Patient-centric blood sample collection to enable decentralised clinical trials and improve access to healthcare

The overall aim of the project generated from this topic is to create and validate the infrastructure and logistics for blood collection by the patient and/or caregiver at home as a healthcare tool and an alternative to the current gold standard venous blood for routine clinical assays. This project will employ only commercially available CE-marked microsampling devices, according to their intended use. The development of new devices for blood sampling or of new clinical assays / analytes is not the focus of this project, and no new clinical assays will be evaluated. Similarly, given their current maturity, home sample analysis is out of scope.

Training materials, customised for patients and caregivers as well as for medical personnel will be developed, ensuring the acceptability of the new approach to these groups. Interactions with regulatory authorities, the European Medicines Agency (EMA), local European agencies as well as regulatory agencies from non-EU European countries and the US Food and Dr

Collecting venous blood samples for diagnostic purposes has been the cornerstone for informing patient care and a key element of clinical trials. Ordering a blood draw has become almost a reflex for clinicians and drug developers, however venipuncture is still the traditional way to collect blood. Venipuncture can be painful and requires individuals to see their healthcare provider or visit a clinic. This results in a burden on patients, doctors, healthcare systems, payers, and the pharmaceutical industry. A particularly high burden may be imposed on vulnerable populations such as children and elderly individuals, as it may lead to increased exposure to disease during a pandemic, or to anaemia (e.g. in oncology). Furthermore, the current procedure is too inflexible to allow for ongoing monitoring for treatment, progression, or intervention in decentralised clinical trials and clinical practice ¹. There is a great need for the acceptance and implementation of patient-centric (as opposed to clinic