Decentralised and hybrid trials – the patient’s voice

The outbreak of COVID-19 was quick to take effect on clinical trials with many ongoing trials being disrupted and planned trials being delayed.

The FDA Guidance of Clinical Trials of Medical Products during COVID-19 Public Health Emergency issued in March permitted sponsors to consider ‘alternative methods for safety assessment’ including ‘virtual visits’ and ‘alternative location for assessment’ in the interest of patient safety.

Deploying in-home and alternative site clinical visits became a real and present option for sponsors and unsurprisingly the demand grew and has continued since. The approach reduced patient burden without the need to visit sites during travel restrictions and at the same time ensuring compliance and scheduled data collection. It also reduced the risk of patients coming into contact with the virus and having to withdraw from the trial due to infection.

As sites began to open their doors again sponsors started asking themselves whether decentralised and hybrid trials needed to be considered more seriously to future-proof the smooth operations of clinical trials and not just during the challenging environment of COVID-19. Now is the time to reflect on what happened during the first half of 2020 and rethink study models to ensure the resilience that sponsors need and also ease patient burden for increased patient recruitment and retention.

What does the patient want?
In autumn 2019, before current conditions, ICON conducted a web based survey to 55,000+ patients through its global site network in North America and EMEA, to establish that what was good for sponsors was also good for the patient. It explored patients’ perceptions and preferences around what makes it easier for them to participate in clinical trials including the concept of decentralised trials. The results were interesting and surprising in some areas.
Patients want options. Whether that is the location of the assessment or the device for patient diaries, patients want to know there are options.

Decentralised trials were attractive to some but not all patients in the survey.

Relationships matter. The patient relationship with site staff is important. All of the patients involved in this study were connected with a site, whether that was through participation in a trial or just screening and these relationships were central to participation.
Age profile is a key consideration.

Analysis of data within specific age groups showed that the 18-24 year old group tended to prefer on-site, face-to-face interaction, the 25-34 year old group was the most open to remote visits and activities, with a steady decline thereafter with increasing age.

The patient perspective on clinical trial participation may differ from what is generally expected at an industry level. Hybrid trials are more likely to be of interest to patients because the attachment with healthcare professionals and the support they provide remains fundamental. Most importantly, we need to continually engage patients in the conversation and ask them what they want so that we can truly deliver on the promise of patient centricity in clinical development. It may be time for another survey given the recent environment changes.

For more information on decentralised and hybrid trials, in-home clinical solutions and how patient insight can enhance your next study visit ICONplc.com/patient-centricity