Site Optimism Sparked by Feedback: A Conversation with Ken Getz

Greenphire actively seeks feedback from everyone involved in research – from trial participants and sites, to sponsors, CROs and thought leaders. It’s that feedback that helps to propel our innovation and ensure that we’re constantly focused on solving the most pressing challenges of today. So, what is on the mind of sites? How can we better support them now in this transformational period for our industry?

I recently had the opportunity to discuss trends with my friend and industry visionary, Ken Getz. We spoke casually about a variety of industry trends and where appropriate, related those trends to insights published in the recent Tufts Impact Report.

I wanted to share the insights from that discussion with you. Enjoy and weigh in with your outlook.

Jim: I’ve been doing a lot of travelling – visiting clients in the US and Europe, visitors in our office, and heading out to conferences, like SCOPE. There’s an unmistakable energy in the industry, people back out on the road, focused on problem solving and collaboration. How about you? Are you back out on the road and what did you think about SCOPE this year, Ken?

Ken: There’s certainly a lot of excitement and focus on the long-term and transformative changes which are underway in the industry.  It was evident at SCOPE, and also in our recent Impact Report. However, where I think people are struggling is with the complexity and customization of study protocols, at each and every level.

Jim: Let’s dive into your report. Sites have certainly encountered some challenges over the past few years – COVID-19, the great resignation, and more. Yet, the latest report showed an improvement in site sentiment. What contributed to that surprising sentiment?

Ken: Both qualitatively and quantitatively, sites surveyed had a more positive outlook on clinical research if they were asked for feedback by their sponsor partners. In fact, sites value knowing that even if their input wasn’t implemented, it was valued and considered. It’s an important demonstration of partnership amongst the study sponsor and research site – opening up two-way communication.

Jim: Opening up a dialog, rather than having a one-sided exchange, is so critical. We believe that here at Greenphire too. We regularly collect feedback from sites on what they like as well as to inform improvements to our solutions. As an example, it was direct feedback and collaboration with sites that shaped the redesign of our workflow to support the introduction of virtual ClinCards a few years ago.  

Let’s talk about another interesting discovery in this report, and that’s who you heard from. There are many kinds of research sites. Were the results uniform?

Ken: While sponsors and CROs had been hearing that sites are discouraged by the current environment, our study found the opposite. In fact, while sites are being asked to do more than before, the industry remains an exciting place to be and worth the curveballs if they’re feeling valued in the process.

The level of optimism overall was high across every segment; 80% of staff at investigative sites are somewhat or very optimistic about the future operating environment for clinical trials. In fact, even the group that we may have surmised to be the most cynical – higher volume establishments, was still more satisfied than we would have predicted. Partly, I believe this is true because the more established the site, the more options can be offered to support patient convenience and lower participation burden.

However, we also wanted to give a voice to sites who are under the radar, including part-time investigators who do one study a year or the PI who’s primarily focused on government funded research and only does one or two private sector funded studies per year. These entities were also optimistic despite their practice not having complete focus on clinical operations.

Jim: Surely, there are areas of opportunity. What were those?

Sites recognize the shifting dynamics in research today – increased technology, more focus on the patient – there’s a lot of potential. However, with more options, comes more complexity. 70% of survey respondents felt that protocols have become more complex in recent years. Integrating and accommodating options creates pain for site staff – especially for administrative vs. clinical personnel. These roles were the least optimistic and the most frustrated.

Jim: At Greenphire, we certainly appreciate the pain and consequence associated with site administrative burden. We see ourselves as being a force multiplier in the battle to improve support for participants without increasing site admin burden. 

What are other pain points that the report covered?

Over the past several years, we’ve heard that the use of more virtual and remote tools / methods would surpass clinical trial pain point themes that were prevalent, pre-pandemic and instead, we saw the opposite. For example, budgets and contracts remain one of the largest headaches, protocols are more complex than ever before, and workforce challenges now are a much bigger problem. On the other hand, technology, broadly speaking, isn’t seen as an approach that is more burdensome than the chronic, perennial pain points.

Jim: Precisely, Ken. At SCOPE, I presented alongside Merck and CISCRP about the burden of travel. DCTs can help with some of the at-home trial activities, but for the most part, you still need to get people to the sites. Travel, budgeting – these are core issues that haven’t gone away, and it’s more critical than ever that we help sites overcome these challenges.

Those issues that you mentioned are the ones that are not very glamorous to discuss, right? They don’t get the headlines in the media but that’s what people are struggling with daily; you know, trying to negotiate a contract where the same issues come up, issues like indemnification, hold back of payments, overhead and other items that you are close to. They seem to come up time and time again and that’s why we had such a strong response to the survey.

Jim: On the other hand, let’s talk more deeply about what is covered in the press, at conferences – DCTs. Decentralized trial solutions do offer convenience, but technology can’t take the place of the doctor – patient relationship. My perception is that the hybrid trial vs. fully decentralized is the model that makes sense for the majority of trials well into the future. And instead, the mission must be to ensure flexibility for the patient but not at the expense of the site. Sites need to be able to manage and oversee the activity which isn’t taking place at the site. I think that’s the coolest tech problem to solve. What did your latest report uncover about the hybrid dynamic for sites?

What we’re hearing in this study from sites is that they may not have all the answers, but they want a seat at the table when decisions are being made about technology. They certainly feel that new approaches will appeal to their patient populations, and they’d like to be able to offer some of them, but don’t make these decisions in a vacuum and then just throw them over the fence. That could be why sites reported in the survey that new technologies and DCTs aren’t considered top pain points, but they are also cited as not being as effective in enhancing volunteer participation as more traditional patient-centric approaches.

Jim: That’s exactly right, Ken. It’s why we incorporate feedback from all stakeholders when we’re enhancing our solutions – to ensure that they’re user friendly and solve meaningful problems in research. We’re in this together!

Ken: One area where sites want their voice heard is regarding diversity. They recognize there’s an issue with patient enrollment, recruitment and retention. However, many need our support with operationalizing solutions. Additionally, our prior research confirmed that the key to diverse patient populations truly lies with hiring personnel who reflect the race and ethnicity of the people you’re looking to attract and enroll in your studies. This is more difficult in certain geographic parts of the country depending on population make up and labor pools.

So sponsors are coming to sites with their goals, but sites need the opportunity to voice their ideas and concerns, and have a seat at the table when brainstorming solutions. We can be innovative here, bringing research studies to where certain demographic communities are, and make progress happen. There’s no question that new models hold promise for research.

Jim: You and I have seen the industry evolve tremendously, and to be honest, the change is just going to accelerate. It’s super exciting, super interesting. What a fun time to be in this space! 

Ken: And I think that’s at the core of sites’ optimism!