P43: Key Considerations for Patient-Centric Decentralized Trials
Principal Clinical Project Manager
LEO Pharma A/S Denmark
To demonstrate how new technology can be used to develop a patient centric approach to running decentralized clinical trials, ensuring patients can complete study procedures in their own time at their desired location and minimising any detrimental impact on data collection.
To ensure patient safety, solid data collection and minimise compliance issues multiple factors need to be considered before implementing a decentralised clinical trial. New technology offers alternative methods for data collection and monitoring compliance, so a different approach is needed
In order to implement our first full decentralised clinical trial in Psoriasis we conducted a full review of our processes and implemented new processes for key clinical trial aspects such as informed consent, data monitoring and cleaning, safety reporting, verification of eligibility and medical history and critical data endpoints. We discussed actively with regulators to ensure novel methods would be accepted. To ensure patient centricity, we worked with CRO and vendors to have a better understanding of patient needs. All stages of the clinical trial implementation were focused on optimising the patient experience and capturing the value enhancing the sue of included technology
From the development of the protocol through to data collection and assessment of endpoints we were able to make many changes to the conduct of our trial to ensure that patient requirements were met and that the clinical trial was easy for the patient to understand. We involved regulators along the process to ensure that we did not compromise on regulation and protected the patient both from a drug safety and data privacy aspect. We provide an overview of some of the changes and considerations needed to initiate these innovative clinical trials.