Challenges for Decentralized Clinical Trials: Will they be effective?
Many life sciences organizations had to quickly adopt remote data collection processes and technologies while conducting clinical trials during the Coronavirus pandemic. This was done to keep clinical trials running and to ensure patients’ safety. Consequently, a lot of organizations adopted decentralized clinical trial models in 2020—something which wasn’t done before. As such, certain challenges for decentralized clinical trial will need to be overcome.
Now, one big question is, ‘to what degree these novel approaches can remain in place once COVID-19 is under control?’.
Here, we highlight some of the challenges for decentralized clinical trials to address.
Data integrity and quality challenges in decentralized clinical trials
Newer clinical trial approaches are risky. In fact, sponsors typically state that preserving data quality while replacing accepted protocols and endpoints is extremely difficult. For example, wearable devices, ePRO (electronic patient-reported-outcome) tools, and apps require clinical and technical validation to ensure that sensors produce reproducible signals relevant to critical outcomes.
Since there’s no permanent criterion in place, decentralized clinical trials are still in their early stages. Although the regulatory landscape is changing constantly, clinical trial sponsors must align their research with the latest guidelines.
If you’re conducting a multi-regional clinical trial, you should recognize the restricted possibilities for variation in research methods and increased regulations. As such, every global clinical trial that implements decentralization must be designed with ample consideration for complexity and with a customized strategy.
In decentralized clinical trials, patient-centric trial designs are pivotal. Since not many patients are familiar with a clinical trial, decentralized elements like home nursing and data-capture devices can increase this feeling. In addition, patients differ in their inclinations for in-person physician visits as opposed to visits over the phone and their comfort and access to technology.
Therefore, sponsors must understand patients, establishing their needs before customizing the trial experience as per their demands.
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ClinicalPURSUIT’s features intelligent electronic data capture (EDC) technology that addresses the challenges of decentralized clinical trials. We ensure you obtain high-quality data using an intuitive, cost-effective solution.
Schedule a demonstration and see Clinical PURSUIT in action – see how our electronic patient-reported outcome software supports decentralized clinical trials!