'Achieving the impossible' is used in the title of your session, could you explain why you used this phrase?
There are many things that sponsors want to achieve with clinical trials and it can seem like an uphill challenge. Ensuring data quality is usually the primary desired outcome but on the way to that, clients also want to make sure that the participant population is diverse, the participant experience is positive, and that studies are completed quicker thanks to higher recruitment and retention figures. But consideration is also needed for the sites and ensuring the burden on the sites is kept to a minimum so that they continue to view research utilising mobile health strategies as a positive treatment option for patients. Balancing all of these considerations can seem to be an impossible task.
What do hybrid trials entail and what are the main advantages - and there are any disadvantages?
Traditional trials require participants to attend a physical location for their study visits. Traditional site models deliver high quality data, direct communication with patients, but the burden is significant for patients to take part.
A fully decentralised trial (DCT) is one where all the data is collected and patient evaluations performed remotely. But the perception or concern exists by some that some decentralized solutions such as mobile health can deliver lower quality data, less effective participant communication, and greater challenges for sites. Whilst the virtual/ DCT model may be the buzz word in clinical circles, facilitating as it can a more positive participant experience, the real challenge to advancement is to support and engage sites, so their experience of, and confidence in, a more decentralized model is positive.
A shift in balance to hybrid – combining site and mobile health - could be the holy grail. A hybrid trial is a mixture of the two, where at-site visits are complemented by remote data collection and mobile health visits, where it is safe and effective to do so. The desired results are high data quality, high quality participant communication through enhanced cross team collaboration, lower participant burden and, crucially, positive site experiences.
Is there still a lot of effort required to dispel the misconceptions surrounding these trials and why do you think some people remain wary?
Yes – uptake of decentralised solutions, even as part of a hybrid trial is still quite low. Part of this is because these patient management strategies are not always built into study protocols from the start and therefore understanding and expectations are misaligned. There have been concerns expressed around the quality and integrity of study data that is collected outside of the clinic setting and whether this will be deemed acceptable to regulators. In my presentation, I will give examples which clearly show it is possible to collect even complex data to the required standards within the home environment.
What can those in patient services do to ensure these trials are a safe positive experience?
A lot of this is about education and collaboration with the sites who are running the trials. It is critical for us to support sites and give clear guidance on what their roles and responsibilities entail when data is collected away from their clinic. Increasing site confidence and understanding of the technology and services, and the resulting data, will mean that sites are more willing to embrace these solutions and present them in a positive way to patients as options for how they can participate.
Why is retention better and what other improvements should be noted?
Options such as mobile health to allow visits to take place in the home, as well as provision of travel and expense reimbursement services to support patients where in clinic visits are either required or desired really help to reduce the burden on patients. We know that participation in trials is a huge commitment and that it is often a struggle to fit this round normal activities such as work and families. These services significant reduce the inconvenience to patients and mean they are more likely to remain on the study until the end. And because of this, fewer patients need to be replaced and studies are completed quicker – which is a huge benefit to clients. Additionally, the use of technology rather than paper to collect data has led to huge improvements in compliance and completeness of data sets.
Could you give some examples of the main positives mdgroup found from working with clients at home?
- Happy patients – reduced burden
- Happy sites – additional support ensures patients remain engaged in studies
- Happy clients – studies complete quicker, data quality is high