strategies to reduce costs. The US Department
of Health and Human Services estimates that the total cost across Phases I, II, III and IV of a clinical trial can
currently range from 40 to US$100 million (depending on the therapeutic area) and is steadily increasing. It is also
estimated that only one in ten drugs that start clinical trials are expected to enter the market [1]. For companies
to remain competitive, and to continue to make life saving drugs available to a wider patient population, the
costs and odds of success for clinical trials need to improve. One of the challenges in drug development is patient
recruitment. Patient enrollment is reported as the most time-consuming aspect of the clinical trials. This is in
part due to many clinical trials taking place at the same time for the same indications and looking to recruit from
the same pool of patients. It has been reported that 20% of cancer clinical trials fail due to inadequate patient
recruitment. According to Tufts Center for the Study of Drug Development, two-thirds of clinical sites do not
meet enrollment requirements for individual trials [2]. One strategy used to improve these odds is to increase patient
access and convenience to clinical trials and by enabling faster decision-making.
Can the concept of POC be used to increase patient convenience, increase patient enrollment
in clinical trials & reduce drug development cost?
Point-of-care (POC) or bedside testing is not a new concept and has been in use as a diagnostic tool for chronic
diseases such as diabetes, where regular monitoring and a need for frequent blood tests are required for more
effective care [3]. Other uses include POC to assess fertility, evaluate cardiac markers [4] and test for infectious
diseases such as the newly US FDA approved Abbott POC detection of coronavirus (COVID-19) [5]. POC testing
has many advantages. In addition to increasing healthcare access for patients, in particular in rural areas where
POC testing may be the only way of advanced testing, it can also be used for testing/monitoring home-bound
patients and enable better and faster decision-making by physicians. Another advantage of POC is for personalized
healthcare. For example, POC can be used for individualized therapeutic drug monitoring allowing for immediate
dose adjustments that could potentially increase efficacy of some drugs [6,7]. One example is development of rapid
POC tests such as the Quantum Blue R
for determination of adalimumab concentrations [8] allowing clinicians
to make quicker treatment decisions. Successful implementation of POC has also been shown to greatly reduce
healthcare costs [5]. Introduction of POC troponin testing, for example, has been able to reduce the length of stay
in the hospitals and fewer costly procedures, resulting in a 25% saving on the costs per patient [9]. POC testing has
been successfully used for triaging patients with human respiratory syncytial virus impacting therapeutic decisions
as well as isolation procedures to significantly liberate capacity during epidemic periods [10].
There are clearly many examples of how POC testing has been successfully implemented. However, the POC
market has remained very limited in utility, and driven mainly by the diagnostic market. This is in part due to the
rigorous process required to get a POC assay through all the regulatory steps. Getting approval for these tests can
be a daunting task that is expensive, time consuming and therefore impractical for use in pharma.
10.4155/bio-2020-0159
C 2020 Newlands Press Bioanalysis (2020) 12(15), 1039–1041 ISSN 1757-6180 1039
Editorial Fischer
Can POC devices be used just as another new technology for drug development?
By ensuring that the devices meet the installation qualification (IQ), operational qualification (OQ) and per-
formance qualification (PQ) standards for installation, operational and performance qualification, respectively,
as well as having a 21 CFR Part 11 compliant software, they could be used as another novel technology tool.
There are currently technologies available for high sensitivity, such as the Quanterix Simoa platform and Millipore
SMCxPro or for low volume, such as Gyrolab technology.
Why not a technology for faster turnaround time?
Although there are technologies that can deliver fast automated assays, one of the advantages with POC is the
ability to get individual patient results without having to batch samples.
Applying the POC concept to clinical trials is appealing as it simplifies the more traditional central lab testing
by eliminating many of the time consuming steps typically involved in the processes, including sample collection,
transportation to the testing lab, performance of test and transfer of the results back to the sponsor. By eliminating
some of the sample handling steps, including costly shipments, these technologies can reduce costs while potentially
help to minimize time-dependent changes in labile analytes (caused by delays in sample transport) and provide
faster turnaround times, enabling faster decision-making. This is a long-term vision, and requires POC technologies
that can produce clinical lab quality assays. It will also require changes to our processes and ability to implement
those at clinical sites. One approach would be to have a gradual implementation process where one assay from a
panel of assays used in a clinical trial would use a POC device. This device could be placed at the central lab, where
the samples can be evaluated as they arrive. Eventually however, the units would be placed at each clinical site
for analysis. This is a very ambitious idea, but could have a game changing impact on the future of clinical trials,
making drugs and clinical trials more accessible to patients at lower costs.
The POC technologies have made great progress in the last decade and can provide instant results with reliable
precision and accuracy comparable with central labs [11]. So appropriate technologies are available. They can
also be used in monitoring and making quick decisions on dosing and dose escalation when there are adverse
reactions associated with treatment, as in cytokine release syndrome observed with immune-based therapies, such
as checkpoint inhibitors, bispecific T-cell engaging antibody constructs and chimeric antigen receptor T cells.
Having immediate actionable results has the potential to positively impact patient care and clinical trial timelines.
The good news is that appropriate technologies are available and improving every day to address a clear need in
patient care. The challenge is their uptake and implementation into our current healthcare and established clinical
trial models. As the potential benefits of these technologies in patient care can be huge, there is a need to overcome
the barriers to implementation. This challenge requires multidisciplinary and multimodal approach involving
collaboration between all stakeholders.
Financial & competing interests disclosure
The author is employee of Genentech, a member of the Roche Group. The author has no other relevant affiliations or financial
involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials
discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
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Point-of-care & utility in clinical trials: making quicker decisions to transform patient care & drug development Editorial
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