Bill Byrom, VP of product strategy and innovation at CRF Health will present at the DIA 2018 Global Annual Meeting on the use of mobile and wearable technology in clinical trials.
Ahead of the conference – which takes place takes place June 24-28 in Boston, MA – Outsourcing-Pharma.com caught up with Byrom to discuss the benefits and challenges of technology and how the industry can work to create meaningful change.
What would you say are the top three trends in clinical trials today?
We see a greater requirement for real-world evidence, often as a condition of post-marketing approval. While it is unclear the degree of real-world evidence that can be generated in earlier phases of drug development, there is a clear desire to understand effectiveness in addition to efficacy to aid regulatory approval decisions. This will impact the way we conduct components of our development programs in future, and we await FDA draft guidance on this topic in the coming years.
There also is increased interest in patient centricity – designing studies that are more convenient to participate in. Some of this involves changes in study design to enable place-shifting – conducting aspects of trials in alternative locations that are more convenient for the patient.
Much of this is facilitated by the use of remote monitoring and telemedicine technologies, but also through leveraging local healthcare facilities such as pharmacies and health kiosks. This will impact the way we design and conduct traditional site-based studies.
Lastly, new digital endpoints. Leveraging technology to learn more about patient health status and intervention effects. In particular the use of mobile, wearable and sensor-based technologies to obtain richer insights into intervention effects while measuring more frequently in home-based settings.
And in what areas will these have the greatest benefit?
eClinical technology has a significant role to play in executing and realizing the benefits of all the above top trends. Technology to make trial participation simpler, reduce the need to attend sites by enabling remote monitoring and telemedicine approaches, promises positive impact on patient recruitment and retention – both highly critical to the success of trials in meeting timelines and providing reliable data.
The increased insights we can obtain through more frequent home-based measurement, and new objective outcome data that was not possible before (for example, measuring tremor daily in Parkinson’s patients using the accelerometer within a smartphone), enables us to build a far richer and more insightful picture of intervention effects which will aid early decision making and contribute to labelling claims in future.
How will the industry need to work to make these more than trends, but changes with real value?
There are a number of initiatives, some of which I’m involved in leading, aiming to increase the adoption of wearable and sensor solutions to collect clinical endpoints in trials. This methodology work is important to facilitate confidence in the full-scale adoption of these solutions.
Pre-planning will enable much of the validation work required to validate new clinical endpoints to be delivered alongside Phase II and III studies. While adoption will take time, this foundational work is the key. We already see positive signals – the EU IMI DIAMOND project call, for example, seeks to bring together pharma and academia to validate new clinical endpoints associated with activity monitoring.
What are some of the latest developments?
One of the more exciting areas is the leveraging of existing technologies in new ways to collect health outcome data.
How have these developments furthered the “Bring Your Own Device” (BYOD) movement?
The BYOD movement has been encouraged by the growing ubiquity of the smartphone. A key barrier, however, has been confidence that displaying a measure on screens of different sizes will ensure that the intended measurement properties of the instrument are maintained when transitioned from paper
Of course, BYOD is not the answer for every study and there still remain studies where providing a dedicated handset to each patient is the solution of choice.
What are some of the challenges of BYOD, in addition to its advantages?
Migration display validity is a challenge – as described above. Also, technical and practical considerations associated with data privacy, data security and the ability of the patient to adjust smartphone settings during the study. These are surmountable but need good solutions and training to mitigate.
As for advantages, in general, it’s thought that enabling the patient to use their own device will provide added convenience which may improve ePRO completion rates.
How can the industry work to keep pace with the rapid advancements in technology?
Adopt a culture of exploring new technology implementation within trials in an exploratory way.
Sharing experience and information to the benefit of the wider clinical research community and enabling others to share the evidence supporting the use of new technological approaches.
And how will it need to balance these advancements without adding to the complexity of clinical trials?
In all cases, we won’t add technology to trials without reason – technologies should map to study objectives, and in the case of endpoints enable the measurement of specific concepts of interest.
There is a balance between adding complexity for sites and burden for patients, with the additional information that can be learnt through the use of new technologies to collect new endpoints.
Researchers should balance the value of the information with the potential impact on trial complexity and burden on a study-by-study basis. In many cases, however, we aim to reduce burden and complexity through the use of technology.