Whether you come from a clinical operations or a commercial background, you are undeniably aware of the challenges bringing a new medicine or a new indication to the market. Often innovative solutions are suggested such as data mining, using artificial intelligence or biomarkers. However, considerable resources are required to deliver a study with such solutions.
In our view, we should first be asking ourselves if we are getting the basics right every time in clinical trial execution as far as the patient is concerned? For example, the relationship between the patient and the principal investigator is critical. Additionally, the previous experience of the research nurse and good site management will also affect the study outcome.
Depending on the number of site visits, and the monitoring required, one solution increasingly offered to support trials is a domiciliary (home) visit to the patient. The research nurse and principal investigator coming to the patient, rather than the other way round, is nothing new. Sometimes this cannot be achieved due to the number of technical interventions required, such as a CT or MRI scan, which are only available in the hospital setting in the UK.
However, where high tech interventions are not required or required only initially, it makes sense to consider a domiciliary (home visit) approach. Modern protocols often require significant patient monitoring; much of this can be delivered in the patient’s home. Advantages include improved patient experience, better patient retention, wider inclusion of the local population and a more natural setting for the patient.
In the US, domiciliary visits are increasingly used to improve patient engagement and the overall study experience. Patients can be put off from enrolling in studies if too much travel is involved. This practice is also becoming more popular across Europe and the UK.
A domiciliary team offers a highly flexible resource able to visit patients in their own homes in order to either recruit them into a study or carry out other visits. The advantages of being able to see patients in their own home include:
The approach makes sense for many studies, including paediatric and elderly trials and equally beneficial in vaccines and longer-term studies. Sometimes trial sponsors will not have considered this approach. Indeed, many investigators are not aware this service is available in the UK. I would strongly recommend considering this option when planning a trial, during the protocol writing phase or earlier. Ask the following question - Can the study build in-home visits from the start or further into the trial?
CHASE clinical offer domiciliary visits and we would be happy to discuss how we can support your study with research nurses or study facilitators. To find out how CHASE clinical can deliver effective home visits for your current or future clinical studies, please contact Andrew Mills on + 44 (0) 7776 656 454or firstname.lastname@example.org