An important keystone of evidence-based medicine they may be, but clinical trials are becoming increasingly difficult to deliver.
There are several reasons for this, most notable perhaps are wider pressures within the NHS, challenges in ensuring representation of the broader patient population and a need to adapt and align with current care pathways.
Traditionally, a clinical trial would typically involve a physical study site at which all trial related activity takes place. Naturally then, that dictates that all participants need to physically travel to that site.
Decentralised Clinical Trials (DCTs) aim to move away from this approach to one where the need for participants to visit trial sites is reduced or completely eliminated through local delivery of trial components.
For example, monitoring blood tests can be done at GPs, patients can complete questionnaires online, and modern technology, for example smart fitness devices like a Fitbit or similar, can be used to collect data on activity or daily functioning.
DCTs are sometimes alternatively referred to as ‘remote’, ‘digital’, ‘virtual’ or ‘patient-centric’ trials and are gaining traction within the clinical research sector due to their potential to promote efficient, patient-centric and technologically enabled delivery of clinical trials. For a full DCT, all elements of trial activity are conducted away from the primary trial site. However, it is recognised that decentralisation is likely a spectrum and, for many trials, a hybrid model may be most appropriate to adopt due to sponsor and regulatory requirements.
The Covid-19 pandemic highlighted some of the vulnerabilities of the traditional clinical trial approach and accelerated change with some clinical trials, incorporating elements of decentralisation.
The need for reduced physical contact motivated the adoption of remote methods, some of which already existed pre-pandemic and began to define the ‘new normal’. It also helped that the Medicines and Healthcare products Regulatory Agency (MHRA) introduced more flexibilities during the pandemic. E-consenting, virtual patient assessments by phone/telemedicine, courier delivery of oral trial medications to patient homes and remote safety monitoring were all adopted by some trials during the pandemic.
Now, both the US Food and Drug Administration (FDA) and European Medicines Regulatory Network are taking steps to support the move to a decentralised approach and have published recommendations.
In March 2021, the UK government set out its vision on direction of clinical trial delivery. A key theme within this is for research to take on a more patient centred approach. The recent review by Lord O’Shaughnessy of UK commercial clinical trials further highlights the need to pursue new approaches facilitating more streamlined working and relieving pressure on the NHS. Much of this is potentially relevant to academic as well as commercial trials. The Government as part of their response, issued a notable recommendation to accelerate new and innovative ways to deliver clinical trials.
Distance to clinical trial site is one of the biggest barriers to patient participation in trials.
CRUK’s own Clinical Research Statement of Intent underscores a desire to work with researchers, government and the NHS to enable the best delivery of trials, and realise the opportunities afforded by new tools and technologies.