Global Site Solutions Summit Recap – Brighter Days Ahead

The experience of the Global Site Solutions Summit this year felt a bit like opening the curtains the morning after heavy storms. A bright outlook for a calm, dry day is welcome after a night of howling wind and heavy rain – even if big puddles remain and storm debris is left to clear.

Of course, COVID-19 is a storm that disrupted our lives for many a night. And unlike a storm, it hasn’t moved out to sea yet. This was evident from everyone wearing a mask during the conference – a reminder we aren’t out of the pandemic yet. But, after nearly two years of no physical gatherings, the Global Site Solutions Summit was held in its usual location in sunny Florida and the friendly eyes above the masks were a positive sign that “normal” days are ahead.

It won’t come as a surprise that research sites are suffering from the consequences of the pandemic and disruptions to clinical trials. Yet, the conference had a cautiously optimistic vibe, and this community was clearly happy to be reunited.

During the keynote, results from the 2021 Site Landscape survey were presented. There are three observations that I’ll discuss here:

• Sites are more financially worse off than they were before the pandemic.
• Sites are moving towards holding sponsors and CROs to account for effective communication.
• Sites see hybrid trials more as the way of the future rather than fully decentralized.

Sites are more financially worse off than they were before the pandemic

Just 60% of survey respondents have three or less months operating cash – a situation that has worsened over the last couple of years. Unsurprisingly, 78% of respondents said that COVID-19 was the primary culprit. Delays in trial starts and reduced and suspended trial activity were the most common reasons cited by respondents. Respondents also shared that net profits over the past couple of years have gone in the wrong direction.

Unlike academic sites with resources to weather these storms, small sites and site networks are vulnerable during times like this. And yet, independent sites and smaller site networks play a pivotal role at the heart of clinical research to expand access for patients to clinical research as a care option and to promote diversity of clinical trial participation.

Sites are moving toward holding sponsors and CROs to account for effective communication

Historically, sites have measured performance by the number of studies awarded and patients screened/enrolled. Interestingly, sites are moving toward additional key performance indicators (KPIs) that are co-owned by CROs and sponsors. For example, 42% of respondents are planning to measure query rates and turnaround time.

At the frontline of clinical research, it is only logical that sites need fast answers to questions at the point of care. In some of the discussions during the conference, site staff took care to differentiate between the type of questions that are urgent and time-sensitive and those that aren’t. All felt that the key is timely support, with hours, days or longer no longer cutting it. It will be interesting to see how sponsors and CROs respond to this new site KPI.

Sites see hybrid trials more as the way of the future rather than fully decentralized

Considering disruptions from the pandemic, it wasn’t surprising to see a rise in sites conducting some portions of their trials virtually. Still, the vast majority (80%) of trials were in a traditional setting, while 16% were in a hybrid setting. Of the sites that were asked by a CRO or sponsor to participate in a hybrid-type trial, 80% said yes. The top reason for participating was because they saw value for patients, but there was also some FOMO (fear of missing out). Of those sites that said no, the main reason they declined was due to lack of comfort on the part of participants or principal investigators.

Site respondents believe decentralized clinical trials take more training time, with 62% indicating that more training is required. On average, it’s estimated that sites spend 17.5 hours per month per trial on training for decentralized trials compared with traditional approaches. Current financial pressures, coupled with hiring and staff retention issues, make new training burdens hard to sustain so it will be interesting to see how this plays out.

Kelly Brown

Guest