The concept of decentralised trials isn't new and clinical trials are increasingly adopting ways to enable trial activities to take place in a patient's own home, but is this the future of research?
The Covid-19 pandemic has changed the way research can be conducted. Many trials that were designed pre-Covid were unable to continue as they were originally set up due to restrictions on access to hospitals and Primary care settings, greater pressure on clinical space and a reduction in capacity within healthcare delivery. The way patient's view their care, and how they access it, has also changed, and more people than ever before own a mobile phone or smart device with an estimated 85% of the European population being mobile subscribers. For vulnerable patients or those with reduced mobility, there is a hesitance to attend appointments in healthcare settings that they may deem unnecessary to their care. This can not only have a detrimental impact on patient recruitment and retention in studies conducted solely through face-to-face contact in hospitals and GP practices, but also bias results where particular patient groups are reluctant to take part in clinical research due to the study design.
So, is a Decentralised Clinical Trial (DCT) right for every study? A systematic review of methods used to conduct DCT's analysed the advantages, disadvantages, facilitators and barriers to DCT's. The review was based on trials conducted remotely with minimal face to face contact with participants. The theme of many of the disadvantages was categorised by lack of communication opportunities, relationship building and researcher control over data collection. However, this type of trial design offers a pragmatic approach that combines the use of technologies and trial delivery in patient's own homes. The review demonstrated better generalisability of results, faster answers to clinical questions, improved self-management in patients, and broader access to research. For patients that may not otherwise be willing to participate, trial designs that enable patients to access research in their own homes can increase the breadth of eligible trial participants, improve recruitment and retention, answer the research question in real world settings, and most importantly, offer more patients the opportunity to take part in research.
At PCR Alliance we are passionate about supporting a Hybrid approach to Research when needed. This type of trial design overcomes many of the challenges faced by decentralised trials and enables a higher level of oversight of trial activity and conduct. We believe that all patients should have access to research and aim to remove the barriers and limitations faced by traditional trial design.
We have our own mobile clinical trials nurses to support practices when on site trials would do better with some home visits.