Whether it’s the search for genetic markers, pharmacokinetics insights, or the monitoring of levels in late stage, end-of-life patients, decentralized clinical trials in oncology are complex, specialized, and highly sensitive. Today, though, the continuous development of point of care testing (POCT) offers the prospect of significant progress in multiple areas.
POCT is still the new kid on the block in decentralized oncology trials. But, just like its use in chronic kidney disease clinical trials, if current patterns continue then it is likely to have a transformational impact.
By analyzing blood, urine, nasal or even sweat samples, the latest POCT devices, such as the Pixcell HemoScreen Blood Test Analyzer, can provide lab-quality results in just minutes – away from hospitals and laboratories.
Currently, there are more than 150 tests that can be completed at the point of care and about 30% of testing is overseen using these hand-held, POCT devices. But in clinical trials, that figure is much lower. This is a clear missed opportunity. By using POCT in decentralized clinical trials, researchers can simultaneously support oncology patients and achieve:
- A dignified and more humanized approach
Cancer patients with a terminal diagnosis understand their future may be short. They participate in clinical trials not for themselves, but for those who come after them. When these patients are reaching the final stages of their disease, there is a huge emotional aspect to the giving of their time and attention. POCT allows these patients and trial participants to be placed on a pedestal and given the respect they deserve. Home nurse visits are conducted at the patient’s convenience and there is dignity inherent in every aspect of the testing, with patients avoiding waiting rooms and lengthy queues. Instead, each test is conducted as a special, one-to-one experience that recognizes the patient’s importance and value.
- Better qualified patients and higher recruitment rates
POCT enables doctors who suspect a patient might qualify for a study to quickly determine if they are correct. The doctor conducts the test using a handheld device, and within 10 minutes they have reliable results to indicate if a patient qualifies for a trial. This is crucial in today’s environment, where the inclusion and exclusion criteria for clinical trials are becoming increasingly complex and many researchers are reporting higher screen failure rates.
- Streamlined operational activity and increased momentum
The use of POCT in decentralized clinical trials can help to avoid lab tests and wasted spend on patients who ultimately do not qualify for trial inclusion. In an age where the average cost of bringing a new drug to market is $1.3bn(1), this is a major advance. Furthermore, by identifying the patient population quickly and accurately, POCT enables patients to get excited about being involved in the trial and establishes early momentum.
- No wasted time for patients
With POCT, patients are spared the time and costs of travelling to and from a clinical site. In some regions, travelling time can extend to several hours, so these are significant savings – especially when the patients may already be suffering extreme fatigue as part of their condition.
- A more diverse data set
POCT unlocks access to previously unreachable patient populations. Those who would have been either uninterested in giving up so much time, or were simply too sick to travel to a trial site, can now be included. POCT can also have an important impact on patient equity, enabling data to be gathered from different groups that may have previously been hard to reach. This helps to ensure clinical trials accurately represent the population of people who are going to receive a set drug.
Many of the tests required in oncology trials are specific diagnostic tests, including genetic tests and esoteric tests. These tests are beyond what would traditionally be seen as ‘routine care’ and have previously been thought of as too complex for POCT. Thankfully, POCT is quickly becoming more specialized, sophisticated, and technologically advanced, and it is now well capable of providing utility in decentralized oncology trials.
Contact us today to talk through your requirements for POCT in oncology trials. We’ll be happy to help.
1. Wouters et al. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA. 2020;323(9):844-853. Available here: https://jamanetwork.com/journals/jama/fullarticle/2762311