How the COVID-19 pandemic is changing clinical trial conduct and driving innovation in bioanalysis.

Thousands of clinical trials all over the world were stopped, disrupted or delayed while countries grappled to contain the pandemic and research resources were redeployed. The long-term effects of the turbulence caused by the pandemic have yet to be fully understood, but it should already be clear that the increased focus on participant needs and on the logistical challenges of current models are not likely to fade away quickly. This disruption is opening doors for rethinking traditional approaches to clinical trial conduct - including decentralizing site visits, introducing new methods of sample collection, rethinking matrix selection, reducing sample volumes and collaborating on device development. These approaches reduce participant burden while improving critical trial data.

The development of patient-centric sampling as an enabling technology for clinical trials.

Accessing patient samples using a whenever/wherever paradigm is needed to enable a better understanding of human biology and disease. The technology for convenient self-collection of blood samples by patients at home is quickly becoming available. The potential benefits of patient-centric sampling far outweigh the short-term challenges associated with implementation of this disruptive approach. This is especially true given we are amid a global pandemic and enabling patients to sample at home would help not only clinical trials, but healthcare in general. This perspective article aims to convince the reader that patient-centric sampling is a reality and that we are on the cusp of an information revolution in clinical trials that will be enabled by patient-centric (e.g., at home) sampling.