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Temporal cancer screening through conventional in vitro diagnostics can be time-consuming and laborious for both patients and healthcare providers. Aside from appointment time alone, the patient has to take time out of their day to travel to a facility for testing and wait an extended period of time for a central laboratory to process their sample in order to receive their results.
Logistical barriers such as these can deter individuals from getting these tests on a regular and timely basis. Early detection is pivotal to minimizing tumor progression and developing successful treatment plans, and there is an evident need for more accessible and convenient methods to screen for cancer. Point-of-care (POC) diagnostics offer just that.
POC oncology diagnostics are tests performed at or near the site of where a patient receives care without the – whether that’s in the comfort of their own home or a nearby urgent care clinic or community testing center. These innovative tests provide results rapidly, allowing for quicker diagnoses and clinical decision-making.
Some of the primary targets of POC cancer screening tests include proteins related to a tumor itself or the body’s response to a tumor, immunoassays, and other biological markers associated with cancer development.
In addition to the convenience and lower time investment these tests provide, they offer many other advantages to oncology screening, including:
Developing these novel diagnostics involves the creation of tests that are innovative, convenient, and highly accurate. In creating clinical research plans for POC oncology diagnostics, researchers should ensure their studies produce the following:
Studies should evaluate the clinical utility of POC oncology tests in all settings they are intended to be performed. This involves recruiting a patient population representative of all the patients who may benefit from these technologies, including various stages of cancer. If ultimately the diagnostic being researched is intended for individuals to use in the comfort of their own homes, a decentralized clinical trial (DCT) model may be adopted. However, for devices that should operate in a variety of different settings, a traditional model involving physical sites will produce more accurate data of its usability.
POC diagnostics are known for their fast turnaround of results. Their clinical trials must not only assess the accuracy and reliability of the results produced, but also the speed of delivery. Cancer can have the ability to progress rapidly, so it is vital that the time it takes to deliver test results meets the practical needs of treatment decision-making. It is also important to ensure there is little variability in the time it takes to produce results.
Part of the convenience POC oncology screening provides is attributable to the fact they can be used by individuals who don’t come from extensive laboratory backgrounds. The development of a test that minimizes user error is crucial to obtaining the most accurate results possible. Test instructions should be as simplified as possible, providing clear and succinct instructions. Sponsors and contract research organizations (CROs) conducting clinical trials for POC cancer detection tests should promote an open line of communication between research teams and patients to address any questions and concerns on how the device is used. Short, step-by-step instructional videos may also be incredibly useful to supplement written instructions.
In addition to being user friendly, these devices shouldn’t induce drastic changes to clinical workflows or require extensive preparation of patients. Clinical trials for POC cancer screening technologies should consider investigating alterations in healthcare delivery, including changes to staff roles to accommodate the utilization of these diagnostics, delays in treatment as a result of integrating new technologies and processes, and more to verify acceptance in clinical practice.
A diagnostic should exhibit high sensitivity and specificity in detecting cancer biomarkers under rigorous testing to ensure patients and healthcare professionals are receiving the most accurate results to make informed decisions pertaining to cancer management and treatment. Clinical research for these POC tests should aim to produce results that can be replicated under a range of clinical conditions and sample qualities. It can be especially beneficial to conduct a trial comparing the “gold standard”, or a diagnostic device already being widely used to detect the same type of cancer.
Beyond measuring their accuracy, these devices should also measure factors such as clinical decision-making and patient outcomes. For premarket clinical trials, obtaining this data can be achieved through incorporating patient questionnaires into the trial’s schedule of assessments. Post market surveillance of POC cancer tests can also further analyze qualitative factors as such.
POC diagnostics have the potential to redefine the way patients receive information regarding their healthcare. The POC diagnostics market as a whole, including oncology, was valued at $49.7 billion in 2023 and is only projected to grow in the coming years as a result of the increased incidence of acute and chronic disease worldwide.
Designing oncology diagnostics fit for real-world settings is crucial to reducing the disease prevalence of cancer on a global scale. Diagnostics companies contributing to the mission of fighting and preventing cancer through POC technology must cater to the uniqueness of these products and their stringent regulatory nuances to enter the market and benefit patients.
Ready to enjoy working with your diagnostics CRO? Lindus Health offers the full suite of CRO services and technology through their “All-in-One Diagnostics CRO” offering. Click here to learn more, or contact us today to discuss your research.
