It is well established that a significant proportion of pharmaceutical clinical trials fail due to challenges with patient recruitment and retention.
In today’s society patients are more aware of their health and wellbeing, are technology-driven, and overall better informed, all of which is changing the way clinical trials are being approached and conducted.
The pharmaceutical and life science industries understand that patient participation is a fundamental requirement to the overall success of clinical trials are therefore proactively focusing on patient centricity. The concept of patient centricity is ensuring the patient is kept informed throughout the process, they understand the outputs of the trial, and minimise the burden on the patient. This enables pharma companies to meet patient expectations, improve trial success rates, and speed up the development timelines of new drugs.
One key outcome of this change is the move towards clinical trial decentralisation, where trials are built around patients in their homes, or in their community, through remote visits and monitoring. This offers significant advantages of convenience for the patient which in turn increases patient recruitment.
One approach employed is ‘smart sampling’ where patients receive a sample collection pack at their home where they follow the clear instructions provided, collect and package the required sample and send it to the laboratory for analysis.
Other clinical trials however are going one step further and are bringing testing to the patient’s home, or community healthcare centres, through rapid near patient testing. This approach is providing real time results, enabling quick patient enrolment, ensuring retention of participants, and empowering patients.
In addition, a study mentioned on biopharmadive.com noted that ‘drugs developed using patient-centric designs were 19 percentage points more likely to be launched’.
Lateral flow immunoassay technology is well placed to provide the solution for patient-centric testing in clinical trials, with its ease of use and rapid turnaround of results. With the advancement of lateral flow Smartphone reader apps, the portability of the device, and the data collection capability, provides a powerful solution for the pharma industry.
Lateral flow Apps have the ability to improve remote trial patient interactions via messaging, FAQs and questionnaire functions. Thus, aiding the collection of valuable information, a process that is lengthy and more difficult using traditional methods.
By breaking down the barriers of traditional clinical trials, patient-centric testing will help accelerate development of new drugs, it is likely that near patient tests will become the default practice for clinical trials in the future.
It is therefore important that medical device manufacturers collaborate closely with the pharma industry to fully understand patient compliance and regulatory acceptance, and to develop a device with high quality analytical performance, and a clear and robust data capture solution.
Published 8th October 2018
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