Crucial connection: Are clinical trial sponsors overlooking the power of site engagement?
We were recently at the SCOPE EU conference in Barcelona, talking about using creative communications to power up the sponsor-site relationship. Site engagement is a growing part of our business, as more clients focus on making each contact point between their study teams and site staff as valuable and inspiring as possible – whether that’s in-person, or in a virtual setting. This is a short recap of how we do it, with some examples and take-outs from an investigator meeting.
Why creative?
First, what’s the evidence for sponsors investing care and attention into their site comms? It’s not our style to simply tell you creative communications make all the difference, just because creative communications are what we do. So here are three pieces of evidence to back us up.
- Principal Investigators (PIs) who run multiple FDA-regulated clinical trials highlight communications as a key component of their approach to recruitment and eligibility challenges1
- Communications is a unifying theme across five recommendations made by the Clinical Trials Transformation Initiative (a public-private partnership between Duke University in the US, and the FDA), to biopharma companies looking to engage with patient groups2
- A global survey of HCPs (not necessarily involved in running clinical trials) about their preferred content styles and formats found interactivity – workshops, meetings, quizzes – ranked highly3
The first point is worth expanding on. The cited article reports a survey of 23 PIs, nearly all MDs, covering 11 specialties, which found they all shared ‘communication’ as a coping strategy. Every one of the examples given was about creating a dialogue between the site and the sponsor, fostering trust and clarity on both sides, to reach a shared understanding of the study’s status and challenges. This sounds banally obvious, but having it singled out by successful PIs begs the question of whether a lack of a similarly constructive relationship is a contributor to the so-called ‘one-and-done’ phenomenon, whereby investigators dip their toes in for a single study, and never come back.
Certainly, our experience of the site-sponsor relationship implies that not every site dedicates the bandwidth the sponsor expects, and not every sponsor sets expectations as clearly as sites would like. There is great deal that could be unpacked in this area, but suffice to say when communications are not prioritised, key questions do not get asked, productive conversations do not happen, and the study stalls.
Art & Science & Investigator Meetings
The typical Investigator Meeting (IM) follows a fairly set formula. It will cover the background to the investigational drug, the scientific rationale for the study design, details of assessments and procedures, and presentations from specific vendors on particular systems. Let us call this the Science part. But the IM is also your chance to set the tone and energy for the effort to come, to foster a sense of collaboration, and create an agenda that is shared across our clinical scientists, clinical operations team, the staff at the sites, and the patients and their families. This is where the Art of creative thinking can help.
During SCOPE we presented an example from an IM we supported for an early phase respiratory study. This meeting included a virtual presentation from an expert patient, but travel and event logistics meant patients could not be present throughout the entire day. However, our client was committed to bringing their perspective to every session. To solve this, we developed a meeting agenda based around the idea of ‘Save a Place’, and brought it to life via a patient film, a recurring reflection exercise, and a workshop that made the study teams’ impact on the patient experience tangible.
Offline and online
Despite moves to curb the trend, trial protocols are increasingly complex, eligible populations are harder to identify, and those potential participants may have alternative options, including whether that is licensed treatments or other studies. For trial sponsors, these pressures mean it is essential site staff thoroughly understand their study’s proposition and can contextualise it for the right people. Immersing them in the study detail, and making that immersion relevant, enjoyable, and memorable, is vital here, whether the interaction is face-to-face or online.
Just as important is acknowledging that effective communication is ongoing – in other words, it is a dialogue. New drugs get approved, protocols need amending, sites learn what is working and what is not. Sponsors need to be able to bring these live insights and updates back to sites in an engaging, light-touch way, to keep the study top-of-mind, and on track.
To hear more about Langland’s site engagement capability please get in touch with Chloe Gower-Page via thinkfurther@publicislangland.com
References
- Dombeck CB et al. Contemp Clin Trials Commun 2019:17:100502.
- Bloom D et al. Ther Innov Regul Sci 2018;52(2):206-213.
- https://epghealth.com/reports/the-future-of-hcp-engagement-impact/