We are seeing a strong push to focus on incorporating the patient voice in drug development, after all, as Janet Woodcock, of the FDA has said, it is patients who are the true experts in their disease, and
“It's clear you have to start with an understanding of the impact of the disease on the people who have it, and what they value most in terms of alleviation before you set up a measurement and go forward with truly patient-focused drug development.“1
Most of us in the clinical trials industry know that we operate within a very conservative model, for good reason – but we also need to enable ‘controlled’ flexibility in our approaches where possible to foster patient centricity. One prime example of this is bring-your-own-device (BYOD) methods for collecting patient-reported outcome (PRO) data. The benefits of electronic data capture are well documented – and I hope most of us in the industry are in agreement. Building upon our traditional methods of electronic data capture - which involve provisioning devices for site-based data capture and remote data capture - we have seen increased interest in participants using their own devices. The app for data capture can be downloaded directly onto their own device or they can access the questionnaires via a web link.
BYOD can be more convenient for many individuals in clinical trials, for reasons such as being more familiar with their own device and not having to keep track of two devices. However, this does not mean that in trials adopting a BYOD strategy, it would necessarily be 100% BYOD; I would always recommend there is a percent of provisioned devices allocated for individuals who do not have a suitable device or who don’t wish to use their own device. This is key for ensuring we are not excluding participants unfairly from trials and leading to bias in the results. We also see benefits for sponsors and CROs when using BYOD strategies, such as reduced costs due to not having to provide devices and less complexity around shipping logistics.
That said, adoption of BYOD for collecting PRO data in clinical trials has been relatively slow and is still approached with some hesitancy from sponsors. There is an absence of publicly available case studies where BYOD PRO data supported regulatory medical product approvals - except for the one example from the Pfizer COVID-19 study. Anecdotally, we know that many more instances of PRO data collected via BYOD have been submitted to regulatory bodies and approved for use on the medical product labeling.
I firmly believe that if sponsors openly publicized examples of their successes in this, we will see more adoption of BYOD in clinical trials, which can enhance patient centricity, diversity, data quality, and efficiencies in clinical trials. There may be a more pressing need for sharing instances where such data was used in support of an approval and used on a labeling claim to put sponsor’s mind at ease when considering this type of data collection strategy, but knowledge more widely of BYOD use for PRO data collect in registrational trials would also be beneficial for the industry.
Our latest article in Therapeutic Innovation and Regulatory Science outlines the issues faced, ending with a call to action to those in the industry who have collected PRO data using BYOD to transparently share this success, and we propose a way to collect this data.
1 PDUFA V Clinical Outcome Assessments Public Workshop, April 1, 2015
Florence Mowlem, PhD | Director, eCOA
Dr Florence Mowlem is Medable’s Subject Matter Expert on digitising the capture of Clinical Outcome Assessments (COAs) in clinical trials, ensuring optimal solutions for clients that meet the scientific needs of their studies. She contributes expertise on solution design for all eCOA types (ePROs, eClinROs, eObsROs, ePerfOs, eDiaries) and advises around project complexities, to ensure adherence with the protocol requirements, that industry best practice are followed, and regulatory considerations accounted for. Flo is an active member of industry consortium (C-PATH eCOA, DIA), has presented at international conferences, and has numerous peer-reviewed publications.
Flo has an MSc and PhD in Social, Genetic, & Developmental Psychiatry from the Institute of Psychiatry, Psychology, & Neuroscience (King’s College London), where her research focused on sex differences in the diagnosis and treatment of Attention Deficit Hyperactivity Disorder (ADHD), and the psychometric evaluation and validation of a new patient-reported measure for use in adult ADHD.